Applications for San Francisco (Batch 12) extended AGAIN through September 30th, 2021!

Sequential Skin raises $1.65 million seed round

Yahoo! News published news that  Sequential Skin raised US $1.65M in oversubscribed seed round to revolutionise skin health with their novel skin microbiome testing kit

Sequential Skin (SOSV IBNY02 2021) provides personalized skincare by using advanced genetic sequencing technology to analyze how genes, skin microbiome, and the environment interact and affect an individual’s skin.

Led by Metaplanet and joined by Scrum Ventures, SOSV, Genedant, and angel investor Ben Holmes, the press release explains “the funding will significantly boost their IP portfolio, using their novel patch-based, skin analysis, to develop further tools to understand how your genetics, epigenetics, and skin microbiome, affect health and disease.”

About Sequential Skin’s mission, the company’s CSO and co-founder Dr. Albert Dashi said, “Our scope is to provide science to people and empower them with the right tools and knowledge so they make the right decision for the future of their skin health and well-being.”

Gwen Cheni’s IndieBio Podcast: Gianna Hoffman-Luca, PhD. Principal at Xontogeny

In this session, Gwen interviews Gianna Hoffman-Luca, Principal from Xontogeny, a therapeutics focused seed-stage VC fund founded by Chris Garabedian, former CEO of Sarepta. Gianna demystifies the funding landscape for therapeutics startups, recommends companies to start solving for data necessary for series A funding, at the seed and pre-seed stage.

SOSV HAX alum Opentrons raises $200 million, reaching $1.8 billion valuation

IndieBio’s fellow startup development program, HAX, just recorded a big win, as reported by Bloomberg in “SoftBank Invests in Robotic Company Behind NYC Covid Testing. HAX alum Opentrons Labworks Inc. raised $200 million in round led by Softbank to reach a valuation of $1.8 billion. The Brooklyn-based, laboratory robotics company used its automated systems to decrease Covid-19 testing result times from 14 days to 24 hours and reduced test costs from $2,000 to $28. Opentrons “has grown to support a community of more than 1,000 scientists and 46 countries.” Other participating investors in the funding include Khosla Ventures and ex-Pfizer Inc. CEO Jeff Kindler.

“Biology opens the door to solve many of humanity’s grand challenges. For far too long, scientists and clinicians have been locked-in by slow, expensive, and overly complex lab solutions that underpin their work.” —Brennan-Badal, Chief Executive Officer, Opentrons

SOSV HAX’s Opentrons is center stage in New York City’s rapidly growing life sciences sector

NY1 published a segment “How New York City is expanding its life sciences industry” featuring Opentrons, an SOSV HAX startup. If you’ve ever taken a COVID-19 test in New York City, it’s highly likely your sample was processed by Opentrons, a Brooklyn-based company that builds lab robots for biologists. And this is by design—pegged as a key to New York’s economic recovery, the life sciences industry has received $1 billion investment and support from the NYC Economic Development Corporation (EDC) and Mayor Bill de Blasio to attract new businesses, capital, and jobs. This week Opentrons received a $200M investment led by Softbank, boosting the company’s value to $1.8B.

“Beyond all our traditional industries, beyond the tech community that has grown so successfully in New York City, we need to build up life sciences. This is the future.” —New York City Mayor Bill de Blasio

Stembionix: Vascularization Technology to Enable Organ Growth

Stembionix is creating the biofabrication infrastructure necessary to grow organs from stem cells. Their innovative vascularization technology is built with the goal of surmounting the challenge of culturing organoids: namely, growing organs larger than 8 mm diameter, at which point the internal cells lose nutrient access and die.  Their vascularization technology is complemented by other systems needed to automate cell culture collection and maintenance.

Review IndieBio NY Demo Day

We spoke with Stembionix Co-founder & CEO Ethan Stillman to gain insight into his technology and motivation in building his startup.

What’s the key insight that led to the formation of Stembionix?

When I look at the state of art stem cell technologies, I ask myself: “Are we the first generation of humans that can legitimately make a claim to live for 200 or 400 years?” That’s a wild question to think about. But if we can solve a couple technical hurdles, we are there. And some of the big hurdles are the vascularization challenge and at-scale manufacturing of these biosystems. That’s exactly what we took on. We are super excited to think about where we can get to with this. 

Building organs is a big challenge. What are you tackling first?

As any new company, our strategy is subject to change. But at present, we make liquid robots. Those are automated systems for culturing tissues or cells. We found a lot of market interests in the robots themselves. 

In addition, this vascularization capability is a platform. Any organoids scientists make can be vascularized. And there are academic needs for vascularization tissues at various stages, from the initial vascularization—how it changes the system and biomolecules produced—to down the road—how big it can get and how to improve that. So, there are lots of research applications there. 

We also want to be translational and be ready for transplant. For example, you will have a heart replacement that’s harvested from your leg. If we can generate that, that would be obviously very useful. 

As a company, we want to make those robots useful to researchers and, in parallel, develop translational regenerative medicine. 

How does Stembionix technology compare with other regenerative medicine technologies?

The 3D printing approach gets a lot of attention. And it sounds good—I want to 3D print a heart. But if you think about the mechanism of 3D printing, it’s not a good engineering approach. 

3D printing uses a little nozzle to deposit things. To print an organ, it will need to deposit cells. So, we have to figure out which cell types we need. A cell type is your cells with different genes turned on and off. So, we have to figure out which genes are on and off at which locations in your organ and toggle it properly. Or we will have to load the printer with some generic cells similar to the one that should be there. 

After placing the cells, we have to hope it binds in a proper way to its neighbors. There are multiple ways cells connect and multiple ways cells talk. Just putting it there and hoping, doesn’t seem like a good engineering approach, from my engineering background. 

What is more interesting to me is the notion that, miraculously, if you take 2000 stem cells and add some cells of the target organ type, those stem cells start to turn into that organ and form an organoid. Then, you take this organoid and put it in some nutrients. The organoid starts to grow and develop. 

But as those organoids grow, the interior cells don’t get the nutrition from the nutrient bath. The outside cells absorb all of the nutrients, so the interior dies. 

To solve that, you need vasculature. Structures like arteries deliver nutrients deep into tissues and remove wastes. If you can grow vasculature and get that vasculature to penetrate the organoid, It’s been shown in various ways that this organoid can grow into a full organ

We can only take the credit for a little engineering work to get these veins to grow. But the tools that biologists have given us are remarkable—let’s not make this a human engineering thing; let’s make use of what nature gives us. It’s just a better way to leverage and go with biology rather than take a skyscraper and make a structural approach. It’s too huge and too engineering centric. 

What’s the most rewarding part of your entrepreneurial journey?

Personally speaking, the most rewarding part is the fact that this is possible. Your daily work is making an impact in some meaningful way in other people’s lives in the world. It’s mind bending. 

If I keep doing this and I do it honestly, wholeheartedly, and strategically, it can really change how the world works. That idea is motivating to me.

Theoretically, we can live to be 150 or 200 years old with Stembionix technology. That’s such an abstract idea for the current human existence. But the notion that there is some valid probability for us to achieve that, is super fascinating. That keeps me going.

Free to Feed: Empowering Breastfeeding Mothers

Free to Feed helps breastfeeding mothers with allergic babies. Breastfeeding babies can react to allergens passed through the mother’s milk, and Free to Feed provides solutions to pinpoint the allergenic source. The current “breast friend” model offers one-on-one consulting to help mothers identify the source in a couple months. Their forthcoming test kit is tailored to shorten this process further to 5 days.

See Free to Feed at IndieBio New York Class Two Demo Day

We spoke with Free to Feed Co-founder & CEO Trillitye Paullin to gain insight into her technology and motivation in building her startup.

What was your key insight that led to the formation of the company?

My key insight is that I am my customer segment. I had two babies, both of whom had severe reactions to food allergens passed in my breast milk. I have gone through the immense pain that breastfeeding parents are going through today. Working towards a solution to that immense pain is what motivated me to build the company and find an answer for future breastfeeding mothers.

What’s your go-to-market strategy?

For Free to Feed, the wonderful part is that we are already helping parents in the long way. Our consulting service helps mothers go through elimination diets and reintroduction, while being a source of  support for them. Our go-to-market strategy is to give them a shorter way, selling them our test strips that will allow them to navigate this journey in a more straightforward manner. 

By going directly to consumers, we eliminate any hurdles for the parents to get our product in their hands. The opinions directly from the parents are impactful — They want to be able to order a test themselves and start their journey without having to go through hurdles to do so. As we expand, we will continue to lean into professional networks and get into nutrition offices.

How do you compare to other types of allergy testing?

Our competition, outside formula, is a fragmented market. Besides formulas for allergic babies, there are certain companies that offer testing capabilities for breast milk, but they are looking at things such as vitamins and alcohol content. These tests are very important for some families, but it’s a completely different ball of wax when you are dealing with allergic reactivity. The content of alcohol or vitamin C is not likely to cause your baby to stay up all night screaming. So, the issue is different. 

The other side of the market is the capability to send your breast milk for specific testing. There are definitely companies that will do testing for you, for things like the fat content of your breast milk. 

The problem with that is in the food allergy space, every time you eat something or breastfeed, the content of your breast milk changes. After you consume a protein, it’s going to spike in concentration in your breast a few hours after ingestion and then slowly go down from there, usually gone within 24h. As you eat your breakfast, around lunch time, the breakfast is now peaking in your breast milk. You need a real-time, at-home test that tells you how your breast milk changes over the day and also tells you immediately, as opposed to 5 days later. 

Breast milk is continuously changing and that’s why it’s so important to have point-of-care testing.

Dr. Trillitye Paullin, CEO of Free to Feed

In short, there are different testing abilities that are already offered to the parents for the breast milk, but none of which are looking at allergy specifically which is a very high pain point. 

In addition to that, it’s different because we are offering this test in a way that would allow parents to introduce those allergens that have implications for early optimal introduction. We can potentially make a massive impact on the number of people who are growing up to have IgE immune anaphylactic shock reactions toward foods like peanuts. 

What’s one thing that is making all your efforts worthwhile?

The most rewarding thing for me is one-on-one consultations. I get to meet struggling parents every single day and I’m honored to share a small part of their journeys. 

These consultations are really important to me because I need to continue to evolve with the problem. My youngest daughter just turned 3 and I’m slowly getting further and further away from the problem personally. But the problem will evolve, whether I’m breastfeeding or not. 

These consultations also remind me why I’m doing what I’m doing. On my hard days, being able to talk to a parent gives me my motivation. Because no matter how hard my day was, her days are way worse. That’s what keeps me doing what I’m doing. 

Immunology-Based Technologies in Startups: Seven Tips from Founders

The immune system is fine tuned to defend the body from foreign invaders, but when the system malfunctions it can spell disaster for a person’s health and quality of life. The panelists of IndieBio’s Biotechnology x Immunology event are using biotechnology to offer solutions to those suffering from immune dysregulation and overactivity. 

Read the top insights from our panelists below or rewatch the event below. 

Apply to be a part of the next IndieBio cohort

Meet our Panelists:

  • Alex Martinez, CEO of Intrinsic Medicine. Intrinsic Medicine is a biotech therapeutics company that is currently developing a safe, effective treatment for Juvenile Idiopathic Arthritis (JIA) from a bioactive, anti-inflammatory sugar found in human breast milk.
  • Trill Paullin, CEO of Free to Feed. Free to Feed is a startup that empowers mothers of food-allergic infants throughout their breastfeeding journey. The company offers consultation services as it develops a food allergen test strip product that gives mothers an “ingredient deck for the boob” and the confidence to feed themselves and their baby without worry.
  • Cody Shiriff, CEO at Serenity Bioworks. Serenity Bioworks is a biotech therapeutics company that uses insights from cellular stress pathways to develop anti-inflammatory drugs for autoimmune diseases. Currently, the company is moving into clinical trials with a compound that can treat kidney inflammation in Systemic Lupus Erythematosus patients.

The panel followed the journey of each company, revealing these 7 tips for building a startup:

1. Identify the Market Need    

Locate a problem before you start working on a solution.

AM: “I started with the market and a deep understanding of the problem itself. Then we were able to go and find a solution for it. Having that match is actually a very powerful competitive advantage.” 

CS: “There are recently approved drugs that have marginally increased efficacy and clinical response in lupus nephritis. We’re talking about 40 percent effective. We want to increase that and we believe that patients and clinicians are going to want to use a drug that’s more effective than that.”  

TP: “The research indicated that the numbers of mothers experiencing food allergic responses were expanding exponentially year over year, especially through breast milk. So 1, the research indicated that it was a problem that was continuing to expand and to grow; then 2, when I found fellow parents that were going through this as well, their pain point matched and or was worse than mine. That is what led me to believe that this is something that should be addressed, it could be addressed, and it is truly a market that is unmet.”

2. Choose your startup team wisely

Find people who can add unique value to your business.

TP: “Finding a co-founder meant finding somebody who could truly understand the problem, and so I ended up finding another woman who’s breastfed through food allergies.”

CS: “For drug development, we found building the team from San Francisco was a little easier. We were able to recruit people from Amgen or from Genentech who have previously developed drugs…those people are critical for people with a science background, like myself,to collaborate with as the company approaches the clinic.”

3. Prioritize efficient business growth

Success requires a commitment to intelligent planning and focused effort.

AM: “Part of our pattern was to find compounds eligible for 505 (b) (2) regulatory pathways so we could rapidly expedite our FDA interaction.” 

TP: “We’re direct-to-consumer so in the midst of [completing our FDA pre-submission package] we are also building out all of our customer-facing pieces: the website, the social media platforms, and navigating what is truly resonating with parents.” 

4. Choose and recruit patient populations

Balance business pragmatism with patient need.

AM: “I was identifying patient populations where the bleeding edge science really points to immune dysregulation and where there is a stagnant standard of care… My goal was to find patient populations where we could show that our drug produced clinically meaningful results within 12-week endpoints without reliance on surrogate endpoints.” 

AM: “People are asking their deepest problem in Google. You can get in front of every person who is looking for your solution and you can educate them on your clinical studies.”

5. Build strong entrepreneurial networks           

Opening lines of communication opens doors to opportunities…

…with your resources:  

AM: “Developing a great relationship with the tech transfer office is a very useful thing. Build that relationship and then once you’ve internally formulated what your screen is, just have an ongoing dialogue. Our compound was actually served up by the tech transfer office at UC San Diego.”  

…with your peers:

CS: “A lot of the network I was able to form by being in San Francisco for that four months [at IndieBio]. The person who just joined our board was somebody who I met at IndieBio.” 

…with your customer:

TP: “I continue to talk to the customer segment to fully understand the customers’ needs because I personally am no longer breastfeeding a food allergic baby.” 

 6. Remember your ‘why’ 

A successful business is driven by the mind and fueled by the heart.

TP: “There’s nothing quite like living and breathing the problem every single day to feel motivated to continue to work towards a solution for other parents.” 

AM: “I talk about ‘comparably mild’ because this is not a mild disease. I think this is an important note. I’m a patient as well. When you’re a patient, there’s no such thing as a mild disease.” 

CS: “The drugs that are currently being used are extreme. It’s cyclophosphamide, which is a chemotherapeutic. While we’re not going to deviate too much from the use of that, we want to get them off of that drug and into remission as quickly as possible.” 

7. If at first you don’t succeed…

Try, try again.

CS:  “I applied to IndieBio the first time and got rejected. I think it was because I was stuck in all the science speak and wasn’t able to properly communicate the bare essentials of what is important for an investment… I had to learn how to properly communicate and the pitch was better the second time. That’s what led to the first money.”  

TP: “Similar to Cody, I applied more than once and the first time I did not get in. If you are listening and have applied, definitely apply again and continue to iterate and improve.”

Apply to be a part of the next IndieBio cohort

Ivy Natal: Turning Skin Cells into Eggs

The future of our species depends on procreation, but today the world is at an all-time high in infertility due to disease, stress, and the decision to delay having kids. But what if we can generate healthy egg and sperm from your skin cells? Ivy Natal is attempting just that using stem cell technologies and CRISPR. I talked with Ivy Natal cofounders, Colin Bortner and Jeff Hsu.

How did you get interested in the fertility field?

COLIN:

That definitely started with Jeff. We are pursuing a revolutionary solution to the problem of the fragility and scarcity of human eggs. Right now, many women can only have children using donor eggs, which has many challenges and obstacles, and donor eggs still don’t allow patients to have a genetic child.

Our solution pulls together different innovations in synthetic and molecular biology and genetics and genomics to solve this particular problem. Jeff became interested in the problem while working at a pre-implantation genetic diagnosis startup, which was his exposure to the application space, but the underlying approach stems from his interests during his PhD and postdoc research.

For me, when Jeff and I started talking about the idea, I was very excited by the potential for patients and for society as a whole. Women have always born a disproportionate share of the costs of having children, which has shaped society. Now, effective contraception has been a revolution in giving women the ability to choose to not have a child, but our company has the potential to provide women certainty in their ability to choose to have a child. It’s the flip side of the same coin.

The science of turning stem cells to eggs has so far only been demonstrated in mice. What bottlenecks do you see for making this possible in people? How do you plan to address those bottlenecks?

COLIN:

Yeah, as you say, this has only been done in mice. About four years ago, a team based in Japan published the landmark result in this area. They successfully differentiated stem cells into egg cells, and then they essentially completed IVF cycles with their mice, and those mice gave birth to fertile offspring.

For a couple of reasons we’re taking a different approach. The first is that a direct translation of the Japanese group’s approach to humans is a non-starter because that would require ovarian tissue from a human fetus. Ovarian tissue from a mouse fetus was a key component of their results. So, part of our motivation is solving that issue.

So this is a kind of bottleneck, which is legal and ethical but also technical. What we mean by technical is that we don’t have a great way to systematically answer the question: what is the mouse ovarian tissue doing to differentiate the stem cells into egg cells? If we could easily answer that question, we could just emulate whatever variables that matter and get the same results, and by extension we could do the same for humans.

Now, without getting too deep into the details, our approach works from the inside out instead of from the outside in. Essentially, we’re using different kinds of sequencing technologies to understand the internal state of egg cells, like which genes are being expressed, and then we’re using new tools to directly change the internal state of skin cells to match the internal state of egg cells, and in doing so transforming the skin cell into an egg cell. We’re still in the early stages of proving out this approach for egg cells, but it has worked with a bunch of other cell types.

The specific engineering challenges in our approach are discovering the genes to turn on or off in order to “reprogram” our skin cells into egg cells, and developing a “safe” tool to do the reprogramming, which eliminates any risk of genome changes. But here we have a huge advantage in that we can work systematically, using sequencing data and computational methods to discover targets and leveraging the synthetic biology ecosystem to do safe reprogramming.

We already have solutions in place for these challenges, and we are now applying them to a proof-of-concept of our approach, but even if we have setbacks, the long term trends are all working for us. Sequencing is getting better and cheaper, the synthetic biology ecosystem is developing rapidly, and the computational methods we’re using are improving almost monthly. We’re making progress quickly, but even if we did nothing for a year, we’d still end up with more data, lower costs, and better tools.

If successful, how might your company change the future of childbearing?

JEFF:

We’re very focused on the immediate goal, which is helping women who would otherwise rely on donor eggs to have genetic children for the first time. That is a super meaningful problem for us, and reason enough to pour everything into this company. That said, our long term goal is to ensure that every person and couple has the choice to have genetic children. There are hurdles along the way, or problems to solve, but this includes women and men of any age, including those with many conditions which currently complicate reproduction, as well as same-sex couples.

What lessons have you learned transitioning from scientist to entrepreneur during the IndieBio program?

JEFF:

One of the big attractions of becoming an entrepreneur is the freedom to work on problems and solutions you are passionate about. The valley is willing to take a risk on founders with plausible solutions to big problems whereas as a scientist you are often constrained to projects and funding that are often related to your previous work in very obvious and straightforward ways, whether that’s in academia or large corporate research organizations.

What Ivy Natal is trying to do would be life-altering for many prospective couples and families. That type of impact you can’t measure by publishing metrics or impact factors, and that’s in many ways shifted my own frame of thinking. Since we are developing a process that not only will work but scales to meet the demand of the market, I’ve learned that it doesn’t matter if we execute a protocol myself or work with partners and vendors. What matters is cost, reproducibility, quality of the results, and ability to scale.

Now, the biggest challenge for me has been transitioning from a fully resourced institution like the Cleveland Clinic to setting up a startup lab in the IndieBio basement. It’s just very different working without the existing physical and human infrastructure of a major research center. In some cases, we’re rebuilding that infrastructure for ourselves and in other cases we’re partnering with vendors to use their infrastructure, almost like cloud computing. For the human infrastructure, we’ve been tapping our existing networks for advice and insights that our team doesn’t have and also working to grow our networks.

We have the additional complication of relocating and starting up our lab work during the pandemic, but we’ve been able to make a huge amount of progress despite that!

What does the next year look like for Ivy Natal?

COLIN:

Right now, we’re completing a proof of concept for our approach. This involves producing a progenitor of egg cells called primordial germ cells, which will prove out a lot of our core hypotheses and de-risk our business. We want to complete this in Q4 of this year, and next year focus on egg cells. Our timeline for egg cells, how far we’ll get in 2021, depends on some of our ongoing work on our proof of concept. After we have data from those experiments and results from our scaling up partnerships, we’ll have a clearer picture of our progress in the next year.

Advanced Microbubbles: Drug delivery across tumor and brain barriers

Getting drugs through the tumor barrier and across the blood-brain barrier is a well-known, major challenge for medicine. Many clinical trials are underway using chemotherapy co-administered with diagnostic microbubbles, energized by ultrasound at the site of the tumor — but these are performing poorly, with inconsistent acoustics, because the bubbles are highly-varied in size.

Today, I sat down with Dr Jameel Feshitan, CEO and Connor Slagle, CTO of Advanced Microbubbles from our current class to learn more about not only the field but also how their product compares to the existing solutions out there. The conversation below is a paraphrased version of our interview.

How did you get into this field of microbubbles?

Jameel: In college, in my final year, I took an elective class on medicinal chemistry which proved to be among my favorite classes. I was fascinated by the design of drugs. The different ways we can engineer poisons into life-saving drugs and how entire drug classes such as, say,statens are found. That started a fire that stayed with me all the way till grad school, at Columbia University. There I had a chance encounter with Dr Mark Borden, he was the first person I met during orientation and he introduced me to the use of microbubbles in medicine. The rest is history.

I learned while there are many applications of bubbles in medical imaging, producing uniform sized bubbles in a reproducible manner was a big problem for the field. You cannot control bubbles of varied sizes. For bubbles to realize their potential for drug delivery they had to be uniform. Uniformity leads to consistency, an essential feature to control the dosage of the drugs our bubbles would enable. My first big project — to make bubbles uniform for their use to deliver drugs — turned into Advanced Microbubbles over time, the only company in the world currently offering uniform size-controlled microbubbles. It was also during my time at Columbia University, that I got to translate this work to that of other labs at Columbia University working on the use of microbubbles to deliver drugs across biological barriers and tumors.

Connor: Similar to Jameel, I had a chance encounter with bubbles. Got introduced to the company via a job-board posting for a chemical engineer to scale microbubble production. Dr Mark Borden, who at that time, was an Assistant Professor at my alma mater at Colorado University Boulder, where I studied Chemical and Environmental engineering, acted as the glue. He provided me with supplemental materials and some of the research on the field; that got me hooked. After going through the research and work done by the company thoroughly, uniform microbubbles emerged as a strangely commonsensical solution. Uniform bubbles and the use of ultrasound to trigger them was such an elegant solution not just for medical imaging but also for drug discovery, where controllable as well as localized response is key.

For you, it might seem commonsensical, but for the readers who are new to the product, injecting bubbles into the body is somewhat terrifying, no?

Jameel: When we talk about injecting bubbles people start thinking about embolisms and clots. It is, in reality, a very well characterized, commonly used and sophisticated engineered product similar to other prevalent delivery methods such as liposomes — which are spherical vesicles with lipid layers — used to deliver a range of drugs into the body. Our proprietary microbubbles are similar to liposomes, engineered on a microscale, except with a gas core. The gas core makes them reactive to ultrasound and they are precisely engineered to last for 30 minutes in the body.

Connor: And to give a bit more context, our bubbles can be easily co-administered with existing clinical protocols for the most part. They are injected systemically, using IV, which is already used in chemotherapy clinics and for most indications they can be triggered in a highly localized manner using conventional ultrasound machines. Our bubbles are designed with the clinic and the patient in mind. It is only for specialized indications of the brain that we look to R&D and partnerships with specialized ultrasound machines.

Now that we understand the concept, how will Advanced Microbubbles impact the space?

Connor: Delivering precise amounts of drugs in a precise space is the holy grail for oncology — really motivates me to work towards this goal. Our lofty goal is to pair our size-isolated microbubbles with promising drugs that can’t get to cancer or are injected at such high doses that cause debilitating side effects to the patient.

One example that comes to mind is glioblastoma, a notorious cancer of the brain that can’t be challenged well today, and a lot of it is due to the blood-brain barrier making it hard to deliver drugs with consistency and safety. With our technology, we have preliminary mice data showing that we can temporarily disrupt the blood-brain barrier. This data is published in a study Advanced Microbubbles did with NIH- NIDA, that showed dramatic improvement in delivery to the brain compared to non-uniform bubbles. And off that study, a dozen partners have interest in using AMB’s bubbles instead of conventional bubbles. Of course, the data is not in-human / clinical data, but offers promise to one day deliver the payload across the barrier and then the barrier heals for normal biological purposes.

Jameel: Couldn’t agree more. I see the potential of Advanced Microbubbles to enable a new standard of care in the field. The standard of care for chemotherapy hasn’t changed in hundreds of years.

With chemo, we have to poison the patient to hope to cure them. Advanced microbubbles can really impact the life of a lot of patients by making chemo less toxic and more efficacious.

Where are you currently in this process?

Jameel: We have been hard at work to get preliminary in-vivo data during IndieBio. Despite the pandemic and limitations of being a pre-seed startup, we were able to work with an excellent partner lab at the University of Texas. Led by company co-founder Dr Shashank Sirisi. Dr Sirsi has been with the company since it’s origins at Columbia University. There he was the key liaison between laboratories for the execution of microbubble development and therapy experiments.

Thanks to his support the team was able to get preliminary results in animal data. In “n of three”, small cohorts of neuroblastoma mice models — a tumor and rare disease that develops in adrenal glands. We are excited to showcase the data this demo day where we demonstrate not only proof of delivery, relative to control, with a commonly used chemo-drug. But more importantly, we show efficacy, a 1mg/Kg effect at significantly lower doses. Sending a strong signal in support of our thesis of low-dose efficacy without chemo-like side effects.

Excited to see this data this demo day. Looking beyond demo day, what does the next phase look like for Advanced Microbubbles?

Jameel: Work in mice models can always go wrong. Demonstrating reproducible and consistent results in-vivo, and in outcompeting non-uniform bubbles is where we are going next. This would mean running larger cohorts. We plan to show the efficacy of the platform in Neuroblastoma and pancreatic cancer animal models by the end of next year.

Looking beyond next year we want to show the versatility of this platform in more than one indication. Extending in-vivo proof of concept in a wide range of chemo toxic drugs expanding the market to other cancers such as breast cancer, prostate, and lung cancer. Showing we can take existing chemo toxic drugs and achieve higher efficacy at hopefully lower doses also plays into our business model to partner with Pharma to enable the efficacy and safety of their old and new drug classes.

With clinical trials coming next, should we be preparing for a long wait to see your product commercialized? Curious to learn more about your regulatory strategy and some learnings in this process?

Connor: At a very high level this data helps us gather more safety data points, setting us on a trajectory to get to IND and therefore, into the clinic in two year’s time. We do realize that there are many indications and potential drugs we can partner with.

Bubbles can go so many places, but at IndieBio, we learned that focus will set you free.

Jameel: Totally. To piggyback off that comment, focus is key. Bubbles have been used in ultrasound imaging, tumor ablation and other medical uses as an approved product for many years. IndieBio emphasized the value of tying key scientific milestones and data to a good go to market strategy. Starting with hard and rare diseases to drug tumors and then opening up to broader markets as we gather more performance and safety data.

Delving into regulatory strategy, early-on, was also a big learning that came out of the program. We didn’t wait instead the regulatory strategy helped us focus on our experiments. We learned how we can leverage the existing safety profile of bubbles and use an accelerated FDA pathway, the 505 (b) 2 to speed up going to market. An eye-opening experience to learn the role of the regulatory process in go-to-market decisions. Furthermore, based on advice from industry experts, we plan on combining this pathway with the orphan drug pathway can cut our time to market to 3 to 4 years.

Connor: When I come to think of it went from the mode of optimizing the best bubble and researching methods to do so in the lab to operationalizing the company to scale and sell the best bubble coming out of that research. In doing so we learned there is a new set of skills one has to code-switch to. Acknowledging this mindset shift is important as there is a stigma of moving too slowly in the lab. It is also exciting as we face a new set of challenges.

Jameel: In all this, I must say, IndieBio network really helped get a sense of the bigger picture and conveying that to a different set of audiences. We are gaining a sense of pitching the company to a rare disease investor versus a platform investor. How to engage different stakeholders and get people excited about what we are doing. We will continue to advance our relationship with regulatory experts and mentors we gained through the program. Look forward to keeping the momentum going around demo day and recruiting post-doc scientists to help speed up our preclinical data package.

IndieBio’s Demo Day is October 27–28, with the New York batch on Tuesday the 27th at 10 am, and the San Francisco batch on October 28th at 10 am. Please follow this link to Eventbrite to RSVP. A single registration will grant you access to both days’ events.

Microgenesis: Restoring the Fertility Biome

Through the development of a simple swab-based test combined with personalized nutraceutical solutions, Microgenesis is helping women facing fertility challenges forge a path to pregnancy and motherhood.  Building off their impressive initial patient results in Latin America and Spain, the team just landed (literally!) in the US to begin offering their infertility solution to the American market.  I wanted to dig a little deeper into Microgenesis’ offerings, upcoming clinical trials, and their future plans.  Here are excerpts from my conversation with co-founder and CEO/CSO, Dr. Gabriela Gutierrez.

Pae Wu: Gaby, your team really caught our attention with your impressive clinical data from Argentina that predated IndieBio.  Out of 287 women that had previously failed at least 4 IVF procedures, 75% of them got pregnant within 6 months!  

Tell us, what are you most proud of accomplishing during this pandemic edition of IndieBio?   

Gabriela Gutiérrez: During IndieBio we studied 15 alpha testers that are at the beginning of their fertility journey and 14 of them are already pregnant!

PW: What motivates you to tackle such a tough challenge?    

GG: Yes, we have worked with the hardest cases of infertility.  I have spent 15 years helping women that already failed IVF treatments. Women that are desperate and looking for a test that can help them to understand the real problem and how to fix it. We intend to replace the painful classic fertility journey of women by focusing on women’s health. 

PW: But you’re not solely working with women who are undergoing IVF, is that right?  

GG: Because we can anticipate the real problem using our test we can treat the patients before they start IVF.  We also work with women who are just starting their fertility journey and couples. 

PW: What’s the customer journey like?  Is this a one-size-fits-all solution?

GG: We send the woman a non-invasive test and we guide her through nutraceutical recommendations that improve her fertility potential while preventing inflammatory diseases.  

Our test is able to identify 64 different infertile biome phenotypes and we have developed 53 different treatment combinations to provide the right solution for every woman.

PW: There are so many fertility tests on the market today – traditional tests through ob-gyns, and newer direct-to-consumer options.  How does Microgenesis’ solution differ?  

GG: The traditional test is based on the evaluation of 5 hormone indicators of ovary function. This information is oriented to determine if a woman with low ovarian reserve/function should go for assisted reproduction. Our test brings information about the real problem and it is actionable. Our fundamental insight is that infertility is associated with an intestinal condition which also can affect ovary function. 

There is no other test in the market oriented to study intestinal microbiome disbalances affecting fertility.  We focus on women’s health, we restore key components to treat inflammation and the reproductive senescence associated, and we get women pregnant during the process.

PW: You’re now in the Bay Area!  Welcome to the US – what’s on slate for Microgenesis here?    

GG: In the next 3-4 months, we will focus on our Seed round to go to the US market next year. 

We have launched our alpha test in the Bay Area with women who are asking about their fertility potential.  We will send them the sample kit with a swab and lancet for a blood drop test.  They can send us the samples to our CLIA lab in Oakland.  They will receive the report by e-mail and we can send them nutraceuticals and customized probiotics for a 90-day treatment based on the results [and] we will work with them through conception and pregnancy. Please refer potential customers to gabriela.gutierrez@microgenesis.net

We also will repeat our proof-of-concept with 86 infertile couples and 20 fertile couples in a clinical trial at Wayne State University with Professor Gil Mor, the chairman of the Clinical Research Center at Wayne State University and president of the American Society of Reproductive Immunology. I have been a member of this society since the last 15 years. 

PW: For your alpha test, you are poised to bring in early users and ship your product — who are you partnering with to make this happen? 

GG: Our partner in the CLIA lab is Renegade Bio, our partner in digital marketing is Bullmetrix, our supplier of probiotics is Sacco System, and the supplier of our customized private label nutraceuticals is Equinox. 

PW: You talk a lot about a couple’s fertility, not just a woman’s.        

GG: We are planning to study male partners during the clinical study at Wayne State.  We know that the markers we hunt for in our test can impact fertility potential in women, and they can also be exchanged by fluids. So we want to test the expression of these markers and restore missing key components of the fertility biome in a male partner, too.  

We also have a scientific collaboration with a pediatric gastroenterologist that will run our study with autistic and celiac infants.  We intend to track the expression of our markers in the family and prevent early onset of diseases associated with microbiome disbalances like autoimmunity.

Check out Microgenesis at IndieBio’s (virtual) Demo Day on 28 October!  Register here for the two-day event (27-28 October 2020).  

Cayuga: Treating All Forms of Bleeding

Cayuga Biotech is a preclinical therapeutics company whose lead compound, CAY001, shows promise to change the way that severe bleeding episodes are treated. We spoke with CEO Damien Kudela, who explained the science and path forward for Cayuga.

Watch and read an abbreviated version of the conversation below.

How did you transition from academia to biotech entrepreneur?

I had never envisioned an academic route for my career and by the time I was done, I was looking for a new way to apply my scientific knowledge. Cayuga was seeded by a conversation I had in my 4th year of my Ph.D., where someone said that there was a real need for this technology and I should think about creating a company to advance it. Since we’d already been in the early stages of patenting my thesis and the CAY001 drug, I figured ‘I’ve already been a starving grad student; why not go be a starving entrepreneur as well?’

How do platelets work with polyphosphate to promote clotting, and where does CAY001 fit in?

If you think of a clot as a brick-and-mortar material, the platelets form the bricks. There’s a second compound called fibrinogen which is the mortar. That constitutes the physical clot. 

The problem becomes how to get that brick wall to plug the wound. Polyphosphate is produced by platelets and is essentially a catalyst for clot formation, a molecule whose job it is to speed things up. Adding polyphosphate helps the clot to form more quickly, which enables the clot to shut off the bleeding more quickly.

Bleeding causes a lot of negative outcomes for patients, so stopping the bleeding has many benefits. Not only are you saving their lives by reducing blood loss, but you can actually reduce the time it takes for them to heal as well. 

Bleeding causes a lot of negative outcomes for patients, so stopping the bleeding has many benefits. Not only are you saving their lives by reducing blood loss, but you can actually reduce the time it takes for them to heal as well. 

How does CAY001 differ from other pro-clotting drugs available?

Typically, many currently available drugs are recombinant factors that are either direct mimics of endogenous proteins or slight alterations of these same proteins. 

The issue with bleeding and clotting is that they are two sides of a seesaw. Typically, a patient is balanced flat but when they get injured, and start bleeding, the seesaw tips toward the dangerous effects of too much bleeding. Unfortunately, what can happen with recombinant drugs is that the balance remains out of whack; they can tip the seesaw in the other direction and they can have the dangerous effects of what’s called ‘throwing clots.’ 

This is a huge problem. All the drugs that treat bleeding currently have a black box label warning because of that. And doctors have to weigh a crucial decision in treating patients, asking whether the patient is critical enough to warrant the safety risk.

Using polyphosphate as a catalyst differs from these drugs because it has an effect on the rate, but it doesn’t affect the specific clotting factors present. For example, polyphosphate has its biggest effect on the clotting factor, thrombin. The patient doesn’t produce more thrombin. Polyphosphate has a more limited effect, so you can hopefully use it in a safer way.

What data support your hypothesis?

We’ve been looking at different tissues, specifically the lungs. This seems to be where a lot of nano-based drugs fail. Obviously, the liver is also a concern, because it plays such a huge role in clotting. And of course, the blood-brain barrier. 

What we’ve done is compared CAY001 to saline in a pig model. Pigs are hyper-clotters, so there was some evidence of clotting, but it was the same in both the saline and CAY001 drug-treated animals. That was likely the results of the pigs’ natural clotting cascade, but obviously, safety is the number one concern, especially in this field. The first question we’re always asked is, “is it safe?”

“Is it effective” is always the second question. We’re on the pathways and have very promising data that we’ve seen so far to lead us through safety, and the remaining IND-enabling studies as well as our clinical trials.

What will your clinical trials focus on for the first indication?

Until IndieBio, we were fully funded by DARPA and the Army. Obviously, bleeding is a huge problem on the battlefield and causes about 50% of deaths. There’s also a huge problem with bleeding here in the U.S., especially as patients age and may need to be prescribed anti-clotting drugs such as plavix or coumadin. The problem is that these patients are already in the clotting phase; they’re given anti-clotting drugs and they go back to a risk of bleeding. A lot of it is done because there is no treatment for bleeding.

There are other conditions where patients may benefit from a drug like CAY001. We’ve been focusing recently on platelet dysfunction. This could also benefit patients on chemotherapy who end up with thrombocytopenia, as well as patients who have congenital platelet disorders. We’ve identified a hemophilia-like genetic disease that affect platelets, as opposed to Factors 8 or 9. There’s a wide range of people who may benefit.

Obviously, everybody thinks the quantity of life is a major benefit, because bleeding can kill very quickly. Stopping a bleed also importantly enables patients to have a better quality of life, so they don’t have to worry about shaving or having an accident, whether the kitchen will be fatal. You can really help to give patients their life back.

Who is the Cayuga Biotech team?

I was at UC Santa Barbara, and the sole graduate student who really did any animal experiment at UC Santa Barbara was Kyle Ploetze. Kyle actually has a very good story of the first time we med; I’ll let him tell it another time. I ended up working with Kyle to test our new drug, and we hit it off while doing the test. The data worked well, and we got along well. Kyle and I jokingly refer to CAY001 as kind of our baby.

We were the two initial co-founders; in 2019, we needed to add a third person to do a lot of our quality controls. We were working on our manufacturing, and Nate, a postdoc at UC Santa Barbara, interviewed and we thought he was excellent, so brought him on board. It’s been excellent working together.

What are the next major milestones for Cayuga on the road ahead?

We had our first meeting with the FDA in May 2020, so we’ve gotten feedback. What we really need to do is finish our PK/PD and tox studies. These will help to figure how the drug is cleared and its toxicity; are there any adverse effects from the drug, what doses are safe, what doses are effective. Really, we need to determine it’s safe enough to move to human trials. We’re excited to present our data at Demo Day.

Learn more about Cayuga Biotech and all of IndieBio New York Class 1 companies at Demo Day.

Brightcure: Reviving, Restoring, and Replenishing a Woman’s Intimate Microbiome.

Brightcure is a company dedicated to improving women’s health. We asked Brightcure CEO Chiara Heide questions about the first product, a bioactive cream that promotes a healthy microbiome in a woman’s urogenital tract. 

Watch and read an abbreviated version of the conversation below.

Your personal story lends a lot of motivation. Will you please share it?

I personally suffered from chronic urinary tract infections, caused by harmful bacteria that enter the bladder and cause an infection. However, I’m not alone; every second woman worldwide suffers from these infections, and many are my friends and family.

I was super frustrated with the treatment situation because urinary tract infections are basically treated by antibiotics. There aren’t validated alternatives available and antibiotic resistance is now much more common. What that means is that many women experience a vicious cycle, to constantly contract infections and subsequently constantly take antibiotics. 

This is not a sustainable solution; it’s bad for the immune system and the natural microbiota. Antibiotics destroy the microbiome of your vaginal flora, and create many side effects, including making it more likely to get another infection because you don’t have the good bacteria in your intimate area anymore. Because of my frustration with this situation, I used my scientific background to look into new solutions. 

Tell us about Brightcure’s unique solution.

It’s very exciting: we basically found a good bacterium and we can use a good actor to fight the bad bacteria. Our bacterium is one that naturally exists on some healthy individuals and animals and can also be found in nature. There is nothing externally introduced.

This bacterium specifically fights the bad bacteria, but it does not affect the good bacteria of the urogenital tract, so it’s perfect for the intimate care area, because it balances your vaginal flora.

By fighting these bad bacteria, it gives the good bacteria room to colonize the vaginal area. This is what balances and promotes the good bacteria in the intimate area.

Is there risk of resistance developing to this solution?

There have been decades of research conducted with this bacteria and there is no associated risk with it. There has been extensive animal research around it and also testing in different human cells, and it has been in no way negative at all. 

This good bacterial strain basically eats the bad bacteria that cause these recurrent urinary tract infections. These normally travel from the rectum to infect the vaginal area. Our strain sees and kills bad bacteria, but it does not affect the good bacteria, those like Lactobacillus that promote vaginal flora. It is very targeted. 

How will women have access to Brightcure’s cream?

We are using this bacterium in our cream. It will be an intimate cream sold as a cosmetic cream that women apply externally to their intimate area; our bacterium is in that cream.

The cream will be sold as a cosmetic, making it a consumer product that women can easily access. We have a newsletter on our website to get the latest updates on our product development and our product itself. We also have a list where you can sign up for pre-launch notification if you are really keen on the product. We’ll have the product ready next year (2021).

We aim to destigmatize the conversation around intimate health. The community aspect is really important for me, because there’s not enough awareness around UTIs and the stress levels around chronic infection. It has a huge impact on women’s life.

To make the claim specifically around preventing UTIs, we will be partnering with clinicians and healthcare providers for rigorous clinical studies. These will allow us to make more specific claims about efficacy in the future.

How does this cream promote a healthy intimate microbiome? 

By fighting these bad bacteria, it gives the good bacteria room to colonize the vaginal area. This is what balances and promotes the good bacteria in the intimate area.

How will Brightcure change women’s intimate health in the future?

I hope to create a huge supportive Brightcure community, who uses our products. I hope we can reduce their suffering and bring back happiness to their everyday life with less stress. I hope we raise awareness for UTI and UTI patients because it has a major impact on a woman’s life, as well as how important the vaginal flora is to boost one’s immune system.

Learn more about Brightcure and all of IndieBio New York Class 1 companies at Demo Day.

Halomine: Making Every Surface an Antimicrobial Surface

Halomine is a company revolutionizing the way we disinfect surfaces. We asked Halomine CEO, Ted Eveleth, to tell us about the first product, Halofilm. 

Watch and read an abbreviated version of the conversation below.

What is your first product, Halofilm, and what does it do?

Halofilm is a very versatile product that allows you to turn almost any surface into an antimicrobial surface. It puts a semipermanent film down on a surface that sticks to both the surface and the chlorine. So in your normal habits of cleaning and disinfecting when you’re using a chlorinated product, the chlorine will last on a surface longer than normal.

Normally, chlorine and almost any active ingredient disappears fairly quickly. What we do is make it stick to the surface to provide continuous protection against pathogens, turning that surface into a continuous pathogen-killing machine, essentially.

How does Halofilm work?

There are 2 molecules required to make Halofilm work. One monomer sticks to the surface; it’s like an adhesive. This is a bio-inspired adhesive derived from muscles; it’s what muscles use to stick to almost anything in an aquatic environment. 

The other is an n-halamine (where we get our name), which is a molecule that interacts with chlorine. Normally, chlorine disappears from the surface. An n-halamine holds chlorine in a covalent bond until pathogens come along, and the chlorine then has a preference for the pathogen, where it kills the pathogen.

Where are major opportunities to use Halofilm?

There are a lot of application spaces: one important space is a hospital. We don’t want to cut back on disinfecting or sanitizing practices in a hospital; what we’re looking to do is to cut back hospital-acquired infections. Halofilm is something that would be used in addition to bleach-containing cleaning agents currently being used. The hope is that it could prevent either hospital-acquired infections or, more relevant these days, is reduce the COVID-19 spread.

Pretty much everything being used in the hospital right now is temporary. It seems very normal to us, but essentially it’s like mowing your lawn. You mow your lawn, it’s the right height. You let it grow for a while, you mow again. In between, the grass gets longer than you might want it. It’s the same with disinfecting: it’s a liquid that kills everything but between treatments, the disinfectant is gone. That provides pathogens the opportunity to land upon those surfaces and take hold, and to be transmitted between people that touch those surfaces. We’re essentially trying to continuously mow the lawn to keep it at the same height and turn periodic disinfection into continuous disinfection.

We’re looking at a lot of institutional uses, ranging from mass transit, cruise ships, hospitals, jails, schools, and office buildings. We originally started thinking we’d go after food processing, packaging and prep to prevent mold as well.

What types of microorganisms is Halofilm effective against?

We have an enormous amount of data on bacteria. We have a recently approved NSF grant that they turned around in record time for the NSF so that we can extend our studies to viruses.

We have done some testing to show that we can deter mold for 30 days. Essentially, once you have a film of chlorine on that surface, it will prevent anything from growing on it or taking over or creating a biofilm.

How safe are HaloFilm and chlorine-coated surfaces?

HaloFilm is extremely safe; we’re only keeping the same amount of chlorine on a surface as you would find in a pool. In fact, we can use the same dipstick to test for chlorine on a surface as you can use in a pool to measure the amount of chlorine. It doesn’t take much chlorine to be effective because it’s so potent against pathogens. It’s very hard to get the chlorine off the surface and you’d have to come into intimate contact with it. When you touch the surface, you’re not having intimate contact because the surface is rough and the finger has fingerprints, creating gaps in contact.

If you went to look microscopically at almost any surface, it would look more like a mountain range than a flat piece of glass. The polymer that makes up HaloFilm actually gets down into these crevices and holds a smaller amount of chlorine where those pathogens will go to hide, which is why it is so effective and yet safe. We’re covering the valleys in chlorine that your finger could never touch but that tiny pathogens can hide in.

Learn more about Halomine and all of IndieBio New York Class 1 companies at Demo Day.

The Future of Drug Manufacturing: Just What The Doctor Ordered

on demand drugs being dispensed

What factors drive innovation and supply chain disruption in the manufacture of medicines? What technologies will be critical over the next decade to increase access to vital medication and to manufacture them sustainably?

We asked these questions to 3 entrepreneur thought leaders in our latest ‘Future of The Planet’ event. Below the video are our key takeaways from the discussion.

Drugs Will Be Made on an Assembly Line

pill assembly line

Believe it or not, most drugs are still produced in batches, like cooking a recipe in a kitchen. The industry is slowly transitioning toward “continuous flow processes,” which are automated assembly lines in which each pharmaceutical “ingredient” is added at different phases of production. 

Continuous flow processes offer several advantages over batch processes, including flexibility and cost. In the simplest terms, this means that once enough of one drug has been produced, one could sterilize the system, alter the raw inputs, and select new pre-programmed settings; voila, an entirely different drug would be synthesized. The drugs would also only be produced when needed, meaning that continuous flow processing allows a manufacturer to delegate resources more efficiently, increase productivity, and adapt to the needs of customers more effectively than by using batch processing.

Each drug batch undergoes heavy scrutiny for quality control to ensure uniformity and safety, but this quality check currently occurs at the end of drug production. Digital analyses of continuous flow processes scrutinize vast volumes of data, and they do so in real-time. This monitoring allows detection and correction for the faintest perturbations during the process, eliminating the need for sample testing, and saving the costs incurred when discarding millions of units of a bad batch. 

The Takeaway: The pharmaceutical industry, much like the automotive industry or the semiconductor industry, will soon master the art of manufacturing millions of individual units at reproducible, high-quality levels.

Drugs Will Be Available on Demand

on demand drugs being dispensed

Imagine a portable handheld drug manufacturing device that uses simple raw materials to produce drugs quickly and efficiently: this seemingly far-fetched technology has been under development at the Defense Advanced Research Projects Agency (DARPA) for quite some time, as explained by Dr. Geoffrey Ling, Founding Director of the Biological Technologies Office of DARPA.

Why shouldn’t on-demand drug synthesis be possible? Ling told the panel that recognized the need for such innovation during his time as a field medic in Afghanistan. There, he often faced limited availability for generic drugs, noting, “if I had a chemistry set, I could have made [these drugs] on my own. I only need some organic compounds made of carbon, hydrogen, oxygen, and a little bit of nitrogen. If I had a pencil, a glass of water, and an egg, I could make bromocriptine. The problem is bounded, and automated chemistry will solve it.”

Inspired by his experience in Afghanistan, Ling joined DARPA, and in 2012 he set out to find and fund researchers who could make his vision of a portable pharmacy a reality. The machines as they currently exist are the size of a refrigerator, but Ling believes soon they could be the size of a briefcase. These machines cycle small amounts of chemicals through a series of tiny chambers that can produce thousands of doses of multiple drugs in a matter of hours. Ling sees these systems as crucial for physicians working in some of the world’s most challenging environments and likens them to 3D printers that could one day assemble drugs such as antibiotics, antibodies to treat autoimmune conditions or insulin for diabetes.

For this on-demand vision to come to fruition, the drug regulatory bureaucracy needs an overhaul, and the cost of such devices needs to come down many orders of magnitude before they can be made widely available. 

Synthetic biology presents another paradigm shift in the pharmaceutical industry. As Aiden Tinofer, CEO of Liberum noted, “the cost of drug discovery has roughly doubled every nine years since the 1980s, and we’ve also realized that a one-size-fits-all approach is not very effective in treating disease. But a growing group of people believes synthetic biology can get us through these problems.”

Technological advances from the synbio field could provide an essential solution for on-demand production, specific to biologics: cell-free protein printing. Genetic material, already cheap to synthesize, can be directly added to enzymatic systems, generating a molecular assembly line producing peptides or antibodies of choice. Using this system, engineered by Liberum, proteins are manufactured in hours at low cost and high fidelity. 

The Takeaway: Increased engineering sophistication both mechanically and biologically will lower the barriers to drug production and offer new ways of making old drugs on-demand for resource-limited users.

Drug Supply and Distribution Will Change

While highly centralized large drug manufacturing plants enable substantial cost efficiencies and scale, COVID-19 has exposed the downsides of a dominant centralized system. A prime example lies in the distribution of the highly anticipated COVID-19 vaccines: distributing vaccines among half the world’s population will require 8000 cargo planes. Emirates, which has one of the largest fleets worldwide, has just 70. The worldwide infrastructure to distribute such a life-saving vaccine is significantly lacking. 

Production of said vaccine relies on a global network of supplies, as well. Global dependency, combined with precarious political relationships, has led various countries to draft legislation requiring many domestic companies to have some local manufacturing footprint. Global supply chains are being rewired as we speak. 

Distribution channels are evolving too. As more services digitize, and customers’ appetite for bespoke products on-demand increases, drug manufacturers are eyeing the tantalizing profits of selling direct to consumers. Technological advances in manufacturing and logistics could enable this shift. The sentiment for autonomous, self-sufficient, localized systems is high and will present real challenges to globalization. 

The Takeaway: A hybrid of drug manufacturing and distribution systems is likely to evolve, whereby different approaches are applied to suit the needs of specific industries, markets, and situations.

How Will Drug Manufacturing Change in the Next Decade?

Supply chains of the future

The only certainty may be that the future holds many changes in drug manufacturing. For one, we should see the establishment of more utility companies in the space of synthetic biologies, such as Ginkgo and Twist Bioscience, that take on the hard work of manufacturing proteins and DNA. This division of labor will save time and resources for the smaller downstream players who can design novel applications, find new opportunities, and ultimately increase human health. 

As the picks and shovels of this industry emerge, drug discovery will skyrocket, the much-promised technologies of cellular and genetic therapies will come into their own, personalized medicine will finally arrive at the push of a button, and new vaccines will be developed much faster in the face of pandemics. And that’s just the beginning. 

Thanks to our panelists:

Geoffrey Ling, Founding Director of the Biological Technologies Office of DARPA, and CEO of On Demand Pharmaceuticals. 

Aidan Tinafar, CEO at Liberum Biotech, a company currently in the IndieBio accelerator program, with a benchtop protein synthesizer. 

Sauri Gudlavalleti, Global Head of R&D at Dr. Reddy’s Laboratories, which develops and manufactures generic medicines that are sold across 17 countries.

IndieBio Coronavirus Initiative

We are seeking up to 8 startups to receive a minimum of $250,000 each to pursue the development of diagnostics, therapeutics, vaccines, disinfection, and other solutions addressing the worldwide problem of emerging infectious diseases.

We have an unprecedented opportunity to contribute to solving the remarkable scale of challenges that Covid-19 presents to our planet. Scientists need funding and they need it immediately in order to work at the pace that the coronavirus is moving. The time to accelerate and mobilize all scientific discovery has arrived. We are excited to work together in finding solutions. 

“There’s a long war ahead and our Covid-19 response must adapt” ~Dr. Tom Frieden, Former CDC Director

IndieBio’s current portfolio of companies, backed by SOSV,  has been built with the anticipation of a future that requires massive systemic change impacting every area of human and planetary health.  We have already made investments in companies like CASPR Biotech, who is working on molecular diagnostics for Covid-19. To read about more of IndieBio’s companies working on Covid-19, scroll down to the bottom of the page. To learn about all of SOSV’s Covid-19 startups visit www.sosv.com/covid-startups.

Members of Caspr Biotech headed to the frontlines.

IndieBio seeks to work with companies that can detect, treat, and prevent COVID-19:

Companies who focus on detection may include those that: 

  • Improve diagnostic capabilities in speed, cost, or scaling.
  • Predict negative post-infection sequelae for COVID-19 patients.
  • Enhance serological testing kits.

Companies who focus on treatment may include those that:

  • Mitigate patient inflammatory reactions (cytokine storms).
  • Regenerate lung function or address other long-term health consequences.
  • Formulate therapeutics for tough-to-penetrate organs like the liver and nervous system.

Companies who focus on prevention may include those that:

  • Develop novel vaccine platforms or formulations.
  • Sterilize contaminated buildings, waters, or foods.
  • Block disease transmission from animal reservoirs or vectors.

Apply your scientific expertise to eliminate the serious challenge of COVID-19:

  • Application is on a rolling admissions basis 
  • Apply at Indiebio.co/apply

About IndieBio: IndieBio enables scientists to become entrepreneurs and build breakthrough companies to solve the world’s biggest challenges through biology as a technology.  IndieBio drives innovation to improve human and planetary health. To date, 116 biotech companies have been through the program, creating a combined valuation of over $2.4 billion. IndieBio is a division of SOSV.

Over a dozen IndieBio startups are already on the front lines of the COVID-19 response. A sample of these includes: 

  • Renegade Bio: Improved Diagnostics. Renegade Bio is testing SF Bay Area’s first responders with a “we come to you” service. Renegade invented an improvement on the CDC testing method, turning four reactions into a single-step reaction and eliminating the RNA extraction requirement. The result is a testing process that is 70% cheaper, taking half the time, for a net 4x increase in throughput. They partnered with Bay Area Phlebotomy & Laboratory Services to open testing for the public with an on-demand, Uber-like service. They are starting testing of all SF Bay Area first responders and police forces, running 1300 tests every three days. https://sosv.com/portfolio/renegadex/
  • Prellis Biologics: Faster Antibodies. Prellis Biologics is 32 days from anti-SARS-CoV-2 human antibodies using bioprinted, human mini lymph nodes. In 2017, Prellis Biologics printed human mini lymph nodes, which they injected with Zika virus. The mini lymph nodes produced human antibodies for passive immunity against Zika. Now, Prellis is doing the same for the coronavirus. In one week, they will be growing immune cells, in two weeks growing lymph nodes, and in a month screening the antibodies. In six weeks the antibodies will be sequenced for scale-up and trials, which could begin in as soon as 10 weeks. This is a much faster turnaround time for antibodies and even if other approaches yield antibodies first, Prellis’ approach is a more rapid way to generate antibodies as the virus mutates.
  • Amaryllis Nucleics: Sequencing for Diagnostics and Epidemiology. Amaryllis Nucleics is developing a universal viral RNA detection kit to detect COVID, Influenza, and other viral infections in the same test, while detecting and tracking mutations as they arise. Using established next-gen sequencing technology and optimizing their RNA sequencing kits for COVID, they can enable thousands of samples to be run per machine each day.
  • Diadem Biotherapeutics: Lung Immune Modulators. Diadem is engineering exosomes to be inhalable cell-specific immune modulators. Exosomes are small, virus-sized particles released by cells to communicate throughout the body. Diadem plans to develop a SARS-CoV-2 vaccine by engineering exosomes with surface bound SARS-CoV-2 proteins and immune-stimulating ligands, effectively turning them into non-replicative virus-like particles (VLP). To increase immune response and memory for the SARS-CoV-2 antigen, the VLPs can be engineered with immune stimulating ligands (e.g. 4-1BB). 
  • mFluidX: Diagnostic Accessibility. mFluiDx is developing a low-cost microfluidic diagnostic to detect COVID-19 in under 15 minutes in decentralized settings. Their chip is as simple and cheap as paper tests, yet has DNA/RNA level sensitivity able to diagnose onsite. 

Learn more details about all IndieBio and other SOSV-backed startups here.

Header image credit: Fusion Medical Animation on Unsplash

IndieBio Call for Applications

SOSV Announces Launch of IndieBio New York

— World’s leading life sciences accelerator expands to New York City —
— Call for Applications Open Now —

(NEW YORK, January 7th, 10:30am EST) — SOSV, the world’s most active investor in both life sciences and hardware, announced that the inaugural cohort of IndieBio New York will start in Manhattan in May 2020, with applications being accepted beginning today.  

“We’re doubling down on life sciences,” said Sean O’Sullivan, founder and Managing General Partner of SOSV. “We are looking to bring what IndieBio has created for the California life science industry to the East Coast. New York is a great hub for life sciences research and financing, and will be a natural center for life science startups.”

SOSV created the world’s first life sciences accelerator in 2014, and in the past five years has backed nearly 200 life science startups with a combined valuation of over $3 billion, raising more than $700 million, and employing over 2,000 people. This number includes pioneering deep-tech startups like Memphis Meats (cellular agriculture), Prellis Biologics (human tissue engineering), Synthex (cancer therapeutics), NotCo (plant-based animal-free food products), and Perfect Day (milk without the cow).

Sweetening an already attractive deal – Up to $2 million per therapeutics startup

SOSV’s IndieBio already has the most competitive terms in the industry, funding 20 to 30 life science startups each year in their program with $250,000 in exchange for a small equity position in the teams. With IndieBio now in New York and San Francisco, SOSV will double the number of startups funded and will also trial a therapeutics track that will fund up to $2,000,000 per startup accepted into the program. This will be the first time an accelerator anywhere has offered such a cash-rich package of benefits.

“We’ve seen a lot of success with our therapeutics startups already,” said Arvind Gupta, SOSV General Partner and founder of IndieBio in San Francisco. “Yet therapeutics companies often require more animal and safety studies in order to de-risk the startups for later-stage capital and unlock huge value creation. We want to see what will happen to our deal flow by offering up to 8 times the capital for an initial group of startups.”

Upon success, IndieBio will expand the therapeutics funding track to as many as 12 therapeutic startups per year across both San Francisco and New York. Therapeutic startups in the program will receive up to two years of wet lab facility, coworking space, and mentoring access to on-staff PhD scientists. SOSV will be building out a 24,000 square foot lab and co-working space for their NY-based startups, more than doubling their space in New York City as part of this expansion.

Solving Global Challenges With Hands-On Support

SOSV invests over $10 million annually in infrastructure — building out and running wet labs, electronic labs, and mechanical facilities, in addition to  offering on-site support teams of dozens of experts, engineers and PhD scientists. The benefits of these programs help startups with accelerated product development and increased access to an ecosystem of corporations, investors and over 1,000 specialized mentors.

“This year nearly $1 billion will go into SOSV-backed companies from VCs and corporate investors,” said O’Sullivan. “On top of the $65 million SOSV invests directly into our startups every year, SOSV’s deep-tech startups are getting huge funding leverage from our syndicate of VCs, angels and corporates.”

SOSV closed the $277 million SOSV IV fund in December 2019. From this fund, SOSV both provides accelerator funding as well as provides post-accelerator follow-on funding of $200k to $2 million per startup, per round, for all startups which go through SOSV programs. 

Call for Applications Solving for Human and Planetary Health

Startups can apply for IndieBio New York’s first cohort until March 1st, 2020 at http://indiebio.co/apply. The program kicks off in April 2020.

Additional Portfolio Highlights

In the life sciences arena, SOSV invests in human and planetary health, as an early investor in plant-based foods, cellular agriculture, computational biology and regenerative medicine.

SOSV is a pioneer in ‘clean food’ and cellular agriculture with investments in Geltor (animal-free collagen), Clara Foods (egg proteins), and Abbot’s Butcher (plant-based meat). SOSV was the initial investor in Jungla (A.I.-driven genomics), acquired in July 2019 by Invitae (Nasdaq: NVTA).  

Therapeutics has always been the core application of biotech, and SOSV has remained one of the industry’s most active funds, investing in cancer therapeutics (Filtricine, A2A Pharma), new modalities for autoimmune diseases (Diadem, DNA Lite), regenerative medicine (Membio, BioAesthetics), and gene delivery (Serenity).

About the IndieBio New York program

IndieBio New York has been created with the support of New York State’s Life Science Initiative, administered by Empire State Development. New York State will invest up to $25 million over five and a half years in support of IndieBio’s work connecting life science entrepreneurs with the tools and resources needed to move their discoveries out of the lab and into the marketplace. The Partnership Fund for New York City will invest $10 million into the startups coming through the program. SOSV also plans to invest an additional $60 million or more into the IndieBio New York startups. 

The program will work alongside New York’s leading academic institutions to commercialize both local and global inventions. Startups funded by IndieBio New York must relocate to New York for the duration of the program, and can leverage the extensive resources of the east coast life sciences industry.

About SOSV

SOSV manages over $700 million with a portfolio of over 900 startups. Managing Partner Sean O’Sullivan created the firm in 1995 after the IPO of MapInfo, the startup he co-founded that pioneered street mapping on computers. In 2010, SOSV opened Chinaccelerator, the first accelerator program in China, and was the first to create accelerators in hardware (HAX) and life sciences (IndieBio). Today, the firm has eight general partners amongst a 110-person staff across nine locations in the US, Europe and Asia.

In both 2018 and 2019, three of SOSV’s startups were selected each year as creators of the Top Inventions of the Year by TIME Magazine, a feat unparalleled by any Fortune 500 company or any other VC. 

For further information: Kayla.Liederbach@sosv.com

Beeline Therapeutics: Supercharging T-regs

Dimitre Simeonov, Michael Wyman, and Chris Chavez of Beeline Therapeutics

Beeline takes engineered immune cell therapy in a new direction. They are unique in how they have engineered regulatory T cells (Tregs), which play a natural role in ramping down the immune system. This has wide applications for autoimmune diseases and organ transplantation.

We talked with company founders Dimitre Simeonov and Michael Wyman.

Since you’ve announced that you’ve successfully engineered Tregs, you’ve had a good number of pharma companies wanting to partner with you. How did you accomplish something they couldn’t do on their own?

A number of companies have learned how to edit the genome of effector T cells, such as killer T cells. The idea of doing similar genetic engineering of Tregs was beginning to be considered. But actually doing it was another story.

To start with, Tregs are just hard to cultivate and proliferate. Then, there were a lot of hurdles to overcome in terms of the genetic engineering. We weren’t just engineering a receptor into the Tregs to localize them to the spot of inflammation. We wanted to go beyond that — to enhance the natural immunosuppressive power of Tregs. This meant delivering a very large genetic payload to a precise spot, without interrupting the normal function of the gene we were targeting. We found unique ways to pull this off.

How do they work, and what’s the benefit of a “living drug”?

Tregs naturally quiet the immune system. They do this through a unique cellular programming that relies on transcription factors, cell surface receptors, and cytokines that help a Treg shutdown other immune cells. Sometimes this process fails as Tregs can be overwhelmed by the immune response. So we supercharge them and put them back into a patient’s bloodstream, so they can migrate to inflammation hotspots, where they can secrete therapeutic proteins to calm an immune response.

As a “living drug”, Tregs have unique advantages over standard molecular therapies. First, we can harness the cell’s ability to produce protein to continuously manufacture therapeutic proteins in the body. And not just anywhere — but precisely at the site that needs the therapy. No more biweekly injections — just a single shot of your own cells. Second, cells can “sense” their environment and respond accordingly by changing gene expression. By engineering our therapies into the “responder genes” our cells will make therapeutic proteins in response to the environment that those cells are in. For example, say we are trying to quell inflammation as in the case of Crohn’s disease — we might engineer our therapeutic so that its expression is increased in an inflammatory environment thereby allowing us to precisely control dose and ensure we are delivering the highest doses to the areas of the body that need them. Finally, cells are complex machines armed with a number of “tools” that allow them to accomplish their functions. This is fundamentally different from the medicines that have so far dominated the clinic — generally drugging a single target or pathway.

Our technique solves a problem that every drug company is challenged with. How to get the drug exactly where you need it, and maintain a dose potency that is appropriate to the severity of the disease.

It’s like having a drug factory in your body.

Yes, though we’re technically not secreting synthetic drugs. We can do that (as long as they are protein-based), but at this point, our cells secrete the natural signalling compounds the body already makes and uses on its own. We’re the first therapeutics company to publicly announce that we’ve made the proteins we’re making from Tregs; it’s very exciting.

Why did you use DNA-cutting enzymes instead of the more conventional viral vectors?

We actually are doing both approaches. With the viral approach, we do get a high expression rate, but it comes at a tradeoff. The virus lands randomly on a cell’s DNA. You can’t control where the virus integrates the payload. And when it integrates, it can disrupt gene function, which might be a pretty important gene. Also, every gene has a different expression level. So in one cell, you might randomly hit an area of the DNA that is highly acvtive, and in another cell, you could hit an inactive area. You end up with different levels of the therapeutic in each cell — or worse some of the cells may not express the therapeutic because the surrounding inactive DNA could spread to your therapeutic.

To get a much more controlled result, we are also using non-viral engineering approaches. This overcomes many of challenges we mentioned earlier and allows us to think about how to use a cell’s natural gene regulation to regulate our therapy.

In what critical indications is your cell therapy most needed?

Helping the transplantation of organs is where physicians are the most excited by what we’ve done. Today, to prevent rejection of a donated kidney, physicians have to give patients a lot of broad systemic immunosuppressants. These patients are already in a weakened state, and having no immune activity is dangerous. Also the drugs make the patient very vulnerable to cancer; one of the most common drugs is classified as a Group 1 carcinogen. There are a lot of patients who don’t even get put on the waiting list for a kidney, because they are too high risk.

By localizing the immune suppression, and helping patients’ immune system not reject a donor organ, we can open the door to new types of transplants that aren’t very feasible yet. One of those is pancreatic islet cells; they produce hormones. People with Type I diabetes could be alleviated with islet transplantation.

One of the exciting potentials of this therapy is long term tolerance — meaning patients could potentially come off of immunosuppressants all together. This is something we are actively working towards.

What’s the next year look like for Beeline Therapeutics?

We have the ability to engineer receptors to help the Tregs home to the right places in the body — over the next year we’re going to expand that platform with more receptors. A kidney donor has to match the patient’s HLA markers. We’ll use the patient’s HLA markers to design receptors to recruit Tregs into the donor tissue.

Also, proving our method works in mice presents an interesting challenge, because we engineer human T-regs, but a mouse’s immune system would attack human cells. The elegant way to solve this is to use a mouse model without any immune system, repopulate it with a human immune system, and then transplant the mouse with human tissue, to see if we can prevent rejection.

Watch CASPR Biotech pitch on IndieBio Demo Day, Tuesday June 25th in San Francisco or via LiveStream. Register here!

Gavilán Biodesign: Overcoming Drug Resistance

Gavilán Biodesign emerged out of the Donald Lab at Duke University, one of the world leaders in computational drug design. During their time at Duke, they redesigned many compounds, including a new Anti-HIV antibody that is now in 9 clinical trials. Their software was also used to predict tumor resistance mutations to 17 leading precision cancer therapeutics and multiple antibiotics. Their work led to 45 papers published in leading journals.

We chatted with three of the company’s founders, Marcel Frenkel, Mark Hallen, and Jonathan Jou.

What has been the limitation of computational drug design?

Using computers to design better drugs has been quite effective when there’s already a lot of knowledge about the compounds and the protein targets they’re hitting. When there’s a lot of data to train on, artificial intelligence can learn and interpolate alternatives, then estimate how well each one works to find a better one.

But those approaches to in silico drug design haven’t worked well for new areas, where there isn’t a lot of knowledge. It’s the difference between interpolation and extrapolation.

To go after biological pathways where there hasn’t been much success in the past — and design entirely novel classes of drugs — a different approach was needed.

How does Gavilán Biodesign do it differently?

Even in a new molecular space, the laws of physics still rule. Our hybrid system uses the best of A.I. and the best physics-based molecular dynamics models. All natural phenomena has to answer to physics; they’re the forces that drive the universe.

We are the only company to use thermodynamic ensembles to model continuous movement.

Then we have a parts library of thousands of molecular parts. Most of these parts have a dozen atoms or so. We don’t bring a drug in from a preset library to evaluate it; we generate every possible combination of those parts, inside the target pocket, simultaneously measuring the impact of every part on the affinity, stability, and specificity of the compound. Every building block of the design is ideal for the target.

While our competitors search through a few million compound variations for the best fit — and the biggest molecular library in the world has 230 million compounds — we can easily and efficiently search through billions of possibilities.

The slightest differences can have huge effects when dealing with van der Waals forces, which repel at one distance, then attract at another. A 0.5 angstrom difference in position can go from a bad clash to a favorable interaction.

Before you came to IndieBio, none of you had experience pitching business partnerships and negotiating deals. But in four months here you already have signed and delivered on a deal with a pharma company and are negotiating four more.

Everybody whose become an entrepreneur has had to learn to do so, whether they were a lawyer, or an accountant, or a banker, or a scientist. And I actually think scientists make the transition better than other people do.

Being an entrepreneur is remarkably similar to science. We’re used to operating in absolute uncertainty. We don’t pretend we know how to sell, or know how to cut a deal. Instead, we experiment rapidly and learn. We form a hypothesis, test it, and gain the most amount of data as fast as possible to improve. Our scientific inclinations apply surprisingly well to entrepreneurship.

So we didn’t go to companies and sell ourselves. We went into meetings to learn what problems and stress points they were having. Then we explained how our technology could help them with their problem. It was more about problem solving than pitching.

How did your time at IndieBio change your business model?

When we first interviewed with IndieBio, we were thinking of just selling our software. We wanted everyone to have it and use it.

During IndieBio, we’ve really learned to shape Gavilán’s strategy to create new value. Not just to replace the software chemists were using. And so that meant moving from a high-volume service business model to using our design tools for what they’re uniquely great at, creating new therapeutics in the highest-value problem spaces facing medicine.

As we’ve done a better job of explaining how we can do that, the most exciting thing is now seeing pharma companies come to us, wanting to design drugs for targets that have long been considered undruggable.

How might your company change the therapeutics industry?

Consider cancer. Right now, precision medicine is pretty good at designing drugs for certain well-known biological pathways. But there’s two major problems with that. The first is that the most powerful biological pathways are not well-known, or else we haven’t had enough success targeting them to even learn how to do it better.

The second problem is that a cancer tumor is highly mutating. The genome changes, and so the protein shape changes, and drugs that worked for maybe a year in patients, now fail. Almost everyone has a loved one who got cancer treatment, recovered for awhile, and eventually succumbed.

Our software has made it possible — for the first time — to discover how a tumor will mutate, years before it actually happens in a patient. We can “discover” it while we are designing the drug itself in the computer. And so we can design drugs that work not just against the tumor before it mutates, but the drug will still work after it mutates. And not just one mutation — all likely mutations.

We see a new age in medicine coming, where massive killers like cancer could be under control. The way polio is a thing of the past, today.

What’s the next year look like for Gavilan Biodesign?

While some of our partnerships with pharma companies are confidential, I can characterize them broadly.

There are undruggable targets that nobody has been able to hit with sub-micromolar affinities to date. You really have to get a 1000x better than that — down to nanomolar range — for a drug’s potency to make a difference in patients.

We are designing several of these in silico. We’ve already delivered one set, and will be delivering more in the coming months to other partners. Then it will take our partners a few months in the lab to confirm the accuracy of what we’ve designed. Even just from these in vitro lab tests, they’ll be able to tell if we are hitting the targets with nanomolar affinity.

When the industry sees the results, we hope it will blow people away. They’ll realize whole sections of biology are now targetable.

Watch Gavilán Biodesign pitch on IndieBio Demo Day, Tuesday June 25th in San Francisco or via LiveStream. Register here!

CASPR Biotech: Revolutionizing Molecular Diagnostics

The CRISPR Cas complex has been a game-changing technology for gene editing. CASPR Biotech is using the incredible accuracy of CRISPR for something different — to revolutionize medical diagnostics.

We spoke with company founders Franco Goytia and Carla Giménez.

There are a couple other prominent companies also using CRISPR-Cas systems for diagnostics. What’s different about your focus?

We are rapidly developing a device for hospitals to quickly detect if a patient has an antimicrobial resistant infection. This is a huge problem for hospitals. It’s not just that 2 million people in the US every year get infected with superbugs, or that the infection rates are even higher internationally. When a patient walks into the hospital with a fever of unknown origin, it takes between 24 hours and three days to amplify the DNA of the bacteria to determine if the patient has AMR. During that time, the patient has to be isolated, making it very stressful and expensive. For every one patient found to have AMR, nine more have to go through this isolation. And during that time, they’re started on wide-spectrum antibiotics, which makes the global problem worse.

How does your solution change that?

We can diagnose AMR infections in under an hour. Most superbugs have one of three sequences of DNA that make them resistant. We code our Guide RNA to detect those, and if they do, our Cas enzymes trigger a signal. Not only does it do so in under an hour, but does so more accurately, and cheaper.

You already have this working?

Yes, in the lab. As well, at a hospital in Argentina we have tested our system to detect infectious diseases like Dengue virus. These aren’t yet automated into a device, but our device development is going incredibly well and we are on track to begin a 510K study with the FDA in one year.

You discovered two novel Cas enzymes, one in the Cas 9 family, one in the Cas 12 family. How did you do that, and how they are different?

Existing IP portfolios held by the primary CRISPR institutions were discovered by searching through the public databases of sequenced bacteria. We went through unpublished data, collected by our partners in the extreme environments of Argentina — regions as diverse as volcanos, high deserts, hot springs, and Antarctica. In these environments, bacteria evolved unique ways of defending themselves against viruses.

We are looking at ways our Cas 12 gives us a competitive advantage. It appears to be more stable at higher temperatures, likely due to the environment where it evolved. Using it at higher temperatures may facilitate other reactions in our system, turning what’s a two-step process into a one-step process.

You’ve been able to make incredibly fast progress during your time at IndieBio. What’s been your secret?

Before IndieBio, we were running on a very thin budget. To order reagents, we might be waiting a few months until we could get the money together. At IndieBio, we got them in a day — and shouted in celebration when they arrived. We showed up at IndieBio really hungry to do science at a much faster pace, to make quick decisions. It’s been an opportunity that we’ve been thankful for, and haven’t taken a single moment for granted.

We’ve also been very inspired by the scientists who created the foundational technologies of CRISPR. The way bacteria has defended itself against viruses has existed for hundreds of millions of years. But it took great imagination to reconfigure it for gene editing. This precedent reminds us, daily, that if we work hard, at any moment we too could make more discoveries.

How big could CRISPR-based diagnostics get?

Certainly, from AMR and infectious diseases we will move into flu detection, respiratory infections, sepsis, and urinary tract infections. But the application go beyond healthcare and the hospital. Just like Google allows us to search the entire internet, CRISPR allows us to search the entire genome for any genetic code. Rapid DNA detection has applications beyond humans into pets, livestock, and plant life. Farming, biosecurity, and new domains of agriculture are all possible.

Watch CASPR Biotech pitch on IndieBio Demo Day, Tuesday June 25th in San Francisco or via LiveStream. Register here!

The MicroBiome is a Drug Factory

At IndieBio, our perspective on gut bacteria is informed not just by the companies we’ve invested in that do human microbiome science, but by all the companies in our portfolio who work with bacteria and biomes in diverse sectors from the Future of Food to the Future of Energy to Biomaterials to Agriculture.

Early Popularization

A decade ago, the microbiome was a novel curiosity. The public learned that there was anywhere from 3 to 5 pounds of bacteria inside our bodies. Each was around one or two microns long — a tenth the size of cells. The number of them was astounding: estimated at 100 trillion. Exactly how they survived inside our bodies, without being attacked by our immune system, was unknown. Western diets (and overly-sanitary conditions) were eliminating our gut diversity; westerners had lost a third of their microbiome diversity, and flora diversity was correlated with health — across all animals, and all conditions. Probiotic drinks showed up on every store shelf, and soon after came the prebiotic supplements that gut bacteria feed on — oligosaccharides, fructans, and galactans.

A New Metaphor Emerges

Society grew to appreciate how the microbiome was important to health. Early research showed the gut was the source of 90% of our serotonin, and 60% of our oxytocin. That state of your gut was directly connected to the state of your mind. For awhile, the gut was often characterized as our “second brain.”

It’s time to upgrade that metaphor. Yes, the biome acts on our brain — but it acts on just about every other part of our body, too. The microbiome is more like a drug factory. It’s the “invisible organ” of the body that interacts with 70% of our immune system, generating our circadian rhythms, and turning our genes on and off.

When we say “drugs,” we’re using the term a little loosely to make the point. They’re naturally made. And in many species of bacteria, their output might not be quite a drug, but it’s a bioactive compound that acts on a pathway elsewhere in the body, either as a primary metabolite or a secondary metabolite. In this sense, the line between a drug and a bioactive compound is virtually indistinguishable, as the definition of a drug is anything with physiological effects. Traditionally, what we meant by “drugs” was that they were made outside the body and then put into the body. Arguably, most of this definition holds, as the bacteria are not of our body, even if they are inside it.

The Drug Factory’s “Top Sellers”

To list all the drugs made by bacteria in our bodies would take far too long. But here’s a short, starter list — solely for the purpose of illustrating the point that the microbiome has widespread impact on the body, for both better and worse:

  • Histamines, both pro and anti-inflammatories
  • Beta-glucuronidase / hormones / estrogen & estrogen cancers
  • Short-chain fatty-acids / histone chrotonylation / HDAC2 / gene regulation
  • 5-HT biosynthesis / Enterochromaffin cells / Serotonin, brain neurotransmitter
  • Chylomicrons / energy-rich triacylglycerol
  • Tyramine / blood pressure & hypertension
  • Microcins that block salmonella
  • Oxalate / protein transporter SLC26A6 / prevents kidney stones
  • Zonulin / haptoglobin 2 / atherosclerosis
  • Glutamate & cytokines / Vagus nerve / Oxytocin
  • Tryptophan & tryptophan antibiotics
  • Glucagon Peptide 2 / GLP2R / bone and neuroprotection
  • Butyrate / Insulin Sensitivity / Diabetes & Obesity
  • Deoxycholate / fat reduction
  • A-tocopherol / Vitamin E / free radical scavengers
  • G-aminobutyric acid / neurotransmitter / muscle tone
  • Cholate / FXR transcription factor / antimicrobial peptides
  • P-aminobenzoate / Folate / blood cell creation
  • Eicosatetraenoic acid / Endocannabinoids anandamide and 2-AG
  • Commendamide / GPR132/G2A / prevents autoimmune disease

All of the above are from the gut, but the gut isn’t the only place we have bacteria. A skin bacteria, staphylococcus epidermis, fights skin cancers — producing 6-HAP, which inhibits melanoma and lymphoma tumor cells.

Other Mechanisms of Action

Making drugs outright is only one way the bacteria in our gut do their work. Another way is that they chop free bioactive peptides or small molecules from longer chain proteins. A lot of what we eat is digested by hydrochloric acid and protease actions into basic building blocks. But food proteins also contain certain biochemical strings that, if chopped correctly, are then biologically active.

The microbiome also interferes with medical drugs. 80% of our current medical drugs are metabolized in the liver, but 20% of the drugs on the market are metabolized by gut bacteria. Since some people have different flora than others, these drugs tend not to work as intended for certain people. For instance, the emerging market of Anti-PD-1 checkpoint blockade immunotherapy has only a 10% success rate. It’s still a matter of debate just how to get that rate up, but many of the solutions being researched involve first transplanting necessary microbiota into the patient. About 50 medical drugs are now understood to be codependent on gut bacteria populations.

The Birth of Microbiome Therapeutics

The race to translate this research into commercial therapies is well under way. There are at least 6 drugs in development to treat cancers, from solid tumors to mucositis, with one candidate already in Phase II. There are three drugs in development for obesity, and five in development for diabetes, with one at Phase II. Fourteen drugs are being developed for Crohn’s and ulcerative colitis, with one of each at Phase II. There are drugs for lactose intolerance, for dental caries, for repeated urinary tract infections, for celiac disease, and several skin diseases, with one in Phase III for acne. Revenue out of this market is expected to begin in 2021 and reach $10 billion by 2024, continuing to go up steadily in the decade beyond.

We view the acceleration of this pipeline as proof of its market potential, but not necessarily as evidence that science has strong command and control over gut bacteria and all they interact with.

Finely-Tuned Control (and Effects)

To gain precise command over the drug factory, a variety of tools and competencies are needed. Science teams with these expertises are what IndieBio looks for and what drives our investments.

  • Daily Fluctuation Tracking. Most microbiome research today uses single-shot samples of patients’ stool samples. But disease states tend to correlate with dramatic, short-term swings in the species population. For researchers to model these correlations, they desperately need a low-cost assay to track population swings. When such a tool is available, we believe it will be widely used — by all manner of researchers, even those who don’t currently factor in microbiome effects. It will also become a common biomarker in clinical trials, and then be required as a companion with microbiome therapeutics.
  • Personalization. Because everybody’s microbiome is unique, and because the bacteria interact with each other, off-the-shelf probiotics are likely to work for some people, and not for others — or, to avoid undesired side effects, they have to be dosed at numbers that are too low to have much impact at all. Companies that built trust with consumers making personalized probiotic services will be able to grow into more and more effective blends.
  • Setting You Up for Life. An infant’s microbiome fluctuates continuously in the first three years, but then largely stabilizes (with the exceptions around the disease-states described here, when health and the microbiome both swing together). There are two significant opportunities in this space. First, how to help an infant’s microbiome, from the first weeks to the first years, and second, how to optimize the biome around that stabilization transition —for a lifelong impact. In the US today, 32% of babies are born by caesarian section,
  • Shared Metabolites. Bacteria by themselves are not the same as bacteria in a biome. A biome is an ecosystem; the bacteria interact, regulate each other, and the metabolites from some bacteria become the feed for others, in a chain reaction. For this reason, transplanting and colonizing individual strains is often ineffective. It’s not enough to formulate a strain in a synbiotic that combines the probiotic with a prebiotic — as soon as that hits the gut, other bacteria may suppress it. Companies that have worked out the interactions within a consortia of bacteria have a much better technology platform.
  • Variants Within a Species. Most news about microbiome-health correlations is based on research looking at relative species populations. People with more of strain X have less of health condition Y, and so forth. But there is still a great deal of genetic variation within a species. Think about all the humans on the planet for a moment — we are all one species, but our DNA (and our health) varies meaningfully. Some of the best microbiome research investigates these differences; cohorts of people with the same species, but some have variants of that species — and dramatically different health functions as a result.
  • Precision editing. Rational design of the bacteria genome is seemingly inevitable. Researchers today are busy editing microbiota as a way of understanding what the edits do — attacking it node by node. The challenge this path faces is that bacteria have ways of sharing their DNA, so precision edits could spread around a microbiome in unintended ways. One approach at a solution is to make the edits in the bacterium chromosome, not in the plasmid. But this has had mixed results.
  • Culturing the Unculturable. 99% of the bacteria found in the wild have been unculturable in the lab; they grow in unusual conditions. A less extreme version of this occurs in the human gut, where some bacteria that have been identified as beneficial have unconventional properties and are particularly hard to colonize. Researchers who have developed expertise in culturing them have an advantage over researchers who’ve merely identified them.

At IndieBio, we are always looking for the next great microbiome company. We don’t just invest in startups — we help create them, often working with post-docs and principal investigators to build a team and transform them into scientist-entrepreneurs. To learn more, visit https://indiebio.co/

Further Reading:

https://www.cell.com/neuron/pdf/S0896-6273(19)30117-5.pdfDiscovery of genetic variants that protect against obesity and type 2 diabetes could lead to new…
Around four million people in the UK carry genetic variants that protect them from obesity, type 2 diabetes and heart…www.cam.ac.uk
The Gut-Hormone Connection: How Gut Microbes Influence Estrogen Levels | Kresser Institute
Emerging research indicates that the gut microbiome plays a central role in the regulation of estrogen levels within…kresserinstitute.com

https://www.chemistryworld.com/features/the-chemistry-of-the-microbiome/3008630.article

https://www.cell.com/cell-host-microbe/pdf/S1931-3128(18)30267-1.pdfGenetically modified bacteria enlisted in fight against disease
People often take medicines to rid themselves of problem bacteria. Now, a counterintuitive approach – turning…www.nature.com
Profiling the gut microbes passed from mother to baby
How an infant is born (by vaginal or cesarean delivery) and what she eats after birth (breast milk or formula)…www.broadinstitute.org
Can Your Microbiome Be Genetically Engineered to Make You Healthy? | Simons Foundation
Some people just know what they want from an early age. “I asked my parents for a microscope at age 6. I don’t have a…www.simonsfoundation.org
The Role of Microbiome in Insomnia, Circadian Disturbance and Depression
Good sleep and mood are important for health and for keeping active. Numerous studies have suggested that the incidence…www.ncbi.nlm.nih.gov
Bifidobacteria and Butyrate-Producing Colon Bacteria: Importance and Strategies for Their…
General Another strategy to increase bifidobacteria and butyrate-producing bacteria in the human colon is through the…www.ncbi.nlm.nih.gov
Lactate-Utilizing Bacteria, Isolated from Human Feces, That Produce Butyrate as a Major…
The microbial community of the human colon contains many bacteria that produce lactic acid, but lactate is normally…aem.asm.org
Mechanisms Linking the Gut Microbiome and Glucose Metabolism
The microbiome is an integral part of the human body with the highest density of bacteria in the gut, ranging from 1 ×…academic.oup.com
Gut microbiota, cannabinoid system and neuroimmune interactions: New perspectives in multiple…
Biochem Pharmacol. 2018 Nov;157:51-66. doi: 10.1016/j.bcp.2018.08.037. Epub 2018 Aug 30. Reviewwww.ncbi.nlm.nih.gov
Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients
Resident gut bacteria can affect patient responses to cancer immunotherapy (see the Perspective by Jobin). Routy et al…science.sciencemag.org
Interactions between Bacteria and Bile Salts in the Gastrointestinal and Hepatobiliary Tracts
Bile salts and bacteria have intricate relationships. The composition of the intestinal pool of bile salts is shaped by…www.ncbi.nlm.nih.gov
Zonulin Regulates Intestinal Permeability and Facilitates Enteric Bacteria Permeation in Coronary…
Several studies have reported an association between enteric bacteria and atherosclerosis. Bacterial 16S ribosomal RNA…www.nature.com
Indigenous Bacteria from the Gut Microbiota Regulate Host Serotonin Biosynthesis
Yano, Jessica M. and Yu, Kristie and Donaldson, Gregory P. and Shastri, Gauri G. and Ann, Phoebe and Ma, Liang and…authors.library.caltech.edu

Oralta: pioneering oral care through the microbiome

Americans spend over 40 billion dollars every year taking care of their oral health, yet conditions like bad breath, gum disease, and tooth decay are incredibly common. Oralta is looking to change the paradigm of oral health by going beyond the symptom based treatment of today’s products. They’re doing this by targeting the oral microbiome, restoring balance between communities of good bacteria.

I sat down with Kishore Nannapaneni, Oralta’s CEO, to learn more about how Oralta is changing oral health.

How did you become interested in microbiome science?

My first job was as a plant scientist at DuPont Pioneer when they acquired Danisco and Genencor. These were both biotech companies working with bacteria, but DuPont didn’t have a bioinformatics staff, and I was put in charge of handling it. This was my first introduction to bacteria and fungi. I loved working with them. They’re much simpler organisms. Their genes have all been annotated, so it’s easy to work with and you can see the results really fast. It’s not like plants where the genomes have not been sequenced, and you can never completely sequence them. There’s a lot of uncertainties with the plant genomes because they’re large,  have a lot of repeats, and a lot of transplants. The relative simplicity of working with bacteria made them incredibly interesting models to work with..

How did you go from working on the microbiome at DuPont to thinking about starting Oralta? And how did you and the team get together?

While I was working at DuPont, Denisco called and said they had started getting their own bioinformatics faculty. I couldn’t continue working with microbial bioinformatics anymore. I’d have to go back to my plant bioinformatics. So, I was looking for a job in microbial bioinformatics and was then hired at Bayer Crop Science where I met Patrick. I never had any problems with my teeth. Patrick, on the other hand, has had a lot of cavities, and he would complain about how he hated going to the dentist. Then, an idea came to us. We were identifying which  bacteria helps plants grow better and helps them fight fungal diseases. Why can’t we do the same for the oral space? Because of the fact that I have good oral hygiene and somebody else doesn’t means that there is a good microbiome and a bad microbiome. If we could identify the bacteria in the good microbiome and put them in people with bad oral health, then we would be able to restore their oral health.

How did that idea become a company and what product are you focused on currently?

Our first product is for bad breath, and the reason we are going for bad breath first is because we can see efficacy in just two weeks. We have a unique formulation formatted as a chewable tablet. People can take it once in the morning and once in the evening after brushing their teeth, and the bad breath levels will drop really significantly in just two weeks. This is an easy way to go directly to the market and make a name for ourselves. We have plans to develop other products in the very near future for other common oral conditions.

What lessons did you learn transitioning into scientific entrepreneurship at IndieBio?

The biggest thing for me at IndieBio was the pace. You’re always working really hard, your peers are working very hard, and IndieBio has been very helpful in pushing us to reach our weekly milestones at a rapid pace. This was the most important thing for me apart from all the connections made through IndieBio and the workshops. For me, the most important thing is that IndieBio sets the pace, and it’s up to you to actually take it beyond the program and work with the same passion and pace.

How do you think success is for Oralta a company can change the dental and oral care industry?

At this point, most other oral hygiene routines are only addressing the symptoms. For example, if you’re brushing your teeth, then you’re only reducing the biofilm and by the evening it grows back. It’s the same thing with mouthwashes, mint, and gum. They’re not addressing the root cause of oral diseases like tooth decay, gum disease, and bad breath. We are addressing the problem at the root. We’re trying to rebalance the oral microbiome from a diseased state to a healthy state. In the case of a bad breath, it’s caused by a bacteria releasing volatile sulfur compounds. Our chewable tablets will replace the odor-causing bacteria and replenish the mouth with good bacteria.

What are the big milestones that as a company you are looking to hit in the near future?

Our first product for bad breath is coming out in November 2018, and our second product for gum disease is coming out in Q2 of 2019. Lastly, our third product for tooth decay is coming in Q2 of 2019. Simultaneously, we are building an Oralta AI platform where we will be sequencing thousands of diseased and healthy microbiomes, which we will feed to a platform. The platform will then design the new generation of probiotics and therapeutics.

When you are talking about using the microbiome to design new therapeutics, how do you see this space of microbiome expanding in the future? Do you think it’s a new frontier of medicine?

There is an emerging body of evidence that suggests the role of the oral microbiome in systemic diseases like Alzheimer’s, oral cancer, cardiovascular disease, etc. This has already been established in the case of the gut microbiome. A lot of companies are already successful in the space where they’ve come up with therapeutics, and there’s an emerging body of evidence in the gut microbiome, the gut-brain access, etc. I think there is a great future for therapeutics in the microbiome space and specifically in the oral microbiome space. Our goal is to be the powerhouse of the oral microbiome space.

Watch Oralta pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream. Register here!

Filtricine: A drug free approach to treating cancer

In the last two decades oncology has seen a revolution as treatment transitions to targeted genetic drugs. Yet each therapy relies on a specific genetic profile, limiting the number of diseases it can target. Filtricine is taking a unique approach to treating cancer, targeting changes in cancer cell metabolism rather than genetics. Their approach aims to provide a side-effect free approach to treating a broad range of cancers which all share these metabolic weaknesses.

I chatted with Xiyan Li, co-founder and CEO of Filtricine about his origins and the company’s mission to revolutionize oncology.

Can you tell us a bit about how you became interested in the science of metabolism?

I’m a trained biochemist so I always understand biology from the chemical perspective. Basically, I believe that chemistry is the foundation of life. For life, you only needed two things: metabolism as the chemical foundation, alongside intelligence. If you understand the chemical foundation, you will have a really powerful solution to solve a lot of biological problems.

How did you take this theory and turn it into Filtricine?

In the world of cancer, many people are just focusing on what’s wrong in the cancer cell’s genome, what genes are mutated, and how those functions may contribute to this malignancy. It may be easy for people to forget that because cancer cells are so good at evading drugs by quickly evolving new mutations, it’s probably not the best idea or best strategy to treat them with drugs that are targeting one form of a gene function. My co-founder and CTO, Jimmy, and I, we were both working on metabolism where it is very well known that cancer cells have a very distinctive type of metabolism, which we usually call the Warburg effect. We take advantage of this change in cancer metabolism to create a new type of therapy.

Can you tell us about this new therapy that you’re taking forward into preclinical studies?

We are focusing on reprogrammed metabolism in cancer cells. Due to cancer cells rapid growth, they make a critical compromise: they give up the ability to synthesize many nutrients inside in the cell. These cells have to rely on getting those nutrients from the blood, but normal cells aren’t reliant on the supply available in blood as they can synthesize these nutrients within themselves. First, we have to find out what these nutrients are and then figure out how to take just those nutrients out of the blood, then we can achieve killing cancer cells while simultaneously leaving normal cells unharmed.

The actual product we’re making is a fully drug free nutrition deprivation diet and dialysis. We give patients a diet designed to specifically deprive the body of certain nutrients cancer requires, but are not necessary for healthy cells. The second part is a plasma-mimicking dialysate designed to further pull these specific nutrients out of the body.

How do you think this approach, if successful, can change the pharmaceutical industry?

I think that there are two things. First, we are a drug-free therapy, so we do not use any drug content and our products are a solution, a mixture of things known by the body to be non-toxic, so we can quickly customize solutions based on individual requirements. This means that it is totally customizable, yet scalable. Second, we are broad-spectrum. So far, almost all kinds of drugs are developed by targeting just one particular indication, while our products have demonstrated a broad spectrum efficacy, and it’s likely that we are hitting on a universal feature that is underlying this cancer metabolism. This means that we can actually kill a variety of cancers through attacking this common feature.

What are some lessons learned transitioning from a research scientist into being an entrepreneurial scientist here at IndieBio?

We were scientists, not entrepreneurs, before joining IndieBio, so we thought of things very differently than after going through the IndieBio program. As a scientist, you only want to be the first and that is your focus, but as an entrepreneur, you want to be the best. What you want is to figure out and execute a viable solution to make your products that are as good as possible.

What are some important milestones that you’re looking to hit in the near future as a company?

We are currently at the preclinical stage, our aim is to move to human trials as soon as possible.

Watch Filtricine pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream.
Register here!

Clinicai: Detecting Colorectal Cancer in Your Toilet

The successful treatment of cancer lies in early detection. If we can detect it as early as Phase 1 and 2, the outcomes for therapy are significantly better. Unfortunately, symptoms oftentimes will not present until Phase 3 and 4 which limits effectivity of therapeutic interventions. Clinicai is making a noninvasive monitor for colorectal cancer with a device that hooks on the side of your toilet. We asked Chun-Hao Huang, co-founder and CEO of Clinicai, about his journey as an entrepreneur.

How did you become interested in the early detection of colorectal cancer?

Chun-Hao: During my Ph.D. I built animal models mimicking human colon disease to find biomarkers and therapeutics. I was passionate about gastrointestinal biology and learned how to monitor mice’s poop every day, dissect the intestine and colon for pathology examination, and realized that, wow, the stool is actually very closely related to our gut system. I also realized that for colorectal cancer, if we can detect early, we can even use current treatments to cure this disease and every single patient would have the chance to survive.

I have now been working in cancer treatment for more than 10 years and have seen that the field puts a lot of effort into trying to develop new therapeutics. However, a lot of diseases, especially colorectal cancer, can be solved even right now if you detect it in time. But the early detection or preventative angles are not so appreciated by the field. So that’s why I started to focus on early detection because I believe the way to actually make cancer manageable today is by monitoring your body to capture the signals at the very outset so we can apply current therapies when they would be most effective.

How did you decide to start the company and how did your team come together?

Chun-Hao: I almost was a scientist for life, and I really wanted to make a big science discovery creating a way to solve cancers. When I was at the Lindau Nobel Laureate Meeting, I heard a lot of top scientists and Nobel laureates talking about the future of medicine and how to manage diseases like cancer. The meeting inspired me but I realized it is actually a very long process from research to benefiting humanity, and I started to wonder if there is a way we can speed up this process and bring biotechnology into our daily lives.

So I asked what is the best way we can accelerate scientific discovery and also bring biotech to our daily life? It’s very interesting to me that the device we use daily is a cell phone when biotech should be the technology we are using every day. I found the answer is to start a company because you can put a lot of resources into building a product actually related to daily life. I met my co-founders Medina Baitemirova, Juan Carlos Guáqueta, and Mr. Toilet Jack Sim at Singularity in NASA Ames, and later on our CTO Dr. Ya-Ju Lin. We all have different expertise, but we share the same vision that we want to detect disease like cancer early. We wanted to make the most comfortable diagnostic platform, which in the end ended up being a toilet. We want to make people actually enjoy health monitoring.

How does your technology work? What is that key insight?

Chun-Hao: It’s pretty interesting, when we started developing this technology we hoped to achieve three things. First thing, if we want to do the most comfortable monitoring and diagnostic at home, then the technology needs to be non-invasive where the user puts in the minimum effort to maximize regular monitoring. Second is digital information; we need to have a technology which can digitalize the substance we detected. Third, it needs to continuously gather the data. The most current methodology, like biomarkers or chemical methods, are not able to do that, so we started testing a bunch of different sensors. We started with a narrow range optical sensor and in the end, we find out that there is a large wavelength hyperspectral imaging originated from space technology that can help us to gather all the information from the stool.

That’s how we started using that technology to check stool samples and that’s how our technology derived. This is not just technology we can use in the lab, or in the hospital, we actually integrated that into a prototype device that will snap on a toilet. Everyone can attach that device at home, I even tried it myself. Then it can turn on when you sit on the toilet and then gather the data. I think these will be pretty powerful in the future, not only for cancer detection but also can help detect other preventable diseases.

What lessons did you learn transitioning from scientist to entrepreneur at IndieBio?

Chun-Hao: As a scientist, every day you go to a lab, you have the experiment you want to do, but some experiments could take a couple weeks or even longer. But when you are designing your experimental plans in a startup environment, like IndieBio, you need to think about how we can leverage different resources to make this process faster. That’s actually what I really like about this environment because you’re still doing the very cool science, but you have a way to speed it up. The other thing which is quite important is that here we’re thinking of how we can actually turn our technology into a real product and then benefit people’s lives. As a scientist in the lab, you try to solve problems, but you don’t usually think that this can actually work in our daily life.Since we joined IndieBio, we have started to talk to the FDA, we talked to insurance companies, we talked to doctors, and especially to the users. We are building things they really want and also doing cool science. This is what makes being a scientist-entrepreneur great.

How do you think your success as a company will change the diagnostics industry?

Chun-Hao: I used a proteomics approach when I was in college to identify biomarkers and in the past 10 years I didn’t see that many biomarkers come into the diagnostic field. I think it’s time that we need something new to disrupt this field. Before we always relied on one or two biomarkers, but at Clinicai we believe the key is to detect signatures or patterns of the disease.

That’s why at Clinicai we are trying to get signatures and patterns from your stool or urine samples and then we use the machine learning to understand those features. I think that that will change the way we think about diagnosing. The other strong advantage we have is to actually bring the diagnostic into our home. Before it’s been pretty difficult and we find our best niche at home where our bathroom and toilet have a lot of information every day. We hope in the future everyone can really enjoy health monitoring and can live longer and healthier.

What milestones are you aiming to hit in the near future?

Chun-Hao: I want to thank IndieBio because we actually met our milestones here. We’ve built our first prototype, which we never thought about that before. The milestone for next year is to improve our prototype and then work with hospitals to install the device in hospital toilets or in patients’ toilets at home to monitor their stool signals for colorectal cancer detection. After that, we plan to go through the FDA path and we are pretty positive about that. After that, we hope our device will be in everyone’s home for future health monitoring and diagnosis.

Watch Clinicai pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream. Register here!

BioROSA: Early Blood Test for Autism

BioROSA is building a blood-based test for diagnosing autism. Autism currently is diagnosed at age four, on average, with behavioral testing. Children are missing critical windows of opportunity where early diagnosis and access to treatment could improve prognosis. At BioROSA, we are mission-driven to enable earlier detection, potentially even before the child is born, in order to achieve better outcomes for children.

What got you into autism research?

John: It started way back in high school as one of my best friend’s brother has a severe form of autism. Seeing such an impaired person at an early point in my life made me wonder what could make the brain function that way, and this led me to do a lot of different neuroscience work in college. I was working on clinical studies in neurology and rehabilitation medicine for stroke and traumatic brain injury patients at UPenn for a while after college, doing some really cool brain imagining research. At Arkansas Children’s Hospital, where I worked from 2010 to 2017, I got involved in cutting-edge autism research and clinical operations while working on clinical studies involving biomarkers for detection and studies aimed at developing treatments to address core symptoms of autism. While at Arkansas Children’s, our team created one of the leading clinical and research operations in this country. It was an amazing group of scientists committed to improving patients’ lives, and the mission and values of that team live on in BioROSA. We highly value these collaborations and relationships with excellent clinicians and researchers.

What prompted you to start the company and how did you meet your co-founders?

John: Working in academia, I was frustrated with how slowly research and development progressed, and I was introduced to entrepreneurship and startup culture at a time when I was losing my passion for academic research. While we were doing amazing, cutting-edge research and changing lives for patients in the clinic, the pace of the work and the inability to treat or see patients from around the world who couldn’t afford to come to see us clinically was really heartbreaking. Though we were seeing amazing outcomes and were publishing a lot, we were too boxed in from an administrative perspective and I started to feel that we weren’t doing enough for patients in need. I feared we would never be able to truly address the autism problem from inside the walls of academia, something needed to change in order for advancements to occur. Thus, BioROSA was born. We have licensed intellectual property to commercialize a novel diagnostic test that can transform autism clinical care and diagnosis. What’s amazing is that our technology is based on what I worked on in Arkansas with a scientist I truly admire and adore, Dr. Jill James.

In working to find a co-founder for BioROSA, I had researched companies who had previously tried to do something similar. One of the most noteworthy was a company called SynapDx, in which Dr. Marie Causey was a co-founder, and when I contacted her she luckily happened to be available. It was serendipitous that she was interested in becoming co-founder and CSO at BioROSA, Marie’s experience in the startup world, in establishing diagnostic labs, and in developing clinical tests is a great fit. We make probably an unorthodox but great co-founding team. We bring different perspectives and she holds me accountable and practical for my big picture dreams!

Let’s talk about your technology. What is the key insight and how did you come up with this diagnostic?

John: We have a body of research based on over 15 years of data in which metabolic systems have been consistently shown to be abnormal in patients either diagnosed with or at risk for autism. Dr. Jill James, another co-founder in BioROSA, made the key biomarker discoveries, but the breakthrough came when our SAB member and collaborator Dr. Juergen Hahn applied machine learning to come up with a robust classification algorithm. We have obtained a global exclusive licensed to Dr. Hahn’s IP from RPI. Juergen is our number one champion and a constant contributor that is extremely hands on.

During the IndieBio program, what are some lessons you’ve learned transitioning from scientists to entrepreneur?

John: First off, I don’t consider myself to actually be a scientist but more an entrepreneur with a passion for science and improving healthcare for patients. I’m fortunate to be surrounded by amazing scientists on our team. As far as lessons learned? You must really get out there, hustle, and be a constant driving force in order to ensure your company has a chance of success. As Arvind said from day one, “nobody cares”. It is your job as a founder to make them care and show why you will change the world and why your team is the capable group that can get things done. You must have extreme perseverance, resilience, structure, organization, meticulous thinking, and as much as I hate it, patience, in order to get things going and for you to position your company into the best chance to take flight. I think that really getting outside of the office, really trying to promote your business, knowing what your customers really want, and trying to promote your cause can go a long way in getting that initial traction. Once you start figuring these things out and getting those first bits of traction can be a pivotal inflection point for your ultimate ability to scale, grow, and succeed.

How do you think the success of your company will change the way autism is currently being diagnosed?

John: We will provide clinicians with a much-needed tool that is missing in the current process for determining who’s at risk for autism and to get at-risk children into services faster than is possible today. In a way, this allows the system to be more proactive instead of reactive in diagnosis and treatment. The ultimate goal is to create opportunities that can lead to prevention, or at least more optimal outcomes, for children.

What are the milestones you’re hitting in the near future?

John: Our first milestones is to conduct a prospective clinical trial of 800 patients in a multicenter study within the next 18 months to bring our first product, an ASD screening tool, to market. The success of this opens the way for the development of our flagship product, a pediatric ASD diagnostic test that will detect autism before children ever develop behavioral symptoms. We plan to secure contracts with pharmaceutical partners to conduct studies to demonstrate the clinical utility of our test as a companion diagnostic for ASD therapeutics as well and to create a new standard of care based on biology (instead of behavior) for this challenging disorder.

Watch BioROSA pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream.
Register here!

Serenity Bioworks: Unblocking Gene Therapy Delivery

Gene therapy recently has been extremely exciting in the news. However, the limitation of gene therapy is ineffective delivery. When injecting genes to be delivered, especially in adeno-associated virus (AAV), we are seeing an induced immune response where the body starts clearing out the virus. Serenity Bioworks is working to rid the immune response and instead induce a tolerance response, allowing the AAV to be dosed and redosed as necessary.

How did you become interested in immune tolerance?

Cody: The immune system is one of the most complex things in the universe, and that in itself is incredibly interesting. There is a lot yet to figure out. The more we understand about the immune system, the better the development of therapeutics will be able to unlock the next frontier of medicine for monogenic diseases. From a holistic viewpoint, our compounds have been detected in contexts where our own cells and microbiome communicate with the immune system to induce tolerance, as well as other instances where immune tolerance is present. Serenity’s key insight and my own interest in immune tolerance induction came from doing research in this area.

When did you decide to start the company and how did your team come together?

Cody: I decided to start the company after I developed my ideas in grad school, which involved applying certain concepts I learned. I decided to raise some money to look at these ideas a little bit more. At the time, I was living with Spencer Berg, my co-founder, and I would come home and talk about what I was up to, certain grants that I’d raised, pitch competitions I’d won. And then he developed an interest as well. Eventually, we got accepted into an incubator in Canada to further develop the technology behind our company.

So how does your technology work? What was that key insight?

Cody: The key insight is understanding how your immune system decides not to attack your microbiome or your own cells. There’s a set of compounds that kept on popping up in these contexts — this is what I was looking at in grad school, though in a different way. We thought that this would be a really good solution for developing tolerance for gene therapy products.

During IndieBio, what lessons have you learned transitioning from scientist to entrepreneur?

Cody: There are so many lessons! For one, you pick up a lot of jargon as a scientist, and you’re used to communicating with scientists. An entrepreneur has to communicate to a broad range of audiences. You might be talking to an accountant, a lawyer, an investor… You will find yourself talking to people who have never heard of your field before. As an entrepreneur, it’s incumbent upon you to properly communicate to a broad range of audiences. You have to lose all of the jargon you pick up in academia and adapt.

And how do you think your success as a company will change the gene therapy industry?

Cody: We are developing an immune-compatible gene therapy. For the last 30 years, gene therapies have been combatting against the immune system. We want to work with the immune system to unlock these therapeutics. If we’re successful we will make these therapeutics safer and more effective.

What milestones are you aiming to hit in the near future?

Cody: In the near future? We’re going to wrap up our first set of studies in vivo, raise our next round of financing and conduct IND-enabling studies next year. We’re also looking to develop partnerships with pharmaceutical and gene therapy companies that are running into issues with the immune system.

Watch Serenity Bioworks pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream.
Register here!

EMBER: Distributed Emergency Response for Cardiac Arrest

Cardiac arrest is one of the most time critical conditions that can strike anywhere. For the patient, each minute until the ambulance arrives has a huge impact on survival and future medical complications. Ember Medical is solving this by connecting the millions of high-risk patients with CPR-trained medical professionals in the community. Their app alerts nearby first-responders and 911, allowing anyone with cardiac arrest to get stabilized while the ambulance is still on the way.

We chatted with Mohamed (Shadi) Wahba, Co-Founder and CEO of EMBER about the company’s origins and progress so far.

How did you become interested in digital health and emergency medicine?

Shadi: I think it all started because I lost a lot of people in my life. I lost my friend when I was 17 years old to cardiac arrest, and then I lost my mother when I was about 21. At that time I was very interested in technology and finding a way to use it to help people in times of greatest need. This was something I sat with for a long time, and I tried a lot of different projects until I found the right idea and team. That’s how EMBER came to be.

How did the company start and how did you get your team together?

Shadi: It all began on a phone call between myself and my cousin, Mo, who is a cardiologist. He wanted to improve defibrillators, and I had the engineering background to help. We came up with a plan to build a, cheaper, faster, smartphone-enabled defibrillator, but soon realized that a new and improved AED didn’t begin to solve the real problem we were trying to address. The main issue causing survival rates to be very, very low in cardiac arrest, or similar time-sensitive emergencies, is that it takes too long for an ambulance to arrive on the scene.

There are nearly 60 million Americans who are CPR-trained or medical professionals. With those numbers the odds are high one will be near a victim and able to provide life-saving support before an ambulance arrives. We realized the solution to improving survival rates was simply to notify these individuals that their help is needed nearby. After further research, we found that several countries were in the process of adopting a similar idea at a governmental level, and studies have shown that this has increased the survival rate significantly. We had the research and the technology, and we knew that this was a platform that not only had real-world potential but real-world successes.

How does EMBER work if I’m just any person off the street who wants to use your product?

Shadi: Our app is available across all app stores to anyone with a smartphone. If you are walking on the street and you or a loved one has a sudden medical emergency, you can tap the in-app alert button to notify 911 and the nearest medics around you that you need help. Of course, there may be emergencies in which your movement may be limited. Our app allows your loved ones to download the app on their own smartphones—we’ve even enabled voice activation for easier access.

What happens when your app gets notified?

Shadi: Once the alert button is pressed, we simultaneously send your location to 911 and to nearby medics. When the medic is notified, they can choose to respond with a one-tap confirmation. They are then guided through in-app navigation to your location and will provide on-site support in the form of CPR and/or defibrillation until the ambulance arrives.

Our medic network will be responding to cardiac arrest cases in our pilot phase, and will then expand to respond to other time-sensitive emergencies such as opioid overdose, hypoglycemia, and anaphylactic shock. When each minute matters, EMBER ensures that a professional from our network is on their way to help as fast as possible.

What lessons did you learn transitioning from this idea into building a company while at IndieBio?

Shadi: It has absolutely been a transformative experience for me. This all started as an off-hand idea and as what felt like a project with my cousin. It’s totally different from building a company where we now have to think about all the different dynamics involved: who we’re going to hire, how to prioritize, what needs to be built first, where to find funding. It’s a much more complex animal. But the thing I loved about IndieBio is that we always had resources to learn from—whether that was the IndieBio team themselves or our fellow startups with vastly different life experiences. The amount of knowledge that I gained about the startup world and how to manage a company through these last four months is unparalleled. I wouldn’t have accomplished nearly as much without this network. It wasn’t an easy transition, but it was amazingly valuable. I can’t say enough about how much I learned and grew, as both a person and a CEO.

What were some of your greatest successes in the first months of building Ember?

Shadi: In just a few months we’ve formed critical partnerships  to build our network of medics, increase awareness, and expand to potential userbases. What started as an idea is now a full-fledged platform backed by partnerships with the American Nursing Association, Sutter Health, and other international organizations. It is very exciting for us to have partnered with the Qatar Foundation where we will be helping to provide emergency support for the World Cup in 2022.

How do you think EMBER’s success can change the emergency medicine landscape?

Shadi: A large part of what we are doing involves integrating with 911. This is a crucial part of improving the Emergency Medical Services (EMS) system as a whole. 911 technology is very much stuck in the 1970’s and 1980’s, which doesn’t make sense when existing technology is capable of so much more. Lives are at stake. Why not use the technology we have to help the most crucial system in our lives? EMBER eliminates the technology gap and brings EMS out of the dark ages. It’s a comprehensive solution, and I do believe it will be the go-to app for medical emergencies.

We can’t afford to waste time in the multistep process of calling 911 and waiting 15 minutes for an ambulance to arrive. EMBER makes it possible to use existing technology to notify and receive help within 5 minutes. Life is our most valuable commodity, we need to make the most out of the technology we have to preserve it.

What milestones is EMBER aiming for in the near future?

Shadi: We have three big milestones that we want to achieve in the near future. The first is to grow our medic network. The more medics we have, the faster response will be and the more lives we can save.

The next will be full integration with 911 dispatch centers. Our goal is to establish a two-way communication to improve their systems for all callers. For our third milestone, we’ll focus on expanding our emergency response efforts to address all time-sensitive medical emergencies, including opioid overdose, hypoglycemia, and anaphylactic shock.

We’re excited to hit these milestones, and many more, to make EMBER the go-to resource for all medical emergency needs in the near future.

Watch Ember pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream. Register here!

Convalesce: Curing Parkinson’s Disease with Stem Cell Therapy

Neurodegeneration is one of the most devastating diseases of aging, and today there is no cure. Stem cells are a very promising way of regenerating the faulty neurons, which would potentially create a cure. Convalesce is working on injecting stem cells into the brain using a special matrix that mimics the brain’s architecture, allowing the stem cells to survive, differentiate. and reconnect those neurons for Parkinson’s patients. We chatted with Subhadeep Das, co-founder and CEO of Convalesce.

How did you become interested in stem cell research?

Subhadeep: When I was a grad student I read a lot about the potential of stem cells in regenerative medicine and I was fascinated by the things stem cell therapies could unlock. Especially so for diseases that cannot be treated using traditional medicine, or are facing certain limitations within current treatment options. Stem cell-based treatment could overcome these drawbacks and limitations, which is how I got interested in the field. It was fascinating for me to work in an interdisciplinary area and not exclusively in hardcore biology or hardcore material science. I started working at the intersections of material science, especially with nanomaterials and stem cells, and when we came up with extracellular matrices which mimic the natural tissue it was a great thing for us from a science perspective. When we found that it could potentially solve some of the very key problems of stem cell therapy for neurodegenerative diseases like Parkinson’s, we eventually came up with a therapy for Parkinson’s disease using our discovery.

How did you decide to start the company and how does your team come together?

Subhadeep: I honestly didn’t have any plan of starting a company when I began my Ph.D. At that time I was just interested in doing cutting-edge science, but eventually, when I saw the potential of the technology that we developed, I was saddened to see that academia is happy with just publishing some papers. I wanted to push it further to bring the technology to the clinic where real people would get help out of the technology. During the final years of my Ph.D., I decided to take the leap to become an entrepreneur and try to commercialize this technology. Eventually, I started participating in startup boot camps, business competitions to at least have an idea of how a startups work and what are the non-science aspects that I should think of to start with.

After I got interested in entrepreneurship, I was talking to my friends and acquaintances regarding my ideas. My benchmate from IIT Bombay, Amrutraj, got interested and he had the type of cell biology background that was complementary to the skills that I have. We decided, okay, let’s give it a shot — let’s form a company and see if we can bring this thing together to solve the pending science problems and then bring the technology to the market.

How does your technology work? What was the key insight?

Subhadeep: The fundamental insight for us was to understand how stem cells would react to their microenvironment. Subsequently, we engineered that microenvironment specifically for neurons. It was such an amazing technical insight to learn during the process, now we believe that we have a platform where we can engineer multiple tissue matrices for multiple applications. The key for us was the realization of how crucial a matrix is for regenerative medicine for any organ. Most of the biology research has been focused on cells which, while crucial, as they are will actually do the job, if you consider any organ there are a lot of support systems that play a critical role. These were sort of neglected by biologists and we tried to bridge the gap between material science and biology by engineering specific niches for organs or stem cells. This was the insight for developing what we are currently doing.

What lessons did you learn transitioning from science to entrepreneur at IndieBio?

Subhadeep: We learned a lot of things during IndieBio, especially how to run a business. We always think about science and focus on the next scientific milestones, but after coming to IndieBio, we realized that there are a lot of things we need to have an understanding of if we are to bring this therapy to the market. When we started this was just a science project, not a business. Here we benefitted by getting insights on running a business and developing a business model, an idea of manufacturing, and the regulatory hurdles that are coming for us. I’d say these are critical to running a business.

How do you think your success as a company will change the therapeutics industry?

Subhadeep: The traditional therapeutic industry works by generating drugs from small molecules, but there is a whole emerging industry focusing on regenerative medicine which encompasses both stem cell therapy and gene therapy. Even in the cell therapy space most of the companies are still focused on cell type because that’s what comes to a biologist’s mind first: how to engineer the cells and get them to work more efficiently. We are radically changing that approach by engineering not only cells but also their microenvironment. If cells get a much better environment to survive and differentiate in, then they can finally do the job they are sent in to do. I think the holistic approach that we are creating will change the way therapies are done today, the microenvironment is critical for cell-based therapies to be successful.

What milestones are in the near future?

Subhadeep: We aspire to apply our first therapy, which is a stem cell therapy for Parkinson’s, in a human brain. We want to treat Parkinson’s patients as soon as possible. Our key milestone is to do our first human trials so that we know we have a cure for Parkinson’s.

Watch Convalesce pitch on IndieBio Demo Day, Tuesday Nov. 6th in San Francisco or via LiveStream.
Register here!

Call for Applications

Biology is the next big technology and we are looking for scientists that will usher the new wave of iconic life science companies.

“Nothing is normal in the new biotech; it’s inherently cross-disciplinary and purposefully attacks preconceptions of what can’t be done.”- Po Bronson

Why Scientists?

Scientists make amazing entrepreneurs due to their technical expertise, problem solving skills, resourcefulness and persistence. Over the years, the number of life science PhDs has been rising exponentially and at the same time running biological experiments is becoming faster and cheaper. Our ability to read, write, cut, copy and paste DNA more efficiently is significantly decreasing costs and increasing speed and accessibility of experiments. Tying these trends together, IndieBio enables scientists to build radically transformative companies through our unique program.

Our Program

We take a design-driven approach to integrate product and business development in continuous feedback loops. Startups can rapidly prototype and get early customer traction at a pace that is closer to an IT startup rather than traditional biotech.

During our 4-month program in downtown San Francisco, scientists leverage $250,000 in funding with our fully-equipped labs, 300+ mentors and a galvanized ecosystem of industry, academia and investors that enables life science businesses to thrive. Our interdisciplinary team works with the companies every day to enable scientists to de-risk their science and business. Together we build the foundations of a viable and scalable business that can impact billions of people.

 

What types of companies do we look for?

We are here to fund scientists that can translate scientific insights into commercializable products that solve large scale human and planetary problems.

The biggest advantage a startup has is the precise focus on solving a problem from first principles. Our most successful founders build on deep technical knowledge with market insights that come from approaching the problem from all angles. As a result, startups create new business models, reimagine antiquated systems, or build industries from the ground up.

We welcome applications of biology for any industry. Thus far, our companies have represented the eight categories below, but we are most excited about companies that bridge multiple categories or invent new categories.

 

Therapeutics

Despite the billions spent in R&D, we continue to treat symptoms and not the causes of disease. New modalities such as immunomodulation and functional metabolomics are setting a new paradigm in drug discovery and delivery. With gene therapy we will have the ability to directly edit our own genomes to fix inherited diseases and transcend our parents’ genetic material. Across all these modalities there has been a rise in platform technologies enabling repeated target and therapeutic discovery.

Regenerative Medicine

Regenerative medicine and tissue engineering will give us control of how we treat damage to our bodies, from losing limbs to restoring loss of function from paralysis to growing whole replacement organs. Furthermore, we can intervene and reverse the processes of aging.

Neurotechnology

We are only beginning to understand the brain. New biological and digital tools are needed to understand and treat neurodegeneration and mental health. Brain computer interfaces open up new possibilities for human consciousness.

Medical Devices, Tools & Diagnostics

Early detection of diseases that can seamlessly integrate in to healthcare workflows not only enhances decision making through precise real-time biomarkers, but also, eliminates centralized labs and administrative bottlenecks that are burdening the healthcare system. The advancement of research tools is critical for unlocking new knowledge that can lead to life-saving solutions.

Future of Food & Agriculture

Food supply cannot catch up with food demand at the same time supply remains inefficient and unethical. New biotechnologies are changing the unit economics of how we produce protein. Vertical integration of food and agtech can enable us to unbundle the food supply system and increase efficiencies of production.

Consumer Biology

Driven by faster and cheaper science, companies will bring biology direct to consumers in an increasingly personalized manner. The first human genome cost $2.7B. Today people can order an at-home sequencing kit for $100. Products are increasingly putting the power in the hands of the consumer to manage their own health.

Computational Biology, BioData, & AI

Biology is rich with data and complexity and companies are increasingly leveraging bio-processes with machine learning and automation, creating bio-feedback-loops to optimize each stage of a life science company: from discovery to manufacturing.

Industrial Biology, Biomaterials, & Clean Biotech

Not only is our demand for commodities unsustainable, the industrial processes for converting commodities into everyday products remains inefficient. Biology is inherently versatile and scalable. Cells, the building blocks of life, live to divide, and under the right conditions they can be engineered to create bio-materials and novel commodities that can then be scaled exponentially using fermentation without harming the planet.

 

Our Application Process

Online Application. Our application process begins with an online submission at http://indiebio.co/apply.

Technical due diligence. Selected companies are invited to a 30-minute video interview that focuses on technical due diligence. We encourage applicants to ask questions about the IndieBio program throughout the process.

De-risking milestones. If the first call is favorable, our team will set up additional calls to discuss the product, the business plan, and discuss the derisking milestones that the company aims to achieve by the end of the 4-month program. Often, homework is assigned to address certain questions. Once discussions are mutually favorable, an offer is made.

Deeper look into how do we evaluate companies. We evaluate companies based on five key questions.

  1. What is the technical insight that gives you an unfair advantage? This is often the core technology that can be patent-protected, whether it is licensed from an academic institution or developed in-house. What advantages does your technology have over competing technologies? How does your technology address the core problems you are trying to solve?
  2. How is the insight made into a product? Science itself is not a product. Product development starts with understanding the end user. What problem are you solving for the end user? What is the form factor? What is the workflow? What are the parameters for a successful drug? What product do you focus on first when you have a platform technology?
  3. How does the product form a sustainable business? What is the go-to-market strategy for roll-out when the startup is cash limited? How to gain adoption? How to navigate regulatory pathways?
  4. Can this business make $1 billion or touch the lives of 1 billion people? Venture capital investment seeks the potential for big returns and big impact.
  5. Is this the team to make it all happen? Arguably, the most important aspect of selecting teams at an early stage is the founders themselves. Do they have the experience and expertise to turn their technical insight into a viable business and propel the company into a flourishing venture? We look for founders who are coachable, able to make decisions rapidly, take responsibility, are resilient, and are passionate about their work. We look for founders who are self-aware and possess a growth mindset.

The interview style is informal conversations and we often instill a mini preview of the IndieBio program during the interviews. Our application timeline is rolling, with set deadlines that batch the interviews. We encourage applying early and sending periodic updates of progress even if you don’t hear back immediately. Updates are also encourage between interviews as it could take time for both sides to come up with good strategies. We also encourage re-applications if you were not selected for one class. Some of our most successful companies reapplied 6 months later with significant momentum. Most ideas and teams will take a while to mature. (Read “I have an idea. What’s next?” for the starter checklist.)

Lastly, we encourage you to due diligence on us. Learn more about our story and our program featured in Neo.Life. Attend or livestream our next Demo Day on Nov. 6th at the Herbst Theatre or watch the previous ones on Youtube. Talk to founders of any of our alumni companies or attend an event at our space.

 

Apply Now!

We look forward to hearing your world-changing idea! Apply now at http://indiebio.co/apply!

MezoMax: The Solution for Slow and Difficult to Heal Bone Fractures

mezomax

Over 600,000 people suffer from slow and difficult to heal bone fractures within the U.S. every year. These ‘non-union’ fractures are common in people with low and imbalanced hormones, such as the elderly, but may also result from infection, inadequate blood supply to the bone, and incorrect splinting. Surgery, which has a low level of success, is the current standard of care. Full recovery from non-union fracture surgery is rare and repeat surgeries are often required.

MezoMax created a first of its kind, convenient, twice daily oral formulation called MMX that works by delivering calcium directly to the bone producing cells to accelerate healing and provide for more complete bone union in non-union fractures. We asked the founder and President of MezoMax, Dmitriy Rybin, PhD., about his discovery and subsequent founding of the company:

How did you become interested in science?

DR: Science is really a tool to better structure and simplify ideas; it is also a means to channel one’s innate curiosity. I’ve always been curious about the variety of the world. My curiosity about our world is diverse, ranging from not only physics and science, but also includes non-scientific exploration. However, it is my scientific training that has allowed me to simplify and connect common principles based upon these experiences.

When did you decide to start a company, and where did your team get together?

DR: My team and I decided to officially start our company a year ago, but this is actually the result of a five year collaboration between my colleagues here in the US and in Russia. I have often thought about starting a company during my 30-year journey in science with my co-founder Dr. Girgoriy Konygin. Our shared work at the Russian Academy of Sciences has been rewarding and is the basis for our company.

How does your technology work?

DR: Our technical approach is based upon fundamental principles of solid-state chemistry reactions that take place under external mechanical loads. Sometimes although the chemical composition of a drug remains unchanged, the molecular crystal is transformed into a new state with unique physical and chemical properties, including a significant increase in biochemical activity. Using this approach, it is possible to obtain new pharmaceutical forms that may not otherwise be possible using traditional methods of fine chemical synthesis or which might otherwise be too expensive to produce.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

DR: Entrepreneurship is a very practical, applied endeavor. An entrepreneur needs to quickly figure out who needs our product, and this became much more important to me when I started thinking like an entrepreneur. It seems rather simple, but it’s not. It’s a pretty big mindset shift. More over, it’s necessary to talk about our product in simple and clear language, and not to use ‘science speak.’ Customers need to understand what our product is and why it’s important to them. Learning to make the extraordinary and complicated be understandable, while still keep it exciting, is no small feat! We could not have adapted to this new way of thinking and articulating our value proposition as quickly as we did without the steadfast support and constant counsel of the IndieBio team. We are and will continue to be grateful for their expert advice.

How do you think your success as a company will change the medical industry?

DR: On the surface, what we do appears to be so simple! In reality, what we’ve done is to create a new and important platform for drug creation, one which is based upon solid-state mechanochemical synthesis. This approach can be used to create new pharmaceutics that were not previously possible or that were too expensive to produce. As such, we believe our approach will continue to be an important basis for much of the future for creating new pharmaceutical treatments.

What milestones are you aiming to hit in the near future?

DR: MezoMax intends to introduce our first compound, MMX, to the US in 2022 for treatment of non-union fractures. Given the extensive clinical safety and efficacy data, we are pursuing an abbreviated approval process based upon the expert advice of four independent regulatory experts. Therefore, one of our first important milestones will be for us will be to meet with the FDA to confirm this viability of our regulatory strategy by March 2019 with the intent of filing our IND by July 2019. We expect to receive our NDA early in 2022, leading to our subsequent product launch.

Watch MexoMax pitch on IndieBio Demo Day, Tuesday April 17th in San Francisco or via LiveStream. Register here!

Terramino Foods: Fungi as an Alternative Protein

Killing an animal and eating its flesh is not the only way to gain protein. Now more than ever, we need alternatives to conventional animal farming and fishing—not just because of animal welfare, but for human and environmental health. What’s happening now is not sustainable.

Terramino Foods uses fungi as a complete protein source which acts as a seafood alternative. Described as healthful, protein-rich, sustainable, ethical, and delicious, the company is working to help people reimagine meat and seafood with fungi, that has the proper taste, texture, and nutrition. We asked the company’s founders, Kimberlie Le and Joshua Nixon, more about their mission:

How did you become interested in science?

I don’t think either of us can remember not being interested in science. We think that science can be boiled down to just being curious and seeking answers about things around us.

When did you decide to start a company, and where did your team get together?

We started Terramino about a year ago upon completion of the alternative meat lab program at UC Berkeley which supports and helps scientists and engineers build a better food system through fixing the problems with animal agriculture/meat.  

How does your technology work?

We use fungi as our alternative protein source that creates well textured, nutritionally similar, amazing tasting seafood and meat products. We are starting with salmon and seafood products which have increased human and environmental health concerns.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

We had already been quite immersed in entrepreneurship through UC Berkeley at the Sutardja Center for Entrepreneurship, however starting a company has been a learning experience in that there are always a million tasks to juggle and only a limited amount of time and resources. The biggest lesson we learned is that execution is the name of the game (thanks, Arvind) and our goal is build a transformative company that truly disrupts that way people consume meat and seafood.

How do you think your success as a company would change the seafood industry, and our environment?

We aren’t just going after seafood – we want to make a large impact on animal agriculture as a whole since it has detrimental impacts on human, animal, and environmental health. Our goal in the long run is to be able to provide a sustainable, nutritious, tasty, and most importantly accessible source of protein for every person on the planet.

What milestones are you aiming to hit in the near future?

We are going to be scaling up production in a few phases and making our processes more efficient to be competitive on price with seafood and meat products. We also want to work on formulation of a range of products that are delicious for plant and meat eaters alike, and all the picky eaters in between. Developing our product line and marketing/branding are also very important since there is a crucial education component to our products.

Watch Terramino Foods pitch on IndieBio Demo Day, Tuesday April 17th in San Francisco or via LiveStream. Register here!

Sun Genomics: Precision Probiotics Based on Your DNA

It all begins in the gut. We know that a balanced gut microbiome is key to a healthy (and happy) life. Probiotics, ingestible products that contain healthy bacteria and yeast, are available for people to buy and help with their digestive issues. But not all probiotics are created equal.

Sun Genomics found that an individual’s genome can help identify which probiotic strains are best for the person. By creating personalized probiotics, the company can eliminate the guesswork that’s involved with buying probiotics off the shelf and help people regain control of their health. We asked Sunny Jain, the company’s founder and CEO, more about their personalized probiotics:

How did you become interested in the gut microbiome?

SJ: I’ve studied Microbiology for a decade now and have always had interest in gut health. However, the real turning point was in early 2016. My son was suffering from a dysbiosis and when I went to the local grocery store to pick up a probiotic, I was faced with the realization that the consumer products on the shelf were utterly confusing. I had no idea what to choose between CFUs, strains, and the refrigerated section. So instead of picking up one probiotic, I grabbed tons off the shelf and began testing them in the lab.  My concerns were validated when the store-bought probiotics did not contain the strains listed on the bottle and failed to survive the gastric system. At that point, I custom formulated a probiotic for my son, alleviating his gut health issue. I realized that targeted probiotics were 8 times more specific and I could ensure they worked.

Sunny Jain
Sunny Jain

When did you decide to start a company, and where did your team get together?

SJ: I began the company by myself in 2016, but once I realized that I had an affordable solution for the world’s health issues, I began hiring key members of my team. We came together in a relatively auspicious way. For example, I connected with our bioinformatics hire, Thibaut Montagne, when he began following Sun Genomics’ Twitter Account.  We began building the team rapidly after Thibaut and all the pieces began to fall into place.

How does your technology work?

SJ: Sun Genomics uses next generation whole genome sequencing and a patented bioinformatics and data platform to process and analyze the DNA of its customers’ gut microbiome. We leverage existing data compiled by the Human Microbiome Project and American Gut Project and integrate that information into our existing technology. Our vast database of over 100,000 genomes allows our team of microbiome scientists to make calls related to not only bacterial strains but fungi, parasites, and viruses found in the gut microbiome, thereby allowing us to create custom probiotics for the end user.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

SJ: IndieBio and its team challenged us to think bigger and innovate quicker. In order for me to share my findings with the world, I was going to have to move from just being a laboratorian to a entrepreneur. During our four months at IndieBio we experienced more growth than over the previous 14 months as a company. We developed and filed additional intellectual property, grew our customer base by 1000%, and hired several key employees to assist us with our growth.

How do you think your success as a company would change the healthcare industry?

SJ: At Sun Genomics we believe, as did Hippocrates, that “All Disease Begins in the Gut.” Billions of people worldwide suffer from disease states and chronic conditions that both Eastern and Western medicine have been unable to diagnose and treat. We believe the gut microbiome holds the key to alleviating some of these conditions including; arthritis, Chron’s, lupus, diabetes, IBD, IBS, colitis, obesity, and perhaps even certain types of cancers. As a microbiome health company, our vision is to not find really expensive solutions for only a few, but affordable solutions for billions of people.

What milestones are you aiming to hit in the near future?

SJ: Sun Genomics is experiencing unprecedented customer growth and soon will announce additional partnerships, publications, and commercialization milestones. We are well on our way to analyzing 10,000 microbiome profiles and becoming a leading contributor to microbiome science. We have developed core technology that is beyond probiotics. Come hear about our newest innovation at IndieBio Demo day on April 17th.

Watch Sun Genomics pitch on IndieBio Demo Day, Tuesday April 17th in San Francisco or via LiveStream. Register here!

Neurocarrus: Treating Pain Without Addictive Opioids

Neurocarrus

Traditionally, people in pain are given Opioids—which, although they relieve pain, can have dangerous side effects such as loss of motor function, and addiction. Ocycontin, Vicodin, and other pain relievers are effective in subduing pain, but they are extremely addictive, which causes major problems in families and communities.

The Opioid Crisis is a reality we’re facing now—but what if pain could be treated another way? That’s exactly what Neurocarrus has been working on. Their new drug delivery technology safely disrupts pain signals without possessing addiction-forming qualities. We asked the company’s CEO, Benjamin Pavlik, more about how this works:

How did you become interested in biotech?

BP: After having reconstructive surgery on my knee in college, replacement of ligaments and anchoring with bio-diffusible and titanium screws allowed me to run again. It was an amazing success, but difficult. This experience changed my life in many ways, and I became interested in working on technology that would be useful for others experiencing similar procedures.

When did you decide to start a company, and where did your team get together?

BP:  My former PhD advisor and I decided to start a company at the University of Nebraska, Lincoln when we realized the incredible potential for this technology.

How does your technology work?

BP: Neurocarrus has developed an injectable non-opioid pain drug called N-001. N-001 is a novel protein that was synthesized to target key sensory neuron structures called actin. It is designed to disrupt peripheral pain signaling without affecting motor function or causing addiction.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

BP: Transitioning from science to entrepreneurship is challenging but rewarding. The communication skill set is different, and it takes time to learn and adjust. Once technical terms are replaced or simplified, sharing science with our greater society enables the research to reach a broader audience to learn and benefit.

How do you think your success as a company would change the healthcare industry?

BP: Our success as a company would change the healthcare industry by providing an alternative to opioids as a front-line pain management solution. This would give millions of Americans who live with pain a less difficult choice and in turn reduce substance abuse.

What milestones are you aiming to hit in the near future?

BP: We are aiming to test N-001 in an advanced animal pain model. A positive preclinical outcome would support clinical trials.

Watch Neurocarrus pitch on IndieBio Demo Day, Tuesday April 17th in San Francisco or via LiveStream. Register here!

JointechLabs: Point-of-Care Cell Therapy

JointechLabs

Stem cells have been a key source of innovation in regenerative medicine, because they possess the ability to self-renew. Adult stem cells are found within the human body, in bone marrow, tooth enamel, and other locations. When someone is injured, the inflammation from the injury acts as a signal for the stem cells to become activated. The stem cells heal the body by traveling to the affected location and changing into the cells that have been damaged.

This process doesn’t always work fast enough to heal all injuries, so stem cells can be manually harvested from areas where they are abundant, and transferred to areas in the body where they are needed. JointechLabs have created a device which makes this process more accessible and affordable for doctors and patients everywhere. We asked Nishit Pancholi, the President and Chief Medical Officer at JointechLabs, more about the company:

How did you become interested in biotech?

NP: We were always interested in the potential of harnessing the natural healing powers of the human body, and use that to enhance healing, and regeneration. It is painful to see near and dear ones continue to suffer from orthopedic problems or non-healing wounds after receiving conventional treatments. Improving science so that one’s own stem cells can be more accessible to help these patients heal became the founding mission of JointechLabs.

When did you decide to start a company, and where did your team get together?

NP: In 2010, Dr. Nathan Katz, who has extensive experience in stem cell biology, started JointechLabs with Felix Pustilnik, who has experience in business and sales. I have a background in medicine with a focus on clinical applications of stem cells, and I joined the executive team as a co-founder later.

How does your technology work?

NP: JointechLabs has created a device to provide stem cell therapies on demand, in a doctor’s office, for 1/10 of the price of conventional alternatives. Although stem cell therapies have been shown to have tremendous potential and efficacy in treating a variety of illnesses, they are currently underused, as the facilities and doctors that are capable of delivering them are few and far between. Stem cells are not easily transported, and so patients often must travel great distances in order to be treated; so inevitably the treatment is also incredibly expensive.

Our technology enables doctors to practice stem cell therapies and allows for development of stem cell therapies for medical indications with unmet medical need. Our device provides access to a high quality cell fraction at the point-of-care, therefore, a doctor can offer cell treatments in the regenerative medicine segment. Going further, our cell therapies will provide treatments for medical indications with unmet medical needs: orthopedic indications, wound healing, vascular indications.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

NP: Stay focused on what’s important for the company development and progress. Identify and clarify your product, development roadmap, regulatory aspects, market strategy and risks mitigation of all listed. Develop an understanding of the costs associated with each step. Prepare for prospective company growth: HR, legal, etc.

How do you think your success as a company would change the healthcare industry?

NP: Patients will receive access to effective treatments for indications with unmet medical needs. Since the condition will be treated in the early stage of development, the cost of indication life-cycle will be reduced dramatically, providing direct benefits to the insurance companies and, therefore, to the patients.

What milestones are you aiming to hit in the near future?

NP: FDA 510K approval for our medical device and brining the device to doctor’s offices. RMAT (Regenerative Medicine Advanced Therapies) FDA designation for our stem cell therapies.

Watch JointechLabs pitch on IndieBio Demo Day, Tuesday April 17th in San Francisco or via LiveStream. Register here!

Onconetics: Genomics-Informed Drug Design

Onconetics
Onconetics

Science is catching up with cancer. We are in a new era of personalized medicine for diagnosing and treating patients, now zooming in even closer, on an individual’s genome. By understanding the genetic causes of cancer, and measuring the differences between someone’s cells that are affected by cancer with the ones that are not, Onconetics can leverage the regulatory network of the cells and create a trigger for a kill gene that only activates within cancer cells. We asked Gabe Hitchcock, the company’s COO and co-founder, some questions about how this all works:

How did you become interested in biotech?

GH: Luke and I became interested in biotech through our own channels, him through his father at UCSF and me through my own undergraduate research in neuropharmacology. Though we had different beginnings, our journeys led us to the same question: how do we make better drugs for patients? Luke and I strongly believe that the key to better treatment lies in the patient’s own genes.

When did you decide to start a company, and where did your team get together?

GH: After months of deliberation, we started the company in the fall of 2016. For the first six months of the company, I was finishing up my B.S. at Oberlin College in Ohio, so I would fly out of Cleveland on weekends to meet Luke in San Francisco, Washington D..C, or New York as we built the company and our network.

How does your technology work?

GH: Our technology is predicated on the understanding that genetics determine the advent and progression of cancer. The hypothesis was simple: what if we could use these unique biomarkers not only to diagnose cancer, but also to guide the development of our drug? In essence, to create a drug that works only within the genetic environment of our choice. This is exactly what we have done at IndieBio: we have engineered a drug that selectively kills cancer cells without impacting healthy tissue. We call this approach Genomics-Informed Drug Design and we see it as the future of medicine.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

GH: Science is a highly iterative process. Ideally, one experiment tells you one thing that informs the next experiment… and on and on and on. When we first started out as entrepreneurs, we applied the same approach. We absorbed all the feedback we could in one go, went back to the lab and restructured, then did it again. However, the same perfectionist approach used in R&D does not always bear fruit in entrepreneurship. It’s easy to get lost in the details and caught in a cycle of endless restructuring. IndieBio helped us hone in on what really mattered: our story, our community, and getting out there. In a sentence, IndieBio helped us get out of the lab and into the Valley.

How do you think your success as a company would change the medical industry?

GH: There’s no point hiding it: what we’re doing is entirely new and disruptive. The success of our company will cause a fundamental shift in the way the medical community treats patients. We’re not screening a single molecule against 1,000 cell lines to see what sticks, nor are we tweaking a chemical a 1,000 different ways to best block a pathway. What we are doing is engineering a drug from the ground up to target cancer. In 15 years, Genomics-Informed Drug Design will be the standard of medical treatment.

What milestones are you aiming to hit in the near future?

GH: In the near term we are planning on transitioning into our own lab space in the Bay Area, making key hires, and moving our therapy closer to IND. Because we are taking a bioengineering approach to medicine, there is also a lot of optimization that needs to be done. This means long hours in the lab, but each new experiment brings us that much closer to the ultimate goal: an accessible, scalable cure for cancer.

Watch Onconetics pitch on IndieBio Demo Day, Tuesday, April 17th in San Francisco or via LiveStream. Register here!

Nivien Therapeutics: Cutting Through Cancer’s Shield

Nivien Therapeutics
Nivien Therapeutics

Cancer cells have defense mechanisms that can cause chemotherapy and other standard cancer treatments to become increasingly difficult for a patient to endure, as stronger drugs are often needed after the cancer cells adapt. Instead of killing cancer cells with stronger drugs, Nivien has a found a way to break down the defense mechanisms of cancer cells by first watching their response to drugs, and then designing small molecules that act against the specific defense mechanisms that the cancer cells are observed to be using. For this reason, Forbes recently called Nivien’s technology “The Trojan Horse of Cancer Treatment”. Nivien’s approach will allow existing drugs to become more effective. We asked the company’s co-founders, Nikita Shah and Nathaniel Brooks Horwitz, a few questions:

How did you become interested in biotech?

Nikita comes from a clinical perspective, preparing for medical school, working as an EMT, and shadowing oncologists. She also built a better preclinical model for testing small molecules (the same class of drug that Nivien is developing) in a biomedical research lab at Massachusetts General Hospital. Nathaniel worked in three biomedical research labs (Boston Children’s, Harvard Stem Cell Institute, Harvard Medical School) and at RA Capital, a biotech venture capital firm. We came together around a shared passion for translating important biomedical research into new medicines for patients.

When did you decide to start a company, and where did your team get together?

We began Nivien under the mentorship of Dr. Derrick Rossi, the scientific founder of Moderna. We decided to start the company when key academic discoveries converged around the importance of our target in cancer resistance. After raising initial venture funding, we recruited Dr. Ken Fang, a principal scientist from Allergan, and Dr. Dharmendra Singh, a veteran cancer biologist from UCLA, Houston Methodist and the NIH.

How does your technology work?

Rather than directly killing cancer cells, Nivien targets the shields that protect cancer from existing treatments. Nivien develops small molecules that inactivate the first upstream regulator of many proteins responsible for the failure of dozens of FDA-approved cancer treatments. We will combine Nivien molecules with existing drugs to create a better reformulated product that has higher effectiveness and lower side effects than current options.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

We learned that science moves much faster at companies than in academia. We also learned to focus on doing “the killer experiment” at each step to prove or disprove a theory as quickly as possible, rather than spending time and money on auxiliary experiments that provide support but not clear answers.

How do you think your success as a company would change the medical industry?

Our mission is to dramatically improve the standard-of-care in cancer therapeutics.

What milestones are you aiming to hit in the near future?

We are filing key patents, establishing partnerships and hiring new team members to fill critical roles moving forward.

Watch Nivien Therapeutics pitch on IndieBio Demo Day, Tuesday, April 17th in San Francisco or via LiveStream. Register here!

Photo credit: IndieBio

Antibiotic Adjuvant: Transforming Antibiotic Use from Chaos into a Coordinated Campaign

Although doctors mean well by prescribing antibiotics, we can’t ignore the fact that antibiotic resistance as an effect of overuse has become an overwhelming problem in the healthcare industry and elsewhere. The situation can appear hopeless to some, but the team at Antibiotic Adjuvant sees it as a challenge they are willing to accept. They have developed software that works with the doctor at point-of-decision, along with the patient’s specific information and information about the facility itself, transforming antibiotic use from chaos into a coordinated, conscious campaign. Using the correct methods, antibiotic resistance therefore becomes preventable. We asked David Flores, the co-founder and CEO of Antibiotic Adjuvant, and Dr. Robert Yancey Jr, the company’s co-founder and Medical Director, to tell us more about their motivation and how it all works:

How did you become interested in healthcare?

DF: When I was a little boy, I wanted to be just like my father, a doctor. However, after being in the O.R. couple of times, I decided to study something else. The bug never seemed to fade on me though. While having another business, I found myself talking to doctors and doing apps in the healthcare space. After learning about this problem from Bob, our Medical Director, I just couldn’t believe how crazy it is that antibiotic resistance is growing so rampantly, and that no one seems able to control it—even though it is preventable!

RY: I have wanted to be a doctor since I was eight years old. It is a gift and a privilege to practice medicine. Infectious Diseases is by far the most interesting sub-specialty in medicine.  It is a little like being Sherlock Holmes. Seeing patients in the hospital getting substandard antibiotics so frequently made me think that there has to be a better way, and as a consequence, I have been working in the field of Antibiotic Stewardship for over 20 years.

When did you decide to start a company, and where did your team get together?

DF: Preventing the increase in antibiotic resistance is a very compelling problem that can be prevented by applying new technologies to existing systems. After doing couple of prototypes and getting good feedback from doctors and nurses, we decided it was time to tackle this problem. We started working in Gainesville, FL and relocated to San Francisco to improve our chances of making this idea a reality while doing IndieBio.

RY: I have been kicking this idea of how to codify algorithms for improved and coordinated antibiotic use for many years, after it became obvious that current methods of Antibiotic Stewardship were inadequate.

How does your technology work?

DF: We have created a software that reduces the time it takes a doctor to prescribe antibiotics, improves communications between pharmacists, doctors, and nurses; saves the hospital millions of dollars in unneeded procedures and loss of funding, and improves patient outcomes. We can do this by improving the way antibiotic stewardship programs are implemented in a health center. Our software uses input from the electronic medical records, lab reports, and other reports to provide personalized antibiotic recommendations for a particular patient and facility. We take into account the health center’s microbiome and create a coordinated antibiotic campaign to prevent antibiotic resistance from occurring in the first place. Since we are with the doctor at point-of-decision, we can affect virtually every patient in the facility and provide true comprehensive antibiotic stewardship.

RY: The basic premise is that given sufficient, easy to understand information, the busy physician will do the correct thing, especially if it is fast. In addition, modern analytics can help even the most knowledgeable physician make better decisions. The fields of Quality Assurance and Infection Prevention are enhanced by identifying and predicting all adverse events and infections in the facility, not just those with a positive culture, and their predisposing factors.  Administration can identify methods to reduce costs that were not visible before. Patients have better outcomes. Win-Win!

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

DF: The main difference I see between science and entrepreneurship is the market forces. In the market, you have to take into account the feasibility of the science but also the costs to create the product. The profit margins have to be healthy, and your customers must want to use your product. The market will reward companies that take these three pieces into account when commercializing a technology/idea.

RY: Saving lives and costs is a great product, but we have to demonstrate that we can execute. IndieBio has helped us execute in so many ways. They have pushed us to be the best we can be, not just an idea.

How do you think your success as a company would change the medical industry?

DF: We will fundamentally change the way antibiotic prescriptions are made in the world. In the future, people will be able to go to the hospital and not acquire an infection while receiving treatment because health centers will not have rampant antibiotic resistance as they do today.

RY: We will transform antibiotic use from chaos to a coordinated conscious campaign to minimize resistance and complications. More intelligent antibiotic use means a safer, more effective, less costly healthcare system.

What milestones are you aiming to hit in the near future?

DF: We are aiming to arm skilled nursing facilities with tools to improve their antibiotic stewardship programs and then start doing a pilot in hospitals.

RY: Out first installation into a skilled nursing facility is underway, and we will reach at least 100 more facilities within 10 months. CMS requirements for Antibiotic Stewardship and Infection Control will drive our sales. Testing in acute care hospitals will begin in early 2019 with demonstration of financial and patient safety benefits within months after that. At that point, AA will add physicians’ offices to the campaign to monitor and control resistance in entire communities. It’s a big goal, but doable according to the CDC.

Watch Antibiotic Adjuvant pitch on IndieBio Demo Day, Tuesday, April 17th in San Francisco or via LiveStream. Register here!

Stelvio Oncology: Live Imaging For a Paradigm Shift in Drug Screening

Stelvio
Stelvio

It’s been clear for some time that a personalized approach to cancer treatment is key in overcoming the disease. Since certain types of cancer, like glioblastoma (brain tumors), have been found to be resistant to chemotherapy, new (and less toxic) approaches are desperately needed to combat the resistant cells. Stelvio is a company with a unique approach to identifying the resistance mechanisms of cancer cells, and overcoming them with targeted therapies for the individual patient. The company’s founder and CEO, Attila Hajdu, explains more:

When did you decide to start a company, and where did your team get together?

AH: We decided to start Stelvio Oncology in May 2017. While we are a relatively new company, we have had a number of major accomplishments which include an invitation to join JLABS San Diego, which is Johnson & Johnson’s innovation centre, where we will be based starting on September 26, 2017. Being a JLABS company exposes us to the ecosystem of J&J’s innovation centre and potential collaborations with the incubator companies as well as J&J. We are also in the middle of an evaluation process with Sanofi to utilize our technology to identify novel targets and molecules in Huntington’s Disease, which opens the door to the formation of Stelvio Therapeutics. We’ll begin the evolution to this new name over the next few weeks.

What problem are you aiming to solve with Stelvio Oncology?

AH: The main problem in cancer remains resistance to chemotherapy based regimens which leads to loss of response to treatment and no viable options for patients afterwards. Not only is chemotherapy based treatment ineffective in cancers like glioblastoma, breast, and lung, but it is also highly toxic. So we are addressing the problem that there is no cure for cancer and ineffective/toxic treatments are still used which give incremental benefit.

The problem we are solving with our work in neurodegenerative diseases is current treatments are ineffective in Huntington’s Disease, which is a neurodegenerative genetic disorder that affects muscle coordination and leads to cognitive decline and dementia.

How does your technology work?

AH: Our technology works by labelling histones within the nucleus which gives each cell an epigenetic fingerprint akin to a bar code, and then we can visualize the changes small molecules or drugs have on the cells using live imaging. This is a paradigm shift in drug screening for disease because it represents a 100 fold improvement in the precision of high throughput screening of proprietary drug libraries.

How did you become interested in biotech?

AH: I became interested in biotech after spending 20 years in big pharma mainly with GSK. I had a strong drive to become a catalyst for change, to solve problems that have a positive impact on people, that could improve their lives for the better.

What lessons did you learn transitioning from science to entrepreneurship at IndieBio?

AH: There were many lessons learned at IndieBio. One main lesson is that clarity creates confidence which was Arvind’s saying over the course of the program. One of the biggest challenges for us has been to explain what we do in a simple manner so that investors could understand and more importantly, write us a check! We’ve learned to communicate more effectively with investors in a simple and meaningful way.

How do you think your success as a company would change the medical industry?

AH: Success for Stelvio would mean ripping cancer out of the pages of medical history books within our lifetime. The same applies to neurodegenerative diseases although this success may not happen within our lifetime!

What are the milestones you’re looking to hit in the near future?

AH: Key milestones are demonstrating that we are stopping tumor growth in vitro and in vivo, screening Johnson & Johnson’s proprietary libraries while housed within JLABS to discover hits which we could further develop into lead candidates, screening Sanofi’s proprietary drug libraries against Huntington’s Disease and potentially other targets such as Multiple Sclerosis, Alzheimer’s, and Parkinson’s Disease, and importantly, closing a seed capital raise of $4 million to fund these milestones.

See Stelvio pitch at IndieBio Demo Day on September 14th in San Francisco or via Livestream! Register here.

Pictured above: Stelvio CEO Attila Hajdu (left) and CSO Alexey V. Terskikh.

DNALite: A New Age of Medicine Is Emerging

DNALite

What if instead of undergoing life-altering chemotherapy or surgery, a patient could take a daily pill to fight cancer? That’s the ultimate vision of DNALite, a new biotech company that wants to actually prevent instead of manage symptoms. Their technology aims to deliver genetic cargo to areas of the body that are hard to reach, giving them the properties they need to kill of the cancerous cells and empower healthy ones. The company’s co-founder Timothy Day explained more:

What problem are you aiming to solve with your company, DNALite?

TD: We are treating diseases for patients that currently have very few treatment options. We are a gene therapy company, and by delivering the correct genes to the necessary cells in the body, we are able to treat the cause of the disease—not just the symptoms. We are focused on tissues that are protected by mucus barriers, like the gastrointestinal tract, lungs, and cervix. The mucus is a necessary protective barrier for these tissues, but it also makes drug delivery a challenge. We are able to overcome this challenge with our technology and are focused on first treating a genetic disease that leads to a 100% chance of colon cancer by age 40.

When did you decide to start a company, and where did your team get together?

TD: We met as students in early 2016 at UC Berkeley. Mubhij had the idea of doing gene therapy for this particular form of colon cancer, and I was working a PhD thesis focused on overcoming physical barriers for gene delivery. We both share the core belief that a new age of medicine is emerging that we want to be part of, and if we have an idea that can help a large number of people we have an obligation to try out that idea. So, we started working on the company on nights, weekends, and in between classes, and haven’t looked back since.

How does your technology work?

TD: We both have virology backgrounds and were inspired by the properties that let viruses penetrate through mucus and deliver genetic cargo to cells. We translated these properties to a non-viral gene delivery system that allows for the delivery of genes to cells protected by mucus for the first time. For our first target indication, the gene that is delivered restores normal tumor suppressor function in cells. For the cells that are already cancerous in this disease, it leads to the cells being killed off or lost, and a regression of the tumors. For cells that are still healthy, it empowers them to suppress cancer mutations and prevents them from becoming cancerous in the future. The vision for this treatment is that instead of these patients undergoing life-altering major surgery and/or chemotherapy, they can just take a daily pill that restores the body’s normal ability to fight cancer.

How did you become interested in biotech?

TD: The appealing thing about biotech is that it is by necessity an applied science, so we are able to take the brilliant biology and chemistry research that has been performed to-date and channel it into something tangible that can change patients’ lives. We also get the privilege to work with top scientists, physicians, and business people to make brand new treatments that treat the cause of the disease and not the symptoms.

What was it like transitioning from science to entrepreneurship?

TD: When starting a new company each person has to wear many hats. Learning to balance all the necessary tasks simultaneously in addition to doing good science is a skillset that has to be learned. As scientists, we tend to carve systematic stories that are only read by a few people in the field, but as entrepreneurs we have realized the importance of selling the vision behind the science.

How do you think your success as a company would change the medical industry?

TD: Many patients with genetic diseases have zero therapeutic options and are either told by doctors that there is nothing that can be done for them or that they have to go through devastating medical procedures that only treat the symptoms of the disease or simply serve to control inflammation. We are actually targeting the cause of the disease and not just the symptoms. This provides medical a new option to patients that is safe, therapeutic and preventative.

What are the milestones you’re looking to hit in the near future?

We have demonstrated efficacy for our first indication in a rat model of the disease. This was one of the first gene therapy attempts for this disease. We are in the process of using that data to optimize our modular system to reach an efficacy endpoint that provides patients with the most meaningful clinical outcome.

See DNALIte pitch at IndieBio Demo Day on September 14th in San Francisco or via Livestream! Register here.

Pictured above: DNALite co-founders Timothy Day (left) and Mubhij Ahmad.

Sugarlogix: Prebiotic Sugar for Your Gut Health

What if sugar was good for you? The consumption of excess sugar has led to health issues in humans, such as autoimmune diseases and IBD, that begin in the gut. Sugarlogix has found a way to create prebiotic sugars to fix this problem and make sugar that’s actually healthy for people to consume. Although there are plenty of probiotic solutions that add good bacteria to the gut, Sugarlogix’s prebiotic sugar is the missing link in actually nourishing those good bacteria. The company’s co-founder and CTO, Chaeyoung Shin, explained more:

Where did everyone on your team first meet?

CS: I’m from UC Berkeley, and that’s where our team got together. We were originally part of a large project funded by British Petroleum to make biofuels out of fermentation. Our co-founding team consists of two professors and two PhD graduate students including myself. After that project, we realized that, “Hey, we could use this technology to make something of higher value.” That’s when we decided to build a company.

So you started with biofuels, and now you’re focusing on sugars?

CS: Yes, but not just any sugar. Prebiotic sugars. These sugars naturally exist in human breastmilk, however they’re not really accounted for anywhere in the market right now. They are starting to make some products that look like it, but not much, because it is very expensive to recreate it outside of a human body. We have the technology to do that in a cost-effective and food-safe way. We brew the prebiotic sugars by using yeast fermentation. It’s just the bakery yeast that we normally use.

How did you become interested in science and biotech?

CS: That goes back a long way. I actually chose to be in the biofuels project during my PhD because I knew we had no way of going around biotechnology. Right now the current industry consists of a lot of chemical-based industries, but we know that these won’t last forever, and also they’re not environmentally friendly. Now in biology, the coolest things happen. Just look at our bodies, it’s amazing what biology can obtain. Improving our knowledge of biotechnology would enable us to mimic biology and use it to our benefit. So that’s how I became interested in that area and I decided to focus my PhD project on it.

Why is Sugarlogix’s technology needed right now, and what problem is it solving?

CS: We know that our current way of living is not the healthiest kind with conventional sugars. We’re exposed to a lot of fatty foods, and that’s why so many people experience gut discomfort. There’s been a huge increase in gut-related diseases, including irritable bowel syndrome and autoimmune diseases which are known to have direct relationships to gut health. One way to prevent that is to provide these types of prebiotics to the gut. In relationship to probiotics (the probiotics are the good gut bacteria), the probiotics are food for the good gut bacteria. Only by having those two components can the good gut bacteria really thrive in your gut. There are probiotic solutions out there, but not the prebiotic part. And by providing the other half, we would really be able to affect people’s gut health in a good way.

What would be the single biggest indicator that your company is succeeding?

CS: Thankfully a lot of people have done research on prebiotic sugars that exist in human breastmilk. It has been long been known as the holy grail of an infant formula ingredient. As long as new research doesn’t come out that proves otherwise, we have solid proof that our technology will benefit people’s gut health. In the long run, an indicator that we’re successful would be the fact that we’re making a lot of profit by selling these prebiotic sugars. The question is different in terms of a short term goal. We want to do a demonstration of a larger size than where we’re currently at. We are hoping to move up to a larger size fermenter to prove to our investors and customers that we can indeed manufacture this on a large scale.

What big lessons have you learned transitioning from science to entrepreneurship at IndieBio?

CS: I never envisioned myself going through this type of transition. I thought I was just going to be scientist. But now my role has dramatically changed, where I’m actively seeking out customers, and actively reaching out to suppliers and investors. For me personally, talking to investors and recruiting them is the toughest part about all this, because you have to sell yourself as well as the company, and it’s something I’m still getting comfortable with. At IndieBio, it’s been really fun to see all the gears of the company come together along with my partner Kulika Chomvong, who is running all the gears.

See Sugarlogix pitch at IndieBio Demo Day on September 14th in San Francisco or via Livestream! Register here.

Photo credit: Or Weizman

Quantumcyte: Cancer Just Got Personal

“I never intended on even giving a crap about cancer. It just happened,” said John Butler. “This isn’t a matter of me wanting to build a business, it’s a matter of wanting to help my wife.”

John quit his job to pursue a better cancer outcome and become co-founder and CEO of Quantumcyte. Together with Quantumcyte’s co-founder and CTO, Dr. Bidhan Chaudhuri, the company aims to look a patient’s cancer at a cellular level in order to match them with the best drugs for their recovery. The two founders explained more:

What’s your company’s background, and what do you do at Quantumcyte?

JB: Bidhan and I are developing a platform technology for doing cancer research. What makes us different from the rest of the world is we are really able to understand an individual’s cancer in order to find them the best drugs to cure it. Our platform is really designed around enabling researchers to better understand a patient’s cancer on an individual level.

So your platform figures out which cancer drugs are best for the individual, since cancer varies so much from person to person. How does it work?

JB: Yes, that’s the goal. To go into scientific detail about what we do that nobody else does…is we take a tumor, and we slice it up and take a microtome section. We put that section onto a slide, and look at it with a microscope and say, “Ok, that’s a T cell, that’s a cancer cell, that’s a stromal cell.” Then we can build a 3-dimensional model of the cells, and also extract the genetic information, the RNA, out of those cells and sequence them. With the 3-dimensional model, we can understand what cells are where in the tumor, and what cells they’re next to. If you can do that, you can really understand what’s going on inside that tumor. If you understand that on a patient level, now you can start looking at the right drugs to shrink that tumor and get rid of it. The way I describe it to people is, we’re really looking at cancer on a personalized level, and we’re trying to find best drugs for the individual.

And will these drugs be developed by someone else?

JB: Yes. So you know the situation with my wife, she was diagnosed with cancer, but now she’s actually doing quite well. The idea we came up with is, we’re going to grab her cancer cells alive, and throw some existing drugs at them and see which ones will work. When you look at the body of literature about cancer, I think there are enough drugs out there that can potentially help any cancer. We could easily partner with other companies who are doing drug discovery, including companies at IndieBio.

Where did you two get together to start working on this?

JB: Prior to Quantumcyte, I worked at a company called Pacific Bioscience, and that’s where we met. I was hired as the manager of manufacturing, and Bidhan was the manager of engineering. We were responsible for taking products from research and moving them through development into manufacturing.

I’m not an oncologist, and Bidhan’s not an oncologist, but we work with them. When we started working on this we said, “We’re not going to learn cancer biology, we’re going to go find the best in the world and work with them.” And that’s what we’re doing.

Since you started at IndieBio, was it challenging transitioning from science to entrepreneurship?

JB: Yeah, just a little. I think Bidhan and I have always been very aggressive in pursuing our efforts. Really understanding how to focus and defocus constantly is something that is required as an entrepreneur. I think something that I’m getting better at understanding is what it means to be in the C-suite: How to be a CEO, how to communicate less like a scientist and more like a non-scientist.

What’s the most challenging thing about building a business?

BC: It’s building a business, that’s the most challenging thing! I come from a big technology background. I can build machines. John is pretty good at the biology side of things. We put it together and say, this is technologically cool. That’s why we started this, because we thought we could solve a problem. But actually going out there and figuring out if there’s a market for it, and figuring out how to translate our vision to other people—people who will be using our tool or even investors—that’s challenging.

We have to tell people about what we believe is happening. We’re at the leading edge of a cancer technology that’s only now starting to come alive, and John has had the difficult task of gathering opinions of key people about it. John has done a fantastic job, but we did spend most of the past couple of years trying to convince people that this is worth something. And that was hard. For us, once we built the technology, we thought, “We’re there.” But really, we had to learn to convince people to believe in our technology as well.

JB: I think the most important thing is establishing relationships. It’s all about relationships, including relationships with investors. Understanding that you need to do that is something that was difficult for us. It took us a while to realize it’s more about building relationships and establishing trust than building a business.

Prior to this, Bidhan comes from the semiconductor industry, and there was an 18-month lead time to build a chip to get into manufacturing. It was pretty straightforward. When you’re talking about what we’re trying to do, at first we didn’t even know we were on the bleeding edge. We just said logically this makes sense. Later on we found out we were one of the very few people in the world thinking about this problem in this way. We let it sit and incubate for a while, and next thing you know we’re having discussions with Ryan Bethencourt about how to sell something we don’t even have, and then actually selling it. The hardest part is realizing it’s about relationships, and it takes a long freaking time.

How do you think your success as a company would change the cancer industry?

BC: As a person who’s outside of the cancer research field, here’s the way I look at it: Cancer started out as a disease that required a person to have surgeries. From there the treatment included chemotherapy. Now cancer therapy has reached a point where people are beginning to understand cancer at a patient level, a cellular level, but still they do not have the tools at hand to do much good about it. What our technology does is it brings all that capability to be very accessible to researchers. And I think this will allow for progress beyond what’s currently achievable today, at a level where it needs to be, a patient level.

JB: One way to think about it is drugs for all cancer patients.

What are the milestones that you’re looking to hit in the near future?

JB: Scientifically, we need to demonstrate that we can use our tool for what it’s designed to do. We need to show that we can take patient cells and look at the cell type, the phenotype, extract the genetic information, and then correlate that genetic information to that phenotype. On the business side, the milestones are to engage with some more thought leaders in the space, and to fund our efforts so that we can really pursue what we want to do with the company. Once we demonstrate that our tool can do what it’s designed to do, everything will fall in line.

See Quantumcyte pitch at IndieBio Demo Day on September 14th in San Francisco or via Livestream! Register here.

An Interview with John Mendelson of DxRx

“Rehab on Your Phone”

dxrx medical

Photo: John Mendelson (center) and the DxRx team.

Not everyone who occasionally overdrinks is seen as an alcoholic in need of help. DxRx is a service for people who want to manage their alcohol consumption using an app, a breathalyzer, and medication if needed. DxRx wants to break the stigma of alcoholism and make treatment obtainable for people who can’t deal with traditional rehab or Alcoholics Anonymous, in terms of financial and social cost. We asked one of the company’s founders, John Mendelson, a few questions:

Tell me about your background, how did you become interested in public health?

My father was one of the first scientists to study alcoholism. His enthusiasm led to my interest in alcohol, opiate, and stimulant addiction, which blossomed into a career in clinical research for addiction treatments. Besides conducting research, I also treat patients. I have been in practice for 30 years and have had the extraordinarily good fortune to watch addictive diseases go from untreatable severe diseases often ending in death to manageable problems.

What problem are you working to solve with DxRx?

If you ask the average American to list the most deadly diseases, alcoholism doesn’t make the cut. Yet alcoholism is a devastating disease that destroys lives and kills more people then diabetes. Despite the toll of alcoholism, most people have no idea what makes a person an alcoholic, how to identify early problem drinking, or treat the disease. Part of the problem is that alcoholism is often viewed through binary lens – you are either a flawed person or the inevitable victim of a purely biological disease. In fact, like most important problems in life, voluntary choices combined with biologic vulnerabilities lead to the eventual disease state. Both my approach and DxRx’s philosophy is to provide tools to enable better choices of when and how much to drink, while also addressing underlying biological motivators of behavior.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

Of all the progress we have made over the past four months at IndieBio, there is one thing that convinces me we are on the right path. Our customers use a breathalyzer every day to measure their blood alcohol content so they can track their progress. When we average the results from the first dozen patients, the results are astonishing. The average patient at DxRxMedical is able to cut their drinking in half in a month.

How do you think success can change your industry?

At present there is no cure for alcohol addiction so treatment needs to be one day at a time. Our light, daily, empowering touches support patients for the long haul. 34 million Americans are estimated to have Alcohol Use Disorder yet only 2.5 million get treatment and only when the disease has done much of its destruction. The costs are enormous with an estimated $16 billion being spent to treating this small proportion of people in need. Success means 34 million people with AUD can get help and prevent hitting rock bottom.

How is your team uniquely able to tackle this? What’s the expertise?

Our team is successful, experienced and creative. I am a practicing physician and NIH-funded researcher with 30 years of experience treating patients and developing treatments for addiction. David Deacon, our CEO, has launched four companies of his own and helped found 20 others. Bob Nix, our CEO, has been a software architect at Athena Health for the last nine years and has been VP of engineering for nine start-ups.

Our Scientific Advisors are all leaders in addiction science. Chuck O’Brien developed naltrexone for addiction and is the leading academic physician in addiction. Ivan Diamond founded the UCSF Gallo Center, edits Alcohol Clinical and Experimental Research and is the leading academic expert in the biology of alcoholism. Warren Bickel is a Psychologist whose works pairs psychological interventions with technology. 

Any big lessons learned transitioning to startup entrepreneurship?

To be concise! I try!

What’s the biggest challenge you’ve encountered so far?

There is a lot of stigma associated with addiction, which fuels denial, and deconstructing this stigma and empowering our patients to take charge has been a big challenge we are quickly learning to overcome. 

What are the big goals and milestones you’re looking to hit in the short term? Long term?

Over the last month we have enrolled our first group of patients and have launched demonstration projects with key stakeholders in medicine including a Yale-associated hospital, researchers at the NIAAA, and the largest hospital chain in California – Dignity Health. The team at DxRxMedical is now rolling out our solution to everyone in California, starting with employees at a few key companies, and hospitals that need a solution for their patients. If we are successful in California, we will scale up by hiring physicians across the country to deliver addiction treatment in every state. 

An Interview With Daniel Dempsey of Venomyx Therapeutics

Venomyx

Just like an Epi-Pen for Snake Bites.

Venomyx

Photo: Deepankar Roy (left), Daniel Dempsey, and Alexio Capovilla of Venomyx Therapeutics.

Snake bites are one of humanity’s oldest medical problems, but they’re definitely not a thing of the past—millions of people are bitten by poisonous snakes every year, and if they are lucky, those people are able to get medical attention quickly enough to not lose life or limb. The process of producing antivenom is outdated—it usually consists of injecting a horse or sheep with poisonous venom and harvesting the antibodies that the animal creates. Venomyx is using biotechnology to eliminate the use of animals from the process of producing antivenom, along with making it available in a portable, easy-to-use injector that makes it seem like the Epi-Pen for Snake Bites. We asked the company’s CEO, Daniel Dempsey, a few questions:

Tell me about your background, how did you get interested in the biotech space?

As cliche as it sounds, I got into biotech to make a difference in the world—specifically to make a difference in the lives of people. I went to school at UC San Diego and studied human biology as an undergrad and then autoimmune disease for my M.S. during grad school, I seized the opportunity to research infectious disease in the Costa Rican rainforest for a summer. It was there (surrounded by snakes) that I became familiar with the problems surrounding conventional antivenom and envisioned what modern biotech research could bring to this space. I returned to San Diego to work for big pharma developing drugs against cancer and inflammatory diseases. I couldn’t shake the feeling that something should be done for people that currently don’t have access to safe and effective antivenom so I studied it in my spare time. I finally decided that we were on to something that should be given a chance and quit my job, forming Venomyx in 2015.

What problem are you working to solve with your company, Venomyx?

We are working to make the world’s first recombinant antivenom that offers broad-spectrum treatment for bites from all medically relevant species of snakes.

Every year 5.5 Million people are bitten by venomous snakes. For the victims of snakebite, this results in disfigurement, disability, or death. Conventional antivenom has been able to approximate treatment of snakebite but is associated with limited efficacy, side effects, and a difficult production process.

Our antivenom is showing early preclinical success as a universal treatment for snakebite. It is a recombinant product which is manufactured at scale using microbial fermentation. The stability of our antivenom means that it does not require cold chain and will be available in the field for the first time ever.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

The entrepreneurial path is not an easy onebut I think that’s why we chose it. At some point, if it seems you have the ability to do something important, it becomes almost a responsibility to act. We’ve definitely received raised eyebrows from people in the past for what we are attempting to do; but we have also received support and encouragement from prominent opinion leaders of our space and that is the most validating of all. There have been many great minds who have dedicated their lives to studying snakes and their venom, so we hope to validate them by getting our solution to market and saving lives with it.

How do you think success can change your industry?

Our product will transform a very old industry that still relies on milking snakes and immunizing horses with the venom. We plan to manufacture our product overseas or license to overseas pharmaceutical companies who are already showing willingness to change. This will lead to a shift in local jobs from animal handling to biomanufacturing and, of course, spare great numbers of snakes and horses as a result.

How is your team uniquely able to tackle this? What’s the expertise?

Dan Dempsey
Deepankar Roy, PhD
Alexio Capovilla, PhD

We each have experience in both research and business as it pertains to drug development. This strong base is then differentiated further where each of us is able to lend unique perspective in the areas of R&D, project management, business development, regulatory compliance, and commercialization. Our complementarity skills help tremendously with the decision making process of an early therapeutics company where important decisions are made daily.

Any big lessons learned transitioning to startup entrepreneurship?

Don’t sweat the small stuffjust keep moving forward. There are so many challenges encountered as a start up and not everything goes as planned. It’s important to stay diligent and stay on your path. I’ve looked back at some of the early setbacks we’ve had as a company and noticed that it’s par for the course and we’re always able to find a way through.

What’s the biggest challenge you’ve encountered so far?

I think there is an inherent challenge associated with operating in our space which is part of the reason there still isn’t a viable solution. Snake venom is a complex drug target and requires the same scientific diligence that you would employ with any other disease indication. Traditionally, pharma companies and investors have been hesitant to venture into a space that falls outside the more widely accepted investment areas. I think we are changing that. They are beginning to see the cost and regulatory advantages of our space and that it opens the doors for our future projects in bacterial antitoxins to combat antibiotic resistant strains which is a huge and growing market.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

We are already showing neutralization of venom from multiple species of snake and plan to finish preclinical development and enter the clinic for Vipax Asia at the end of 2017. The acute nature of our trials combined with our qualification for fast track status means we can complete clinical trials and gain approval as early as Dec 2019. Once our clinical trials are underway we plan to shift focus to development of Vipax for our other three regions (U.S., Africa, South America) as well as our bacterial antitoxin programs.

Learn more about Venomyx by watching Daniel pitch on IndieBio Demo Day Feb. 9th! Register for the event or LiveStream here!

An Interview With Hyunjun Park & Nathaniel Roquet of Catalog Technologies

Storing Information in DNA

Photo: Nathaniel Roquet (left) and Hyunjun Park of Catalog Technologies. 

As the amount of information that humans create grows exponentially, hard drives and older methods of storage are becoming obsolete. DNA has been discovered to be effective medium for storing the world’s information, and it has several advantages in terms of storage space and shelf life. Catalog Technologies is not only storing info in DNA, but making the process economically viable so that it becomes more common in the near future. We asked a few questions to the company’s founders, Hyunjun Park and Nathaniel Roquet:

Tell me about your background, how did you become interested in science?

Hyunjun: Former postdoc in Prof. Timothy Lu’s group at MIT, Hyunjun obtained his BS at Seoul National University and PhD at the University of Wisconsin Madison. While in graduate school, Hyunjun worked at the university technology transfer office (WARF) and participated in the Wisconsin Entrepreneurial Bootcamp. Upon coming to Cambridge for his postdoc, he participated in MIT’s Venture Mentoring Service, as well as StartMIT, an intensive training program for startup founders.

Nate: Nate is a PhD candidate in the Harvard Biophysics program, conducting his thesis research in Prof Timothy Lu’s lab at MIT. He received his BA in physics from Princeton University. Nathaniel has a deep passion for fostering STEM education, especially with underprivileged or underrepresented youth, participating in various education outreach programs including serving as a teacher/mentor for Science Clubs of Mexico, Science Club for Girls, Citizen Schools, and the MIT Undergraduate Research Opportunity program.

What problem are you working to solve with Catalog Technologies?

As our tagline “Infinite Data Archives” suggests, we want to leverage the inherent characteristics of DNA to preserve humanity’s knowledge forever, in a very sustainable way.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

We want to make the greatest possible positive impact through our activities. If we are able to show that we are making a bigger positive impact through a startup than through other means, we would know that we are doing the right thing

How do you think success can change your industry?

DNA information storage has been talked about for several decades for the following reasons: 1) DNA is extremely information dense. For a given volume, DNA can store ~1,000,000X more information than SSD. 2) DNA will retain the info for thousands of years under the right conditions. This compares to decades in magnetic tape. 3) It is essentially free to copy DNA, making it possible to make many redundant copies of the information you want to archive. One of the biggest reasons DNA is not yet a major information storage medium despite these advantages, is the high cost of synthesis of DNA. If you try to store information at the point of synthesis, the cumulative cost of synthesis would get prohibitively high for large data sets. This is why our technology has the potential to disrupt the industry.

How is your team uniquely able to tackle this? What’s the expertise?

We are pioneering a paradigm shift in information storage that was invented in house. The fact that we are using DNA molecules to do this means that we can draw on our own expertise as highly trained scientists, as well as from a pool of world-leading experts that we are closely affiliated with. When it comes to the team make up, the two of us have highly complementary skill sets and have a deep level of trust in each other’s abilities.

Any big lessons learned transitioning to startup entrepreneurship?

We learned that many things we’ve picked up as scientists, such as logical and quantitative analysis skills are very useful as entrepreneurs. At the same time, we felt an immediate need to learn how to communicate our long-term vision with a general audience.

What’s the biggest challenge you’ve encountered so far?

Public speaking, social media, and engagement with the press.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

Our external milestones are set as the ability to encode a given amount of information within a day. In the immediate term, we are shooting for a megabit stored by Demo Day. In one year, we aim to get to a gigabyte.

Learn more about Catalog Technologies by watching them pitch on IndieBio Demo Day Feb. 9th! Register for the event or LiveStream here!

An Interview With Brendan Griffen of Scaled Biolabs

Scaled Biolabs

A Biomedical Lab the Size of Your Phone.

Scaled Biolabs

Photo: The Scaled Biolabs team – Brendan Griffen (left), Justin Cooper-White, and Drew Titmarsh.

Biological experiments are time-consuming, and space-consuming, while requiring repeated manual motions from lab technicians. But technology has allowed Scaled Biolabs to shrink down the entire system of experimentation down to the size of your phone. Using microfluidics, scientists can conduct thousands of individual tests in one fell swoop and accelerate the rate of discoveries. We talked to the company’s CTO, Brendan Griffen, a few questions about how this all came to be:

Tell me about your background, how did you become interested in biotech?

My academic background is in computational physics with an specialization in astrophysics, theoretical physics, and cosmology. I’ve spent the last ten years working on large projects trying to understand the origin of our universe, the evolution of stars, and galaxies.  From these experiences, I’ve seen first hand the power of a supercomputer in solving some of the most complex problems in the world. This is fundamentally because we’ve been able to control the flow of electrons through circuits at increasingly smaller scales. Biology is similar in many ways but instead of mixing and moving electrons from point A to point B, we’re moving fluids. This is the fundamental way biomedical research is currently done so it always perplexed me as to why we continue to use clunky equipment to interface the human scale with what we’re actually interested in (e.g. cells interacting). This is what excited me about the future of biotechnology, our ability to do biology at nature’s scale. The potential to miniaturize most of biological research means that in the next 50 years, we will likely transform our lives even more dramatically than what computers have done in the past 50 years.

I’ve always been interested in biotechnology but never had the opportunity to apply myself to developing these ideas. When I saw the technology my co-founders Drew Titmarsh and Justin Cooper-White had developed, I immediately understood that a microfluidic approach to experimental biology is exactly what’s needed to make the aforementioned future a reality. In order to be part of this exciting future, we formed our company Scaled Biolabs.

What problem are you working to solve with Scaled Biolabs?

We are accelerating discoveries in biology. We’ve taken the functionality of a modern biomedical R&D lab and shrunk it all down on a system the size of your phone. By shrinking things down we rely on less expensive materials, less highly trained manual labor, and most importantly we can execute numbers of experiments on an unprecedented scale. We can run nearly 10,000 experiments on a single system and additionally resolve every single cell in every one of those experiments. Why is this important? If a biologist can run down every single possible path in a maze of possibilities faster, then they can find the optimal solution which gets them to their desired outcome sooner rather than later.

Stem cells are one such maze and a very active area of research right now — how do we turn stem cells, the ‘blueprint cell’, into different parts of the human body? Our collaborators have already grown human kidney and beating heart tissue in our system because they found the optimal method for getting to those outcomes faster than traditional methods. At Scaled Biolabs, we enable these kinds of breakthroughs by allowing scientists to get more done, cheaper and sooner.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

All discussions of “what has value?” tend to link back to a basic notion of health and wellbeing. I personally believe that our team really does have the potential to deliver fundamental improvements to human health. Take just one example — in 2005, 65 million people died from kidney disease. Being able to regenerate a patient’s kidney from their own stem cells, which won’t be rejected by their immune system, will literally save lives. If we had to boil it down to a single reason for doing all of this then it’s that — accelerating the advent of regenerative medicine to meet the needs of millions of patients who can’t be helped by a pharmaceutical drug.

How do you think success can change your industry?

Apart from meeting patient’s needs, success to us is creating a new status quo in our industry. Biological research is in desperate need of an upgrade, and should our approach be successful, we would be enamored to see it more widely used. We don’t want to stop just there though. Unknown problems on the horizon will require solutions not yet invented, and so being successful will mean not just creating a new status quo, but also continually creating novel technological solutions.

How is your team uniquely able to tackle this? What’s the expertise?

We’ve got complementary talent trained around the world.

Our CEO, Drew Titmarsh, is a trained chemical and biological engineer and co-inventor of the microbioreactor technology which is the workhorse platform of Scaled Biolabs. He has coordinated multidisciplinary projects at the Australian Institute for Bioengineering and Nanotechnogy (Brisbane, Australia), and the Institute for Medical Biology, A*STAR (Singapore) in the areas of tissue engineering and regenerative medicine.

Our CSO Professor Justin Cooper-White is a global leader in tissue engineering and microfluidics, and co-inventor of our microbioreactor technology. With 20 years of expertise in running and funding large research programs, he currently holds the positions of Professor of Bioengineering in the Australian Institute of Bioengineering & Nanotechnology and the School of Chemical Engineering at the University of Queensland, Director of the Australian National Fabrication Facility-Queensland Node, and Office of the Chief Executive Science Leader within CSIRO, Australia’s federal research institution.

I’m the CTO and have ten years in computational physics employing a wide variety of hardware and software tools to create solutions to big data problems. My previous four years research as a postdoctoral fellow at MIT has provided me with a wide range of interdisciplinary skills which are well suited to our challenges ahead.

Any big lessons learned transitioning to startup entrepreneurship?

It’s been quite a dramatic transition. The following three areas are where we’ve found the biggest lessons:

  1. Being OK with moving more quickly than you’re comfortable with. Academia tends to have a perfection focused mindset because the operational timescales are much longer. In industry, things are measured in days. The closest analogy I’ve found is it’s like morphing from a mammal into an insect — your priorities certainly change!
  2. As the phrase goes, “it’s not what you know, it’s who who you know”. Academia tends to (in the ideal case) be more of a meritocracy where what you know really does give you the greatest return. In industry, having strong relationships with people you can lean on for help or to stage a warm introduction often converts into something of great value.
  3. Follow up. No one cares about your business more than you, so you really have to make that extra effort to follow up with people if an email or call thread goes cold. Even if there is not a quid pro quo to be had on the business side, it is always very useful to keep all learning opportunities available. There are large number of tools online now which allow you to maintain several hundred conversations at once and ensure that you don’t let potentially important relationships go cold.

What’s the biggest challenge you’ve encountered so far?

Our biggest challenge has been our messaging and identity (i.e. “what are we?”). This is often the case for platform technologies — you can address multiple problems but the key is to find the underlying compelling narrative which brings it all together. Thinking more fundamentally about our technology and which direction we are heading has really helped us solve this problem. Traction also does wonders to identity woes because you get validation that what you’re building is something people want, so it’s much easier to speak to that than just a lofty garage band idea.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

At the moment we are focused on providing value to customers who seek the advantages of our technology. We are in the early stages of our long term goal of placing our system in every research lab around the world. These are primarily companies either creating high quality stem cells or turning stem cells into different tissues of the human body. In the very long term we want to place our instrument in all doctor’s offices so that unfortunate folks who are diagnosed with cancer can get personalized treatment plans tailored to their own immune system and cancer type. With this two pronged approach we aim to become industry leaders in both regenerative medicine and personalized medicine. We’ve got a long journey but we’re making good strides.

Learn more about Scaled Biolabs by watching them pitch on IndieBio Demo Day Feb. 9th! Register for the event or LiveStream here!

An Interview With Steve Kazemi of Pure Cultures

Pure Cultures

Enough With All the Antibiotics in Livestock.

Pure Cultures

It’s no secret that much of the animal meat consumed by humans contains antibiotics that are excessively used in the raising of livestock. This leads to damaging health effects in humans, and contributes to the ever-growing issue of antibiotic resistance. In comes Pure Cultures, a startup creating a solution for farmers who want to raise healthy animals and eliminate the overuse of antibiotics in the food chain. We asked the company’s CEO and co-founder, Steve Kazemi, a few questions:

Tell me about your background, how did you get interested in science?

I got interested in science early because my father is a petroleum engineer and a PhD professor at Colorado School of Mines. He always stressed the importance of science and math. I remember being around 10 years old when I asked for a chemistry set. It came with a burner, a set of chemicals, and a book of a couple hundred experiments. I probably completed half of the experiments within a few days.  

After college I moved back to Colorado and I was employed by Hauser Chemical in Boulder, where we were extracting Taxol from the bark of the Yew tree. Taxol is still one of the best chemotherapies for cancer. The culture of the company was similar to a university. There were many PhDs working at the company, and they had an open office policy where they would teach chemistry and engineering on a regular basis.  I loved the fact that we were saving lives with a novel cancer drug. Then we moved to producing high quality herbal products. I was excited to be affecting health with a more natural approach.

What problem are you working to solve with your company, Pure Cultures?

Bacteria are crafty. Their job is to learn how to survive in harsh conditions. When antibiotics are used in humans or animals, they kill both the good and bad bacteria, and the bacteria learns how to adapt quickly. Some bacteria are able to develop a resistance to the antibiotic dosed. If an animal or human then gets exposed to another pathogen that requires medical treatment, dosing with an antibiotic might not work because the bacteria are immune. This is what has caused 700,000 deaths a year in humans.

Antibiotics also travel up the food chain to humans from eating animals. 80% of human antibiotics produced are used in our livestock to promote weight gain, and many are used on healthy animals. By reducing even a small amount of these antibiotics, it will have a greater effect on saving human lives because the rate of antibiotic resistant bacteria generation will be slowed.

Pure Cultures believes that developing natural solutions to use as an alternative to antibiotics will have a significant effect on human health and our environment.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

When our solutions produce data that validates our product effectiveness, and our customers pay us, we will have validation we are building the right business.  

How do you think success can change your industry?

Our innovative natural solution is disrupting the animal nutrition space and will ultimately affect the health and wellness of meat-eating consumers.

How is your team uniquely able to tackle this? What’s the expertise?

The Pure Cultures team is constantly working to improve its technology – and move the science of probiotic product development forward. We have complementary backgrounds in science and business strategy. I have over 20 years of experience managing probiotic manufacturing operations for clients such as Trader Joe’s and Perrigo which generated $35 million in annual sales, in addition to having expertise in fermentation and operations.

Colleen is the co-founder and CMO, with over 20 years of marketing and business strategy experience working with Fortune 500 companies. She has deep experience in B2B sales and marketing strategy and execution. For the last five years she has served on the Board of Directors for Tomboyx, and consulted for several startups, accelerators, mid-level, and B2B enterprise companies located in major hubs nationally. Colleen and I are married and have a blended family of an 11-year-old, 15-year-old, 20-year-old and 28-year old.

Any big lessons learned transitioning to startup entrepreneurship?

Yes, great businesses are built on customers. Learning how to find customers and sell product has been challenging and rewarding.

What’s the biggest challenge you’ve encountered so far?

Time and money. We are constantly having to make decisions on where to focus our time to move as quickly as possible. We are on the cutting edge of a health conscience boom. We have the opportunity to be one of the first products on the market with our proprietary solution. We want to make smart decisions but move quickly.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

In the next four months, we want to raise our financing round while focusing on generating revenue. 2017 has started out great for us and we want to keep up the momentum.

In the long term, we intend to hire a CSO and broaden our understanding of how to produce novel antimicrobial agents.

Learn more about Pure Cultures by watching Steve pitch on IndieBio Demo Day Feb. 9th! Register for the event or LiveStream here!

Magnetic Pulses to Combat Depression: An Interview With Mehran Talebinejad of NeuroQore

NeuroQore
NeuroQore

Photo: The NeuroQore team (Mehran on far left). 

Depression is a major burden in many people’s lives who we know. Some of the treatments that are prescribed, like medication, are not always effective or without major side effects. Drug-resistant depression is sometimes treated with electroshock therapy, which is risky, despite being the gold standard. In comes NeuroQore, a new device that aims to treat depression by sending magnetic pulses to a small region of the brain, which is safer than electroshock therapy. We asked NeuroQore’s CEO, Mehran Talebinejad, a few questions:

Tell me about your background, how did you get interested in the biotech space?

As a teenager I was fascinated with brain machine interfaces (BMI) and mind uploading. This drove me to study Biomedical Engineering and go towards neural prosthetics and brain surgery. Fast forward 10 years after getting into the university, and I did my first brain surgery. During this surgery I realized the brain is so extremely complex, and machine BMIs have a long long way to go before being publicly available. I also realized non-invasive brain tools and neuromodulation is super important since we don’t have easy access to the brain while the skull is blocking us!

So how did you try to turn that complexity into something practical you could work on?

Among non-invasive approaches to brain stimulation or neuromodulation there are only two very promising approaches: the first is electroconvulsive therapy (ECT) or electroshock therapy. This is the gold standard for treatment of drug-resistant depression. The second is the magnetic brain stimulation or repetitive transcranial magnetic stimulation (rTMS), which emulates ECT in smaller brain regions without convulsion. ECT requires hospitalization, anesthesia, and has severe cognitive side effects (memory loss) and a risk of death. Less than 1% of patients are willing to endure ECT! On the other hand, rTMS is outpatient, has no systemic side effects and is widely accepted by patients. I saw the potential of rTMS and I had a vision to make it more accessible and more effective for treatment of drug-resistant depression and a range of other brain disorders (psychiatric and neurological).

What problem are you working to solve with your company, NeuroQore?

TMS is a platform tech with a range of applications, but we are focused on drug-resistant depression at this time. Over 16M patients are diagnosed with major depressive disorder (MDD) every year in the US, and more than 4M remain drug-resistant. Which means they do not get satisfactory results from drugs in the first line of therapy. There is an option for them to do ECT, but as I mentioned less than 1% willing to endure ECT (still over 100,000 patients/year). So there is a large unmet need, or I would say crisis, for drug-resistant depression. Depression is among few disorders in medicine where a patient says “I rather die than have this”! NeuroQore is set to make TMS accessible and more effective as an alternative option to ECT.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

The indicator is being able to execute on my own vision and feeling satisfied after seeing patients getting into remission. Patients bring us all types gifts and flowers in the last sessions of their treatment, and almost all of them have been super satisfied, which is very fulfilling for me.

How do you think success can change your industry?

NeuroQore is set to change mental health care and psychiatry as we know it, a condition that has been relatively unchanged since the 1960s. Patients with depression will be able to go to our centers (i.e. the “Apple Store for Depression”), monitor their depression with physical evidence (biomarkers not just anecdotal questioners), and finally get effective outpatient treatment! Today mental health care and psychiatry both suck, it is literally depressing to get depression treatment.

How is your team uniquely able to tackle this? What’s the expertise?

We have a great multi-disciplinary team and have been working together for over a decade. My academic background is in biomedical engineering, neuroscience, and technology management. I was selected as a rising star CEO by Invest Ottawa and I have been recognized and awarded many times for my work at NeuroQore as a co-founder and CEO.

Adrian is my co-inventor and co-founder, and has been working with me for over 14 years. He is an award winning expert in scientific research and development, with academic background in electrical and biomedical engineering specialized in non-invasive approaches.

Jonathan is a pioneering rTMS clinician/psychiatrist. He is very well known and well respected in the psychiatry society, and has had amazing contributions to improve clinical rTMS for depression treatment. He has experienced over 2,000 patients in his practice to date.

Brittany is an angel, she is our anticipatory patient service expert, with an academic background in psychology and mental health neuroscience. Her role is crucial in patient experience, which is very important for mental health. She is helping us change mental health care as we know it with her innovative service approach.

Any big lessons learned transitioning to startup entrepreneurship?

Life can be very exciting and fulfilling, but as an entrepreneur I must be ready for anything above and beyond what I know and have learned. I must be ready to learn on the fly and adapt to new situations.

What’s the biggest challenge you’ve encountered so far?

Educating the government, the public, and clinicians about rTMS and non-drug depression treatment… and removing the stigma of depression.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

In 2017 we will have four centers operational/active in California (SF, LA, Oakland, and Long Beach), and in the long term we are planning to repeat this model across the US with over 100 centers in the next three years.

Learn more about NeuroQore by watching Mehran pitch on IndieBio Demo Day Feb. 9th! Register for the event or LiveStream here!

Doctors Meet Data Science: An Interview with Karim Galil of Mendel Health

Mendel Health
Mendel Health

Photo: The Mendel Health team with Karim in the center.

Do you ever feel your medical records are an unorganized mess, making it impossible for doctors with their busy schedules to match you with the latest treatments that are most optimally matched to your needs? In comes Mendel Health, a way for your data to be “in the driver’s seat”. Thousands of treatments for cancer and other diseases are in trials, and few doctors know about them… which is something Mendel Health is working to solve. So people do not lose their chances of beating disease. We asked the company’s CEO, Karim Galil, a few questions:

Tell me about your background, how did you become interested in public health?

I went to med school and got to practice medicine for a couple of years. I was very frustrated with how the practice of medicine was immune to the rate of advancement in technology.

What problem are you working to solve with Mendel Health?

We are trying to stop needless deaths in medicine. Every day thousands of patients pass away. It’s all too common that after their death we learn about a clinical trial that would have saved them. This is due to the huge increase in the rate of research, and the inability for any human to stay up to date. To make the promise of precision medicine real we have to find ways for doctors to keep up with all this research and data.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

Our success metric: Number of  patients matched to a new trials or research which was never mentioned to them before AND it saves their life!

How do you think success can change your industry?

It will close the gap between research and the practice of medicine. This means faster drug development cycles and patients generating a wealth of data. All that will accelerate biomarker discoveries and curing terminal illnesses like cancer.

How is your team uniquely able to tackle this? What’s the expertise?

What is unique about our team is the multidisciplinary skills. You have a physician leading a team of doctors and a technical PhD leading a team of data scientists.

The intersection between medicine and data has sparked solutions to many problem other AI companies have been facing in healthcare.

Any big lessons learned transitioning to startup entrepreneurship?

Move fast. The faster you fail, the faster you will succeed.

What’s the biggest challenge you’ve encountered so far?

The biggest challenge has been getting the data team to understand medicine and getting the medical team to understand AI.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

Our goal is matching 10,000 cancer patients to effective treatment options, which was not considered possible before using Mendel.ai.

Learn more about Mendel Health by watching Karim pitch on IndieBio Demo Day Feb. 9th! Register for the event or LiveStream here!

Designing Drugs In Silico: An Interview With Ed Painter of A2A Pharmaceuticals

What if people suffering from cancer, tuberculosis, and other life-threatening diseases didn’t have to wait as long for the right drugs to be developed to help them stay alive? A2A Pharmaceuticals is a biotechnology company committed to the advancement of innovative scientific research and new therapeutic agents. We asked the company’s founder, Ed Painter, a few questions:

Tell me about your background, how did you get interested in the science/biotech space?

From my initial exposure to biotech companies like Amgen and Genentech doing research on cancer and other life threatening diseases around 20 years ago, I have been fascinated with process of building businesses around critical therapeutics. My success with investments in public companies gave me a great understanding of what is needed to make a company succeed.

What problem are you working to solve with your company, A2A Pharmaceuticals?

With A2A Pharmaceuticals we are addressing the extremely high cost and long time needed to make new therapeutics available to patients. We use both proprietary and commercially available software to make the process dramatically less expensive, faster and more likely to result in success.

“With A2A Pharmaceuticals we are addressing the extremely high cost and long time needed to make new therapeutics available to patients.”

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

Few people get a chance to save a person’s life. That is the greatest accomplishment to which A2A aspires.

How do you think success can change your industry?

By illustrating the effectiveness of using computational tools to develop new drug candidates, we hope to help drive more interest and investment in software tools that can help get new medications to patients.

How is your team uniquely able to tackle this? What’s the expertise?

The capabilities of A2A’s team range from founder Sridhar Vempati’s skills with selection of disease targets to Brendan Kelly’s skills with development and use of drug design tools.

Any big lessons learned transitioning to startup entrepreneurship?

We are learning every day. The lessons most critical include making sure employees are happy and the power of networking to find the people who will make the company work.

What’s the biggest challenge you’ve encountered so far?

One of the most important dynamics we face on a daily basis is the need to manage expectations as we strive to exceed.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

A2A is currently doing proof of concept work on a Leukemia drug. We hope to have positive results before the end of January. We are also working on partnerships with other pharmaceutical companies to help advance our new drug programs for cancer and drug-resistant bacterial infections as well as programs conceived by third parties.

Learn more about A2A Pharmaceuticals by watching Ed pitch on IndieBio Demo Day Feb. 9th! Register for the event or LiveStream here

IndieBio and NIH’s National Institute Drug Abuse announce collaboration on $100k Startup Challenge

IndieBio and NIH's National Institute Drug Abuse announce collaboration on $100k Startup Challenge
IndieBio and NIH's National Institute Drug Abuse announce collaboration on $100k Startup Challenge

IndieBio and the National Institute on Drug Abuse (NIDA ), part of the U.S. National Institutes of Health (NIH) are excited to announce a historic new collaboration aimed at accelerating the formation of biotech startups which will tackle the issues of drug abuse and addiction in the USA via the “$100K to Start a SUD Startup” Challenge.

Estimated at seven hundred billion dollars a year in total cost to the economy, drug abuse is one of biggest health-related issues in the country. Drug use and substance use disorders (SUDs) affect millions of Americans and impose enormous costs on society. In 2014, nearly 27 million people in the U.S. were current users of illicit drugs or misused prescription drugs.

This collaboration looks for biomedical and psychological approaches to treating or preventing SUD by taking basic research and creating a startup to commercialize the application of the underlying technology. “We built IndieBio next to 6th street, an area of San Francisco that has a high concentration of drug abuse because we believe it is important to be part of change in whatever you do.” Said Arvind Gupta, Managing Director of IndieBio.

Ryan Bethencourt, IndieBio Program Director continues, “We see the effects of drug abuse and its criminalization daily and believe there must be a better way to help those affected by this disease. Working with NIDA to help scientists start startups is what we are already set up to do. Drug abuse is a huge and seemingly impossible problem, exactly the type of challenge we like to take on.”

In 2016, NIDA will be awarding $10,000 prizes to 10 winners of the Challenge contest. The Challenge is to turn a research idea into a working prototype of the product. If the product prototype is successfully validated, it is expected that the decision to create a biotech startup will be made no later than 6 months after the prize is awarded.

If you are a researcher who believes your work could qualify and you think you can change the world with your technology, please apply today!

For more info on the $100,000 for Start a SUD Startup Challenge, please visit: www.challenge.gov/challenge/100000-for-start-a-sud-startup/

About the National Institute on Drug Abuse (NIDA):

The National Institute on Drug Abuse (NIDA) is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science. Fact sheets on the health effects of drugs and information on NIDA research and other activities can be found at www.drugabuse.gov.

About IndieBio:

IndieBio is short for Independent Biology, a new way for scientists, entrepreneurs, and tinkerers to shape their own destiny and make something that matters. Funded out of the SOS Ventures, IndieBio is the first accelerator to exclusively focus on life science startups. IndieBio provides seed funding and intensive mentorship to drive the transition of ideas from bench to prototype within three months, and launching graduate companies with disruptive technologies into the world of biotechnology. For more information on IndieBio please visit: http://sf.indie.bio/

Enabling Proactive Medicine with the Immune System: an Interview with Anitha Jayaprakash of Girihlet

Enabling Proactive Medicine with the Immune System: an Interview with Anitha Jayaprakash of Girihlet

The immune system is the cornerstone of our health and ability to fight disease, but there are no methods to truly monitor its status. As a result, medicine is forced into being reactive to illness, rather than fighting disease before it starts.

Girihlet is working towards a future where the immune system is monitored at every doctor’s visit and we can predict our resilience to disease before it happens. I talked with Anitha, one of the co-founders, about how her team is tackling this problem, the future of Girihlet, and how this technology can change public health. Check out her pitch live on February 4th on IndieBio’s Demo Day Livestream!

AK: Tell me about your background, how did you get interested in the biotech space?

AJ: I’ve always been interested in the field of biology and all the processes going on inside the human body so it was natural for me to go to Mount Sinai School of Medicine and get a PhD in Genetics. That lifelong curiosity about the human body still exists. Given that, the goal is to be able to understand and monitor the immune system, which is an integral part of the human body.

AK: What problem are you working to solve with your company, Girihlet?

AJ: Medicine is currently reactive, and we want to make it proactive. There are so many components being measured today to monitor health, but they don’t give us a clear picture of what’s going on. We think measuring your immune system is a more complete window to your health because it’s highly dynamic, predictive, and retains memories of past events. We are currently building an immune database using proprietary technology that can give us infection profiles that show your ability to fight infections before you get them

AK: If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

AJ: We want this technology to reach and help the general public. We were concerned that if this technology were sold it wouldn’t get to the public and reach its full potential. As the inventors, we‘re best positioned to bring this technology to the masses and have a big impact on public health.

AK: How do you think success can change your industry?

AJ: We want monitoring the health of the immune system to become the norm. It’s also critical that everyone would have the right to access their own health profile and information.

AK: How is your team uniquely able to tackle this? What’s the expertise?

AJ: Our expertise is in analyzing big data and finding patterns. We have a deep understanding of the genome, including its limitations. We’ve also built many novel sequencing technologies. There’s a lot of data being generated and analyzed in many industries. But the problem is most people aren’t generating accurate data. We have the biological expertise to be able to ask the right questions in order to get the right information. To complement that we have the ability to analyze this data to create useful applications.

AK: Any big lessons learned transitioning from academia to startup entrepreneurship?

AJ: As an entrepreneur it’s very important to always keep yourself connected to the science world so you don’t get lost in your work and fall behind relevant advancements. There’s no longer the scientific debate and rigor of the scientific world to keep you grounded and guided. So we’ve built a really strong scientific advisory board to make sure we don’t lose our scientific edge.

AK: What’s the biggest challenge you’ve encountered so far?

AJ: Getting researchers to believe in a startup and that we’re well positioned to build technologies. We need to convey to the scientific community that together we can solve significant scientific problems and have a tangible impact on public health.

AK: What are the big goals and milestones you’re looking to hit in the short term? Long term?

AJ: Short term we want to validate the clinical application of our technology. We’ve started collaborating with clinicians at UCSF and Mount Sinai to further this goal. In the long term, we want to develop this valuable immune database that will help us identify patterns of health and bring it to the general public.

Get in touch with Anitha at anitha@girihlet.com

Creating a Functional Window to the Brain: an Interview with Henrik D. Kjeldsen of Truust Neuroimaging

Creating a Functional Window to the Brain: an Interview with Henrik D. Kjeldsen of Truust Neuroimaging
Creating a Functional Window to the Brain: an Interview with Henrik D. Kjeldsen of Truust Neuroimaging

Modern neuroscience is still relying on old methods that don’t allow us to truly understand what’s happening in the brain in real-time. As a result, we have a limited understanding of brain-related disease and ability to treat conditions early.

Truust’s neuroimaging technology is providing real-time data in order to visualize energy flow in the brain, and, as a result, be able to predict and treat brain-related diseases before they start. I spoke with the Henrik, the CEO, to learn how he discovered this problem, limitations of today’s technology, and how Truust can change the field. Check out his pitch from IndieBio’s Demo Day Livestream!

A: Tell me about your background, how did you get interested in the biotech space?

H: I met my co-founder, Lars, about 15 years ago, while working as an electrical engineer. As a result of the computational problems presented while working on the Semantic Web I got interested in artificial intelligence and did a Master’s of AI in the Netherlands. I realized current AI approaches are not able to handle such complex problems, and we need to study real intelligence to figure it out. So I went to the UK to do a PhD in Experimental Neuroscience, where I faced a new problem; current tools are only able to see very little of what is going on in the brain. This not only makes it very difficult to understand the brain, but also makes it impossible to diagnose brain-related problems early enough to catch disease before they present with behavioral symptoms or become actual structural changes in the brain. This made us realize that we need to improve our neuroimaging tools, and based on the idea of super-resolution we initially created a solution for specialized micro-electrode arrays that worked surprisingly well. Since then I spent some time at CERN, the global leader in experimental particle physics, where I really came to understand the potential of super-resolution signal processing techniques.

A: What problem are you working to solve with your company, Truust?

H: A major problem in neuroscience is that we are relying on statistical analysis to understand connections in the brain since we can’t actually see real-time energy flow. With our super-resolution method, we can see the actual flow of electromagnetic energy from point A to B which means we now have a window into the living dynamic brain for the first time. So using existing EEG hardware we will collect huge amounts of data that machine learning can be applied to and understand EEG biomarkers of a wide range of brain-related problems. We envision a future with an EEG terminal in every doctor’s office as part of every physical; and the doctor does not even have to be an expert, our biomarker system is all the assistance they need.

A: If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

H: Seeing all different kinds of people, from random kids to experts in the field, get really excited about our prototypes visualizing energy flow in the brain, tells us that we are really doing something new at the cutting edge of understanding the brain

A: How do you think success can change your industry?

We are going to revolutionize neuro-imaging to make it useful and relevant to the general population and their healthcare. It will become much lower cost than current MRI and PET techniques

A: How is your team uniquely able to tackle this? What’s the expertise?

H: We have a unique perspective on the brain being cross-disciplinary between electrical engineering, AI, physics, and neuroscience. This allows us to take a physical and computational approach to what has traditionally been a biological problem. We have worked on these problems in one form or another for a long time, and what we are doing now is a natural culmination of that path.

A: Any big lessons learned transitioning  to startup entrepreneurship?

H: We’ve had the expectation fulfilled that things move very fast. We can do things much quicker than in academia or in large companies. That’s actually one of the reasons we left those to form a  startup. Things were moving very slowly. In a startup we are learning much faster since we’re able to experiment and iterate so much faster.

A: What’s the biggest challenge you’ve encountered so far?

H: Talking about what we do in a way that isn’t too academic. There’s a balance between being technically correct and not being overly technical. These are new ideas that people aren’t generally familiar with, so communicating the nuances while still letting them see the big picture can be tough.

A: What are the big goals and milestones you’re looking to hit in the short term? Long term?

H: In the short term we want to validate our technique with a number of different labs on hard, real world problems, like better seizure localization for epilepsy. Our long term goal is to truly understand the brain, which would open up many more general applications all across medicine and research.

Get in touch with Henrik at henrik.kjeldsen@truustneuroimaging.com

Reprogramming Cancer and the Future of Medicine: an Interview with Andrew Gray of Vali Nanomedical

Reprogramming Cancer and the Future of Medicine: an Interview with Andrew Gray of Vali Nanomedical
Reprogramming Cancer and the Future of Medicine: an Interview with Andrew Gray of Vali Nanomedical

Drug delivery is one of the greatest challenges in treating cancer today. There are a multitude of effective drugs that aren’t able to be delivered to tumor sites, or can not be delivered in combination.

Vali Nanomedical is now solving these drug delivery problems with a revolutionary programmable drug delivery system, and working towards a future where in vivo cellular reprogramming can cure disease without even using drugs. I talked with Andrew, Vali’s CEO, about his path to entrepreneurship, its challenges, and the future of Vali. Check out his pitch from IndieBio’s Demo Day Livestream!

AK: Tell me about your background, how did you get interested in the biotech space?

AG: I have PhD in molecular biology, focusing on cancer and developing cancer vaccines as a grad student. I got involved in nanotech knowing that starting a company was the goal. Early on I took a class on entrepreneurship and knew right away that was the path for me, not traditional academia. Going into startups has been really exciting since it’s been a goal for some time.

AK: What problem are you working to solve with your company, Vali?

AG: The biggest issue in cancer is delivering drugs to where they need to be. There are a lot of great drugs out there that can’t reach the right place or are toxic. At Vali Nanomedical, we created a programmable nanoparticle that homes onto cancer cells and releases drugs there but doesn’t harm healthy cells. It’s like making a smart missile that knows when it has missed and refuses to detonate when it’s in the wrong place.

AK: If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

AG: This is the first time in my entire career that I’ve felt like I’m at home. Every day flies by and is exciting.

AK: How do you think success can change your industry?

AG: We envision a world where drugs aren’t used at all to treat disease. Instead, we’d use our technology to reprogram cells to either return to a healthy state or, if they’re too far gone like cancer cells, reprogrammed to kill themselves. Ultimately we want to make cancer a disease of the past.

AK: How is your team uniquely able to tackle this? What’s the expertise?

AG: We have a fantastic team with very complementary skills. Prof. Mike Wong is a physician-scientist who has dedicated his career to finding better ways to treat cancer. As I mentioned, I’m an expert in the molecular biology of cancer. Prof. Pin Wang is an absurdly accomplished and productive biomedical engineer at USC. The founding team is backed up by industry veterans, including former director of BD at Amgen Holly Hartman and Prof. John Daniels, who literally launched an industry by inventing and commercialized collagen for injection. Between us, we have all the skills necessary to make our grand dream a reality.

AK: Any big lessons learned transitioning from academia to startup entrepreneurship?

AG: You have to reframe the way you talk about your work. Academics are trained to talk about the things they’re 99% sure they’ve figured out. As an entrepreneur, you talk about problems that you haven’t solved yet and demonstrate you have a plan to get there.

AK: What’s the biggest challenge you’ve encountered so far?

AG: Finding the right first addition to the team. It was only by good luck and timing that I found the perfect person to add to the team. He was an amazing materials scientists named Don Johnson, who’s also a PhD.

AK: What are the big goals and milestones you’re looking to hit in the short term? Long term?

AG: Short term are building multiple partnerships with pharma to deliver drugs they can’t deliver now, either alone or in combination to treat cancer. We’re uniquely capable of doing combination therapies. Like I said, in the long term we want to make cancer a disease of the past.
Get in touch with Andrew at andrew.gray@valinano.com

Powering Discovery with Proteomics: an Interview with Jun Axup of MYi

Reprogramming Cancer and the Future of Medicine: an Interview with Andrew Gray of Vali Nanomedical
Reprogramming Cancer and the Future of Medicine: an Interview with Andrew Gray of Vali Nanomedical

Next-generation DNA sequencing technology has revolutionized biological research over the last decade, but very few advancements have been made in proteomics, the next great frontier of biological data.

MYi is developing these new methods to study proteins in order to better understand, manage, and cure disease. I spoke with Jun, the company’s COO, to learn about the team’s expertise, the potential of the field of proteomics, and the impact MYi hopes to have. Check out her pitch live on February 4th on IndieBio’s Demo Day Livestream!

A: Tell me about your background, how did you get interested in the biotech space?

J: Our team knew each other from our time at The Scripps Research Institute, where I obtained my Ph.D. in chemical biology. I’ve always wanted to apply my work to therapeutics, but after working in that industry, I realized the slow pace of biological discovery. Leaps in innovation only happen after technological breakthroughs that make research better, faster, cheaper, and more accessible. Hence at MYi, we are doing just that.

A: What problem are you working to solve at your company, MYi?

J: MYi is developing high-throughput assays to look at multiple proteins in a single sample by utilizing the advancements in next-generation sequencing. Proteomic analysis today is very low-throughput and expensive because it is difficult to amplify and manipulate the signal of proteins. However, if we can bridge protein technologies with DNA technologies, like PCR and sequencing, we open up a lot of opportunities. We do this by putting DNA tags on protein-binding molecules, like antibodies. With our technology, we will enable the next wave of biological data and facilitate precision medicine.

A: If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

J: There are too many diseases, both common and rare, that we can’t cure or even effectively manage.  Our inability to do so is due to a major knowledge gap in our understanding of the molecular basis of these diseases.  While DNA sequencing has begun to fill in these gaps, our genetics are only a part of the story.  MYi is further filling this knowledge gap by analyzing proteins in an unbiased way to find disease patterns that no one knew were even there. Our biggest validation would be to find the root cause of an individual’s disease in a manner that would lead to an intervention.

A: How do you think success can change your industry?

J: Like how next-generation sequencing technologies enabled and accelerated the field of genomics, MYi hopes to bring that growth to proteomics. Furthermore, this will create a flood of data that, in combination with genomic and exome data, will inform therapeutic development.

A: How is your team uniquely able to tackle this? What’s the expertise?

J: Our team consists of accomplished scientists in personalized medicine and bioinformatics, like Nicholas Schork (CEO) and Kristopher Nazor (CSO), who have shown that big data approaches can advance our understanding of complex diseases such as cancer or even autism. Additionally, we have experts in bioconjugation and nucleic acid chemistry, such as Devon Cayer (CTO) and myself. We are also joined by a seasoned business officer, Maria Forero. Together, we have the technical and business experience to realize the vision that we all share.

A: Any big lessons learned transitioning from academia to startup entrepreneurship?

J: Being in academia and in a startup are actually very similar: long hours, low pay, drive to innovate, and responsibilities to funding agencies (grants/journals vs investors/customers). The biggest difference is that in a startup you are a part of a team that is all running towards the same goal. The camaraderie and support is invaluable.

A: What’s the biggest challenge you’ve encountered so far?

J: Running a biotech startup in a lean manner has been very challenging. Unlike software-based companies, biology has a lot of overhead in lab space, consumables, and operational logistics that are both expensive and time-consuming. It’s a huge challenge to juggle the science, business, customer acquisition, and funding all at once while under a time crunch. But that’s also why this stage of a startup is the most fun and exciting.

A: What are the big goals and milestones you’re looking to hit in the short term? Long term?

J: The first major milestone is to get our first assay kit on the market. From there we hope to scale, create follow-up products, and partner with other organizations to develop diagnostics and therapeutics.
Get in touch with Jun at jun@myidiagnostics.com

Bringing Space Technology to Healthcare: an Interview with Jeff Nosanov of V-Sense Medical

Bringing Space Technology to Healthcare: an Interview with Jeff Nosanov of V-Sense Medical
Bringing Space Technology to Healthcare: an Interview with Jeff Nosanov of V-Sense Medical

Tracking vital signs is a crucial means for preventing disease. However, it’s a big time demand on caretakers of the most vulnerable patients and rarely done for much of the general population.

V-Sense is developing monitors using NASA Jet Propulsion Lab radar technology to remotely and continuously monitor key vital signs. I talked to the company’s CEO, Jeff Nosanov, about learning how to apply this new technology, lessons moving from research to startups, and goals for V-Sense. Check out his pitch live on February 4th on IndieBio’s Demo Day Livestream!

A: Tell me about your background, how did you get interested in the biotech space?

J: I always wanted to be an astronaut and started college in engineering because of this. I later switched out to approach the space world from a different angle and got the first ever Space and Telecommunication Law degree. That got me my job at NASA Jet Propulsion Lab (JPL) testing clinical application for a new radar technology. My biotech interest started in 2012 after my newborn was in the NICU for a week and we kept having problems with his vital sign monitors. I found out this is a very common issue in medicine and almost considered commonplace, which I thought was really strange and unfortunate. I knew the technology I was involved with could remotely measure vitals and realized it would be very helpful for this application. Then when my second child was born and had the exact same problem in the NICU, I got a really passionate about applying this technology to medicine. When we moved to Bethesda for my wife’s residency I left NASA and had the freedom to pursue this startup and technology.

A: What problem are you working to solve with your company, V-Sense?

J: Understaffing is a huge problem in nursing homes across the US. Due to this nurses and staff can’t measure vital signs on schedule and as often as needed. This results in missing a lot of important information on patients that could improve quality of care and save money. We’re automating this time-consuming task which is a win for everyone. As we expand into consumer homes we can provide the same service to millions more people.

A: If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

J: I’m really excited about the day I get a call from our first customer that says we saved someone’s life because of our device.

A: How do you think success can change your industry?

J: For five years at the JPL I would hear from my wife, who was in medical school,  how some techniques doctors use are brand new and others are two thousand years old. We often have a big gap between techniques doctors are using and what modern technology can do. I’m interested in bringing more advanced technology to medicine via the rapid innovation possible in a startup. There’s a lot of great technology sitting in research labs throughout the country but no one is having the light bulb moment to apply it. I want to see more innovative medical technology coming out of space technology research.

A: How is your team uniquely able to tackle this? What’s the expertise?

J: I spent two years working with the team that invented this technology, mostly looking at how to apply it clinically. So I’ve been working with this technology and its users for years. My CTO, Hector, spent over a decade at JPL working on tons of radar technologies and applications. After that, he did a lot of product consulting and is perfectly positioned to bring this technology out to the world. Plus, we still have access to JPL and the tremendous minds working there.

A: Any big lessons learned transitioning from research to startup entrepreneurship?

J: The power of going out and directly talking to your customers. It’s not really clear who our customer is with research since we don’t know if our technology will reach the outside world. In business we can go out and ask the user to design it with us and how to make it as useful as possible for them.

A: What’s the biggest challenge you’ve encountered so far?

J: The medical community is fairly conservative, for understandable reasons. It can be a challenge to communicate possibilities of radar technology since they aren’t trained to know its nuances and applications. We have to communicate in a collaborative manner to explain the potential and value of this new way of doing what they already do. Having a wife who’s a physician has been really helpful since I can interact with and learn from so many different physicians.

A: What are the big goals and milestones you’re looking to hit in the short term? Long term?

J: Raising another round of funding that allows us to get to market in the nursing home space. Once we do that we’ll be reaching a sufficient install base so that the data gathered can be used to predict medical events for nursing home patients. From there we’re releasing a consumer product for the home that does the same thing.

Get in touch with Jeff at jeff@vsensemedical.com

Putting Biological Supercomputers in the Palm of your Hand: an Interview with Oshiorenoya Agabi of Koniku

Putting Biological Supercomputers in the Palm of your Hand: an Interview with Oshiorenoya Agabi of Koniku
Putting Biological Supercomputers in the Palm of your Hand: an Interview with Oshiorenoya Agabi of Koniku

As ambitions to create newer and faster supercomputers grow, so do the challenges. Increasing computational power comes with demands of scale, stability, and accessibility.

Koniku is a startup working to solve this by harnessing the power of biological neurons to create the next generation of supercomputers. I talked with Koniku’s CEO, Oshiorenoya E. Agabi, about his story, goals for Koniku, and changing the science of computation. Check out his pitch live on February 4th on IndieBio’s Demo Day Livestream!

A: Tell me about your background, how did you get interested in the biotech space?

O: I was born and raised in Lagos, Nigeria where I also did my bachelors. While getting my master’s in physics I remember a Russian professor telling me that if I wanted to make an impact I needed to go to a field where not a lot has been done and there’s opportunity to quantify everything. Following his advice, I took a course in neuroscience and knew right away this was it. Since then I’ve been working in computational neuroscience – quantifying how neurons function, engineering how to talk to them, and building tech out of them. After writing my master’s thesis on using biological neurons to do computation, I went to Imperial College in London to do my PhD in Computational Neuroscience and Bioengineering. That’s where I founded Koniku.

A: What problem are you working to solve with your company, Koniku?

O: The question is how to build a truly cognitive system. To do larger applications, we currently have to build massive and unscalable server farms. If we ever want to get to the point of doing significant computations we have to move away from the silicon paradigm. Koniku eventually aims to build a device that is capable of thinking in the biological sense, like a human being. We think we can do this in the next two to five years. We’re currently engineering neurons such that they are sensitive to particles in parts per trillion. With our computational backend, we’ll have a device that can be used for particle detection and be used for industrial, military, and agricultural application.

A: If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

O: We want to prove  we can connect to neurons and structure biological systems, and have the ability to package that.

A: How do you think success can change your field?

O: If we’re just 60% successful as a company, we’ll change computing as we know it. We’ll see a massive shift away from the silicon computing industry. Similar to what silicon did for the information age, we’ll do this for biotech.

A: How is your team uniquely able to tackle this? What’s the expertise?

O: We have a wealth of business and technical experience and expertise. This is a massive undertaking so we are still looking for more people with experience in computational neuroscience.

A: What’s the biggest challenge you’ve encountered so far?

O: In the near term it has been delivering game-changing devices and generating early revenue. We don’t want to just move fast and break things, we want to deliver an amazing product at the same time. Since we’re building a device we can’t just update it as needed. It has to perform exceptionally well every time a customer or user buys a product. We want to deliver an exponential advantage.

A: What are the big goals and milestones you’re looking to hit in the short term? Long term?

O: In the short term we would like to start delivering our sensing controls and computing devices to customers in the aviation and pharma sectors that have signed with us. We want to deliver an amazing product.

Our long-term goal is building a strong user base that lets other people make money off our devices. In the next two to five years we want this base of people programming and building separate applications for our device. It will be a true platform technology that people can build secondary products out of.

Get in touch with Osh at agabi@koniku.uk

Creating a pick and place machine for DNA synthesis: an interview with Jeff Clayton of Genesis DNA

Creating a pick and place machine for DNA synthesis: an interview with Jeff Clayton of Genesis DNA
Creating a pick and place machine for DNA synthesis: an interview with Jeff Clayton of Genesis DNA

In recent years we’ve seen an exponential ability to sequence DNA. What in the recent past it cost billions of dollars is now available for under one thousand dollars. However, the cost of synthesizing new DNA is still prohibitive and causing bottlenecks in research and industry.

Genesis DNA is working to create new methods to standardize DNA synthesis and make it cheaper, faster, and more reliable. I talked to the company’s CEO, Jeff Clayton, about his background, lessons from creating a start up, and Genesis DNA’s goals. Check out his pitch live on February 4th on IndieBio’s Demo Day Livestream!

Tell me about your background—how did you get interested in the biotech space?

I started off in chemistry as an undergrad since I always had an interest in biochem and biology, but ultimately went in the engineering direction for grad school since I thought there were a lot of opportunity for devices. I saw merging silicon and biological systems as a way to get the best of both worlds. My co-founder, David, also has a chemistry background but went more towards bio-engineering. The idea of Genesis DNA was born from a combination of his expertise in biology and mine in engineering.

What problem are you working to solve with your company, Genesis DNA?

We are developing a next-gen platform for DNA synthesis to standardize the process of assembling genes. The current assembly process is unpredictable. Every time you want to build a gene you have to design and build all the building blocks. This makes it difficult to know how long it will take and how successful a particular build will be. By standardizing the process it becomes easier and more cost effective to build custom DNA sequences.

If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the single biggest indicator to you that you are doing the right thing?

Our customer testimonials. It’d be a lot more difficult to work on this problem if we didn’t have people telling us all the time that today’s tools are still inadequate. We’ve heard from almost every biotech company that we’ve talked to that the ability to write DNA has become a huge bottleneck for research.

How do you think success can change your industry?

A great tool for DNA synthesis can do for biology what great microfabrication tools did for electronics. They increase freedom of design and make ideas more accessible and affordable to explore.

How is your team uniquely able to tackle this? What’s the expertise?

Ultimately we’re building a tool that builds biology so the expertise needed is heavy on both the biology and engineering sides. Which our team has.

Any big lessons learned transitioning from academia to startup entrepreneurship?

At IndieBio we’ve parallelized our research much more than we ever did in grad school. In a startup you don’t have the luxury of trying one thing at a time and waiting like in academia. This has been a really gratifying experience because you can achieve a lot of key metrics and get key results much faster.

What’s the biggest challenge you’ve encountered so far?

Besides the tech, learning how to effectively communicate science and its significance to the outside world. It’s not something you get a lot of practice at doing in academia.

What are the big goals and milestones you’re looking to hit in the short term? Long term?

In the short term we’re aiming to validate our chemistry for the synthesis of a short DNA sequence. Our ultimate goal is to greatly simplify the way researchers get DNA. We want it to be delivered in less than a week for simple or complex sequences and an order of magnitude cheaper than what is currently available.

Get in touch with Jeff at jeff@genesisdna.com

Unlocking Gene Therapy for the Masses: an interview with Ryan Pawell of Indee

Unlocking Gene Therapy for the Masses: an interview with Ryan Pawell of Indee

The science of gene therapy poses one of the greatest technical challenges in modern medicine. Researchers and industry face the significant challenge of introducing new functioning genes into cells, and doing so in a scalable and affordable manner.

Indee is a biotech startup developing new tools for gene therapy to bring it to the masses. They’re  currently part of IndieBio’s second class of startups. I talked to the company’s CEO, Ryan Pawell, about his story, transitioning to entrepreneurship, and the future of Indee. Check out his pitch live on February 4th on IndieBio’s Demo Day Livestream!

A: Tell me about your background, how did you get interested in the biotech space?

R: I have a B.S. in Mechanical Engineering. My senior project was developing tools for cervical spinal surgeries, and I also worked for a couple years on portable oxygen concentrators to treat breathing disorders like COPD. I realized I wanted to get into stem cells, and thought microfluidics was a good route since it was a high value and low-cost tech for stem cell manufacturing with good potential business models. All that led me to do a Microfluidics PhD in Australia.

A: What problem are you working to solve with your company, Indee?

R: Indee is solving scalable gene delivery. This is really important for gene therapy since right now scales are limited to just a few thousand wealthy patients per year. Creating a scalable process can treat tens of millions of people that die from multiple diseases every year.

A: If you could only pick one thing to validate your reason for forming a startup, what would it be? In other words, what would be the biggest indicator that you are doing the right thing?

R: I just don’t like having a boss. My first job was working for myself, and it was more rewarding and flexible. The whole point of this startup is to work on something that helps other people while enjoying the benefits of self-employment. Right now at an early stage startup there aren’t really any benefits of self-employment [laughs].

A: How do you think success can change your industry?

R: We’re looking to ultimately manufacture these life-changing therapeutics for tens of millions of people every year.

A: How is your team uniquely able to tackle this? What’s the expertise?

R: Our team consists of two full-time employees (myself included), eight advisors, some high-value contractors, and IndieBio/SOSV. Our expertise is in both microfluidics, fluid dynamics, and cell biology. My co-founder, Matt, handles the biology and business development. I do the engineering and operations. Having a co-founder with complementary and effective skillsets has made a huge difference.

A: Any big lessons learned transitioning from academia to startup entrepreneurship?

R: Startups are exciting, challenging, and fast-paced. Academia… not so much.

A: What’s the biggest challenge you’ve encountered so far?

R: It can be tough to stay on top of everything. We have a great two person team but when the work piles up three would be nice [laughs].

A: What are the big goals and milestones you’re looking to hit in the short term? Long term?

R: Our big goals are to verify our technology and sign our next investment. In the short term we want to show gene editing and be able to process 10,000 samples a week. This is proof of concept for a 50-fold improvement over current manufacturing scales without spending 43 million dollars for a manufacturing plant, because we don’t have that. In the long term we’d like to use that system to manufacture 10,000 therapeutics per week so we could treat half a million patients per year.

Get in touch with Ryan at rpawell@indeetx.com

Blending Life and Computer Science – R. Machiraju

Blending Life and Computer Science – R. Machiraju
Blending Life and Computer Science – R. Machiraju

I believe that computing shall be even more pervasive and ubiquitous than it is today

and will evolve into a high-impact, use-inspired basic science1. Over the last seven decades,

we have seen the beginning of a major technological revolution, the Information Revolution.

Many of us who are middle-aged or part of the baby-boomer generation have been witness to

this growth. The last decade has especially seen computing emerge from its strongholds in

engineering and the mathematical sciences and has diffused not only into all corners of

academia (biology, social sciences, humanities, etc.) but also more impressively into quotidian

life. It is the latter aspect that will drive computer science and provide even more growth

opportunities. Witness the growth of companies like Google, which have made search and to

google an overloaded and essential verb. The social impact of computing is at its all time high

and its ubiquity and pervasiveness will only grow. In my opinion, growth will be in democratized

iComputing: computing for everybody and by everybody.

We are at the confluence of many perfect storms of opportunity. Processing and storage

hardware is cheap and is increasingly available in the cloud. Mobile and traditional

communication systems and the Internet connect us and our embedded devices, our vehicles,

our homes, and our offices into a global matrix. Yet, I believe we have seen only the tip of the

iceberg.

Therefore, computer science will be better served if it considers itself to be a broad

discipline with a myriad of interacting components and not just a slew of vertical silos wherein

practitioners design and build compilers, operating systems, architectures, and graphics

systems, while some propound algorithms and theory. It must also rely on disciplines other than

mathematics (e.g. physics, statistics) for intellectual succor. I increasingly believe that computer

science is a use-inspired science with a high-impact footprint where many sub-disciplines are

applied to solve problems. Use and value will drive the discipline of computer science. Further,

in the age of austerity and growth in the developing world, there will be an emphasis on use-

based research and development. Still, there will be a place for fundamental and basic work.

Consider this. Louis Pasteur, a founding father of modern microbiology, began his quest with

the more basic need of preserving food2. I believe that computer science will also head this

way, use-driven and use-inspired yet innate to the human experience.

In marked contrast to the early formative years of computer science, which overlapped

with the ebb and flow of cold war funding and patronages, the eco-system of today is

dramatically different. Computer science will not be just driven by the next new hammer that is

invented at the behest of high priests or driven by plain curiosity. However, there will be

incentives in finding nails everywhere around us, like geocachers, to construct new hammers or

adopt existing hammers. Consider Google’s PageRank algorithm. It should be noted that the

original and well-touted PageRank algorithm or hammer had a purported use. With the passage

of a decade, the venerable algorithm has to also act as an honest broker, thus bringing in

additional constraints to search and a rethinking of the mathematical and algorithmic

underpinnings.

I have followed this mantra in my own work. I embedded myself increasingly in the

physical and biological sciences by learning the subtleties and nuances of the other science and

realizing scalable, and robust methods and workflows. The interpretable and actionable end-

result – vortices in unsteady flow, distinction between dyscalculics from normal subjects, robust

subtypes of triple negative breast cancer – is paramount rather than the singular method. Often

new basic methods or foundational principles had to be discovered or re-invented within the

constraints of the user-science. Robust engineering practices already achieve this two-step

tango; computer science will increasingly adopt the same tango as it increasingly addresses the

needs of the larger population.

Computational modeling and data analysis will play an important role in defining salient

processes and associations that can be stored and processed in portable, scalable, and robust

prototypes and systems. These systems will be deployed in a multitude of human-centric

applications that in turn parlay human sensory perception and more usefully cognition. This is

my utopian albeit utilitarian view of computer science.

The role of mathematics and statistics especially in the age of Big Data cannot be

understated. Foundational work in theoretical regimes will continue; the increased emphasis on

high-dimensional and probabilistic learning algorithms offers one example. Similarly, 3D printing

and novel manufacturing processes could not have become a reality without the pioneering

work of geometer Prof. Herbert Edelsbrunner and many others. New systems and programming

languages will also be required. The growth of graphical processing units and probability

processors (Lyric Labs) will only usher expedited growth in hitherto unexplored application

areas. There will always be a need for compilers for all these specialized solutions; the

demands of a probabilistic language where a variable carries the semantics of a distribution will

require some deliberation. Human-computer interaction will be even more stressed and

text/speech/image/video/ processing will be eventually woven into a single tapestry of a user

interface.

Applications will form the inter-disciplinary bridges to others in social sciences,

engineering, and medicine and it is through applications that the user plays an important role.

Personalized medicine and all the associated advancements in the physical and biological

sciences will require a bigger role from computing software and infrastructure, while traditional

consumers in enterprise computing, finance, weather prediction, etc. will continue to place even

more demands on real-time services and storage.

In academia, there will be more branches and rivulets. Cybersecurity, systems biology,

finance, fluid dynamics, medical imaging, neuroscience, etc. already vie for attention from

academics in various departments of computer science. E-governance, social media, social

innovation, and smart cities will follow, especially spurred by the availability of Big Data3. Each

of these inter-disciplinary growth opportunities will lead to a reexamination of cross-disciplinary

fault lines and new flurry of research will ensue. The exact shape and form of these changes will

depend on the local academic, business and cultural environment.

The delivery of curriculum will also experience a sea change. There is certainly an

interest in all things computing; we have seen this in burgeoning enrollments at both university

and K-12 levels. Some of the new improvements will be of vocational nature. It is therefore not

surprising that one speaks of imparting the three Rs and C to the uninitiated4. Similarly, there

will be an increased emphasis on active learning in flipped classroom settings where students

actually engage in problem solving while being part of collaborative teams. This pedagogical

approach is increasingly shown to be effective in more general settings5. In many settings,

computer science is already taught in this manner and is likely to become the norm.

In closing, it is my opinion that computer science will adopt a utilitarian face and will

make even greater forays into interdisciplinary ventures while strengthening all components in a

cross-disciplinary fashion. By placing computer science squarely in Pasteur’s quadrant2,

practitioners can engage in a rigorous albeit a very relevant science and in essence enable

computer science to play an even more important role in modern life and human civilization.

This is a guest post by Raghu Machiraju, CEO, Abiobot (IndieBio Alumni). Raghu also serves on the faculty at Ohio State University in the Department of Computer Science and Engineering.  He also has an appointment in the College of Medicine at OSU.  His interests include image analysis and visualization especially as they apply to topics in biology, medicine and engineering. Over the years he also been increasingly working on problems of computationally biology and bioinformatics.

1 Marc Snir, Communications of the ACM, ViewPoints, Vol. 54, No. 3, March 2011.

2 Stuart Cantrill, Speaking Frankly: The allure of Pasteur’s quadrant, The Sceptical Chymist, July 7, 2013.

3 Data Science for Social Good, 20th ACM SIGKDD Conference, http://www.kdd.org/kdd2014.

4 Leah Hoffman, Computer Science and the Three Rs, Communications of the ACM, Vol. 55, No. 12, October 2012.

5 Freeman et al. Active learning increases student performance in science, engineering, and mathematics, PNAS,

doi: 10.1073/pnas.1319030111

IndieBio and SpaceGAMBIT – Announce Partnership to Accelerate Space Biology

IndieBio and SpaceGAMBIT - Announce Partnership to Accelerate Space Biology
IndieBio and SpaceGAMBIT - Announce Partnership to Accelerate Space Biology

Today we’re delighted to announce our partnership withSpaceGAMBIT to accelerate Space Biology, we believe one of the weakest links in making humanity a multi-planetary species is the understanding and development of biotechnologies which could be deployed in every aspect of life in space.

In this partnership, IndieBio will be supportingSpaceGAMBIT with open source capacity building biotechnologies that have potential applications in space and SpaceGambit will be supporting IndieBio in developing novel biotechnologies that could have novel applications in space but would require experienced space industry partners.

SpaceGAMBIT democratizes space technology by funding open-source projects that tackle everything holding us back from being a spacefaring species. They work with partners and the maker movement to find out what’s keeping us stuck on Earth, engage the crowd to find solutions, and share the results with the world. They’ve worked with NASA and the White House, and are now adding IndieBio to their list of partners to help hack humanity to the stars.

Onwards and Upwards from your friends at IndieBio and SpaceGAMBIT!

http://www.spacegambit.org/

http://sf.indie.bio/

Reimagining the Future with Biology

Reimagining the Future with Biology
Reimagining the Future with Biology

Today, Bolt Threads, previously Refactored Materials announced that they’d raised $40M in their latest round of financing and expect to have their yeast derived spiders silk (10x stronger than steel per weight) available for sale by 2016.

The new Bolt Threads biomaterial will have applications we can only now dream of and likely many, we have yet to dream and this is only the beginning of the new bioeconomy that’s being built around us, in university, commercial and biohacker labs around the world.

Over the last four months, our first IndieBio class in San Francisco (IB1), we’ve seen what’s possible when scientists, innovators and pioneers join together to accelerate how we build our world with biology.Amazing companies, products and services have been built in a spirit of camaraderie and collaboration (both within the first cohort and with the broader community) which is stark contrast to many of the innovation silos we’ve all experienced in academia and industry.

Our first time founders have worked side by side with each other and veteran entrepreneurs and scientists (across all industries) to reimagine a world in which previously intractable problems might now be solved with applied biology.

  • Pembient has shaken up the world of Rhino conservation by challenging the status quo, sometimes education isn’t enough, if you have an approach which is failing, change it.
  • Clara Foods is helping us to reimagine food with beautiful and delicious Meringues, to start with, which have excited Chef’s globally as a new way to innovating in the kitchen humanely!
  • Extem are powering regenerative medicine with the first and most extensive global stem cell bank, supplying researchers globally with the cells they need to deliver on the promise of regenerative medicine, helping patients in dire need.
  • Arcturus Biocloud have launched the first consumer biotech cloud service, enabling applied biology and science from anywhere with a simple user interface with users signed up on the platform from over 100+ cities globally (and growing).

These are only a few of the companies who you’ll see presenting on our first Demo day, June 11th, in San Francisco, in which we invite you to attend, our general admissions are now sold out due to massive interest but this event is also for the broader global community and will be live streamed, so whether you’re in SF, Mumbai, London or further afield we invite you to join us! We’ll be sharing our livestream calendar invite on @indbio soon!

If you’re a scientist, entrepreneur or biohacker and have a re-imagined vision of the future, built with applied biology that you’re currently working on or would like to build, we’d also love to invite you to apply for our $250k funding package, we’ll be funding our next class of 15 new companies in SF in September and our first early applications deadline is June 30th 2015, get your application in ASAP, don’t wait for the deadline, as we’re currently interviewing teams for consideration into the next class!

The Story of Fire, Stone, and Biology

The Story of Fire, Stone and Biology
The Story of Fire, Stone and Biology

It was the Titan, Prometheus, who created man.

Prometheus glanced down on the Earth and noticed that rainwater was making nature live, without it trees and bushes died, giving way to desert.

Prometheus discovered the power of earth and water, so he mixed clay with water, moulding the shape of the first man.

It was in the shape of the gods that he created mankind.

For some, the well trodden mythology of the theft of fire from the gods by Prometheus, to share with humanity is seen as both a great sacrifice and a parable, that not even a titan is allowed to share the tools of the gods.

But fire and stone isn’t the only lesson which the Titan Prometheus can teach us, even in his punishment, chained to a rock, suffering in agony as his liver is eaten by an eagle, eternally, he gave us one more gift.

Regeneration.

It appears that even the ancient Greek’s knew of the liver’s ability to regenerate after injury, it’s an ancient learning hinted through mythology and yet, only recently have we really started to unravel the mechanisms of regeneration, not just in the liver but across the bodies of humans and other multicellular organisms.

“In Biology, Regeneration is the process of renewal, restoration, and growth that makes genomes, cells, organisms, and ecosystems resilient to natural fluctuations or events that cause disturbance or damage”

So what do we, as humanity now know about regeneration?

  • We know that our DNA has built in repair mechanisms
  • We know that our cells have “shredders” which are constantly on the search for damaged proteins, destroying the old to ensure our cells continue to function.
  • We know that our tissues are constantly replenished by adult stem cells, as we get broken down by wear and tear, our bodies do an incredible job of repairing us, until they can’t.
  • We know that some organisms still retain their regenerative capabilities, long past the embryonic stage.
  • Flatworms can be cut in half and regenerate entirely, salamanders retain the ability to regenerate organs, eyes, tails and many more of their body parts and humans retain a limited amount of regeneration (although not the ability to regenerate damaged organs or limbs… yet).

So can we 3D print human organs yet?

No, not yet but we’re starting to understand some of the most complex technologies on this planet, DNA, proteins, cells and our living tissues, which turn chaos into order.

We have been able to strip hearts of cardiac cells, repopulate their scaffolding and restart them, they beat.

We’ve been able to keep lungs alive outside of the human body for a few hours (previously they’d foul within minutes), match and transplant hearts, lungs, kidneys and more successfully into living donors and this is just the beginning.

The technology of life

We’re beginning to understand the language of the gods, DNA is the code in which life is written and as we remember, in memorial, those who have lost their lives or have been severely wounded in battle for our freedoms, we can now offer them a glimmer of hope.

This year, the Department of Defense launched a new Organ preservation initiative supported by the Organ Preservation Alliance and New Organ. Companies like Organovo are now printing more and more complex tissues, we can, as of today, grow organoids (small organ like tissues) of most major human organs and researchers at universities across the globe are diving deeply into regenerative medicine and the development of a new area of science, organogenesis.

Prometheus, on that rock of eternal damnation, gave us one last gift, regeneration.

Extem – The future of stem cell based therapy.

Extem - The future of stem cell based therapy.
Extem - The future of stem cell based therapy.

We are a group of scientists and engineers designing a new system to mass-produce adult stem cells. Our pilot project is the rapid large-scale production of mesenchymal stem cells, for use in basic research and bioprinting.

With federal science budget cuts of almost $600M in Canada alone between 2008 and 2013, it is becoming increasingly difficult for researchers to fund their experiments. We are removing the difficulty and expense of isolating primary cells by delivering ready-to-use stem cells straight to your lab.

Our ultimate goal is to empower researchers and other enabling technologies to revolutionize bio-engineering through the integration of stem cell tools. In pioneering a global source of stem cells, we aim to exponentially accelerate stem cell research and open the gate to new stem cell-based therapies in regenerative medicine and tissue engineering.

-the extem team

Stem cells, research, and bio-engineering – the future of stem cell based therapy.

Ethan’s Journey: From Postdocalypse to Venture Funded Biotech Entrepreneur

Ethan's Journey: From Postdocalypse to Venture Funded Biotech Entrepreneur
Ethan's Journey: From Postdocalypse to Venture Funded Biotech Entrepreneur

Hi, my name is Ethan. I’m the Founder and CEO of Perlstein Lab. Perlstein Lab is a biotech startup and public benefit corporation based in San Francisco. Our mission is precision (personalized) orphan disease drug discovery. In this inaugural post, I will briefly recount the genesis of Perlstein Lab, the science behind our evolutionary approach, and why Perlstein Lab takes online outreach seriously.

18 months ago I faced the most important decision of my professional life: continue to try to break into academia, or leave for greener pastures. Like so many other members of Generation Postdocalypse, I could not ignore the prospects of endless competition for publications, grants and jobs . Was there a way to blend curiosity-driven research with tangible therapeutic outcomes? Of all things, Twitter became my global learning and support group, and I started to investigate options beyond the ivory tower. Very quickly I discovered communities of patient advocates, including inspiring parents of kids with orphan diseases, who convinced me that solving orphan disease puzzles would be the ideal path forward.

When I began putting together a formal business plan and slide deck last Fall, I was most confident about the science underlying our evolutionary drug screening platform, which is based on genome-edited primordial disease models: yeast, worms, flies and fish. When I was a grad student in Professor Stuart Schreiber’s lab at Harvard between 2002 and 2006 I validated yeast as a model for pharmacology. I then advanced these ideas as an independent fellow at Princeton from 2007 to 2012 by studying the pharmacology of antidepressants in yeast cells.

I knew I was onto something when I attended Rare Disease Day 2013 at NIH and learned that very few (if any) orphan disease researchers leverage primordial disease models, even though ancestral forms (aka homologs) of many orphan disease genes are evolutionarily conserved in simpler organisms. Instead, the vast majority of orphan disease research relies on mouse models of disease, and has relied on mouse models for the last 30+ years.

Most biotech startups don’t have a blog or Twitter presence. Perlstein Lab will be different from the typical biotech startup with respect to online outreach, especially patient engagement. What initially drew me into the orphan disease space was the openness, zeal and grace of patient advocates on Twitter and the blogosphere, so it’s only fair that Perlstein Lab returns the favor. As a for-profit company, we obviously have to be mindful of proprietary concerns. Wherever possible we will strive to engage patients, advocates, scientists or the public on our science, and share the week-to-week victories and tribulations of a 5-person biotech startup.

Ethan Perlstein is a Molecular Biologist, founder of Perlstein lab, a venture funded Orphan disease biotech startup and Mentor at Indie Bio. Feel free to reach out to Ethan