Amelia Edwards
March 22, 2018

Founder Feature: EpiBone

What if everything you needed to recover from an injury or illness was already residing within your own body? Nina Tandon and her team at EpiBone are trying to make this idea a reality with their mission to harness the body's healing power and develop a new method of skeletal repair. The EpiBone team has figured out how to use a bioreactor to mimic the conditions found in the human body which enable bone growth. In just three weeks, they are able to build a personalized bone graft out of adult stem cells that is ready for implantation.

With a PhD in tissue engineering and an Executive MBA in healthcare entrepreneurship from Columbia University, Nina has been making waves in both the academic and commercial world with her revolutionary bone growth process. Fast Company named her as one of the top 100 creative people in business and she also is a TED Senior Fellow. In 2017, Nina was also named as a Finalist in Heritage Healthcare's Annual Innovation Awards.

Currently, EpiBone is on track to begin their first human clinical trials this year with a plan of going to market in 2023 if all goes well. We caught up with Nina to learn more about what it has been like to grow her company in New York City and how EpiBone has been received within the medical community.

Interview with CEO Nina Tandon

What inspired you to create a company focused on skeletal repair and biotechnology? Did you always want to be involved in the healthcare field?

Nina Tandon (NT): For as long as I can remember, I've been interested in the field of healthcare. In my academic training, I took as many undergraduate classes as I could find in biomedical engineering, and eventually pursued a PhD in that field. While I was studying, I also became increasingly aware of (and interested in) the industry side of the healthcare. First as a pharma/med device consultant at McKinsey, then later as a post-doc pursuing an MBA in parallel, in preparation for starting EpiBone. Throughout these varied experiences, it became clear to me that there were several ingredients to a successful biomedical enterprise. The basic science had to already be solid and worked out, the aim needed to serve a high unmet need among patients, and the management team had to straddle the worlds of clinical science and business considerations.

During my PhD and post-doc work at Columbia, I had pursued varied interests related to regenerative medicine; from my base in cardiac tissue engineering, to skin wound-healing, retinal regeneration, and even a project related to fruit fly ovarioles! My co-founder, Sarindr Bhumiratana, was focused more deeply on skeletal tissue engineering, and it became clear that the work he was pursuing was ready for "prime time"-that is, for translation out of the lab and towards the clinic. We joined forces to spin the company out of Columbia, bringing our complimentary skill-sets together to do so. Now, as the team has grown to 20, that collaborative spirit is integral to what makes EpiBone such a fun company to be a part of.

How has your experience been in regard to starting a company in new york city? Have you found there to be a robust biotech and health tech community?

NT: Despite being a smaller life-sciences cluster compared to Boston and San Francisco, we have nonetheless found New York City to be an enormously supportive environment to launch EpiBone. We have been the recipients of funding via the BioAccelerate program from the New York City Partnership fund, and the Empire State Development Fund. We have also taken advantage of significant tax breaks from the city and state, through programs like Start-UP NY, and the Biotechnology Tax Credit. Being located in NYC also gives us access to many top-tier VCs, and pipelines of talent from our many top-tier academic and biotech institutions in the tri-state area.

Nonetheless, we do feel that there are some significant barriers to growth of our industry in the five boroughs that need to be addressed for a truly thriving, robust community to develop here. Although we have seen progress with regard to the availability of affordable lab space for early-stage companies; for companies like ours with teams of 20+, who are beginning clinical trials, shared lab space just isn't an option. Additionally, the cost of building and outfitting 10,000-30,000 square feet of lab space can be very capital intensive. Even though NYC is flush with funding from the NIH, venture capital, and talent, we have yet to truly see the dots connect, and the funding gap close for biotech startups. Nonetheless, I am optimistic about the future of biotech in the Big Apple, as we are starting to see critical mass building here amongst academia, real-estate, industry, as well as on the policy side. As Frank Sinatra said, "If you can make it here, you can make it anywhere!"

Who makes up your target demographic population when it comes to actually need a personalized bone graft as opposed to other graft options?

NT: After blood, bone is the most transplanted human material resulting in millions of transplantations everywhere from dental to ankles. In these procedures, bone is literally cut out of your own (or a donor's) body and carved manually, before being implanted to the site of repair. At EpiBone we envision that instead of repairing ourselves with these transplants or synthetic implants, we can combine the best of what we've learned from digital fabrication, with that of regenerative medicine. This next generation of medicine will allow us to do more than patch ourselves up, and instead allow us to truly heal.

Our technology at EpiBone is a platform technology - at the moment, we can grow bones, cartilage, or a combination of the two, and looking ahead our vision is to create a kind of "one-stop-body-shop" for human parts. As a small company, it's important for us to choose a first application that can serve to showcase our technology's unique advantages, while serving as cornerstone from a technology, regulatory, and IP perspective. For us, this means bones in the head and face. This is where shape really matters, the current treatment options are dismal, and the load-bearing requirements are minimal. While we have successfully tested our technology in preclinical trials, we are currently on the verge of our first-in-human clinical trials. We hope that our work will help mark a pivotal moment in medicine, where you are the cure for what ails you.

How long did it take you to develop your method of bone growth? What did you learn along the way that surprised you?

NT: Within the academic lab, a steady stream of PhD students and post-docs worked for over a decade to develop the technology that eventually became EpiBone - I sometimes joke that rather than an "aha moment" our journey was more like an "ahhhhhhh-haaaaaaaa" moment! Along the way, we learned many surprising facts (science is like that!), but one of my favorites was learning that our fat tissue contains an appreciable number of stem cells with comparable potency to that of bone marrow. Fat tissue often gets a bad rap, and I like to think of these stem cells as "unsung heroes." These stem cells are in many ways the true heroes of EpiBone, growing the tissues we hope will someday transform patient's lives.

How has epibone been received within the medical community?

NT: We find that the medical community comprises some of our strongest supporters! They know first-hand the costs to the medical system of two important trends that are squeezing us - first, as a population, we are getting injured earlier and earlier in life (e.g. ACL tears are up 400% for those under the age of 18 in the past decade) and second, we are living longer than ever. It's clear that we need our treatments to last as long as we do. In a way the concept of EpiBone is quite simple - we are helping body's natural capacity to heal by connecting to the power of our own stem cells, living in our own bodies.

Surgeons are always on the lookout for medical solutions that can simplify surgeries and improve their outcomes. At the same time, hospitals are becoming increasingly focused on delivering value-based care. From a scientific perspective, the medical community recognizes that our bodies have an incredible capacity to heal themselves, and that sometimes all they need is a little help. Creating treatment options that are more natural, simpler to administer, and more effective that current treatments, are something that I think everyone can rally behind.

Do you think precision medicine is the way of the future? Do you have any concerns about the ethical implications or unique cybersecurity issues that may arise from sequencing individuals?

There has been a big push towards precision medicine since former president barack obama's 2015 announcement of the precision medicine initiative (pmi).

NT: As the CEO of a precision-medicine company, I think it's safe to say I believe that personalized treatments are the future. The world's first clinical trial was recorded in the book of Daniel in the Bible, and many would agree with me that despite some dazzling successes we haven't made much progress since then. It's clear that a one-size-fits-all approach still isn't working! This realization is fueling a new era in medicine that will hopefully see everyone benefit.

Ethical and cybersecurity implications abound when we consider our path towards more personalized approaches in medicine. Fortunately, we are not the only industry facing these types of challenges. In the age of "big data" how we manage, store, and use information is of increasing concern to everyone. We take these concerns seriously at EpiBone, and are doing our part by endeavoring to be ahead of the curve with regard to chain of custody and quality assurance, in addition to engaging in bioethical conversations.

What are your next 3 milestones for Epibone?

NT: We need to submit our final IND to the FDA, complete our Series A financing, and then complete our first clinical trial! Our company is at an interesting turning point, and can't wait to get our product in the hands of the people who need it the most.

If you know someone else as inspiring and innovative as Nina who you would like to nominate for the 2018 Heritage Healthcare Innovation Awards nominations are being accepted until March 23rd.

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