This special October BioHaven brought together thought leaders from both academia and industry to focus on building high quality, scalable businesses in regenerative medicine. Regenerative medicine is not a new field, but rather a broad, interdisciplinary, translational branch of medicine and tissue engineering that focuses on replacing, engineering or regenerating human cells, tissues or organs to restore or establish normal function. Whereas significant progress has been made over the past few decades, the commercial success of the field has been hampered due to complex nature of the products, the significant amount of capital needed and regulatory hurdles. The panelists for this talk included Drs. Mei Wei, Professor at UConn and Founder of OrteoPoniX; Valerie Horsley, Assitant Professor of Molecular, Cellular and Development Biology at Yale; Chris Loose, Executive Director at Yale CBIT and Co-founder of Semprus Biosciences; Kyle Kolaja, Vice President of Business Development at Cellular Dynamics International; and was moderated by Amogh Sivarapatna, PhD student in Biomedical Engineering at Yale.

Before answering questions, the panelists each gave short presentations of their work and experience. Dr. Horsley’s laboratory uncovers basic stem cell functions, which may have implications for a variety of diseases, and represent opportunity for commercialization. Moving forward, she is open to the possibility of commercializing technology that comes from her lab and would use talented and driven students to lead such commercialization efforts.

Dr. Wei formed Orteoponix LLC in March of 2014 to address the osteoporosis and bone fracture market using patented bone graft and fixation technology from her laboratory at UConn. They first started work using capital from several sources, including NSF, and Nextgen CT, a small amount of support from a private company, and UConn third bridge. They are currently working towards applying for a federal SBIR grant. For Dr. Loose, it was all about addressing the unmet clinical need in developing antimicrobials and a vascular catheter with less thrombus formation under Dr. Bob Langer. After winning the MIT 100K business competition, the founders had a vetted plan for long term commercialization and ‘piggybacked’ on the regulatory filings of a previously established company. Because of their clear plan and accelerated regulatory pathway, they were able to give VCs a clear and compelling path for investment. Semprus Biosciences went on to secure $29M in VC funding, led by 5AM Ventures and the DOD, and built a team of 38 before being sold to Teleflex for $80M. Dr. Loose heavily stressed that when you start a company, seek the right advisors and confirm unmet need as quickly as possible. For him, that involved walking into the hospital and speaking with doctors.

Finally, Dr. Kolaja of Cellular Dynamics International discussed his company’s business model as a first mover in a new field. Primarily, CDI focuses on a tools business for drug discovery and toxicology screening using human pluripotent stem cell derived cells but hopes to move towards cellular therapies and tissue engineering materials. This complex business ensures a high quality product with a $30M quality monitoring system to make sure the supply chain ensures consistent, batch-to-batch production of cells for use in these applications.

The panelists fielded some great questions, generally aimed at making the transition to a start-up.


 

By Amogh Sivarapatna and Kevin Rocco (Soft Tissue Regeneration)