Regenerative Medicine is the application of cellular and non-cellular technologies to generate or repair tissues for therapeutic purposes. Such technologies may include stem cells, growth factors, drugs, biomaterials and devices, alone or in combination. “Tissue Engineering” has been commonly used to describe the processes of development of these technologies in support of Regenerative Medicine applications. While progress has been made in the engineering of skin, cornea, cartilage, bone and blood vessels, more complex tissues such as kidney, heart, brain and liver remain to be conquered. To a great extent, commercialization challenges limit progress in the field. These include difficulty in meeting FDA regulatory requirements of often complex combinations of novel technologies that have never before been seen by the Agency. Reimbursement, clinician and patient acceptance challenges add to commercialization complexity. The panel will explore these issues and clarify what is being done now by companies that are active in this industry to clarify approval and acceptance pathways so that this exciting technology can move forward to the bedside.
Julie Allickson,Ph.D. - Director, Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine
Tim Bertram, Ph.D. - Chief Executive Officer, inRegen
Anil Goyal, Ph.D. - Founder and Managing Director, OpenDoors Group (Moderator)
Peter Johnson, M.D. - Principal, MedSurgPI
Jeffrey Lawson, M.D., Ph.D. - Chief Medical Officer, Humacyte