The regenerative medicine sector, comprised of tissue engineered products and cell and gene therapies, has grown rapidly over the past decade, including significant therapeutic advances that offer the prospect of optimizing and transforming patient care. There has been a dramatic increase in the number of approved cell and gene therapies and available funding for these products, and yet both progress in development programs and approvals for tissue engineered medical products (TEMPs) have lagged behind. In this Cell & Gene article, Lev Gerlovin, Andrew Thomson, and Jack Vailas analyze product development programs in tissue engineering and discuss three key hurdles restraining the growth of this sector:
- Complex manufacturing requirements relative to those for cell and gene therapies that present significant challenges for scaling production and quality control
- Undefined approval pathways leading to inconsistencies in the time, cost, and data required to bring TEMPs to market; and,
- Insufficient reimbursement streams and a lack of innovative funding options.