The 11th annual Business of Regenerative Medicine: Innovation, Clinical Translation, and Entrepreneurship Symposium took place on July 17th-18th. The event was hosted by the Center for Cellular Immunotherapies and the Institute for Regenerative Medicine at the University of Pennsylvania in partnership with Case Western Reserve University, the Harvard Stem Cell Institute, the Parker H. Petit for Institute Bioengineering and Bioscience at Georgia Tech, and the Centre for Commercialization of Regenerative Medicine (CCRM). Akron Biotech was a proud sponsor of the event.
The symposium brought together speakers from various companies, universities, and clinical institutions to present new research findings and clinical results, as well as to foster discussion regarding the challenges of translating cell and gene therapies from academic research centers to commercial manufacturing facilities. Researchers from the University of Pennsylvania and representatives from Novartis offered lessons learned on the basis of the successful translation and approval of Kymriah by the US Food and Drug Administration (FDA).
Panels on ethical and regulatory issues as well as on innovation intermediaries rounded out the dynamic two-day symposium. A panel discussion chaired by Brock Reeve of the Harvard Stem Cell Institute titled “Regulatory, Ethical and Public Policy Issues in Cell and Tissue Therapies” fostered discussion regarding the challenges faced by regulators in ensuring that patients have access to safe and efficacious treatments while being protected from unregulated and actively marketed stem cell therapies.
Colleagues from CCRM, Georgia Tech’s NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT), the International Society for Cell and Gene Therapy, and the Advanced Regenerative Manufacturing Institute (ARMI) discussed the evolving role that professional societies and public-private consortia play in supporting the commercialization of novel cell and gene therapies as well as engineered tissues. These entities fill important gaps in the translational continuum, supporting therapies as they move from the bench to the bedside.
Akron works closely with cell and gene therapy developers, and tissue engineering companies, as well as with public-private consortia such as ARMI, the Standards Coordinating Body (SCB), and the FDA in order to facilitate the complex process of clinical translation. We develop and provide the high-quality GMP ancillary materials required to bring these new, transformative treatments to patients. Please reach out to learn about what we do, and how we can work collectively toward our common goal: accelerating innovation to improve healthcare outcomes.