What Comes First? Cell Therapy Manufacturing or Clinical Data?

From my perspective at DiscGenics, investing in the manufacturing process well into the clinical phase is no longer going to be an option for cell and gene therapy developers. Our industry must address the issues related to product manufacturing and quality early in clinical development if cell and gene therapies are truly going to be successful bringing life-altering and, in many cases, life-saving, therapies to patients in the future. 

RMAT Policy Briefing Takeaways

Earlier this summer, I attended the Regenerative Medicine Advanced Therapy (RMAT) policy briefing with FDA Commissioner, Dr. Scott Gottlieb, hosted by the Alliance for Regenerative Medicine (ARM) in Washington, D.C. I left the meeting very inspired by Dr. Gottlieb’s leadership and encouraged by the agency’s commitment to fostering greater innovative development in the field of cell and gene therapy.