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.

During the briefing, Dr. Gottlieb shared his enthusiasm that cell and gene therapies are finally becoming a therapeutic reality, and his expectations that they will soon become a mainstay of how we treat a wide range of illnesses. He also spoke in detail of the many actions the agency is taking to support the efforts of our industry, including providing clarity to developers on manufacturing parameters, safety measures and pathways toward clinical development.

You can see his complete remarks here.

It’s energizing to finally see cell and gene therapies coming to fruition, but as Dr. Gottlieb alluded to, successfully ushering them through development and ultimately making them available to patients is not going to be without challenges. I invite you to read on for my next post about manufacturing and find out why I believe it’s the most critical issue facing cell and gene therapy developers today in our quest to deliver safe and effective products to patients.