Developing a manufactured allogeneic cell therapy requires orders of magnitude of increased rigor over minimally manipulated cells when it comes to not only proving that the product has a therapeutic effect, but also that it meets critical safety standards and is manufactured consistently from lot to lot.
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.
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.
How could it be in this age of technology that cutting a patient open so painstakingly and then proceeding to put all this hardware into their back, was really the best and sometimes only option for millions suffering from chronic back pain?
I left that visit thinking: “There’s got to be a better way.”