Peter Bross, MD, on Regulating Cell Therapies: Lessons Learned

“There were a lot of lessons that came away from [the approval of PROVENGE], from the analysis of clinical trials to the manufacturing, to how we determine doses for these products. Since that time, of course, we've seen the emergence of the CAR T-cell products too.”

As cell therapies become more prominent options in treating oncologic indications, regulatory guidance for the approval of these biologic products continues to adapt and calibrate to the benefit-risk profile of these therapies which are unlike more traditional small molecule medicines.

Peter Bross, MD, acting chief, oncology branch, Center for Biologics Evaluation and Research, FDA, gave a regulatory perspective on evaluating biologic therapies at the Onco Cell Therapy Summit (OCTS) USA 2022, held June 29-30 in Boston, Massachusetts in a talk called: FDA’s Clinical Regulatory Perspective: Designing First-In-Human trials for Cellular and Gene Therapy Products.

Bross has a decade of experience in regulating cell therapies and had a hand in approving the first cell therapy, sipuleucel-T (PROVENGE), for treating prostate cancer. CGTLive spoke with Bross to learn more about changing perspectives on cell therapies through the years and lessons learned with early approvals.

REFERENCE

Bross P. FDA’s clinical regulatory perspective: Designing first-in-human trials for cellular and gene therapy products. Presented at: OCTS USA 2022, June 29-30, Boston, MA.