The chief of the oncology branch of the Center for Biologics Evaluation and Research at the FDA discussed how academia and industry can work best with regulatory agencies.
“When working with the FDA, it’s a matter of clear communication and transparency. We are very limited in time. We encourage sponsors, both academic and commercial industry, to request meetings. Unfortunately, sometimes we can't accommodate everyone's requests. I just hope that people recognize that we have a lot of competing priorities, but we want to help and will help as best we can. In terms of how we can optimize that communication, transparency is very important.”
Regulatory guidance for cell therapies continues to adapt and calibrate to the benefit-risk profile of these therapies, which are unlike more traditional small molecule medicines, as they become more prominent options in treating oncologic indications.
Peter Bross, MD, chief, oncology branch, Center for Biologics Evaluation and Research, FDA, shared the 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 shared his perspective of the regulatory side of approving cell therapies, informed by his years of working with them and experience in approving the first cell therapy, sipuleucel-T (PROVENGE), for treating prostate cancer. CGTLive spoke with Bross to learn more about how academia and industry can work best with the FDA to ensure clear communication and efficient pathways to approval.