Wolfe Appointed to FDA Advisory Committee
Published February 22, 2022
Gil I. Wolfe, MD
story by dirk hoffman
Gil I. Wolfe, MD, UB Distinguished Professor and the Irvin and Rosemary Smith Chair of neurology, has been appointed to the Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee.
Wolfe’s four-year term runs through March 2026. The 15-member panel meets three to four times a year.
According to the FDA website, the Cellular, Tissue and Gene Therapies Advisory Committee “reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions.”
Clinical Focus on Neuromuscular Disease
Wolfe says he is looking forward to serving on the FDA committee because his clinical focus has always been neuromuscular disease and many of those disorders such as muscular dystrophy and spinal muscular atrophy (SMA) are genetically inherited disorders.
“There have been major advances in the last five years in some of these disorders, particularly SMN gene-linked SMA,” he says. “I look forward to expanding my scope into other areas of medicine where antisense technologies, viral vector gene transfer therapies and cellular-based approaches are leading to significant progress.”
Wolfe notes that while these new therapies are very promising and are a growing and important area in medicine, “there are still many, many diseases that are begging for advances.”
“We have seen some advance in muscular dystrophies, but one must realize these positive developments only apply to a couple of forms of these diseases among some 50 different forms of muscular dystrophy,” he says. “There is still a long way to go.”
Deliberate Review of Data Tied to Applications
Wolfe says his main responsibilities on the committee will be “reviewing data tied to applications for FDA approval in the area and providing recommendations via its established voting process.”
“I am pleased the FDA is availing itself of Dr. Wolfe’s expertise in neurology and neuromuscular medicine,” says Allison Brashear, MD, UB’s vice president for health sciences and dean of the Jacobs School of Medicine and Biomedical Sciences. “The committee’s review of promising and innovative cell, tissue and gene therapies is vitally important work.”
Increased Attention on FDA a Positive Step
The FDA and its advisory committees have received increased attention from the media and public due to the COVID-19 pandemic and Wolfe sees this as a positive.
“Obviously, the attention has been on the advisory committee that handles vaccines for the most part, but I think it is good for Americans to know that there are systems in place to allow for the FDA to make its most informed decisions, both with external and internal experts, when it comes to protecting and advancing our citizens’ health,” he says.
“These decisions touch all of us, but they are based on careful, educated and informed decision-making.”