Shares in more than a dozen gene and cell therapy developers tumbled by double digits Wednesday after a well-known critic of the speedy approval paths their treatments often rely on was named to lead the FDA office that regulates them.
Dr. Vinay Prasad, an oncologist and contrarian voice in clinical research, was hired by FDA Commissioner Martin Makary to run the Center for Biologics Evaluation and Research. He will succeed Peter Marks, who resigned from the FDA in March after nine years in the role.
Marks’ departure was acutely felt by the makers of gene and cell therapies, many of which are currently struggling to attract investment. He oversaw clearance of the first gene therapy, the first cellular treatment for cancer and the first CRISPR gene editing medicine, among others. He also advocated strongly for the FDA to be…