OTP to Host Town Hall on Nonclinical Assessment of Cell and Gene Therapy Products

Experts from the Food and Drug Administration’s Center for Biologics Evaluation and Research Office of Therapeutic Products (OTP) will host a virtual town hall on Tuesday, June 4, to answer stakeholder questions related to chemistry, manufacturing and controls (CMC) information submitted with biologics license applications (BLAs) for gene therapy products.

FDA requires sponsors to provide CMC information as part of investigational new drug, biologics license and new drug applications. For gene therapies and other biologic products, the CMC information should describe the sponsor’s commitment to perform manufacturing and testing to assure product safety, identity, quality, purity and strength (including potency).

The program will take place from 11 a.m. to 12:30 p.m. ET. Registration is complimentary but required. Attendees may submit questions during the registration process (prior to May 13) or during the live event. Recordings from OTP’s previous town halls are available online.