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

Experts from FDA’s Center for Biologics Evaluation and Research Office of Therapeutic Products (OTP) will host a virtual town hall on Wednesday, Aug. 30, to answer stakeholder questions related to nonclinical assessment of cell and gene therapy products.

Data from nonclinical studies provide information on the safety and activity profile of an investigational product and guide the design of early-phase clinical trials. A 2013 FDA guidance document includes recommendations on the substance and scope of nonclinical information needed to support clinical trials for investigational therapies, vaccines and certain biologic-device combination products.

The program will take place from 11:30 a.m. ET – 1 p.m. ET. Registration is complimentary but required. Attendees may submit questions during the registration process (prior to July 21) or during the live event. Recordings from OTP’s previous town halls are available online.