FDA to Host Public Listening Meeting on Advancing CGT Development Through Data Sharing

The Food and Drug Administration’s Center for Biologics Evaluation and Research’s Office of Therapeutic Products (OTP) will host a virtual public listening meeting on Sept. 18 to gather input from cell and gene therapy (CGT) manufacturers and other stakeholders on leveraging prior knowledge to support product development and regulatory review.

OTP invites speakers to share perspectives on how internal and public data can advance CGT development from clinical, nonclinical and chemistry, manufacturing, and controls (CMC) perspectives. Discussion topics include types of data that sponsors are willing to share, data leveraging between partners, integration across disciplines and mechanisms to support effective data sharing.

The meeting will take place from 10 a.m. ET to 4 p.m. ET. Registration is free and open to the public. Registration information is available online.