Session Details

Speakers, titles, times, and locations of ASGCT presentations

Detailed Program

Fireside Chat: Regulating Cell and Gene Therapies from IND to BLA

The pipeline of CGTs in development are increasingly being converted to FDA-approved commercial products. With that exciting reality comes the need to ensure a smooth regulatory continuum from pre- clinical development and IND submission through the BLA process. This fireside chat-style session will feature Dr. Peter Marks from the Center for Biologics Evaluation & Research (CBER) at the Food and Drug Administration (FDA).

This site uses cookies to offer you a better user experience and to analyze site traffic. By continuing to use this website, you accept our use of cookies.