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Cell and gene therapy products represent some of the most exciting new drugs that biopharmaceutical companies are looking to bring to market. Based on recent clinical successes, an increasing number of cell and gene therapies are currently in clinical development. However, despite the tremendous amount of clinical activity, manufacturing these products remains challenging. Consistently manufacturing a cell therapeutic with critical quality attributes, generating high-quality gene therapy vectors, and transitioning from small product lots to commercial size production are just a few challenging areas. Although the U.S. Food and Drug Administration select FDA) does not have all the answers, it is committed to advancing product development through applied scientific research, policy development, flexible application of regulations, optimal application of expedited development programs, and ongoing dialogue with product developers.

In this GEN Keynote webinar, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research select CBER) at the FDA, will share how CBER is providing oversight to organizations during the critical developmental and manufacturing stages for biological products, as well as throughout the product life cycle.

A live Q&A session will follow the presentation, offering you a chance to pose questions to our expert panelist.

About GEN KEYNOTE webinars:

GEN invites renowned experts to lecture on topics of broad interest to the biotechnology and biomedical community. Look for more GEN KEYNOTE webinars in 2020!

Produced with support from:

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Peter Marks, MD, PhD
Director of the Center for
Biologics Evaluation and Research
U.S. Food and Drug Administration