BIO-ASGCT-FDA Science Seminar Series: Harnessing AI/ML for Intelligent Decision Making in Cell and Gene Therapy Manufacturing

About the Series: The Cell and Gene Therapy (CGT) Science Series are seminars focused on scientific topics related to cell and gene therapy products. The CGT Science Series is intended to foster scientific exchange between the Biotechnology Innovation Organization (BIO), the American Society of Cell & Gene Therapy (ASGCT), and FDA’s Center for Biologics Evaluation and Research (CBER) review staff on a variety of topics that span the CGT product lifecycle. The seminars are planned as 60-minute virtual webinars featuring a speaker from one of the three organizations. The CGT Science Series will enable a deep dive into a specific technical and/or scientific area. Topics in the series may include but are not limited to nonclinical, CMC, clinical, or post-market phases of development related to CGT product lifecycle.

In this webinar, Dr. Rombel will discuss the opportunities where AI/ML can be used to address cell and gene therapy manufacturing bottlenecks, quality issues, and high production costs. The presentation will focus on applying AI/ML in real-world settings to make tangible improvements in process development and manufacturing resulting in fast, reproducible, and cost-effective delivery of cell, gene, and RNA therapies.

This webinar series is co-hosted with ASGCT and the FDA. 

Note: Webinar registration and attendance are limited to BIO members, ASGCT members, and FDA CBER reviewers.