05th March 2025 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC |BOOK FREE SEAT FOR THIS WEBINAR
Cell and gene therapy (CGT) is particularly well-suited for the application of big data analytics. Although our understanding of these complex therapies remains limited, CGT manufacturing processes and analytical methods generate substantial datasets that can be analyzed using artificial intelligence and machine learning algorithms. These advanced computational tools are instrumental in identifying critical characteristics of novel CGT products, optimizing manufacturing and analytical methods, and defining predictive biomarkers, among other applications. This presentation will discuss the role of big data in the development and manufacturing of CGT products and will explore opportunities for crowdsourcing data in the precompetitive space.
Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC

Scott R. Burger, MD, is the founder and principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, providing expertise on GMP manufacturing, regulatory, and strategic aspects of these products. With over 30 years of experience, Dr. Burger has consulted for over 200 companies across North America, Europe, Australia, and Asia, advising on a wide range of CGT products for immunotherapy and regenerative medicine at all stages of development. Dr. Burger has served as an expert witness in cases involving CGT intellectual property, commercialization, FDA regulatory affairs, and GMP compliance.
Dr. Burger has consulted on over 100 regulatory submissions for CGT products and has been an invited speaker at internal FDA workshops. Additionally, he has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT executive committee, advisory board and committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis. He has authored over 200 scientific publications and presentations and received numerous honors and awards.
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