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Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics
Session Chair(s)
Peter W. Marks, MD, PhD
Director, Center for Biologics Evaluation and Research
FDA, United States
This session will discuss the current state and challenges of individualized cell-based therapeutics and gene therapies that will become increasingly important to address the variety of molecular defects present in serious rare diseases.
Learning Objective : Explain the concept of individualized advanced therapy medicinal products; Outline the technical challenges (preclinical, clinical, manufacturing) involved in their development; Discuss the regulatory challenges of such products from a global perspective.
Speaker(s)
NIH Perspective
Philip (P.J.) Brooks, PhD
National Center for Advancing Translational Sciences (NCATS), NIH, United States
Deputy Director, Division of Rare Diseases Research Innovation
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