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Wednesday, June 17 • 11:30am - 12:30pm
#320 L: Advanced Therapy Medicinal Products: Facilitating Individualized Gene Therapies and Cell-Based Therapeutics

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-728-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Peter W. Marks, MD, PhD


NIH Perspective
Philip (P.J.) Brooks, PhD

avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching... Read More →
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →

Wednesday June 17, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   06: PreClin Dev-EarlyPhaseCR, Session