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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.

Chair

Peter W. Marks, MD, PhD

Speaker

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


Speakers
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

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States
Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... 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