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Wednesday, June 26 • 10:30am - 11:30am
#341: The Evolving Gene Therapy Regulatory Framework: A Brave New World

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-679-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will bring together panelists with regulatory expertise in gene therapy to present an update on recent changes to the regulatory framework and discuss its impact on the development of gene therapy products.

Learning Objectives

Outline recent changes to the regulatory framework for gene therapies. Discuss impact on progression of new and existing development programs in gene, genetically-modified cells and genome editing; Identify areas and disciplines where gene therapy sponsors would like to see further change.


Snehal Naik, PhD, MA


Peter W. Marks, MD, PhD

Anne-Virginie L. Eggimann, MS

Sandy Macrae, PhD

Robert Pietrusko, PharmD

avatar for Peter Marks

Peter Marks

Director, Center for Biologics Evaluation and Research, FDA
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 Anne-Virginie Eggimann

Anne-Virginie Eggimann

Senior Vice President, Regulatory Science, bluebird bio, Inc.
Anne-Virginie joined bluebird bio in 2011 to lead global regulatory strategy and create innovative pathways to accelerate the development of bluebird bio’s gene therapy products. Previously, AV was an Executive Director at Voisin Consulting, leading rare diseases, oncology, and... Read More →

Robert Pietrusko

Senior Vice President, Regulatory Affairs and Quality Assurance, Voyager Therapeutics
Robert G. Pietrusko, Pharm.D. is Senior Vice President, Regulatory Affairs & QA at Voyager Therapeutics, Inc. He has directed the worldwide approval of more than 30 new products and new indications and is a recognized leader in the pharmaceutical industry. Before joining Voyager... Read More →
avatar for Sandy Macrae

Sandy Macrae

Chief Executive Officer, Sangamo Therapeutics
Sandy Macrae serves as a member of the Company’s Board of Directors. He has twenty years of experience in the pharmaceutical industry most recently serving as the Global Medical Officer of Takeda Pharmaceuticals, where he established and led the Global Medical Office, which encompasses... Read More →
avatar for Snehal Naik

Snehal Naik

Associate Director, Janssen Research & Development, LLC
Snehal brings a confluence of early discovery, innovation and scientific expertise to her current role of North America regulatory liaison for cell & gene therapies and microbiome at Janssen.With a keen interest in influencing policy, she staffs the regulatory committee, gene therapy... Read More →

Wednesday June 26, 2019 10:30am - 11:30am PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics What's Next,Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum