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Monday, June 15 • 1:30pm - 2:30pm
#124 SL: Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-544-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA at multiple levels, from the Commissioner to CBER Director to reviewers, has identified manufacturing as the most crucial issue in gene therapy. The panel will focus on innovation in this area and how the pioneers hope to overcome capacity limits

Learning Objectives

Describe the current state of gene therapy manufacturing; Analyze the challenges associated with manufacturing of gene therapies; Identify potential solutions to issues related to gene therapy manufacturing.

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Panelist
Peter W. Marks, MD, PhD

Panelist
Karen Walker

Panelist
Mike Paglia



Speakers
avatar for Nancy Myers

Nancy Myers

President and Founder, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and... Read More →
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 Karen Walker

Karen Walker

Senior Advisor, Cell and Gene Manufacturing, Genentech, A Member of the Roche Group
Karen Walker is a Sr. Advisor, Cell and Gene Therapy Manufacturing at Roche/Genentech. She brings 30+ years’ experience in the Biopharmaceutical industry, holding positions in Technical Development, Technical operations, Regulatory Affairs and Quality, including the role of VP and... Read More →
MP

Mike Paglia

Senior Vice President, CMC Operations, ElevateBio
Michael has over 16 years of experience building, leading and motivating process development and manufacturing teams to support clinical programs from early development to late stage clinical trials.


Monday June 15, 2020 1:30pm - 2:30pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Forum |   09: Regulatory, Forum