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Tuesday, June 20 • 10:30am - 11:45am
#213: Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This forum will provide an overview of the regulatory context for the coming surge of disruptive innovation. We will discuss the challenges involved and explore how FDA and others could collaborate to develop new approaches to facilitate this innovation. We will describe the steps FDA has already begun taking to prepare, as well as lay out where the agency could go further.

Learning Objectives

Explain how disruptive innovations will challenge regulatory frameworks; describe how FDA, companies and patients may approach collaborating to facilitate disruptive innovations such as gene therapy, combination products and microbiome exploration; Explain how regulatory approaches may change in order to accommodate this innovation

Chair

Nancy Bradish Myers, JD

Speaker

Panelist
Richard Moscicki, MD

Gene Therapy Cures: How Will They Break the Mold?
Anne-Virginie L. Eggimann, MS

Panelist
Tal Zaks, MD, PhD


Moderators
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 →

Speakers
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 →
avatar for Richard Moscicki

Richard Moscicki

Deputy Center Director for Science Operations, OCD, CDER, FDA
Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., joined the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), as Deputy Center Director for Science Operations. A nationally recognized expert in clinical research and development, Dr. Moscicki... Read More →
avatar for Tal Zaks

Tal Zaks

Chief Medical Officer, Moderna Therapeutics
As chief medical officer, Dr. Tal Zaks oversees preclinical development, clinical development and regulatory affairs across Moderna and its ventures. Prior to joining Moderna, Dr. Zaks was senior vice president and head of Global Oncology at Sanofi, where he was responsible for all... Read More →

Tuesday June 20, 2017 10:30am - 11:45am
S403ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  05: Regulatory, Forum