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Wednesday, June 21 • 10:30am - 11:45am
#312: CRISPR: Regulatory Challenges in the Gene Editing Revolution

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

This panel will explore the implications of CRISPR technology for product development and how it could bring significant changes in our treatment of disease. Panelists will discuss: the forces that will either drive the technology forward or potentially hold it up; how FDA is approaching CRISPR regulation; and global collaborative efforts to establish guiding principles for regulators.

Learning Objectives

Discuss the potential for gene editing technology to revolutionize disease management; Recall perspectives on how the technology can be used.

Chair

Nancy Bradish Myers, JD

Speaker

FDA Perspective
Ritu Nalubola, PhD

Panelist
Kurt von Emster, CPA

Panelist
Eva Essig



Moderators
avatar for Nancy Myers

Nancy Myers

President, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President of Catalyst Healthcare Consulting. Catalyst is a regulatory strategy and policy firm focusing on innovative technologies. Ms. Myers served as Senior Strategic Advisor in FDA’s Office of the Commissioner and has held senior positions at PhRMA... Read More →

Speakers
avatar for Kurt von Emster

Kurt von Emster

Managing Partner, Abingworth
Kurt joined Abingworth in 2015 and was promoted to Managing Partner shortly thereafter. He currently holds board positions at CRISPR Therapeutics, SutroVax and CymaBay. Kurt began his career as a Biotechnology and Healthcare Analyst and Portfolio Manager at Franklin Templeton in... Read More →
EE

Eva Essig

Head of Regulatory Affairs, Intellia Therapeutics, Inc.
Eva is Vice President, Regulatory Affairs at Intellia Therapeutics. With over 25 years in regulatory affairs, she has has been involved in developing therapeutic biologics, small molecules, blood products and biosimilars. Most recently she was Vice President, Global Regulatory Af... Read More →
avatar for Nancy Myers

Nancy Myers

President, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President of Catalyst Healthcare Consulting. Catalyst is a regulatory strategy and policy firm focusing on innovative technologies. Ms. Myers served as Senior Strategic Advisor in FDA’s Office of the Commissioner and has held senior positions at PhRMA... Read More →
RN

Ritu Nalubola

Senior Policy Advisor, Office of Policy, Office of the Commissioner, FDA
Dr. Ritu Nalubola is a Senior Policy Advisor in FDA’s Office of Policy, Office of the Commissioner. She advises senior leadership at FDA on complex and cross-cutting policy issues, including related to biotechnology, nanotechnology, food safety, nutrition, and international con... Read More →


Wednesday June 21, 2017 10:30am - 11:45am
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616