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Monday, June 25 • 11:00am - 12:30pm
#124: Analyzing Innovations Progress in the Gottlieb Era

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-535-L04-P; CME 1.50; IACET 1.50; RN 1.50

FDA Commissioner Scott Gottlieb has advanced an ambitious plan to modernize drug development and FDA’s approach to regulation. He has taken bold new approaches to streamline clinical trials, engage in efficient, risk-based regulation, and advance innovation.

Gottlieb is focused on transformative innovations that hold the promise of both significantly impacting disease and reducing overall health care costs.

How is the agency’s approach impacting innovation? Is it making a difference? Are further changes needed? What does the future of drug development look like under Gottlieb? Where are the key opportunities for collaboration between FDA and industry?

This DIAmond Session will bring together top regulatory thought leaders from FDA, industry and the venture capital world, for an interactive, forward-looking discussion of FDA’s modernization plan and its impact on development of innovative therapies.

Learning Objectives

Describe FDA’s Medical Innovation Development Plan; Identify implications for the future of drug development under Commissioner Gottlieb; Plan for impact of regulatory changes on drug development and business plans.

Chair

Nancy Bradish Myers, Esq, JD

Speaker

Panelist
Sandra A. Milligan

Panelist
Kathy Hibbs

Panelist
Doug Cole, MD


Speakers
DC

Doug Cole

Managing Partner, Flagship Pioneering
KH

Kathy Hibbs

Chief Legal and Regulatory Officer, 23andMe
avatar for Sandra Milligan

Sandra Milligan

Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck Research Laboratories
Sandra Milligan serves as senior vice president and head of Global Regulatory Affairs and Clinical Safety at Merck. She is a graduate of George Washington University School of Medicine and Georgetown University Law Center. Sandy served on DIA’s board from 2011 to 2017, served on... Read More →
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 →

Monday June 25, 2018 11:00am - 12:30pm EDT
Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  13: DIAmond, Forum