Expediting Drug Development and Review for Serious Conditions

Track:
Regulatory Affairs and Submissions

Day & Time:
June 25, 8:00AM - 9:30AM

Session Number:
211

Room Number:
253A

Level:
Intermediate

Type:
Forum

Title:
Expediting Drug Development and Review for Serious Conditions

Chair(s):
Robert J. Temple, MD
Deputy Center Director for Clinical Science, CDER
FDA, United States

Description:
This forum will provide clarity about FDA’s expedited drug development and review programs and ways in which the EMA enables drug development. It will emphasize the importance of expediting drug development to address the critical need for new therapies to treat serious or life-threatening diseases that lack therapeutic alternatives.

Learning Objective(s):
Discuss FDA’s and EMA’s processes and programs for expediting drug development. Identify the importance of these processes and programs to speed the development and review of drugs for serious or life-threatening diseases for patients who lack alternative therapies.

Presentation(s) & Speaker(s):
From Gatekeepers to Enablers: How Drug Regulators Respond to a Challenging and Changing Environment
Hans-Georg Eichler, MD,MSc
Senior Medical Officer
European Medicines Agency, European Union, United Kingdom

A Pharma Company Perspective on Expedited Development Pathways
Robert Metcalf, PhD
Vice President, Global Regulatory Affairs - US
Eli Lilly and Company, United States

Panelist
Jeff Allen, PhD
Executive Director
Friends of Cancer Research, United States