Orphan Drug Development: Global Regulatory Challenges and Initiatives
Wednesday, June 27, 2012
1:30 - 3:00PM ET

This impactful session will focus on the critical need for developing orphan drugs, provide a review of global orphan drug development challenges, and offer information on various strategies designed to overcome these challenges.

Registration

Chair

Kinnari Patel, PharmDKinnari Patel, PharmD
Associate Director, Global Regulatory Sciences, Bristol-Myers Squibb Company, US

Speakers

Timothy R. Cote, MD, MPHSummary of NORD Activities/Initiatives
Timothy R. Cote, MD, MPH
Chief Medical Officer, National Organization For Rare Disorders (NORD), US
Jonca C. Bull, MDRegulatory Challenges and Initiatives: Strategies for Success
Jonca C. Bull, MD
Vice President, Drug Regulatory Affairs, FDA Liaison Office, Novartis Pharmaceuticals Corporation, US
Marlene E. Haffner, MD, MPHCurrent Challenges in the Designation and Development of Orphan Products
Marlene E. Haffner, MD, MPH
President and CEO, Haffner Associates, LLC, US