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Expediting Drug Development Through FDA’s Breakthrough Therapy Designation
Session Chair(s)
Todd Paporello, PharmD, MBA
Vice President, Global Head of Regulatory Affairs, Specialty Care
Sanofi, United States
FDA’s Breakthrough Therapy Designation (BTD) has evolved as industry and the agency have gained experience with the program. In this session, an attorney will analyze the evidence that FDA has required for designations, FDA will discuss BTD’s impact on development and review, and industry will review lessons learned from a product approved with BTD.
Learning Objective : Recognize the opportunity of Breakthrough Therapy Designation (BTD) to expedite access to treatments; Identify the evidence required for designation; Describe industry and FDA’s experiences with Breakthrough Therapy Designation including key considerations for maximizing its value.
Speaker(s)
The Breakthrough Therapy Designation: An Analysis of FDA’s Precedents to Determine Eligibility Criteria and Their Value
Alexander Varond, JD
Goodwin Procter LLP, United States
Partner
CDER Breakthrough Therapy Program: What Happens Post-Designation?
Miranda Raggio, BSN, MA, RN
FDA, United States
Breakthrough Therapy Program Manager, Office of New Drugs, CDER
Breakthrough Therapy Policies
Michelle Rohrer, PhD
Genentech, A Member of the Roche Group, United States
Senior Vice President, Global Head of Product Development Regulatory and Policy