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Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry
Session Chair(s)
Shannon Thor, PharmD, MS
Deputy Director, Office of Global Policy & Strategy, Europe Office
FDA, United States
This session will compare recent hands-on experience with expedited regulatory pathways in EU and US (PRIME and Breakthrough Designation) both from the regulators’ and sponsor’s viewpoint. It will also include analysis of data comparing each program’s utilization and scope. A panel debate will be structured around statements that both panelists and the audience will be able to vote upon with the aim of inspiring honest discussion on the real benefits, drawbacks and future opportunities of these regulatory tools in the EU, US, and globally.
Learning Objective : Describe Breakthrough Therapy and PRIME program aims, parameters, and regulatory agency experience in implementation; Discuss the sponsor perspectives on utilization of PRIME or Breakthrough Therapy pathways and how decisions about timing of engagement of FDA and EMA are made; Review utilization data of Breakthrough Therapy and PRIME pathways and concurrent and discordant decisions on sponsor applications for these designation.
Speaker(s)
Experience with Breakthrough Therapy Applications: Viewpoints on Progress, Potential, and Lessons Learned
Sandra Kweder, MD
Greenleaf Health/Elilquent, United States
Principal, Drug and Biological Products
Experience with PRIME Applications: Viewpoints on Progress, Potential, and Lessons Learned
Zahra Hanaizi, PharmD, MPharm
European Medicines Agency, Netherlands
Scientific Officer, PRIME Coordinator, Scientific and Regulatory Management Dept
FDA Update on Breakthrough Therapies
Christopher Joneckis, PhD
FDA, United States
Associate Director for Review Management, CBER
Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Industry Perspective
Samuel Rigourd, PharmD
Alnylam Pharmaceuticals, United States
Senior Director Regulatory Affairs
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