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Wednesday, June 26 • 4:15pm - 5:30pm
#392: Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Experience, Analysis, and Reflections from EMA, FDA, and Industry

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-735-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Shannon Thor, PharmD, MS


Experience with Breakthrough Therapy Applications: Viewpoints on Progress, Potential, and Lessons Learned
Sandra L. Kweder

Experience with PRIME Applications: Viewpoints on Progress, Potential, and Lessons Learned
Zahra Hanaizi, PharmD, MPharm

FDA Update on Breakthrough Therapies
Christopher Joneckis, PhD

Breakthrough Therapy and PRIME Expedited Regulatory Pathways: Industry Perspective
Samuel Rigourd, PharmD

avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →
avatar for Zahra Hanaizi

Zahra Hanaizi

Scientific officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency (EMA)
Zahra Hanaizi joined EMA in 2007 as Product Team Leader, managing centralised medicinal products initial marketing authorisation applications, maintenance and life-cycle activities, mostly in the therapeutic area of Oncology. Since 2015, she has been working on the creation, implementation... Read More →

Christopher Joneckis

Associate Director for Review Management, CBER, FDA
avatar for Samuel Rigourd

Samuel Rigourd

Senior Director Regulatory Affairs, Alnylam Pharmaceuticals
Samuel Rigourd joined Alnylam Pharmaceuticals in 2016 as Senior Director of Regulatory Affairs, where he leads the global registration strategy of a new class of medicines, RNA interference therapeutics. He has over 15 years of experience in regulatory affairs, in various roles both... Read More →
avatar for Shannon Thor

Shannon Thor

International Policy Analyst, Office of Global Policy and Strategy, European Off, FDA
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service, serving as an international policy analyst in FDA's Europe Office, working closely with European regulatory counterparts to accomplish international public heath goals. Previous... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session