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Wednesday, June 21 • 10:30am - 11:45am
#326: Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Preliminary clinical evidence showing substantial improvement over existing therapies on at least one clinically significant outcome is required to qualify for breakthrough therapy designation. This session will focus on how to optimize chances of early breakthrough therapy designation and developments in the breakthrough therapy space.

Learning Objectives

Describe the key considerations and challenges in the design of early clinical trials to provide sufficient evidence of early benefit; Discuss successful case examples of novel therapies that have never before received FDA approval; Learn about developing issues related breakthrough therapy designation.


Alexander Varond, JD


Breakthrough Therapy Designation: Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation
Alexander Varond, JD

Patient Advocacy Perspective
Jeff Allen, PhD

FDA and Office of Tissues and Advanced Therapies Perspective
Ilan Irony, MD

avatar for Alexander Varond

Alexander Varond

Associate, Goodwin Procter LLP
Alexander J. Varond works on drug development and medical devices, advertising and promotion, and enforcement issues. He counsels clients on drug development matters such as clinical trial design, REMS, orphan drug designation, formal dispute resolution, and patent and exclusivity... Read More →

avatar for Jeff Allen

Jeff Allen

President and Chief Executive Officer, Friends of Cancer Research, United States
Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As... Read More →
avatar for Ilan Irony

Ilan Irony

Deputy Director, DCEPT, OTAT, CBER, FDA
After training at UCSF and NIH and years of practice in Internal Medicine and Endocrinology, Dr. Irony joined FDA CBER in 2000 as a clinical reviewer. He also worked in the Endocrine Division in CDER as a reviewer and team leader. In 2011, he returned to CBER first as branch chief... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Forum