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Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation
Session Chair(s)
Alexander Varond, JD
Partner
Goodwin Procter LLP, United States
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 Objective : 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.
Speaker(s)
Breakthrough Therapy Designation: Optimizing Early Clinical Strategies to Support Breakthrough Therapy Designation
Alexander Varond, JD
Goodwin Procter LLP, United States
Partner
Patient Advocacy Perspective
Jeff Allen, PhD
Friends of Cancer Research, United States
President and Chief Executive Officer
FDA and Office of Tissues and Advanced Therapies Perspective
Ilan Irony, MD
Janssen Pharmaceutical Companies of Johnson and Johnson, United States
Senior Director, Global Regulatory Leader
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