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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
Partner, Goodwin Procter LLP, United States
Patient Advocacy Perspective
President and Chief Executive Officer, Friends of Cancer Research, United States
FDA and Office of Tissues and Advanced Therapies Perspective
Senior Director, Global Regulatory Leader, Janssen Pharmaceutical Companies of Johnson and Johnson, United States
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