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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Accelerated Approval and Emerging Surrogate Endpoints

Session Chair(s)

Julie  Lepin, MA

Julie Lepin, MA

Vice President, Regulatory Affairs Oncology

Amgen, United States

Accelerated drug approval pathways may allow investigational cancer drugs to be approved early by demonstrating a favorable benefit-risk profile based on a surrogate endpoint (e.g., progression-free survival) that is expected to predict a real clinical benefit (e.g., overall survival). Typically, once a drug is approved under this pathway, it must undergo postapproval confirmatory studies to evaluate the actual clinical benefit . As oncology therapies become more effective and targeted, clinical trials are becoming more difficult to enroll and conduct. Traditional endpoints like overall survival become untenable due to the availability of patients to participate in the study and the amount of time needed to demonstrate a statistically significant difference. Extended development times delay the ability to get new and innovative therapies to patients, and, at the pace of new molecule development, risk making effective therapies obsolete before they ever get approved. Surrogate endpoints are important, even critical, tools in improving how cancer drugs are developed and evaluated. This session will focus on the successes and challenges of various accelerated approval mechanisms and discuss the regulatory and clinical challenges of new and innovative surrogate endpoints that may soon be used to provide patients with early access to new and innovative therapies.

Learning Objective : Describe successes and challenges of various accelerated approval mechanisms; Discuss regulatory and clinical challenges of new and innovative surrogate endpoints.

Speaker(s)

Patricia  Keegan, MD

FDA Update

Patricia Keegan, MD

TopAlliance Biosciences, United States

Chief Medical Officer and Senior Vice President

Kelly  Robinson, MSc

Health Canada Update

Kelly Robinson, MSc

Health Canada, Canada

Director General, Marketed Health Products Directorate

Falk  Ehmann, MD, PhD, MS

EMA Update

Falk Ehmann, MD, PhD, MS

Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands

Head of Innovation and Development Accelerator – ad interim

C. Ola  Landgren, MD, PhD

Academic Update

C. Ola Landgren, MD, PhD

Memorial Sloan Kettering Cancer Center, United States

Professor of Medicine and Chief of Myeloma Service

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