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Tuesday, June 16 • 11:30am - 12:30pm
#225 L: Accelerated Approval and Emerging Surrogate Endpoints

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-566-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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


Julie Lepin, MA


FDA Update
Patricia Keegan, MD

Health Canada Update
Kelly Robinson, MSc

EMA Update
Falk Ehmann, MD, PhD, MS

Academic Update
C. Ola Landgren, MD, PhD

avatar for Kelly Robinson

Kelly Robinson

Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, Health Canada
Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market review and regulation of biologics and pharmaceuticals. Kelly is the Director of the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics in the Biologics and Genetic Therapies... Read More →
avatar for C. Ola Landgren

C. Ola Landgren

Professor of Medicine and Chief of Myeloma Service, Memorial Sloan Kettering Cancer Center
Dr Ola Landgren has designed studies to define biological mechanisms of transformation from myeloma precursor disease to myeloma. He has developed (1) early interventional clinical trials for patients with high-risk smoldering myeloma to delay/prevent transformation; (2) modern intervention... Read More →
avatar for Julie Lepin

Julie Lepin

Vice President, Regulatory Affairs Oncology, Amgen
Julie Lepin is a regulatory professional with vast experience across many facets of the profession. She has led numerous major new license applications across many countries, which encompassed scientific advice and advisory committee meetings with multiple health authorities around... Read More →
avatar for Falk Ehmann

Falk Ehmann

Chair of Innovation Task Force, European Medicines Agency
Falk Ehmann is a medical doctor with a PhD in Experimental Medicine and expertise in European and International law. He is currently chairing the EMA’s Innovation Task Force (ITF). His main areas of expertise include Pharmacogenomics, Nanomedicines and Borderline and Combined Medicinal... Read More →

Patricia Keegan

Associate Director for Medical Policy, Oncology Center for Excellence, FDA
Dr. Keegan is a medical oncologist and served as a Clinical Assistant Professor in Medical Oncology at the University of North Carolina - Chapel Hill, prior to joining FDA. For many years, she was a Division Director in the Center for Biologics Evaluation and Research (CBER) and Center... Read More →

Tuesday June 16, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session