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Monday, June 15 • 3:30pm - 4:30pm
#133 L: FDA’s Considerations on Benefit-Risk Assessment for Human Drug Review

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-542-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA will present an overview of considerations on benefit-risk assessment across the drug development lifecycle and solicit input from session attendees.

Learning Objectives

Explain FDA’s approach to benefit-risk assessment throughout the lifecycle of drug development; Identify important milestones along the drug development lifecycle for communication between FDA and stakeholders on key considerations for regulatory benefit-risk assessment; Describe how early planning should be considered to collect data that may inform benefit-risk assessment.


Graham Thompson


Key Considerations and Patient Experience
Kerry Jo Lee, MD

Benefit-Risk Planning and Statistical Considerations
Gregory Levin, PhD

Post Market Benefit-Risk Considerations
Judith Zander, DrMed, MD

Additional Analysis to Inform Benefit-Risk Assessment
Hong Yang, PhD


Gregory Levin

Deputy Director, DBIII, OB, OTS, CDER, FDA
Greg Levin is a supervisory mathematical statistician at the Center for Drug Evaluation and Research within FDA. He joined FDA after receiving a PhD in biostatistics from the University of Washington in 2012. At FDA, Greg has helped regulate products across a wide range of therapeutic... Read More →
avatar for Judith Zander

Judith Zander

Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER, FDA , United States
Judy Zander is the Director of the Office of Pharmacovigilance and Epidemiology (OPE), in the Office of Surveillance and Epidemiology (OSE), in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA).She oversees the Divisions of Pharmacovigilance 1 and... Read More →
avatar for Kerry Jo Lee

Kerry Jo Lee

Clinical Advisor, Office of New Drug Policy, CDER, FDA
Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →

Graham Thompson

Operations Research Analyst, Decision Support and Analysis Team, OSP, CDER, FDA, United States
Graham Thompson joined FDA in 2012 and currently serves as an operations research analyst for the Decision Support and Analysis Staff (DSAS) in FDA’s Center for Drug Evaluation and Research (CDER). He works on CDER projects and initiatives related to benefit-risk assessment and... Read More →
avatar for Hong Yang

Hong Yang

Biologist, OBPV, CBER, FDA, United States
Dr. Hong Yang is a senior advisor for benefit-risk assessment in OBPV/CBER/FDA. She holds Ph.D. degree in Biological Engineering. Dr. Yang has expertise in benefit-risk assessment of biological products and Modeling and Simulation to inform drug development. She has been devoted in... Read More →

Monday June 15, 2020 3:30pm - 4:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session