Attending this event?
Back To Schedule
Tuesday, June 21 • 4:15pm - 5:15pm
#277: Quantitative Benefit-Risk Approaches in Drug Development and Approval: Examples from FDA and Industry

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-590-L04-P ; CME 1.00; RN 1.00

We focus on application of quantitative benefit-risk approaches in drug development and approval. Talks by experts in government and industry will demonstrate how to implement various analytic methods. Methodological considerations will be discussed.

Learning Objectives

Identify the value of quantitative benefit-risk approaches to address uncertainties and assess tradeoffs in complex drug approval decisions; Discuss considerations for implementing various quantitative benefit-risk approaches; Distinguish between different methods with respect to statistical properties, utility, and ease of implementation.


Sai Hurrish Dharmarajan, PhD


Quantitative Benefit Risk Assessment at FDA/CDER:: Rivaroxaban for PAD
Leila Grace Lackey, MHS, PhD

Benefit Risk Assessment of COVID-19 Vaccine
Hong Yang, PhD

Benefit Risk Assessment
Zhong Yuan, MD, PhD

Benefit Risk Approaches
Kevin Marsh, PhD, MSc


Sai Dharmarajan

Mathematical Statistician, OB, OTS, CDER, FDA, United States
Sai is a Statistical Reviewer in the Division of Biometrics VII, Office of Biostatistics at CDER, where he joined in June 2018. As a reviewer, he supports the statistical review of over-the-counter drug product applications, epidemiological research projects and safety surveillance... Read More →
avatar for Leila Lackey

Leila Lackey

Program Lead, Decision Support Service, OPSA, OSP, CDER, FDA, United States
Dr. Lackey has a Master of Health Science from Johns Hopkins in Environmental Health Sciences and a doctorate from UCLA in Environmental Science and Engineering. Professionally, she has worked for the Environmental Protection Agency and for the Food and Drug Administration leading... Read More →
avatar for Kevin Marsh

Kevin Marsh

Vice President, Patient-Centered Research, Evidera, United Kingdom
Kevin Marsh is Vice President of Patient Centered Research (PCR) at Evidera. PCR has over 130 scientists dedicated to the integration of the patient's experience into product development. Kevin's specialism is in the use of patient preference data to inform health decisions, including... 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 →

Zhong Yuan

Senior Director, Epidemiology, Janssen Research & Development, United States
Dr. Yuan is a physician by training and a trained epidemiologist. He has about 10 years of experience in Academic research and more than 20 years of experience in Pharmaceutical Research and Development, with nearly 70 publications in peer reviewed journals. As a Senior Director... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Session