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Thursday, June 18 • 11:30am - 12:30pm
#421 L: Quantitative Benefit-Risk Assessment: What Methods are Being Used? How Far has Industry Come?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-732-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will describe the results of a recently conducted industry-wide survey on the use of quantitative benefit-risk assessment (qBRA) methods within life science companies. In particular, it will describe whether and to what extent such methods are being utilized, what are the types of qBRA methods being utilized, challenges to implementing qBRA within these organizations, and strategies for overcoming those challenges.

Learning Objectives

Describe when, why and to what extent qBRA is being adopted within different life science companies to inform decision making; Describe the range of frameworks and methods being utilized within life science companies to implement qBRA; Identify the challenges to introducing qBRA within life science companies and ways that these have been overcome, including factors to facilitate successful implementation.


Meredith Smith, DrPH, PhD, MPA


When, Why, and to What Extent qBRA is Being Adopted Within Different Lifescience Companies to Inform Decision Making?
Kevin Marsh, PhD, MSc

What Are the Types of Benefit-Risk Assessment Frameworks Being Used Within the Pharmaceutical Industry Currently and What are the Range of qBRA Methods Being Employed?
Brett Hauber, PhD

What Are the Challenges to Introducing qBRA Within Lifescience Companies and Ways that These Have Been Overcome?
Rachael L. DiSantostefano, PhD, MS

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 Rachael DiSantostefano

Rachael DiSantostefano

Senior Director, Epidemiology, Janssen Research & Development, LLC, United States
Rachael L. DiSantostefano, MS PhD, is a Senior Director in the Epidemiology Department within Janssen Pharmaceuticals, R&D, LLC. She has more than 25 years of pharmaceutical research experience across the quantitative disciplines of epidemiology, biostatistics, and health outcomes... Read More →
avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →

Thursday June 18, 2020 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Forum