Benefit-Risk Evaluation: The Past, Present And Future

A short article by Juhaeri JUHAERI, VP & Head, Epidemiology and Benefit-Risk at Sanofi

Keywords: benefit-risk, methods, patient, preference, quantitative, structured, weight

Introduction

In the last two decades, there has been a shift in the approach to evaluating the benefit-risk (BR) profiles of medicinal products from an unstructured, subjective, and inconsistent, to a more structured and objective, process. This article describes that shift from a historical perspective; the past, the present, and the future, and highlights key events and initiatives that played critical roles in changing the field.

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Juhaeri JUHAERI is a VP & Head, Epidemiology and Benefit-Risk at Sanofi.

He has held Global Head/VP roles in Medical and Pharmacovigilance functions in the pharmaceutical industry for more than two decades. Currently, Juhaeri is responsible for the epidemiology and real-world evidence strategy to ensure the positive benefit-risk profiles of all products in Sanofi’s large portfolio, encompassing a wide range of therapeutic areas.

Juhaeri has built and developed various teams at Sanofi, including Epidemiology, Signal Detection, Benefit-Risk Evaluation and Global Safety Sciences, brought and implemented state-of-the-art methods and approaches in epidemiology, real-world evidence, signal detection, and benefit-risk evaluation, implemented global change management programs, led successful epidemiology programs leading to products’ approval and maintenance, as well as demonstrating value through safety. He has a track record in leading different working groups in various public-private collaborations between pharmaceutical industry, academia, and regulatory agencies. Currently, he is the industry leader in “Methods” Working Group in IMI – PREFER (a European Consortium Project to strengthen patient-centric decision-making throughout the life cycle of medicinal products), evaluating why patient preference studies are needed, what patients expect and need from the studies, when to do them and how to do them.

Juhaeri has authored and co-authored numerous peer-reviewed publications and presented in various scientific conferences. He serves as an Adjunct Assistant Professor at his alma mater, the Gillings School of Global Public Health, University of North Carolina at Chapel Hill.