The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE in Postmarketing Studies – FDA Watch
In this fourth part of our series in collaboration with Analysis Group, Wayne chats with Dr. Marianne Cunnington, Managing Principal at Analysis Group, and Dr. Robert Reynolds, Vice President and Head of Development Sciences at GSK. Together, they discuss the evolution of postmarketing drug surveillance, the current scope of postmarketing studies, triggers for postmarketing commitments and requirements, safety and effectiveness questions best addressed after approval, studying populations excluded from clinical trials, standards for robust postmarketing evidence, real-world evidence in confirmatory studies, AI and automation in postmarketing research, transparency in study protocols and results, FDA monitoring and enforcement of postmarketing requirements, and much more.
This episode and the rest of our series do not include the usual Headlines segment.
About Our Guests
Dr. Marianne Cunnington
Dr. Marianne Cunnington is a Managing Principal at Analysis Group where she focuses on regulatory epidemiology with design and execution of real-world post marketing safety studies, as well as real world studies to support the approval of new products in the context of innovative regulatory pathways.
Prior to joining Analysis Group, Dr. Cunnington worked for 20 years as a pharmaceutical industry epidemiologist specializing in the generation of real-world evidence in support of the development and lifecycle management of pharmaceutical and vaccine products, with particular focus on regulatory risk management strategies and product benefit risk assessments. Her research expertise includes design, negotiation and execution of real-world components of risk management plans for multiple new product submission with regulators across multiple geographies (US, UK, Europe, Japan, South Korea), post approval safety studies in the EU, postmarketing requirement/commitment studies in the US, and pregnancy registries. Dr Cunnington held several senior Epidemiology positions within Novartis and GlaxoSmithKline. She currently serves as an elected Board member on the International Society for PharmacoEpidemiology.
Dr. Cunnington holds a BA in Biological Sciences from the University of Oxford, a Masters in Epidemiology from the University of Cambridge and a PhD in Epidemiology from the London School of Hygiene and Tropical Medicine.
Dr. Robert Reynolds
Dr. Robert Reynolds is Vice President and Head, Development Sciences, at GSK, where he leads an organization responsible for RWD/E strategy, science, and analytics, including advanced statistical modeling for innovative trials and development programs. Formerly, he led the Global Epidemiology group responsible for epidemiology and RWE in support of R&D and regulatory decision-making. Prior to joining GSK, he led Global Epidemiology at Pfizer. Dr. Reynolds has published extensively on design and methods for RWE and pragmatic trial designs, including numerous studies evaluating medicine safety and effectiveness.
Dr. Reynolds has extensive experience in collaborative international engagements with regulators, industry peers, and other stakeholders. He is the former PhRMA Topic Lead for the ICH M14 Working Group, which developed an ICH harmonized guideline on “General Principles on Planning, Designing, Analyzing, and Reporting of Non-Interventional Studies that Use Real-World Data for Safety Assessment of Medicines.” Previously, Dr. Reynolds served on the Steering Committee of the IMI PROTECT project and led the pharmacoepidemiology work package on behalf of industry partners; sponsored work with the Reagan Udall Foundation to develop policies and procedures to enable access to FDA’s Sentinel Surveillance system by biopharmaceutical sponsors; and served on the Editorial Board of Pharmacoepidemiology and Drug Safety. He is a Fellow and former Board Director of the International Society for Pharmacoepidemiology (ISPE) and an Adjunct Associate Professor of Epidemiology at the Tulane School of Public Health and Tropical Medicine.
Dr. Reynolds holds an AB in Biology from Bard College and a MSc in Epidemiology and ScD in Population and International Health from the Harvard T.H. Chan School of Public Health.
