News
Use of Real-World Evidence in Post-Marketing Commitment Studies Explored by Managing Principal Marianne Cunnington on FDA Watch Podcast
Approaches to post-marketing monitoring of new product safety and effectiveness have evolved over recent decades with real-world evidence (RWE) playing an increasing role in fulfilling post-marketing commitments for the US Food and Drug Administration (FDA). In an installment of the FDA Watch podcast’s series on RWE in regulatory contexts, Analysis Group Managing Principal Marianne Cunnington, who specializes in RWE for risk management, joined Robert Reynolds (GlaxoSmithKline) to discuss how RWE supports these commitments and how evolving evidentiary standards could strengthen the value of RWE for patients and prescribers.
Participants explored the evolution of post-marketing studies, including the triggers for FDA-mandated studies and the questions that can only be answered in real-world settings. The conversation covered standards to support regulatory expectations for robust evidence generation, alongside opportunities for emerging technologies to improve the scope, quality, and efficiency of post-marketing research. Participants also considered the new draft guidance by FDA that discusses approvals based on a single pivotal trial supported by confirmatory evidence; this change may further increase the need for robust pre-approval and post marketing RWE. The participants emphasized the value of early evidence-generation planning and engagement with FDA to help sponsors balance accelerated development timelines with post-marketing obligations.
Analysis Group is proud to sponsor FDA Watch’s “The Rise of Real-World Evidence in Regulatory Strategy” series.
Learn more about Part IV: Real-World Evidence in Post-Marketing Commitments, or listen on Spotify or Apple Podcasts
Listen to other episodes in the series:
Part I: Real-World Evidence in Rare Disease Drug Development
Part II: Real-World Evidence in Medical Devices
Part III: Real-World Evidence in Accelerated Approvals
Associated People
Marianne Cunnington
Managing PrincipalDr. Cunnington specializes in regulatory epidemiology, including the design and execution of real-world post-marketing safety and effectiveness studies, as well as real-world studies to support the approval of new products through innovative regulatory pathways. Her research expertise includes design, negotiation, and execution of real-world components of risk management plans for new product submissions with regulators across multiple geographies (US, UK, Europe, Japan, South Korea); post-approval safety studies in the EU; post-marketing requirement and commitment studies in the US; and pregnancy registries. Prior to joining Analysis Group, Dr. Cunnington spent more than 20 years as a pharmaceutical industry epidemiologist focusing on the generation of real-world evidence (RWE) to support the development and life cycle management of vaccines and pharmacological therapies. Dr. Cunnington held several senior epidemiology positions within Novartis and GlaxoSmithKline (GSK). At GSK, she chaired the peer review forum for all pharmaceutical RWE projects, provided epidemiological expertise for the company’s Global Safety Board, and was a managing board member of the Innovative Medicines Initiative’s public-private partnership, building an integrated European real-world data network to monitor medication safety in pregnancy. Dr. Cunnington serves on the board of the International Society for Pharmacoepidemiology as an elected representative of European industry and service providers.