Profile photo: Terri Madison

Terri Madison, PhD, MPH

An epidemiologist with years of experience using evidence-based science to reinforce the risk-benefit profile of biopharmaceutical products.

Dr. Madison is an epidemiologist with over 25 years of experience using evidence-based science to reinforce the risk-benefit profile of biopharmaceutical products and optimize appropriate access.

Her previous industry roles include Vice President, Epidemiology and Risk Management at Xcenda, President of i3 Drug Safety, and Chief Operating Officer at STATPROBE, where her experience included providing strategic consulting services for numerous studies conducted to generate evidence to support the value proposition of products for payers, risk management and REMS programs, and helping manufacturers design and implement studies to meet requirements of regulatory authorities including PASS and PMR studies.

Dr. Madison is an industry expert in epidemiology, drug safety, and risk management. Her comprehensive understanding of regulations and guidance documents, and broad knowledge of existing programs across a variety of products and product classes, enables her to provide evidence-based strategic advice that synergizes risk management and safety strategy with the overall value-driven commercial strategy to maximize appropriate patient access and product risk-benefit.

Dr. Madison has been an invited presenter and panelist at various workshops and public forums regarding risk minimization, data ownership and privacy issues, and issues surrounding the reportability of adverse events from administrative databases. Dr. Madison’s core research interests and expertise include pregnancy surveillance, risk management, design and conduct of observational cancer studies, and effects of race and socioeconomic status on disparities in health outcomes. Her work in these and other areas has been published in peer-reviewed journals and she has authored several book chapters.

Dr. Madison is an active member of the Drug Information Association and International Society for Pharmacoepidemiology (ISPE), and is an active participant in ISPE’s Benefit- Risk Assessment, Communication, and Evaluation Special Interest Group.

Employment History / Recent Positions

2014–Present, Vice President, Epidemiology & Risk Management

2010–2013, Vice President, Epidemiology & Risk Management

2005–2010, President
i3 Drug Safety

1993–2004, Chief Operating Officer

1986–1993, Manager
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company


University of Michigan
Epidemiology : PhD

University of Michigan School of Public Health
Epidemiology : MPH