Lexington, KY–(Marketwired – Feb 27, 2014) – Mapi, the leading expert in Observational Studies, Health Economics and Real-World Evidence, announces the appointment of Dr. Terri Madison as Vice President, Epidemiology & Risk Management, North America in Real World Evidence, reporting to Will Maier, Chief Scientific Officer
Posted on 5 March 2014
Lexington, KY–(Marketwired – Feb 27, 2014) – Mapi, the leading expert in Observational Studies, Health Economics and Real-World Evidence, announces the appointment of Dr. Terri Madison as Vice President, Epidemiology & Risk Management, North America in Real World Evidence, reporting to Will Maier, Chief Scientific Officer. Dr. Madison will join Mapi’s experienced team of scientific consultants who are experts on Epidemiology and Risk Management study design and execution and ensure that studies meet scientific, regulatory and commercial objectives. She will be based in Ann Arbor, MI, USA.
Previously Vice President, Epidemiology and Risk Management at Xcenda, President of i3 Drug Safety, and Chief Operating Officer at STATPROBE, Dr. Madison joins Mapi’s scientific experts who already conduct more than 250 international studies every year in more than 100 countries on all continents, covering all therapeutic areas.
Will Maier, Chief Scientific Officer, Mapi, says, “We are delighted to have Terri Madison at Mapi. Her 25 years of experience and in-depth understanding of global safety regulations, and her expertise in epidemiology, drug safety, and risk management are a perfect match for the vision of our company.”
Dr. Madison has provided strategic consulting services for several risk management and REMS programs, and helped manufacturers design and implement comprehensive safety surveillance studies to meet requirements of regulatory authorities including PASS and PMR studies.
James Karis, President and Chief Executive Officer, Mapi North America, says, “Mapi’s objective is to help our clients maximize appropriate patient access and product risk-benefit. Dr. Madison’s comprehensive understanding of the applicable regulations and guidance documents, and her broad knowledge of existing risk management and safety surveillance programs across a variety of products and product classes, will be a tremendous asset. She will provide evidence-based strategic advice, and explain the critical importance of synergizing risk management and safety strategy with overall value-driven commercial strategy.”
Dr. Madison has been a 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 (DIA) and International Society for Pharmacoepidemiology (ISPE), and is an active participant in ISPE’s Benefit-Risk Assessment, Communication, and Evaluation Special Interest Group.
Dr. Madison received her PhD and MPH in Epidemiology from the University of Michigan. She was a recipient of a National Institutes of Health pre-doctoral fellowship in Cancer Training and Prevention from the School of Public Health’s Departments of Environmental Health and Epidemiology.
Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help its clients secure product approval and reimbursement while meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers. For more information about Mapi, visit: www.mapigroup.com.
Senior Vice President, Global Business Development & Marketing