Multi-sponsor Pregnancy Exposure Registries: Physician, Scientific Advisory and Industry Insights

Jessica Albano, PhD, MPH, Vice President – Epidemiology & Analytics, Syneos Health

Jessica Albano, PhD, MPH, is Vice President, Epidemiology & Analytics, at Syneos Health. She received her undergraduate degree in Biochemistry at Earlham College, MPH at Emory University and PhD in Epidemiology from the University of Pittsburgh. She has conducted research as an Epidemiologist with the American Cancer Society and the University of Pittsburgh Cancer Institute.

For the past 16 years, her work as a Pharmacoepidemiologist has focused on evaluating the safety of drugs in the post-approval setting utilizing non-interventional research methods, including prospective and retrospective study designs and primary and secondary data sources. Jessica has overseen the delivery of two dozen pregnancy registries, including single- and multi-sponsor models, presented at NIH- and FDA-sponsored pregnancy methods workshops and authored a book chapter on this topic.

Sara Ephross, PhD, Senior Director - Epidemiology, Syneos Health

Sara Ephross, PhD, is Senior Director – Epidemiology at Syneos Health. She has 30 years of pharmacoepidemiology experience in industry, consulting and CROs. Sara received her PhD in Epidemiology and holds an adjunct faculty appointment at the University of North Carolina (UNC) Gillings School of Global Public Health.

Her areas of expertise include the design and implementation of pregnancy registries, enhanced pharmacovigilance, claims-based database studies, cohort and case-control studies and systematic reviews/meta-analysis. All of these topics are related to the use of medications and biological products during pregnancy.

Dr. Sigal Kaplan, PhD, BPharm, Director, Pharmacoepidemiology Leader, Teva Pharmaceutical Industries Ltd

Dr. Sigal Kaplan (PhD, BPharm) has served as Director of Epidemiology at Teva since December 2012. She leverages more than 25 years of pharmacoepidemiology experience in regulatory and pharmaceutical industry with strong expertise in safety assessment, risk management, real-world data, pregnancy databases and registries.

At Teva, she leads and oversees the execution of global post-marketing requirements and post-authorization safety studies (PASS) and other safety studies, guiding them from inception to publication. She plays a key role in promoting the use of real-world evidence (RWE) for regulatory decision-making across various departments and in designing epidemiologic and risk minimization strategies for regulatory submission.

Since 2017, she has successfully led the design, implementation and management of pregnancy registries to inform healthcare professionals and practices. Her experience spans diverse therapeutic areas, including neurology, migraine, respiratory, oncology and women’s health.

Laura McKain, MD, FACOG, Board-certified Obstetrician and Gynecologist

Laura McKain, MD, FACOG is a board-certified obstetrician and gynecologist with over 15 years of experience in the pharmaceutical industry. Dr. McKain’s work is dedicated to ensuring the safety and efficacy of therapies for women, with a strong focus on providing women of reproductive age access to medications that optimize their health. She has extensive expertise in the design and execution of pregnancy drug exposure registries and has worked across a variety of organizations, including contract research organizations, large and medium-sized pharmaceutical companies, start-up biotechs, and non-profit organizations. Her work has contributed to several new drug approvals and expanded the information available to help women make informed decisions about treating chronic medical conditions during pregnancy.