Pregnancy exposure registries remain an important study design in the assessment of medication safety when used during pregnancy. However, slow enrollment, low numbers of patients and long study duration are well-known limitations.

The US Food and Drug Administration (FDA)’s draft guidance on the conduct of post-approval pregnancy safety studies (May 2019) encourages pharmaceutical companies (sponsors) “to work together directly or through consortiums to develop or support multiproduct registries.” Likewise, the European Medicines Agency (EMA) addresses pregnancy registries in their Guidelines on Good Pharmacovigilance Practices (Dec 2019) urging the creation of disease registries over “medicinal product-specific registries.” While there is concrete regulatory interest in the development of collaborative multi-sponsor efforts, numerous challenges remain.

This webinar will examine the conduct of multi-product/multi-sponsor pregnancy registries from several key perspectives. The expert speakers will review scientific methods in the context of regulatory precedent, provide pharmaceutical industry perceptions of internal and external considerations, offer Physician/scientific advisory committee member perspective and identify best practices to overcome obstacles.

The expert speakers will cover:

Historical context for pregnancy registries and current state of affairs with regard to regulatory considerations in light of revised guidances from FDA and EMA, including real-world data (RWD) approaches and descriptive pregnancy safety studies, issues with timing of approvals and inter-agency coordination while highlighting missed opportunities for collaboration
Industry viewpoints on operational considerations and practical challenges in setting up and maintaining single-product and collaborative registries
Physician, professional society and scientific advisory committee member perspectives
Examples of successful multi-sponsor collaborations and lessons learned

Register for this webinar today to understand how pregnancy exposure registries are helping in assessing medication safety and thus enhance pregnancy safety studies.

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Speakers

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.

Message Presenter

Who Should Attend?

This webinar will appeal to those wanting to understand the benefits, opportunities and mechanics of pregnancy exposure registries as well as those in the following fields/having the following job titles:

Pharmaceutical and biotech
Regulatory affairs
Professional societies and scientific advisory committee members
Clinical Researchers and Scientists
Healthcare Providers and Obstetricians

What You Will Learn

Attendees will learn about:

Historical context of single- vs multi-sponsor pregnancy exposure registries and current landscape
Methodological, scientific and operational best practices
Lessons learned from successful multi-sponsor pregnancy exposure registries
Industry viewpoints on operational considerations and practical challenges in setting up and maintaining single-product and collaborative registries
Physician, professional society and scientific advisory committee member perspectives
Examples of successful multi-sponsor collaborations and lessons learned

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Syneos Health®

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Together they share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. They support a diverse, equitable and inclusive culture.

To learn more about how we are shortening the distance from lab to life^®, visit syneoshealth.com or subscribe to our podcast.

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

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