The Pediatric Research Equity Act (PREA) and Its Implications for Oncology Development

The Pediatric Research Equity Act (PREA) of 2003 gives the FDA the authority to require pediatric studies in certain development programs, with the goal of obtaining pediatric labeling for more products and thereby expanding access to new medicines for children. It was amended by the FDA Reauthorization Act (FDARA) of 2017, in ways that have had a far-reaching impact on oncology drug developers.

An oncology product’s molecular target, rather than its indication, is now the key in determining whether a program requires pediatric studies, so sponsors anticipating that PREA requirements will be deferred or waived entirely may be surprised when the FDA requires pediatric trials before accepting a marketing application. Therefore, sponsors should begin early in development to understand how PREA affects them and plan how to incorporate its requirements into their development programs.

Join this webinar with the experts from Camargo Pharmaceutical Services and Paidion Research to explore whether PREA requirements apply to your program, how compliance can expand the market potential for your product, and how PREA and FDARA are helping to address unmet needs for pediatric oncology patients.

Speakers

Stacey Ayres, PhD, Vice President of Regulatory and Strategy, Camargo Pharmaceutical Services

Stacey Ayres, PhD, has spent over 25 years in the pharmaceutical industry and frequently participates in regulatory meetings at the FDA encompassing a broad range of therapeutic areas including oncology, endocrinology, urology, dermatology, and neurology. Her experience includes interactions with CBER to facilitate the development of novel cancer therapies such as oncolytic viral therapies and with the Oncology Center of Excellence to receive early advice and facilitate pediatric cancer drug development. She has participated in IND, NDA, and ANDA preparations and submissions and provided successful strategic regulatory approaches to Orphan Drug Designation requests and the FDA’s expedited programs for serious conditions. She has authored numerous peer-reviewed publications and has received both federal and private grant support. Previously, she has worked as a Research Associate in Clinical/Medical Affairs, managing and conducting research projects from Phases I–IV. She received her Ph.D. in Interdisciplinary Studies (Physiology) from the University of Cincinnati.

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Kumar Ilangovan MD, MSPH, MMCi, FAAP, FACP, Medical Director, Paidion Research, Inc.

Kumar Ilangovan, MD, MSPH, MMCi, FAAP, FACP, is a board-certified pediatrics, internal medicine, and clinical informatics physician who serves as Medical Director of Paidion Research. He has worked on clinical and applied research for over eight years and practiced clinically as a general pediatrician and internist for 13 years. His current role involves the oversight of safety and data integrity for pediatric clinical trials as well as providing medical leadership for Paidion. His pediatric clinical trial experience spans Phase I-Phase III trials, and he has a specific interest in pediatric rare disease therapeutic areas.

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Mihai Anghel BSc, MBA, Cert. in Law, Manager of Oncology Solutions, Camargo Pharmaceutical Services

Mihai Anghel has been involved in the pharmaceutical and biotech industries for the past 16 years, in roles that include applied R&D work, project management, new product launch, licensing and CRO services management. He has been a part of organizations of all sizes and has been instrumental in their business success and revenue growth. In his current role, he serves as the primary point of contact for evaluating new oncology projects and programs and designing customized Camargo solutions to meet sponsors’ needs and drive program success. He holds a BSc and MBA from McGill University and a Certificate in Law from Queen’s University.

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