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.
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.Message Presenter
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.Message Presenter
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.Message Presenter
Who Should Attend?
- Regulatory Affairs
- Clinical Operations
- Clinical Development
- Clinical Affairs
- Clinical Outsourcing
- Commercial Affairs
- Market Access
- Project Management
- Medical Affairs
What You Will Learn
- The background and purpose of PREA and how FDARA has amended the requirements for oncology programs
- How sponsors can determine whether they will need to conduct pediatric studies and at which stage of development they should begin considering PREA
- The continued impact of PREA and FDARA on the oncology development landscape
- How complying with PREA and adding a pediatric indication for a product can expand its market potential
Camargo is a strategic drug development, regulatory, and commercial partner for emerging biopharma companies focused in rare and complex therapeutic areas. We have expertise in rare disease, oncology, pediatrics, the 505(b)(2) regulatory pathway, and more specialty areas. Our integrated Strategy, Regulatory, Nonclinical, and Clinical solutions help clients accelerate development from concept to commercialization.
For nearly 20 years, we have helped clients successfully position high-science, creatively bold strategies to regulators and accelerate development with confidence.
Paidion Research, Inc., a global pediatric clinical research organization, is now part of Camargo. Together, we are impacting healthcare for children through end-to-end pediatric drug development solutions to reach more patients faster. Learn more →
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