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Expert Tips for Pediatric Drug Development and Regulatory Success
2021 年 03 月 17 日

While the pharmaceutical industry in the US and EU has made tremendous progress in pediatric drug development with over 850 products containing pediatric labeling, there is still a significant lag between attaining approval for a drug for adults and the first pediatric label information.

Why is this?

Conducting pediatric clinical studies has well-known challenges. From an operational standpoint, it is becoming increasingly difficult to recruit pediatric subjects for clinical studies as multiple companies compete to recruit the same small populations. The physiological differences between adults and kids can also create unique development challenges, including the need for easy to swallow pediatric formulations, crafting dosing strategies for patients with lower blood volumes, and addressing potential drug toxicity due to maturation factors. Therefore, pediatric study designs usually need to be adapted from the ones used in adults.

The regulatory landscape is also constantly changing. Last year brought an increase in pediatric regulatory requirements like the RACE for Children Act, which closed a legislative gap to ensure that innovative drugs are also developed for pediatric cancers.

We need to adopt innovative approaches to designing pediatric trials that reduce patient and family burden while maintaining scientific rigor in the development of products for children. In this webinar, our regulatory and drug development experts discussed the unique challenges facing pediatric biotech and pharmaceutical programs and provided tips on navigating complex global regulations and applying model-informed drug development (MIDD) approaches to optimize trial designs and thus de-risk drug programs.


Eva Gil Berglund, PhD

Dr Eva Gil Berglund joined Certara as Senior Director in Clinical Pharmacology and Regulatory Strategy 2019 and is part of the Pediatric Practice Area. She is Pharmacist by training and has a PhD in Clinical Pharmacology, both Uppsala University, Sweden. Eva has 20 years of experience working as a Reviewer and Senior Expert in Clinical Pharmacology at the Swedish Medical Products Agency and in the EMA Network of National agencies.  She has been Rapporteur for several EU Clinical Pharmacology guidance documents (drug-drug and drug-food interactions, PBPK, paediatrics, pharmacogenetics, etc.), extensively involved in interregional communication and in the work of EMA working parties including Pharmacokinetics WP and Paediatrics WP.

Jacquelyn Binns, BS

is an Associate Principal Regulatory Writer in the Regulatory Services group at Certara. Jacquelyn has over 20 years combined experience in the pharmaceutical industry, clinical diagnostic care and research, and medical writing. In her current role, she routinely provides guidance on regulatory strategy and clinical development across all stages of drug development and has led many successful regulatory submissions in the US and Europe across a variety of therapeutic areas. In addition, Jacquelyn has held positions in drug discovery and development at Merck and Co., Inc., as well as in a clinical setting at the Children’s Hospital of Philadelphia and the Hospital of the University of Pennsylvania. Jacquelyn received degrees neuroscience and psychology from Cedar Crest College.

Lynne Georgopoulos, RN, MSHS, RAC

is Vice President, Regulatory Strategy, Integrated Drug Development. Lynne has over 30 years of diverse biopharmaceutical and CRO industry experience developing and providing strategic guidance and clinical development and regulatory advice at all stages of product development. Most recently, Lynne was VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm.  Lynne received a nursing degree from Russell Sage College, and a Master of Science in Health Sciences in Regulatory Affairs from The George Washington University. She is regulatory affairs certified through the Regulatory Affairs Professional Society (RAPS) and has authored book chapters and articles on pediatric drug development.

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