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Using PK/PD M&S for Pediatric Drug Development: Regulatory Insights into Practical Issues

On-Demand Webinar
Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional clinical trials can be problematic for ethical and logistical reasons. Children are a challenging population, especially neonates and infants, as organ maturation affects drug exposure and response.
Pharmacokinetic (PK)- and pharmacokinetic/pharmacodynamic (PK/PD)-modeling and simulation (M&S) plays an ever more crucial role in pediatric drug development. The usefulness of M&S in pediatric drug development includes clinical trial simulation, dose selection, choice and optimization of study design, endpoint selection, and extrapolation.
This webinar addressed some of the challenges associated with pediatric drug development and the advantages (and limitations) that pediatric population PK modeling can provide. Our speakers, Drs. Nastya Kassir and Justin Pittaway-Hay provided an overview of the regulatory perspectives into common issues that are raised during regulatory submissions of M&S data for pediatric populations.

About Our Speakers

Dr. Justin Pittaway-Hay is a PK assessor at the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA) and has been a member of the EMA’s Modelling and Simulation Working Party (MSWP). Prior to joining the MHRA, he worked in clinical drug development for 15 years. Dr Pittaway-Hay was conferred his PhD in Medicine (Pharmacology) from the University of Adelaide, Australia.

Dr. Nastya Kassir joined Certara (formerly Pharsight Corporation) in August 2008. She has applied PK and PK/PD modeling and simulation tools to drug development decisions across a range of therapeutic areas. Her expertise includes scientific and regulatory consultation on drug development programs for small and large molecules in various phases of drug development, particularly in pediatrics, orphan diseases and in the therapeutic areas of inflammation (rheumatoid arthritis, psoriasis, psoriatic arthritis) and oncology. Nastya has authored or co-authored more than 60 abstracts/manuscripts in the field of PK/PD. Dr. Kassir has a PharmD and has earned a PhD in Pharmaceutical Sciences from the University of Montreal, Faculty of Pharmacy and is a fellow of the American College of Clinical Pharmacology.


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