Leveraging Modeling and Simulation for Neonatal and Infant Drug Development

On-Demand Webinar

When it comes to drug development, children are not just small adults. Moreover, not all children are the same. Children under the age of 2 are the most heterogeneous due to differences in maturation of organs, drug metabolizing enzymes, and transporters. Babies from birth to one month of age―neonates―are the least studied and most fragile patient population. In fact, less than 5% of pediatric trials include neonates. Failure to study this population has led to widespread off-label prescribing likely resulting in under-dosing, over-dosing, and adverse events.

Modeling and simulation can help reduce the uncertainty of drug dosing in pediatric populations. In this webinar, Certara’s Dr. Alice Ke explained how modeling and simulation aligns with the directionality of regulatory, ethical and testability factors. She focused on the rapid advances in the use of physiologically-based pharmacokinetic modeling (PBPK) to support in drug development for this population. Dr. Ke presented several case studies illustrating how PBPK informs first-in-pediatric dosing and clinical study design.

About Our Speaker

Webinar-1speaker-KeDr. Alice Ke is a Consultant and Scientific Advisor at Certara. Her research interests center around applying PBPK and PK/PD modeling to predict complex drug interactions and PK/PD in special populations.

Alice Ke obtained her PhD in pharmaceutics from the University of Washington, Seattle, where her research focus was on assessing fetal and CNS drug distribution using clinical imaging techniques. She then accepted an ORISE fellowship in the Office of Clinical Pharmacology at the FDA, where she developed and validated PBPK and population PK models to support dose adjustment for pregnant women. After completing her fellowship, Dr. Ke was a research scientist in the Department of Drug Disposition and PK/PD at Lilly Research Laboratories, where she applied population PK and PBPK modeling & simulation techniques to advice the design of clinical pharmacology studies.

When it comes to drug development, children are not just small adults. Moreover, not all children are the same. Children under the age of 2 are the most heterogeneous due to differences in maturation of organs, drug metabolizing enzymes, and transporters. Babies from birth to one month of age―neonates―are the least studied and most fragile patient population. In fact, less than 5% of pediatric trials include neonates. Failure to study this population has led to widespread off-label prescribing likely resulting in under-dosing, over-dosing, and adverse events.

Modeling and simulation can help reduce the uncertainty of drug dosing in pediatric populations. In this webinar, Certara’s Dr. Alice Ke explained how modeling and simulation aligns with the directionality of regulatory, ethical and testability factors. She focused on the rapid advances in the use of physiologically-based pharmacokinetic modeling (PBPK) to support in drug development for this population. Dr. Ke presented several case studies illustrating how PBPK informs first-in-pediatric dosing and clinical study design.