The Increasing Role of Pharmacometrics in Drug Development

The cost of a new drug from discovery to launch is approaching $3B with the underlying time for development reaching up to 12 years. Given the costly and lengthy process, scientific and regulatory leaders in the pharmaceutical industry need to leverage all available tools to get drugs approved quickly and efficiently, bringing safe and efficacious medications for human needs. In recent years, pharmacometrics has emerged as an invaluable modeling and simulation tool that helps to de-risk and accelerate the drug development process. It facilitates the integration of preclinical/clinical development data and provides a scientifically based framework for designing a rationale dosage regimen and treatment optimization. There are several pharmacometrics techniques that can be elicited at various stages in the drug development pipeline to help make the approval process more efficient and get the most efficacious doses with increased safety for all patients, including special populations. 

This webinar will provide an overview of different pharmacometrics tools and techniques, including guidance as to when they can be applied and key considerations about why this may be necessary for most of your studies.

Speakers

Felix Boakye-Agyeman, MD, PhD, Director, Pharmacokinetics, Synteract

Dr. Felix Boakye-Agyeman has a unique background in medicine, clinical pharmacology, and laboratory medicine. Over the past several years, Dr. Boakye-Agyeman has used several pharmacokinetic techniques to help predict and optimize doses in both adult and pediatric populations. He has experience using very sparse and opportunistic sampling to develop popPK models. As a clinical pharmacologist (Pharmacokineticist / Pharmacometrician) for Mayo Clinic, Pediatric Trial Network (PTN), and Duke Clinical Research Institute (DCRI), he has collaborated closely with a cross-functional trial and project teams, physicians, and external government or industry representatives with regard to the pharmacokinetic aspects of each clinical trial or project.

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Rakesh Gollen, PhD, Director, Pharmacokinetics, Synteract

Dr. Rakesh Gollen is an experienced pharmaceutical scientist with over eight years of industrial experience focused on the development of novel drugs working in both preclinical and clinical drug development, with expertise across multiple therapeutic areas with emphasis on early and late-stage submissions. Dr. Gollen’s expanded skillset involves the prediction and optimization of safe and efficacious doses in clinical setting for adults, pediatric, and other specific patient populations requiring dose regimen modification using various Pharmacokinetics/Pharmacometrics approaches like PK/PD, popPK and PBPK.

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