Sponsored | Physiologically Based Pharmacokinetic (PBPK) Applications in Model Informed Drug Development (MIDD) - Do You Know the Current Landscape of Regulatory Acceptance?

Recorded On: 10/30/2024

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Model Informed Drug Development (MIDD) is critical component in the drug development process and regulatory review, particularly for clinical trial design and dose selection. Physiologically Based Pharmacokinetic (PBPK) modeling, a vital part of MIDD, is commonly used to assess complex drug-drug interactions (DDIs).

The FDA recently issued guidance to promote diversity in U.S. clinical trials, including underrepresented racial and ethnic groups, pregnant and lactating women, pediatric subjects, and patients with co-morbidities. PBPK modeling supports this initiative by predicting drug exposures in varied populations.

This webinar will discuss the current regulatory acceptance of PBPK applications, highlight relevant case studies, and address the future of PBPK in dose optimization and enhancing trial diversity for underserved groups.

Key Takeaways:

Role of MIDD in clinical trial design and dose selection.
Regulatory acceptance of PBPK modeling for complex DDIs.
FDA’s focus on diversity in clinical trials.
Advances in PBPK models for predicting drug exposure in diverse populations.
Future challenges in regulatory acceptance of PBPK, especially for vulnerable populations.

*This is a sponsored webinar conducted by Certara.

Yuan Chen

Senior Fellow

Genentech

Dr. Yuan Chen is a Senior Fellow in the Department of Drug Metabolism and Pharmacokinetics at Genentech. Dr. Chen has more than 20 years of pharmaceutical industry experience in the drug metabolism and pharmacokinetic discipline working at Genentech and Roche. She has been DMPK and project lead for many discovery and development programs in broad therapeutic areas and contributed to the clinical candidate nomination and filing of IND, NDA and BLA to the regulatory authorities. Dr. Chen’s current research focus is on physiologically based pharmacokinetic (PBPK) modeling for the prediction of human PK in different populations, drug absorption, and CYP-and transporter-mediated drug-drug interactions. She leads PBPK effort and oversight the PBPK strategy and support to discovery and development projects at Genentech, including interactions with HA on MIDD and PBPK applications in drug labeling. In addition, Yuan has been an active member on IQ PBPK expert working groups and contributed to many PBPK white papers.

Eva Gil Berglund

Senior Director, Regulatory Strategy

Certara

Dr. Eva Gil Berglund joined Certara Drug Development Support in 2019 as Senior Director in Clinical Pharmacology and Regulatory Strategy. Eva supports companies in Clinical Pharmacology Regulatory Strategy. She has 20+ experience as Clin Pharm Reviewer and Senior Expert at the Swedish Medical Products Agency, and has been lead writer of several EU Clinical Pharmacology guidance documents including in DDIs, PBPK, Pediatrics and has been a member of the EMA Pharmacokinetics and Paediatrics EMA working parties.

Karen Rowland Yeo

Senior Vice President, Client & Regulatory Strategy

Certara

Karen is Senior Vice-President, Client & Regulatory Strategy at Certara UK Limited’s Simcyp Division. Prior to this, she was the Head of PBPK Consultancy Services at Simcyp where she led a team of scientists engaged in Consultancy projects relating to the application of physiologically based pharmacokinetic (PBPK) modelling in drug development. Her work has focused on the use of PBPK models for assessment of drug-drug interactions and dosing of special populations and she is the author/co-author of more than 100 peer reviewed articles in these areas.