Changes to Population PK/PD data and supplemental information based on FDA Guidance for PopPK

Recorded On: 09/29/2023

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In this presentation the speakers highlight the updates in the latest FDA Guidance for Population PK that impact the PMx Datasets, Report and eSub aspects. They provide some discussion and recommendations on how to incorporate the changes into the submission package.

Neelima Thanneer

Head of Data Science and Clinical Pharmacology Analysis and Reporting

Bristol-Myers Squibb

Neelima is currently working in BMS as the Head of Data Science & Clinical Pharmacology Analysis and Reporting. She has extensive experience in Pharmacometric Programming, Data Standards and Workflow Automation. She has built and been leading Pharmacometric Programming group over the past 15 years at BMS. She co-led the ISoP Population PK data standards working group as well as the CDISC ADaM ADPPK Working Group. She also co-founded PKPD Programming Forum under ISoP to create a platform for Programmers to share best practices and challenges.

David Radtke

Eli Lilly

Dave is a pharmacometrician with Eli Lilly and Company and has been with that group for 28 years. He has been involved with the ISoP Population PK data standards working group as well as efforts within the CDISC community for ADNCA (non-compartmental PK), ADPPK (population PK), ADADA (anti-drug immunogenicity), and is a member of the Controlled Terminology group for pharmacokinetic data.