Overview of CDISC ADaM Population PK Data Standard ADPPK Implementation Guide

Recorded On: 01/19/2024

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This Webinar provides an overview of the work done by the ADaM sub-team (ADPPK) to build a CDISC ADaM standard for data supporting Population PK (PopPK) analysis while accounting for use within a broad number of software packages. The associated software packages typically impose strict constraints on input data format, and common analysis data conventions in the expert community tend to make limited use of ADaM standards. This webinar describes the BDS-like implementation used for the PopPK standard and discusses how we managed the differences between CDISC standards and analysis needs in this specialized area. It highlights the advantages of implementing the ADaM ADPPK standards for improving quality, efficiency, and collaboration across the industry. The webinar also includes FDA’s perspective on adopting these standards.

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.

Fang Li

Senior Pharmacometrics Reviewer at the Division Pharmacometrics

Food and Drug Administration

Dr. Frank Fang Li is a senior pharmacometrics reviewer in the Office of Clinical Pharmacology at the FDA. With 16 years of experience in the Division of Pharmacometrics, he stands as a leading specialist in the application of quantitative clinical pharmacology at the FDA. His extensive tenure with the Agency positions him as one of the top experts capable of utilizing modeling and simulation analyses to make challenging regulatory decisions, particularly in the evaluation of applications in model-informed drug development (MIDD).

Dr. Li has attained a high level of expertise as a clinical pharmacometrician across more than 10 therapeutic areas, including oncology, cardio-renal, antiviral, anti-infectives, dermatology, rheumatology, pulmonary, bone, reproduction, and urology. He has successfully reviewed over 300 NDA/BLA/IND, QT, and MIDD applications, contributing significantly to CDER and FDA's mission.

Luke Reinbolt

Navitas

Luke has worked in the Pharmaceutical and Biotech industry for 18 years, specializing in the areas of Statistical Programming and Clinical Pharmacology. He has worked for Navitas Data Sciences (previously DataCeutics) for the last 10 years. Currently, he works with a group of programmers that support a Modeling and Simulation Analysts group within Clinical Pharmacology. He has extensive experience working with NCA and POPPK files. Luke is a member of the ADaM team and is the lead of the ADNCA and co-lead for ADPPK sub-teams within ADaM. Luke lives in Lincoln, Nebraska, with his wife and enjoys traveling.