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Pharmacometrics & Pharmacokinetics (PMK) Community

Monday, January 10, 2022

4:30 PM – 5:30 PM ET

Network and Community Chair(s)

Neeraj Gupta, PhD

Senior Director
Takeda
Qi Liu, PhD

Associate Director for Innovation & Partnership, Office of Clinical Pharmacology
US Food and Drug Administration

Network and Community Speaker(s)

Kosalaram Goteti, PhD

Senior Scientific Director & Portfolio Section Head
EMD Serono
Klaus Romero, MD

Chief Science Officer Executive Director, Clinical Pharmacology
Critical Path Institute
Hao Zhu, PhD

Acting Director
US Food and Drug Administration

Session Description

This session will build upon the FDA public workshop titled "Best Practices for Development and Application of Disease Progression Models” planned from Nov 2021. This session will dig deeper to discuss the role of disease progression models from consortium, drug developers and FDA view. This session will also highlight the opportunities and limitations in the development and application of disease progression models.

Learning Objectives

1. Discuss the role of disease progression models in drug development and regulatory review.

2. Highlight the opportunities and limitations in the development and application of disease progression models.

Session Schedule

4:30 PM - 4:35 PM ET
PMK Accomplishments and Vision for Next Year
Neeraj Gupta, PhD & Qi Liu, PhD

4:35 PM - 4:47 PM ET
Disease Progression Models: FDA Perspective
Hao Zhu

4:47 PM - 4:56 PM ET
Disease Progression: C-Path Perspective
Klaus Romero, MD

4:56 PM - 5:05 PM ET
Disease Progression: SLE Case Study
Kosalaram Goteti, PhD

5:05 PM - 5:30 PM ET
Panel Discussion and Live Q&A
All Speakers