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Session 4: The Evolution of MID3 and the Intersection of Biostatistics and Clinical Pharmacology in MID3 Clinical Trials
Session Chair(s)
Jonathan Haddad, MPH
HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States
Lei Nie, PhD
Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
FDA, United States
This session will briefly describe the intent and potential benefits of the MID3 approach. We will share current activities to pilot MID3 and to develop guidelines for the use of MID3 in clinical trials. Opportunities for best working practices and collaboration between the biostatistics and clinical pharmacology functions within both the agency and industry will be explored. It is assumed that the audience will have a basic familiarity with MID3.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand joint industry-regulatory authority efforts to pilot and embed MID3 in drug development
- Understand areas of difficulty requiring special attention related to implementing the MID3 framework
- Gain insight to where Biostatistics and Clinical Pharmacology functions can collaborate on MID3 trials
Speaker(s)
Model Informed Drug Development (MIDD): Opportunities for Collaboration
Lei Nie, PhD
FDA, United States
Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
Model Informed Drug Development (MIDD): Opportunities for Collaboration
Hao Zhu, PhD
FDA, United States
Division Director, Division of Pharmacometrics, OCP, OTS, CDER
Otilimab Case Study
Anubha Gupta, PhD
GSK, United Kingdom
Pharmacometrician/Clinical Pharmacologist
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