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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.


Session 4: The Evolution of MID3 and the Intersection of Biostatistics and Clinical Pharmacology in MID3 Clinical Trials

Session Chair(s)

Jonathan  Haddad, MPH

Jonathan Haddad, MPH

  • Senior Director, Clinical Statistics
  • GlaxoSmithKline, United States
Lei  Nie, PhD

Lei Nie, PhD

  • Associate Director of Biometrics II, 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)

Lei  Nie, PhD

Model Informed Drug Development (MIDD): Opportunities for Collaboration

Lei Nie, PhD

  • Associate Director of Biometrics II, Office of Biostatistics, OTS, CDER
  • FDA, United States
Hao  Zhu, PhD

Model Informed Drug Development (MIDD): Opportunities for Collaboration

Hao Zhu, PhD

  • Deputy Division Director
  • FDA, United States
Anubha  Gupta, PhD

Otilimab Case Study

Anubha Gupta, PhD

  • Pharmacometrician/Clinical Pharmacologist
  • GSK, United Kingdom

Contact us

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1.888.257.6457


Additional Information

Biostatistics Industry Resource Kit