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  6. About the Quantitative Medicine Center of Excellence (QM CoE)
  1. CDER Quantitative Medicine Center of Excellence (QM CoE)

About the Quantitative Medicine Center of Excellence (QM CoE)

A core value of the QM CoE is collaboration, and the primary CoE membership includes interdisciplinary experts that work in CDER. To ensure the CoE is equipped to carry out its mission, the CoE will be governed by leadership from the Office of Generic Drugs, Office of New Drugs, Office of Pharmaceutical Quality, and Office of Translational Sciences. Staff from other FDA Centers will be key stakeholders in all activities of the CoE, including but not limited to, development of best practices, trainings, and outreach.

QM CoE Executive Board

  • Board Chair: Issam Zineh, PharmD, MPH, FCP, FCCP, Office Director, Office of Clinical Pharmacology, Office of Translational Sciences
  • QM CoE Director: Raj Madabushi, PhD, Associate Director for Guidance and Scientific Policy, Office of Clinical Pharmacology, Office of Translational Sciences
  • Board Project Manager: Daphne Guinn, PhD, Sr. Regulatory Project Manager, Office of Clinical Pharmacology, Office of Translational Sciences  

QM CoE Members

  • Stella Grosser, PhD, Director, Division of Biometrics VIII, Office of Biostatistics, Office of Translational Sciences 
  • Robert Lionberger, PhD, Director, Office of Research and Standards, Office of Generic Drugs
  • Qi Liu, PhD, Associate Director for Innovation and Partnership, Office of Clinical Pharmacology, Office of Translational Sciences
  • Lei Nie, PhD, Director, Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences
  • Nikolay Nikolov, MD, Office Director, Office of Immunology and Inflammation (OII), Office of New Drugs
  • Thomas O’Connor, PhD, Deputy Director, Office of Pharmaceutical Quality Research (OPQR), OPQ 
  • Bhagwant Rege, PhD, Division Director, Division of Biopharmaceutics (DB), Office of New Drugs (NDP), Office of Pharmaceutical Quality
  • James Smith, MD, MS, Director, Office of New Drug Policy, Office of New Drugs
  • Liang Zhao, PhD, Director, Division of Quantitative Methods & Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs
  • Hao Zhu, PhD, Director, Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences

To learn more about the establishment of the QM CoE, view the CDER statement

 
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