Dear Colleagues:
I would like to share a very important milestone for Division of
Pharmacometrics (DPM) at FDA
( https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/division-pharmacometrics).
Today, DPM is the largest division (N=31) across all the review divisions
within Office of Clinical Pharmacology at US FDA (OCP,
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-clinical-pharmacology)!
When I joined FDA in 2003, there were only four pharmacometric reviewers
scattered across three clinical pharmacology divisions (DCP1/2/3, back then
there were only 3 divisions within Office of Clinical Pharmacology and
Biopharmaceutics, OCPB, which later changed to OCP). Over the years, the
function of pharmacometrics was first centralized under Dr. Larry Lesko's
(former OCPB and OCP Office Director) leadership and Dr. Bob Powell served as
the first head of Pharmacometrics followed by Dr. Joga Gobburru and Dr. Vikram
Sinha. We grew from a Team to Pharmacometrics Staff and eventually Division of
Pharmacometrics. The number of review teams also increased from 2 to the
current 7 (5 pharmacometric teams, 1 PBPK team and 1 cross-discipline QT team).
We are proud of our achievements and, more importantly, appreciate the
accumulative efforts and hard work of our current and former colleagues both
within and outside FDA, including you all. We will build upon the success and
move the field of pharmacometrics to the next level in the years to come.
Thanks
Yaning Wang, Ph.D.
Director
Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Phone: 301-796-1624
Email: [email protected]<mailto:[email protected]>
Disclaimer: The contents of this message are mine personally and do not
necessarily reflect any position of the Government or the Food and Drug
Administration.