Formation of the Division of Pharmacometrics within Office of Clinical Pharmacology at FDA
Dear all:
Please see the following announcement about the establishment of
Division of Pharmacometrics within Office of Clinical Pharmacology at
FDA. For those of you not familiar with FDA organizational structure,
here is a brief explanation. The hierarchy in the organization in terms
of groups is as follows: center, super office, office, division, staff,
team. FDA Pharmacometrics started as a team, elevated to staff and now
it is a Division. This is an important achievement for all of us working
in this field, not just for FDA. With the formation of the new Division
of Pharmacometrics, FDA has committed to increase the size of the group
(minimum 20 employees, we are 17 currently) and recognized the long
standing contributions of scientists both within and outside FDA. As
Larry pointed out, this is a milestone for the profession of clinical
pharmacology. We should all be proud of this achievement!
Yaning Wang, Ph.D.
Team Leader, Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Science
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Phone: 301-796-1624
Email: [email protected]
"The contents of this message are mine personally and do not necessarily
reflect any position of the Government or the Food and Drug
Administration."
Quoted reply history
______________________________________________
From: Lesko, Lawrence J
Sent: Tuesday, February 17, 2009 9:23 AM
Subject: New OCP Division
Dear Colleagues:
It is my pleasure to announce that the Center for Drug Evaluation and
Research has approved a new Division of Pharmacometrics in the Office of
Clinical Pharmacology (OCP) to be led by Dr. Joga Gobburu as its
Director. Joga is a recognized leader in the field of pharmacometrics
and has been a key strategist in enabling the pharmacometrics team to
reach its potential as contributors to the public health mission of FDA.
This change is designed to align with the strategic plan of our Office
and to enhance the use of quantitative methods in drug development and
in the review of INDs and NDAs. The new Division will help us continue
to deliver the value-added products and services of pharmacometrics to
our colleagues in other CDER Offices, the pharmaceutical industry and in
various public-private partnerships. It's fortunate that we have a
group of successful reviewers and experienced thought-leaders brought
together in the Division of Pharmacometrics to better drive future
growth and innovation in regulatory science.
The formation of this new Division in FDA is a milestone for the
profession of clinical pharmacology. The adoption of quantitative
methodologies as more routine in assessing dose-response, benefit-risk,
biomarker qualification and drug-disease models is the culmination of
the hard work of many dedicated scientist-clinicians within FDA and in
the external community over the past 15-20 years. We now see a new era
of opportunity and responsibility to deliver the types of analyses and
problem solving that our "customers" want most from pharmacometrics into
the future.
I speak for the entire OCP family to say "congratulations" and to
express how proud and appreciative we are of the scientific
accomplishments of our pharmacometrics group.
Larry