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CDER News Along the Pike
September 15, 2006
Volume 12, Issue 1
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OCPB Science Day
2005
Clinical
pharmacologists explore future
of pharmaceuticals
By Ray Baweja, Ph.D., Sophia
Abraham, Ph.D., Sandra Saurez, Ph.D., Abimbola Adebowale, Ph.D.,
Charles Bonapace, Pharm.D., Srikanth Nallani, Ph.D., Patrick Nwakama,
Pharm.D, Venkat Jarugula, Ph.D., Chandra Sahajwalla, Ph.D., Shiew
Mei Huang, Ph.D., and Larry Lesko, Ph.D.
The 14th
Science Day sponsored by the Office of Clinical Pharmacology and
Biopharmaceutics enthusiastically celebrated the theme of “Molecules
to Bits: The Future of Pharmaceuticals” in October.
The keynote
address was presented by Juan Enriquez, a business leader,
author and academic who is recognized as an authority on issues
related to the economic and political impacts of life sciences. His
lecture focused on the theme of how we generate “wealth and better
living” for citizens of this planet and which countries end up being
wealthy versus those that stay poor.
During the
Renaissance from the 14th to the 17th centuries in Europe, arts and
banking flourished. This was followed by the Industrial Revolution.
The mid-20th century saw the independence of 61 countries over a
span of 13 years, and later in the century it was technologically
the era of computers. Currently, we are in the “digital” and
“genomic” revolutions.
In each
instance, he noted, that whichever country adopted the latest
technology, stayed on top. Still, over the course of time, neither
any one “country” nor any given “technology” can be taken for
granted. Consistently no one country or continent has stayed on top.
It is always an evolutionary and turning process on this planet.
The current era
is that of genomics. He compared the current infancy of the genomics
revolution to that of European navigators who even with “perfect”
maps of their time, knew that they had “landed somewhere” but did
not know exactly where.
Similarly, with
the human genome project, science is setting out to “map” each one
of us, and this mapping will eventually change everything. He
congratulated the Agency for taking the lead in this area mentioning
that it has a “front row seat” and was complimentary of its national
initiative toward developing a guidance.
The podium
presentations covered:
-
Imaging biomarkers for drug discovery in Parkinson’s disease.
-
Applications of exposure-response to optimize benefit-risk ratio
for combination therapy.
-
Concentration QTc relationship derived endpoint for
decision-making.
-
Genomics in drug development.
-
Semi-mechanistic PD modeling.
-
Clinical pharmacology issues for oral inhaled insulin.
-
Updates on drug interactions and pharmacogenomics guidances.
-
Similarly,
the posters covered a range of topics, such as:
-
Pharmacogenomics information for drug labels.
-
Repository of drugs used in pregnancy and lactation.
-
Applications of population pharmacokinetics in drug labeling.
-
Improving drug development efficiency of drugs for osteoporosis.
-
Current opinions on drug-drug interactions studies.
-
The President’s Emergency Plan for Aids Relief.
The
Commissioned Corps team had a visual presentation in which they
highlighted their assistance in the Katrina relief effort both in
the state of Louisiana and through their coordination efforts from
the Washington area. The finale of the day was the Talent Hour, and
features included Middle Eastern dancing, a demonstration of radio
broadcasting and folk and country melodies.
Science Day
began in 1996 and, over the years, has seen participation of
clinical pharmacologists from the Uniformed Services University of
Health Sciences, Walter Reed Army Institute of Research, Office of
Generic Drugs, CBER, Center for Drug Development Science at
Georgetown University, the National Institutes of Health, University
of Maryland and the Medical College of Virginia.
To
date there have been about 250 scientific presentations, including
the seven podium and 26 posters for 2005. Distinguished guest
speakers have shared the latest findings in the field of medicine,
clinical pharmacology, optimization of the drug development process,
and have included Drs. Curtis Wright, Carl Bjornsson, David
Greenblatt, William Jusko, Bill Evans, Robert Powell, Janice
Schwartz, Jay Cohen, Stephen Naylor and Kenneth Kaitin.
The main theme of Science Day has been to share and exchange
scientific information and ideas among clinical pharmacologists.
The authors are members of OCPB, and Larry Lesko is the office
director.
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Views and opinions expressed are those of the authors
and do not necessarily reflect official FDA or CDER policies. All
material in the Pike is in the public domain and may be
freely copied or printed. Deadline for submitting articles is the
15th of each month.
Date created: September 14, 2006 |
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