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Genomics
at FDA
Background Information on Genomics
Pharmacogenomics
The action of drugs in the human body is
influenced by an individual's genetic background: however, this
background is unique for each individual. Therefore, two individuals
can react quite differently to the same drug. Pharmacogenomics is
the field exploring these differences, providing new knowledge and
tools to treat people on an individual basis. Often, the result of
this research is referred to as "personalized" or "targeted
medicine."
Pharmacogenomics is having an ever increasing
impact on drug discovery and development. The FDA is encouraging
this effort and is putting significant emphasis and support into
personalized medicine, promoting the translation of research
findings into medical practice. Several examples of targeted
therapies exist already. Herceptin for the treatment of breast
cancer is one such example, the drug is effective only in situations
where the cancerous tissue carries (overexpresses) a specific
marker. If that marker is not present, the patient sees no benefit
from treatment and is unnecessarily exposed to the potential risk
associated with drug treatment.
Education
The FDA has organized various workshops (see
Upcoming Events for future workshops and
Publications
for proceedings from past workshops) with PhRMA, BIO and other
organizations designed to both educate and provide feedback on
pharmacogenomics. In addition, a number of
articles have been
published, encouraging a broad public education in pharmacogenomics
and personalized medicine.
A new lecture series entitled
“Pharmacogenomics from the Ground Up” designed for scientists with
diverse academic and professional backgrounds is being held
regularly and has been integrated into the ongoing education for
reviewers within CDER. So far, the course is set up in three
sessions
Additional
continuing education lecture series are planned to include speakers
from the diagnostic and pharmaceutical industries responsible for
the development of molecular diagnostics and of drugs for which pharmacogenomic data made a difference in therapeutic efficacy or
safety.
Please see these presentations for more information on pharmacogenomics.
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Date created: March 22, 2005, updated September 6, 2007 |
