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Genomics at FDA: Background Information on Genomics
Background Information on Genomics
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.
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
- Concepts and Tools in Pharmacogenomics
- Submissions and Labels in Regulatory Pharmacogenomics
- Final training on ArrayTrack, an integrated genomics analysis tool developed by the National Center for Toxicology Research (NCTR)
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.
- Personalized Medicine: What Is It? How Will It Affect Health Care?,
Felix W. Frueh, Ph.D., CDER, 11th Annual FDA Science Forum, April, 2005. This presentation provides a very basic understanding of genomics and pharmacogenomics. - Genetic Testing to Help Reduce Chemotherapy Toxicity This June, 2007 FDA Patient Safety News video webcast discusses individualizing a drug's dose based on pharmacogenomic information.
- How FDA Advances Personalized Medicine Sept, 2007 consumer-friendly article.
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