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FDA Guidance Encourages Model-Based Drug Development
The U.S. Food and Drug Administration's (FDA) "Guidance for Industry: End-of-Phase 2A Meetings" encourages sponsors to use modeling strategies and clinical trial simulation scenarios "to facilitate the exploration of trial design alternatives to increase the likelihood for successful trials." However, it may still seem that there are more open questions than available answers in this new and still largely uncharted area.
Personalized medicine in warfarin therapy
Pathology practice and pharmacogenomics.
Pharmacogenomics. 2010 Jan;11(1):105-11
Authors: Trent RJ
New technologies emerging from the Human Genome Project and the rapidly expanding direct-to-consumer DNA testing have provided a challenging environment for the entry of pharmacogenomics into clinical practice.
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Press covers FDA/industry biomarker plans
Nature Reviews Drug Discovery's (NRDD) Bethan Hughes reports on a joint FDA/industry effort to develop a common perspective on stratified medicine.
As reported in the NRDD article, the FDA's experiences with Voluntary Exploratory Data Submissions (VXDS) raised awareness at the agency that the complexity and cost of clinical development with biomarkers was a concern for industry. Reaching outside the Beltway to industry and academia, the FDA hosted a workshop at its White Oak, Maryland campus on October 21 and 22, 2009. Adaptive Pharmacogenomics's Michael Palmer organized and chaired the White Oak workshop.
Stroke pharmacogenomics.
Expert Opin Pharmacother. 2009 Dec;10(18):2947-57
Authors: Billeci AM, Agnelli G, Caso V
Circulatory disease accounts for fifteen million deaths each year, of which stroke accounts for four and a half million- with an estimated nine million stroke survivors annually. The overall incidence rate of stroke is 2 to 2.
Meaningful use of pharmacogenomics in health records: semantics should be made explicit.
Pharmacogenomics. 2010 Jan;11(1):81-7
Authors: Shabo Shvo A
The recent emphasis on 'meaningful use' of electronic health records in health information technology reforms (e. g. , as in the US stimulus package) can leverage the pharmacogenomics field.
FDA Partners with GlaxoSmithKline and Adaptive Pharmacogenomics to Advance Personalized Medicine
Pharmacogenetics in reproductive and perinatal medicine.
Pharmacogenomics. 2010 Jan;11(1):65-79
Authors: Alfirevic A, Alfirevic Z, Pirmohamed M
The clinical application of pharmacogenetics has been well accepted by some medical specialties, but not all.
Clinical pharmacology and pharmacogenetics in a genomics era: the DMET platform.
Pharmacogenomics. 2010 Jan;11(1):89-103
Authors: Sissung TM, English BC, Venzon D, Figg WD, Deeken JF
While no genome-wide pharmacogenetics study has yet been published, the field of pharmacogenetics is moving towards exploratory, large-scale analyses of the interaction between genetic variation and drug treatment.