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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.
The intersection of pharmacology, imaging, and genetics in the development of personalized medicine.
The intersection of pharmacology, imaging, and genetics in the development of personalized medicine.
Dialogues Clin Neurosci. 2009;11(4):363-76
Authors: Gerretsen P, Müller DJ, Tiwari A, Mamo D, Pollock BG
We currently rely on large randomized controlled trials and meta-analyses to make clinical decisions; this places us at a risk of discarding subgroup or individually specific treatment options owing to their failure to prove efficacious across entire populations.
[Pharmacogenetics/pharmacogenomics in psychiatry]
Nippon Rinsho. 2010 Jan;68(1):155-62
Authors: Ueda M, Ishiguro S, Watanabe T, Saeki Y, Shimoda K
Pharmacogenetics/pharmacogenomics has been developed so rapidly in these twenty years and the pharmacogenetic/pharmacogenomic research in psychiatry is also the case. Especially, the impact of genetic polymorphism (e. g.
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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.
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.
FDA Partners with GlaxoSmithKline and Adaptive Pharmacogenomics to Advance Personalized Medicine
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.