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Clinical application of PGx: heating up
The reporter concluded that "it is possible to predict how someone will respond to certain drugs, such as warfarin". In addition to our own efforts, we are excited to see increasing movement of pharmacogenetics knowledge towards clinical application.
CER is compatible with pharmacogenomics
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Where and when should biomarkers be incorporated into drug development?
CDER Director Janet Woodcock and Office of Clinical Pharmacology Director Lawrence Lesko, and others from industry and academia, addressed these questions October 21 and 22 at a workshop held at the FDA's White Oak Campus. Adaptive Pharmacogenomics' Michael Palmer organized and chaired the workshop.
Janet Woodcock opened the "Workshop on the Impact of Biomarkers on the Complexity and Cost of Drug Development" and noted the agency's continuing commitment to supporting the use of biomarkers in drug development. Lawrence Lesko chaired a panel discussion. Over the two day workshop, FDA and industry representatives finalized two benchmark therapeutic area scenarios, in oncology and Alzheimer's Disease. The benchmarks are the results of an eight month effort by FDA, MIT, Adaptive Pharmacogenomics, and several major pharma companies. They will be used to evaluate software tools for assessing the complexity and cost of clinical development with biomarkers.
For more information on Adaptive Pharmacogenomics' one day course based on the workshop, download the course brochure (http://www.adaptivepharmacogenomics.com/users/FebruaryFDAbiomarkerWorkshopCourse01.pdf).
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Warfarin label change to reflect PGx info!
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.
Pharmacogenetics and anticoagulant therapy: two cases of genetically determined response to warfarin.
Rev Port Cardiol. 2009 Sep;28(9):995-1004
Authors: Cortez-Dias N, Correia MJ, Coutinho A, Fernandes C, Diogo AN, Lopes MG
Inter- and intra-individual variability of response to warfarin means that its anticoagulant effect must be monitored, given the risk of thromboembolic complications and bleeding.
The 8th annual pharmacogenetics in psychiatry meeting report.
Pharmacogenomics J. 2009 Dec;9(6):358-61
Authors: Aitchison K, Serretti A, Goldman D, Curran S, Drago A, Malhotra AK
PMID: 19841640 [PubMed - indexed for MEDLINE]