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Medco-FDA PGx Alliance Aims to Improve Drugs

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The US Food and Drug Administration said in late August that it plans to use patient databases held by pharmacy-benefit manager Medco to help it assess the pharmacogenomic safety and efficacy of currently marketed and investigational drugs, and to determine which drug labels should be updated to include genetic risk information.

"A goal of this collaborative research is to identify drugs currently approved, or drugs to be approved in the future, for which pharmacogenomics may improve the dosing, effectiveness, or safety," says Lawrence Lesko, director of FDA's Office of Clinical Pharmacology.

Medco, the second-largest PBM in the US with 60 million beneficiaries, said in a statement it will "supply a large portion of the data to be used in the reports for the FDA." For its pharmacogenomic studies and labeling updates, the FDA will plumb Medco's claims database for prescription volume, prescription patterns, and treatment outcomes in its studies of marketed drugs.

Although the exact nature of Medco's reports to the FDA will not be determined until the FDA begins its studies, Lesko says he imagines that the reports could possibly "identify specific drugs with links to outcomes for which genetic factors may play a role," and offer insight into "what barriers exist to physician and patient acceptance of genetic testing and what their attitudes are."

According to a Medco spokesperson, the first projects under the collaboration will be determined in the fall. The agreement runs through the end of August 2010.

"Initially, we'll be looking at drugs like [warfarin] and tamoxifen, and any new tests that may come to market during the course of our collaboration," according to the Medco spokesperson.

Lesko says the collaboration will be supported by FDA's Critical Path funds, since one of its main aims is to "assess drug safety using new tools, including pharmacogenomics."

— Turna Ray

PGx & Molecular Dx Notes

Richard Caruso has left Health Discovery's board to launch Smart Personalized Medicine, a firm aiming to develop a breast cancer prognostic test based on Health Discovery's support vector machine technology. The company plans to collaborate with MD Anderson Cancer Center on the test.

Myriad Genetics is conducting a review to consider splitting up its molecular diagnostic business and pharmaceutical business as independent operating entities.

The International Serious Adverse Events Consortium will collaborate with electronic medical records provider Cerner on identifying genetic markers to help predict individuals who are at risk for a range of serious drug-related adverse events.

Datapoint

20
Number of genes XDx's FDA-cleared AlloMap uses as biomarkers for rejection probability in heart transplant patients

Funded grants

$494,460/FY 2008
Biomarkers and Outcomes in the Diabetes Prevention Program
Grantee: Ronald Goldberg, University of Miami
Began: May 1, 2008; Ends: Apr. 30, 2011
This award from NIDDK will help Goldberg and his colleagues assess novel biomarkers for diabetes prevention. "This proposal will provide novel information on the disease pathways involved in the development of diabetes," the abstract says, "and thereby create improved opportunities for prediction and methods of treatment in the development of type 2 diabetes and its complications."

$84,205/FY 2008
Compartmental analysis of proteomic biomarkers during intra-uterine infections
Grantee: Peta Grigsby, Oregon Health and Science University
Began: Jun. 13, 2008; Ends: May 31, 2009
Grigsby will study biomarker profiles of intra-amniotic and choriodecidual inoculation with Ureaplasma parvum in a nonhuman primate model. "Complementary in vitro studies will determine the tissue sources and production rates of candidate biomarkers, and address the role of matrix metalloproteinases in the proteolytic cleavage of IGFBP-1," the abstract says.

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