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Biomarkers- progress in a complex world.

“Must Do ” events for 2007? Clinical Biomarkers Summit, Biomarker World Congress , Biomarker World Asia, Biomarker Discovery Summit, Cancer Biomarkers 2007 -- touting topics like: biomarkers in early drug development, biomarkers in clinical development, clinical biomarkers for go/no-go decisions, biomarkers to monitor response therapy, --even environmental biomarkers. See pharmaceutical taxonomy at http://www.genomicglossaries.com/content/Biomarkers.asp “What’s it all about?”

Looking forward from September 2004, longtime DHHS/FDA/CDER director Lawrence J. Lesko Ph.D. FCP and DHHA/FDA/OC Deputy Commissioner, CMO Janet Woodcock M.D. wrote an article published in “Nature Review” entitled ,”Translation of pharmacogenomics (PGx) and pharmacogenetics (PGt): a regulatory perspective” (Volume 3 September 2004). They shared their perspective that DNA based tests could lead to improvement in drug selection, identifying optimal dosing, maximize drug efficacy or minimize risk of toxicity. Rapid advances in basic research had identified many opportunities for the development of “personalized” treatments for individuals and/or subsets of patients defined by genetic and/or genomic traits. However, the integration of these tests into routine clinical practice remained a major multidisciplinary challenge even for well established biomarkers. (“Biomarker- a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or pharmacological responses to a therapeutic intervention.")
What was the promise of PGx and PGt? the potential to identify sources of inter individual variability in drug responses that affect drug efficacy and drug safety. The identification of PGx biomarkers could lead to the development of PGx tests used to individualize therapy. The authors concluded that PGx and PGt had the potential to revolutionize the drug development process and could help bring a fresh approach to addressing the pipeline problem outlined in the FDA Critical Path white paper (released 3/16/04).

Flash forward: June 1, 2007 NIH News reports on a published study- a blood test that detects proteins commonly released by a growing tumor could one day become a useful tool for monitoring the effectiveness of chemotherapy and radiation treatment in people with advanced throat cancer. The findings could help lead to the development of a blood test that enables doctors to detect the recurrence of throat cancer early on when there is still time to pursue a second line of treatment, such as surgery or drug therapy. It’s the largest long-term study of its kind. http://www.nih.gov/news/pr/jun2007/nidcd-01.htm
FDA/CBER released draft guidelines (1/ 9/07) that contain definitions of key terms about genomic biomarkers-- it represents the FDA's current thinking on this topic.http://www.fda.gov/cber/gdlns/iche15term.htm The definition of what constitutes a genomic biomarker is key to understanding the definitions of PGx and PGt (and might be applicable to proteomics).

“Regulatory agencies, pharmaceutical companies, the clinical community, third party payers, and patient advocacy groups are all interested in strategies that can improve the cost, quality, and time of drug development and reduce risks associated with drug therapy” (Lesko,Woodcock 2004 article).Basic research on biomarkers has not only significantly impacted drug R&D—it has also advanced the area of disease-related biomarkers that are used for disease screening and prognosis—think of biomarkers like blood glucose for diabetes diagnosis and management and cholesterol for cardiovascular risk.

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