Validating biomarkers for effective drug development

Affiliations of authors: ST-Consulting, Glen Echo, MD (SET); Biostatistics and Data Management, Array Biopharma, Inc, Boulder, CO (GMC); Ontario Institute for Cancer Research, Toronto, ON, Canada (JED); Biometric Research Branch, National Cancer Institute, Bethesda, MD (LMM); CCS Associates, Mountain View, CA (CCS); College of Medicine, University of Central Florida, Tampa, FL (SIG) Affiliations of authors: ST-Consulting, Glen Echo, MD (SET); Biostatistics and Data Management, Array Biopharma, Inc, Boulder, CO (GMC); Ontario Institute for Cancer Research, Toronto, ON, Canada (JED); Biometric Research Branch, National Cancer Institute, Bethesda, MD (LMM); CCS Associates, Mountain View, CA (CCS); College of Medicine, University of Central Florida, Tampa, FL (SIG) Affiliations of authors: ST-Consulting, Glen Echo, MD (SET); Biostatistics and Data Management, Array Biopharma, Inc, Boulder, CO (GMC); Ontario Institute for Cancer Research, Toronto, ON, Canada (JED); Biometric Research Branch, National Cancer Institute, Bethesda, MD (LMM); CCS Associates, Mountain View, CA (CCS); College of Medicine, University of Central Florida, Tampa, FL (SIG) Affiliations of authors: ST-Consulting, Glen Echo, MD (SET); Biostatistics and Data Management, Array Biopharma, Inc, Boulder, CO (GMC); Ontario Institute for Cancer Research, Toronto, ON, Canada (JED); Biometric Research Branch, National Cancer Institute, Bethesda, MD (LMM); CCS Associates, Mountain View, CA (CCS); College of Medicine, University of Central Florida, Tampa, FL (SIG) Affiliations of authors: ST-Consulting, Glen Echo, MD (SET); Biostatistics and Data Management, Array Biopharma, Inc, Boulder, CO (GMC); Ontario Institute for Cancer Research, Toronto, ON, Canada (JED); Biometric Research Branch, National Cancer Institute, Bethesda, MD (LMM); CCS Associates, Mountain View, CA (CCS); College of Medicine, University of Central Florida, Tampa, FL (SIG) Affiliations of authors: ST-Consulting, Glen Echo, MD (SET); Biostatistics and Data Management, Array Biopharma, Inc, Boulder, CO (GMC); Ontario Institute for Cancer Research, Toronto, ON, Canada (JED); Biometric Research Branch, National Cancer Institute, Bethesda, MD (LMM); CCS Associates, Mountain View, CA (CCS); College of Medicine, University of Central Florida, Tampa, FL (SIG) A workshop sponsored by the National Cancer Institute and the US Food and Drug Administration addressed past lessons learned and ongoing challenges faced in biomarker development and drug and biomarker codevelopment.Participants agreed that critical decision points in the product life cycle depend on the level of understanding of the biology of the target and its interaction with the drug, the preanalytical and analytical factors affecting biomarker assay performance, and the clinical disease process.TB drug clinical development programs take a minimum of six years to complete -- far longer than most trials for other infectious diseases.New drugs and drug combinations must prove safe for human use, and they must demonstrate their efficacy against , which requires months of treatment.For example, HIV/AIDS drug development was revolutionized by the validation of biomarkers like viral load and CD4 counts, which reliably predict success of treatment and allowed for a dramatic reduction in the duration of clinical trials.Biomarkers will help streamline clinical development of new TB cures.

Such work is ideally suited to precompetitive research and public–private partnerships, and this has been recognised within the Innovative Medicines Initiative (IMI), a Joint Undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, which has initiated projects in the areas of drug safety, drug efficacy, knowledge management and training. In 2010, the TB Alliance received a grant from the United States Food and Drug Administration to establish a Consortium for Tuberculosis Biomarkers (CTB), comprised of the TB Alliance, CDC's TB Trials Consortium (TBTC), and NIAID's AIDS Clinical Trials Group (ACTG). CDC TB Trials Consortium and the AIDS Clinical Trials Group of the U. NIAID, NIH, to identify biomarkers for TB, which can dramatically speed the time and decrease the cost of clinical trials for new TB drugs.New imaging and bioassay technologies are providing the basis for developing biomarkers that will facilitate development of these molecularly targeted drugs.Biomarkers may be used in early drug development to elucidate the mechanism of action of a drug and provide preliminary evidence of its effect.

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