4th US FDA-Drug Information Association pharmacogenomics Workshop, held 10–12 December, 2007

Medco Health Solutions Inc., 14401 Falling Leaf Drive, Gaithersburg, MD 20878, USA.
Pharmacogenomics (Impact Factor: 3.22). 02/2009; 10(1):111-5. DOI: 10.2217/14622416.10.1.111
Source: PubMed


The 4th US FDA/Industry workshop, in a series on Pharmacogenomics, was on 'Biomarkers and Pharmacogenomics in Drug Development and Regulatory Decision Making' and was held on December 10-12, 2007 in Bethesda, MD, USA, with clear objectives to continue the dialogue that began in 2002 for enabling the use of biomarkers and pharmacogenomics in drug development and regulatory decision-making. This brief commentary will highlight the major topics and outcomes discussed at this meeting that was jointly sponsored by the FDA, The Pharmacogenomics Working Group (PWG), The Pharmaceutical Research and Manufacturers of America (PhRMA), The Biotechnology Industry Organization (BIO) and The Drug Information Association (DIA).

Download full-text


Available from: Larry Lesko, Aug 22, 2014
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: While pharmacogenetics - the correlation of genotype and response to medicines - currently has a small but measurable impact on the prescribing practice of clinicians, the advent of the ;personal genome' is likely to change this significantly. Advances in high-throughput technologies aimed at characterizing human genetic variation, including chip-based genotyping and next-generation sequencing, are poised to provide a flood of information that will affect both pharmacogenetic discovery and pharmacogenetic application in clinical practice. In order for this flood of information to not overwhelm both researchers and clinicians alike, a variety of new and expanded information management tools will be needed, including electronic medical records, bioinformatic algorithms for analyzing sequence data, information management systems for storing, retrieving and interpreting whole-genome sequence data, and pharmacogenetic decision tools for prescribers.
    Preview · Article · Nov 2009 · Personalized Medicine
  • [Show abstract] [Hide abstract]
    ABSTRACT: The past decade of pharmacogenomics was driven by the sequencing of the human genome to create ever denser maps of genetic variations for studying the diversity across individuals. Today, genotyping technology is available at a fraction of the cost of what it was 10 years ago and many pharmacogenomic variations have been studied in detail. Still, we are only starting to gain an understanding of how pharmacogenomic-guided drug therapy affects clinical outcomes: real-world studies that demonstrate the clinical effectiveness and address the economic implications of pharmacogenomics are needed to help decide when and how to implement pharmacogenomics in clinical practice, how to regulate pharmacogenomic testing and how the healthcare system will integrate this new science into an environment of rapidly increasing cost.
    No preview · Article · May 2010 · Pharmacogenomics
  • [Show abstract] [Hide abstract]
    ABSTRACT: This chapter contains sections titled: Introduction Critical Path Initiatives Guidance for Industry Voluntary Exploratory Data Submission (VXDS) Biomarker Qualification Process Labeling and Pharmacogenomics Level of Evidence in Pharmacogenomics and Pharmacogenetics Genetics and Genomic Tests Education and Training Conclusion References
    No preview · Chapter · Aug 2012
Show more