Development of techniques to analyze biological specimens for biomarkers of disease or therapeutic response. Results of OR's project will support CVM's ONADE in establishing/evaluating efficacy claims for new animal drug applications. The data generated will be used in the review and evaluation of the efficacy of new and existing veterinary therapeutics. In vivo diagnosis of several diseased states relies on the use of biomarkers, which are substances produced in the body used to examine specific aspects of one's health. Here, the Office of Research is evaluating biomarkers of inflammation of the goat mammary gland. A proteomic analysis, which is the study of proteins, of milk from the mammary glands of infected goats would provide a preliminary assessment of the properties and specificity of biomarkers that could successfully be used to develop treatments for mastitis. ON TRACK ON TRACK 1. Initiate research protocol to further investigate protein biomarkers of mastitis 5/31/2010 Completed 5/31/2010 2. Initiate animal phase of study to determine biomarkers of inflammation 8/12/2010 Completed 8/12/2010 3. Initiate investigation of genetic biomarkers of inflammation 11/30/2010 Completed 10/1/2010 4. Initiate the study of protein biomarkers of inflammation 1/31/2011 Completed 11/1/2010 5. Develop general approaches and analytical techniques for proteomic analysis of complex biological matrices 12/30/2010 Completed 12/30/2010 6. Complete identification and data of protein biomarkers of inflammation in the goat mammary gland 1/31/2012 <i>(12/30/2011)</i> <i>(1/31/2013)</i> Completed 9/24/2012 7. Publish manuscript 12/30/2011 <i>(4/30/2012)</i> <i>(12/30/2012)</i> <i>(1/31/2013)</i> Delayed 8. Provide CVM reviewers with biomarker response patterns data that may be used by industry to support anti-inflammatory claims for new veterinary drugs 5/30/2012 <i>(12/30/2012)</i> Completed 11/2/2012 9. Provide expert consultation to CVM reviewers for evaluation or proteomic data submitted in support of new animal drug applications 5/30/2012 <i>(12/30/2012)</i> Completed 11/2/2012 The dates in italics under the milestone due dates are modified due dates which had to be updated due to real-time delays. The milestone status reflects the modified dates. biomarkers measurable characteristics that indicate the transition between biological states (i.e. healthy or diseased) In vivo in the living organism ONADE Office of New Animal Drug Evaluation mastitis inflammation of breast tissue proteomic analysis the study of proteins http://www.fda.gov/AboutFDA/Transparency/track/ucm203425.htm FDA-TRACK CVM Dashboard http://www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarianNewsletter/ucm222136.htm OR on the Cutting-Edge of Research - Biomarkers ਍††਍਍਍਍਍਍਍