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2	Context Critical Path Initiative http://www.fda.gov/oc/initiatives/criticalpath Inter-Agency Oncology Task Force http://0-www.fda.gov.lilac.une.edu/oc/initiatives/reports/priorities2004.html Oncology Biomarker Qualification Initiative http://www.fda.gov/bbs/topics/news/2006/NEW01316.html http://www.fda.gov/oc/mous/domestic/FDA-NCI-CMS.html
3	Critical Path Initiative
4	Critical Path Approach Recognize an unanticipated slowdown in development and delivery of new products. Need for new toolkits for evaluation and standards in safety, utility and manufacturing. Biomarkers a prominent part of the strategy for change.
5	Critical Path Opportunities
6	Opportunities Topics Better Evaluation Tools Streamlining Clinical Trials Harnessing Bioinformatics Manufacturing Devices Developing Products to Assess Urgent Public Health Needs Specific At-Risk Populations -- Pediatrics
7	Biomarker Opportunities Biomarker Qualification and Standards Qualifying Disease and Disorder-Specific Biomarkers Cancer Markers of Disease Progression in Prostate Cancer Drug Targets as Critical Path Tools – Cancer Therapies Safety Biomarkers
8	Inter-Agency Oncology Task Force
9	Oncology Biomarker Qualification Initiative
10	Four Key Areas Standardizing and evaluating imaging technologies… Developing scientific bases for diagnostic assays to enable personalized treatments… Instituting new trial designs to utilize biomarkers… Pooling data to ensure that key lessons are shared from one trial to another…
11	OBQI Process
12	OBQI Key Features Public-Private Consortium A biomarker validation and translation program; not a discovery program Requires sharing of information, with protection of pre-existing IP and broad public dissemination of new IP Reach larger goals through specific projects Need scientific proposals and more partners
13	OBQI Contacts Your Industry Association FDA OC – Dr. Wendy Sanhai wendy.sanhai@fda.hhs.gov Critical Path Institute – Jeff Jacob JJacob@c-path.org