1	FDA’s Critical Path Initiative: Opportunities for Metabolomics Richard D. Beger Center for Metabolomics Division of Systems Toxicology National Center for Toxicological Research Jefferson, AR 72079 Richard.Beger@fda.hhs.gov 2^nd Metabolomics Society Meeting Boston, MA June 28, 2005
2	“The views expressed here are those of the author and not necessarily of the U.S. Food and Drug Administration.”
3	Overview FDA’s Critical Path Initiative FDA Critical Path Opportunities Voluntary Genomics Data Submission (VGDS) FDA ArrayTrack software File format for ‘omics’ data submission
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5	Critical Path for Medical Products Explicitly states “applying technologies such as genomics, proteomics, bioinformatics systems, and new imaging technologies to the science of medical product development…provide tools to detect safety problems early, … and lead to new clinical endpoints. Major Opportunity: Bridging biomarkers to permit monitoring of functional pathways, drug efficacy, damage, and damage-response in both preclinical and clinical models.
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9	VGDS Milestones May 2002: First FDA-DIA PGx workshop – Introduction of “Safe Harbor” concept for PGx data submissions November 2003: Release of draft Guidance for Industry: Pharmacogenomic Data Submissions November 2003: Second FDA-DIA PGx workshop – Discussion around biomarkers, voluntary vs. required submissions, first public comments February 2004: Docket for guidance “officially” closed – 35 sets of comments received March 2004: First VGDS received July 2004: First IPRG-sponsor meeting to discuss VGDS
10	VGDS Milestones, cont’d January/February 2005: Interdisciplinary Pharmacogenomics Review Group (IPRG) formally created March 2005: Final Guidance for Industry: Pharmacogenomic Data Submissions published, together with two companion documents detailing the VGDS process and the IPRG March 2005: Genomics at FDA website goes live April 2005: Third FDA-DIA PGx workshop – Looking ahead: translating PGx into clinical trials and clinical practice May 2005: First FDA/IPRG-EMEA/PGWP-sponsor meeting to discuss VGDS March 2006: First panomic submission
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13	What Does the New PG Guidance Do? Introduces a classification for genomic biomarkers Introduces a new data submission pathway to share information with the FDA on a voluntary basis Encourages the voluntary submission of exploratory genomic data Introduces new agency-wide PG review group Interdisciplinary Pharmacogenomics Review Group (IPRG) Clarifies how the FDA will review genomic data submissions
14	What Does the New PG Guidance Not Do? Does not provide information on how to validate genomic biomarkers Does not provide information on how to use genomic biomarker during drug or device development process (scientific vs. regulatory guidance) Does not expand into other “-omics’ areas such as proteomics or metabolomics Does not create new processes for the review of required data submissions
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19	ArrayTrack – Summary
20	VGDS: Clinical submission
21	VGDS: Non-clinical Submission
22	VGDS Best Practice document
23	VGDS Best Practice document: Metabolomics Section
24	VGDS Best Practice document for Metabolomics
25	Acknowledgements Array Track Megan Cao Steve Harris Hongmei Sun Hong Fang Qian Xie Feng Qian Jie Wu Huixiao Hong Roger Perkins