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Pharmacogenomics Update RCRIM TC Philip M. Pochon Covance Enterprise Architecture

Pharmacogenomics Update RCRIM TC Philip M. Pochon Covance Enterprise Architecture. History. HL7 Models Single Gene (Genetic Locus) common message element Draft Standard for Trial Use – May 2005 (Revised May 2006) Multiple Gene (Genetic Loci) model common message element

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Pharmacogenomics Update RCRIM TC Philip M. Pochon Covance Enterprise Architecture

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  1. Pharmacogenomics Update RCRIM TC Philip M. Pochon Covance Enterprise Architecture

  2. History • HL7 Models • Single Gene (Genetic Locus) common message element • Draft Standard for Trial Use – May 2005 (Revised May 2006) • Multiple Gene (Genetic Loci) model common message element • Draft Standard for Trial Use – Jan 2007 • Pharmacogenomics Clinical Research Message • Extension of the CDISC/HL7 LAB message • Draft Standard for Trial Use – May 2006 • Clinical Genomics Clinical Practice Message • Piloted in pre-ballot form, June 2006 • CDISC SDTM • Pharmacogenomics domains • Under development

  3. Genetic Locus CMET Structure Expression Data The Genotype and its Alleles Sequence Data Significant Variations Clinical Phenotypes

  4. SDTM Domain Assumptions • CDISC PG Domain Content • Specimen Data • Specimen Preparation Results • Testing Methods • Mainly Derived from RCRIM/CTLAB • CDISC PR Domain • Genetic Results • Interpretation of Results • Links to Scientific databases • Mainly Derived from CG CMETs

  5. CTLABR2 Changes Needed • Inclusion of new genetic LOCI CMET to handle multiple gene tests

  6. FDA Use Issues • Need to Handle Animal and Human Genetic Data • SDTM domains can easily be converted to CDISC SEND domains • No format/message available for the animal observation data • FDA Pilot to include National Center for Toxicology Research (NCTR), which has used Array Track with animal data

  7. Current State • SDTM and HL7 message work well with SNP Probe, Sequence, Electrophoresis and PCR methods (Classic Genetic Method) • Some model fitting work with Gene Expression Array data • Need to continue/expand this work

  8. Next Steps • Vocabulary development • At least for Genetic Methodologies • Implementation Guide for pilot participants • CMET guide updated in draft model • CTLAB Release 1 guide available to be updated • End-to-end pilot projects • Use of • HL7 Pharmacogenomics Message • CDISC SDTM Pharmacogenomics Domains • Pre-Clinical data with CDISC SEND?

  9. Time Lines for 2007 • Q1 • Complete Gene Expression Array Work • Informal Vocabularies Completed • HL7 XML to SDTM mapping completed • Q2-Q3 • Complete Implementation Guide • Execute pilot projects (4+) • Submission and Lab to Sponsor • Q4 • Lessons Learned and Recommendations

  10. Contact Information Philip M. Pochon Covance CLS 8211 SciCor Drive Indianapolis, IN 46214 phil.pochon@covance.com

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