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Next-Generation DNA Sequencing as a Tool for Clinical Decision-making in Cancer Patient Management

Next-Generation DNA Sequencing as a Tool for Clinical Decision-making in Cancer Patient Management. NCI Workshop Bethesda, MD May 3 – 4, 2012. Challenges. Rapidly Changing Landscape Pace of technology development Pace of information generation (TCGA, 1000 Genomes)

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Next-Generation DNA Sequencing as a Tool for Clinical Decision-making in Cancer Patient Management

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  1. Next-Generation DNA Sequencing as a Tool for Clinical Decision-making in Cancer Patient Management NCI Workshop Bethesda, MD May 3 – 4, 2012

  2. Challenges • Rapidly Changing Landscape • Pace of technology development • Pace of information generation (TCGA, 1000 Genomes) • Need for larger, diverse research teams • Trial designs • Cost • Regulatory issues

  3. Technology • Genome sequencing has become faster, cheaper • Several platforms already in use • New platforms sequence “deeper”, faster • Produce copious amounts of data • Patients already having sequencing done; presenting data to their clinicians for interpretation and ACTION. • Data on what action is appropriate is sparse

  4. Data Analysis • High dimensional: more data than samples • Few experts: each experiment has “unique” modeling algorithm • Repeatability • Validation (samples, data) • Data integrity (quality assurance, control)

  5. Diagnostic Development: research test to clinical utility Necessary Assay Characteristics • Reproducible (intra and inter lab; ? Inter platform) • Clinically validated in more than one set of appropriate samples • Clinically useful • ?Predictive

  6. Goals • Bring together multidisciplinary experts to enhance communication • Define hurdles • Develop recommendations to overcome current obstacles

  7. Agenda/Outcome • Short talks with question period • Analytic issues • Data analysis/bioinformatics • Clinical/regulatory • Breakout sessions • Reporting session • Meeting report

  8. Meeting Planning: Thanks • Margo Cavenagh • FDA CDRH: • Elizabeth Mansfield • Association of Molecular Pathology • Jane Gibson, Mel Limson, Mary Williams • NCI • Jack R. Collins, Sean Davis, John Jessup, Lisa McShane, Paul Meltzer, Mei Polley, Mark Raffeld, JoyAnn Phillips Rohan, Robert Stephens, Liquiang Xi

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