nci workshop bethesda, md may 3 – 4, 2012 next-generation dna sequencing as a tool for clinical...
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NCI WorkshopBethesda, MDMay 3 – 4, 2012
Next-Generation DNA Sequencing as a Tool for Clinical Decision-making in
Cancer Patient Management
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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
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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
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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)
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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
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Goals
• Bring together multidisciplinary experts to enhance communication
• Define hurdles• Develop recommendations to overcome
current obstacles
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Agenda/Outcome
• Short talks with question period– Analytic issues– Data analysis/bioinformatics– Clinical/regulatory
• Breakout sessions• Reporting session• Meeting report
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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