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

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