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Evidence Needed to Support the Clinical Utility of Molecular Diagnostics
January 10-11, 2013
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Spacer Evidence Needed to Support the Clinical Utility of Molecular Diagnostics - Agenda


Thursday, January 10, 2013

8:00 - 8:10 Welcome and charge to group Larry Norton
8:10 - 8:45 Keynote Steven Gutman
Long Day's Journey into Night: Molecular Diagnostics and the Quest for Clinical Utility
8:45 - 9:05 Special report Daniel Hayes
Generation of an OMICs-based Tumor Biomarker Test: the Institute of Medicine Recommendations for a Pathway Forward
9:05 - 10:00 Panel discussion Moderator: Richard Schilsky
Walter H. Koch (Roche)
An industry perspective on the development of companion diagnostics

James M. Rae (University of Michigan, Ann Arbor)
Development of a pharmacogenetic predictor

Steven Shak (Genome Health)
Translating omics predictors to different diseases - tailoring technology to the purpose
10:00 - 10:20 BREAK
10:20 - 10:30 Charge for breakout session 1
Define clinical utility in each context, and evidence needed to establish it.
10:30 - 1:00 Breakout session 1
Group A Targeted agents, trial design, intended use
Leaders: Stanley Hamilton, William Barlow, David Carbone
Conference Room A

Group B Targeted agents, trial design, intended use
Leaders: Michael Birrer, Lisa McShane, Mickey Williams
Conference Room B
Group A Intrinsic breast cancer subtypes
Leaders: Matthew Ellis, David Ransohoff, Sheila Taube
Conference Room C1

Group B Ovarian, NSCLC and colorectal gene expression profiles
Leaders: Fred Waldman, Mei Polley, Magdalena Thurin
Conference Room C2
Group A Solid tumors, including functional imaging
Leaders: Tracy Lively, Daniel Sullivan, Gene Pennello
Conference Room G1

Group B Leukemia and lymphoma
Leaders: Jerald Radich, Kouros Owzar, Stephen Hunger
Conference Room G2
1:00 - 2:20 LUNCH
2:20 - 2:30 Charge for breakout session 2
Discuss strategies for collecting the evidence described in session 1.
2:30 - 5:00 Breakout session 2

Meet with the same groups in the same rooms as in the morning.
5:00 - 7:00 Breakout chairs prepare presentations for the morning session

Friday, January 11, 2013
8:00 - 8:15 Announcements and logistics
8:15 - 8:45 Report of assays to guide treatment Michael Birrer
8:45 - 9:15 Discussion
9:15 - 9:30 BREAK
9:30 - 10:00 Keynote James Doroshow
Opportunities and Challenges for NCI in Translating Novel Discoveries to Useful Clinical Tests
10:05 - 10:35 Report of assays to classify tumors Fred Waldman
10:35 - 10:50 Discussion
10:50 - 11:20 Report of assays for monitoring disease status Jerald Radich
11:20 - 11:45 Discussion
11:45 - noon Next steps: Janet Dancey, Barbara Conley

General Information

For conference related questions please contact Julia Lam


Natcher Auditorium
Building 45

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