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May 6-7

Companion Diagnostics Assay Development

Tissue and Time: Perspectives on Companion Diagnostic Development

Ron Mazumder, Ph.D., MBA, Global Head, R&D and Operations, Janssen Diagnostics, Janssen Pharmaceutical Companies of Johnson & Johnson

Companion Diagnostics – Immunoassay and Other “Wet” Markers – Method Development and Choice of Platform –Challenges and Considerations

John L. Allinson, FIBMS, Head, Biomarker Strategy, Drug Development Services, LGC Group

Evaluation of PD-L1 as a Potential Companion Diagnostic for Nivolumab, a Novel Immune Checkpoint Inhibitor for the Treatment of Cancer

James Novotny, Ph.D., Group Director, Pharmacodiagnostics, Bristol-Myers Squibb

CDx Development and Commercialization Strategies

Making Disciplined Decisions in Companion Diagnostic Development Using Clinical Epidemiologic Techniques 

Kenneth Emancipator, M.D., Director, Companion Diagnostics, Merck Research Labs

Regulatory Perspective on in vitro Companion Diagnostic Devices

Eunice Lee, Ph.D., Division of Immunology and Hematology Devices, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA

Dollars and Sense: Making the Most of Companion Diagnostics

Steven Gutman, M.D., Myraqa Strategic Advisor, Illumina, Inc.

Talk Title to be Announced

Alan T. Wright, M.D., CMO, Roche Diagnostics Corporation

Partnering Strategies for CDx Development

R&D and External Partnering Approaches to Pharmacodiagnostic Development

George A. Green, IV, Ph.D., Director, Pharmacodiagnostics, Bristol-Myers Squibb

Andrea H. Lauber, Ph.D., Head, Technology Transactions for Clinical Biomarkers, Bristol-Myers Squibb

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