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Robert McCormack,
Vice President Scientific and Medical Affairs Veridex (a Johnson & Johnson compnay) Dr. McCormack received his B.S. degree in medical technology from the University of Wisconsin, River Falls, and his M.S. and Ph.D. degrees from the University of Minnesota in hematology and immunology, respectively. His early career was spent in genetic, molecular, and cellular research at the University of Minnesota, 3M, and Hybritech. He transitioned to clinical and regulatory affairs at Hybritech and was part of the team that successfully gained FDA approval for PSA in the early detection of prostate cancer. In 1995 he joined Sanofi Diagnostics Pasteur as Director of Clinical and Regulatory Affairs, and Worldwide Group Leader for cancer diagnostics. He joined Johnson & Johnson in 1998 as Vice President of Clinical Affairs for Ortho-Clinical Diagnostics. Under his direction, Ortho-Clinical Diagnostics became the first diagnostics company to gain FDA approval for hepatitis assay testing on random access automation for clinical laboratories. In 2001, Raobert was appointed General Manager of the Cellular Diagnostics Group at Veridex, LLC, a Johnson & Johnson start-up dedicated to the development and commercialization of novel cancer diagnostic tests. The Cellular Diagnostics Group successfully launched their first product in 2004 for the detection and enumeration of circulating tumor cells in patients with metastatic breast cancer. In 2005 he assumed the role of Vice President of Scientific and Medical Affairs at Veridex, and his group successfully conducted clinical trials to launch the first molecular test for assessing axillary nodal status in women diagnosed with breast cancer. Robert is currently Director of Technology Assessment focused on novel cellular and molecular cancer technologyAppearing: DAY 2 WEDNESDAY 22 SEPTEMBER – IMPROVING PRE-CLINICAL & EARLY DEVELOPMENT 10.30am Panel discussion: strategies for development, approval and reimbursement of cancer diagnostics in conjunction with targeted therapies
- The challenge: both the diagnostic and the drug must be approved and reimbursed.
- Considering the options for pharma companies in diagnostic development – internal development, external partnerships or outsourcing?#
- Strategies for overcoming regulatory and reimbursement concerns – who needs to make the initial investment? What are the regulatory considerations? Who ultimately pays for a diagnostic test?
Vice President Pharma Business Development,
QIAGEN President Molecular Diagnostics,
Abbott Molecular Senior Director and Global Head of Diagnostics,
Pfizer Global R&D Robert McCormack, Vice President Scientific and Medical Affairs,
Veridex (a Johnson & Johnson compnay) 11.40am Incorporating circulating tumor cells in drug discovery and development
- The introduction of the first automated system for detecting and enumerating rare CTCs in peripheral blood has opened the potential of CTCs for both clinical and research applications at a global level.
- Capabilities now include protein and molecular characterisation of captured tumor cells and use in target discovery.
- Advantages and advances and incorporating CTCs into drug discovery, development and clinical trials.
Robert McCormack, Vice President Scientific and Medical Affairs,
Veridex (a Johnson & Johnson compnay) |
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Conference:
Day 1
September 21, 8:30am - 5:30pm
Day 2
September 22, 8:30am - 5:30pm
Day 3
September 23, 9am - 5:30pm
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