Dublin, Ireland (PressExposure) July 17, 2014 -- Robert T. McCormack, Head of Circulating Tumor Cell R&D at Janssen Oncology R&D to give a featured presentation on, "Informing Treatment Decisions with Circulating Tumor Cells: Listening to the Cancer" at the 2014 Biomarker Europe Summit on October 9-10, 2014 in Dublin, Ireland by GTCbio.
Managing therapy for metastatic cancer patients is made difficult by the lack of well-validated biomarkers to guide treatment choices and accurately ascertain their therapeutic efficacy. Moreover, the pathways to develop sufficient clinical evidence to reduce the use of these markers to clinical practice are ill-defined, confusing, or difficult to implement for most diagnostic companies. CTCs were introduced as a clinical research tool ten years ago. Early studies demonstrating a stronger correlation of CTC numbers to tumor biology, rather than the amount of tumor, as is common with many serum tumor markers, heightened interest in CTCs and their potential clinical applications in patient management. Although targeting therapy with CTCs is developing much attention, it remains in the realm of clinical research, owing mostly to the lack of convincing evidence of clinical utility. Conversely, the body of evidence developed for CTC enumeration as an indicator of therapy effectiveness has reached a level in which CTC results can confidently be used to make informed treatment-management decisions. Dr. McCormack's presentation will focus on the decade-long development of this evidence, from concept to clinical use, emphasizing recent phase 3 studies defining the performance and benefit of CTC use in both metastatic breast and metastatic prostate cancers.
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, Robert 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, CellSearch, 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, Clinical 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 Head of Circulating Tumor Cell R&D and Technology Innovation and Strategy for CellSearch within the Janssen Oncology R&D Biomarker group.
GTCbio's Biomarker Europe Summit will address the latest developments in the biomarker arena from discovery to translation to commercialization. Presentations span across multiple disciplines and cover topics such as discovery and validation strategies, the challenges of clinical translation, novel technologies including next-generation sequencing, regulatory and reimbursement issues and companion diagnostics. Scientific data, case studies and discussions will be facilitated by key representatives from pharma, biotech, academia and the public sector.
The Biomarker Summit consists of two co-located conferences:
1) Biomarkers in Drug Discovery & Development
2) Biomarkers in Diagnostics
For more information, please visit http://www.gtcbio.com