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CONFERENCE SERIES: Biomarkers & Diagnostics

Recorded at: Next Generation Dx Summit

Digital Course: Roadmap for Accelerating Commercialization of Molecular Diagnostics 


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About this Product:
This course is focused on the development of molecular diagnostics as they make their way from biomarker discovery and initial proof of clinical performance through to commercial launch and market development. The course emphasizes identification of critical hurdles that when addressed early, can materially accelerate progress. Vital areas that are covered include reimbursement strategies, regulatory path decisions, physician education and key opinion leader development. A case study of an early stage molecular diagnostics company is shared to illustrate a real world roadmap including:

  • Rationale for reimbursement – understanding coverage
  • FDA clearance and navigating claims language and timing
  • Maximizing clinical study results while addressing costs

William Cook, MBA, Principal, Strategy and Business Development Clinical Diagnostics, WECA
Patrick Terry, CEO, Applied Clinical Genomics, Technic Solutions, LLC
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP


William Cook, MBA, Principal, Strategy and Business Development Clinical Diagnostics, WECA
William Cook Bill Cook has over 30 years experience bringing a strong scientific and commercial background to succeed in translating technology into value added business opportunities; driving diagnostic products from inception through to successful commercial launch in the global market. Bill formulates and implements diagnostic roadmaps to address valuation, regulatory, medical economics, guidelines, reimbursement, clinical studies, key opinion leader, manufacturing, distribution and education with the successful launch of diagnostics in oncology, cardiovascular, infectious and related disease fields, worldwide.

Bill is Principal at WECA, consulting with companies in commercialization of new diagnostics and other novel technologies. Clients include Aviir, Cepheid, Cortex, diaDexus, Diagnocure, GlycoTech, Genentech, Geron, Lab Corp, Kyokuto Pharmaceutical, Lipomics, Mitsubishi, Pathogenica, Toray and UCSF/UCB.

Prior as VP Molecular Diagnostics, Affymetrix, Bill formulated new opportunities for the global diagnostics program. As VP, Strategy and Business Development at Applied Imaging Corp., Bill championed commercialization of cellular imaging systems, the circulating tumor cell initiative as well as the sale of the company. Bill held senior level management positions with diaDexus, Inc. where his relationship management culminated in the highly successful launch of the PLAC® test for assessing cardiovascular disease risk. Prior to this, Bill held various management positions with Chiron, where he built a $40mm global oncology diagnostics business, Ciba Corning, Shell Oil’s Triton Biosciences and Beckman Coulter with responsibility for worldwide market development, technology assessment, strategic alliances and commercialization.

Bill holds an MBA in International Marketing from National University, San Diego, and a BS in Microbiology from California State University, San Diego with courses at Columbia University and UCLA. He is an invited speaker at industry events

Patrick Terry, CEO, Applied Clinical Genomics, Technic Solutions, LLC
Patrick Terry Patrick F. Terry:  a serial entrepreneur, having founded a series of innovative philanthropic, research, and commercial organizations based on the life sciences, applied technology, and social-network theory. In 2000, he and a group of leaders in the fields of genomics, bioinformatics and biotechnology founded Genomic Health, Inc., a pioneering personalized medicine company based in California. He has been involved with founding numerous other biotechnology companies over the last few years.  He is actively involved with the next generation of precision medicine companies across the human disease and technology spectrum here in North America and Europe.   He has experience doing hands-on bench science, coordinating human genetics research, conducting biomedical research, delivering medical innovations to patients, and manages multiple life science patents. 
He has received many honors and awards in the business and scientific communities in the U.S. and internationally.  He has dedicated his career to helping people and advancing a patient-centered perspective in research, product development, and translational medicine.

Patrick is the Founder:  Genomic Health, Personalized Medicine Coalition, PXE International, Genetic Alliance BioBank, BioLogos Foundation, Technic Solutions, European Personalized Medicine Association, Coalition for 21st Century Medicine, and GRAND Therapeutics

Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag LLP
Bruce Quinn Bruce Quinn, M.D., Ph.D., MBA, who served as the Contractor Medical Director for the California Medicare Part B program, currently practices within the Foley Hoag's Government Strategies practice, where he focuses on Medicare coverage and payment matters for new technologies.

Bruce is a national leader in the areas of Medicare coverage and payment, claims and billing, and Medicare contractor reform processes. Dr. Quinn works with companies, providers and venture capital investors to develop strategies for Medicare payment for new technologies. A large part of this work is on local and national coverage decisions. Bruce focuses, in particular, in the rapidly evolving field of molecular diagnostics and personalized medicine. He also advises clients on Medicare Administrative Contractor (MAC) reform and its effect on payment policy.

Before serving in the Medicare Part B program, Bruce was a physician executive in the Health & Life Sciences division of Accenture and was a clinician-scientist at Northwestern University School of Medicine. He also held academic positions at New York University School of Medicine and UCLA Center for Health Sciences.

About this Product:
3 Presentations
Over 192 Slides
172 Minutes
Single Copy $345
Site License $1380

About the Conference:
The Next Generation Dx Summit (Enabling Point-of-Care Diagnostics, Trends in Cancer Diagnostics, Molecular Diagnostics for Infectious Disease, and Co-Development of Drugs and Diagnostics) is designed to bring together all of the major players in the Molecular Diagnostics arena. We assemble an impressive faculty of speakers from industry, government, and the leading academic institutions.  This meeting showcases advances in technology, research and diagnostic development, with an emphasis towards application, to meet the demands of the clinic.  Plan to attend next year’s event and network with key players in the industry who are driving rapid change.

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