CONFERENCE SERIES: Biomarkers & Diagnostics
Recorded at: Molecular Medicine Tri-Conference
Digital Course: Roadmap for Accelerating Commercialization of Molecular Diagnostics
About this Product:
This digital course is focused on development of molecular diagnostics as they make their way from biomarker discovery and initial proof of clinical performance through to commercial launch, partnership delivery, and market development. The course will emphasize identification of critical hurdles that when addressed properly, can materially accelerate progress. Vital areas to be covered include product pricing, reimbursement strategies, regulatory pathway decisions, provider engagement and key opinion leader development.
This digital course includes two bonus presentations including: “Deconstructing the Drug Development Process: The New Face of Innovation” and “To the $1,000 Genome — and Beyond”
About this Product:
Over 142 Slides
Individual Copy: $345
Site License: $1380
Agenda At A Glance:
Examples and case studies of molecular diagnostic companies in Europe and North America will be shared to illustrate a real world roadmap including:
Rationale for reimbursement – understanding coverage
Payor engagement priorities and sequence
The linkage of product concept and pricing
Regulatory clearance and navigating claims language
Maximizing clinical study results while addressing evolving evidence demands
Alternative business models to achieve return on investment
William Cook, MBA, Principal, Strategy and Business Development, Clinical Diagnostics, WECA
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 F. Terry, Principal, Pricing & Market Access Practice, Scientia Advisors
Patrick Terry, a Principal at Scientia Advisors, heads the company’s Pricing, Reimbursement & Market Access practice helping firms in therapeutics, diagnostics and medical devices, develop sound reimbursement strategies, implement market access solutions accelerating delivery of products and services, realize maximum clinical impact, and deliver value-based pricing in modern healthcare delivery systems in both North American and European markets.
With over eighteen years of experience in senior leadership positions as an international investor, board member, chairman, and industry representative, for some of the world’s leading life science research and product development companies, Patrick is known worldwide as a research and industry trail blazer. His specialties include applied genomics, stratified genetic medicine, advanced molecular diagnostics, pharmaceutical development, clinical translational medicine, companion diagnostics and intellectual property rights.
Patrick has a deep background working with US and European regulatory agencies, policy groups, health technology assessment organizations, federal and state governments, medical professional societies, trade organizations, advocacy groups, centers for Medicare & Medicaid, and private payer & provider groups.
Prior to Scientia advisors, Patrick co-founded a cutting edge, publicly traded, personalized medicine company, Genomic Health, Inc. [NASDAQ: GHDX], as well as a variety of privately held biotechnology companies. He helped secure nearly a billion US dollars for a number of personalized medicine companies in North American and Europe. He was also instrumental in the creation of organizations which are currently influencing modern healthcare delivery around the world, including the Personalized Medicine Coalition, the European Personalized Medicine Association, and the Coalition for 21st Century Medicine.
Bruce Quinn, M.D., Ph.D., Senior Health Policy Specialist, Foley Hoag, LLP
Bruce Quinn, M.D., Ph.D., who served as Contractor Medical Director for the California Medicare Part B program, is a full time physician executive with Foley Hoag LLP. Dr. Quinn aids clients who face strategic planning issues regarding Medicare coverage and payment matters for advanced technologies and comparative effectiveness issues.
Dr. Quinn 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. One area of his expertise focuses on the emerging 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, Dr. Quinn was an executive in the Health & Life Sciences division of Accenture and was a clinician-scientist at Northwestern University School of Medicine, leading pathology research for Northwestern’s NIH-funded Alzheimer Research Center. He also held academic positions at New York University School of Medicine and UCLA Center for Health Sciences.
This digital course includes two bonus presentations including: “Deconstructing the Drug Development Process: The New Face of Innovation” delivered by Kenneth Kaitin, Ph.D., Director, Tufts Center for Study of Drug Development and “To the $1,000 Genome — and Beyond” delivered by Kevin Davies, Ph.D., Author, The $1,000 Genome; Editor-in-Chief, Bio-IT World. These two talks were presented as part of the Plenary Keynote at the Molecular Med Tri-Conference.
Deconstructing the Drug Development Process: The New Face of Innovation
Kenneth Kaitin, Ph.D., Director, Tufts Center for Study of Drug Development
For over 30 years, the Center for the Study of Drug Development at Tufts University has documented the increasing challenge of bringing new pharmaceutical products to market. To succeed in today’s competitive marketplace, research-based drug and biotech companies must not only maintain their focus on R&D efficiency and output, but they must also be able to adjust to a rapidly changing and highly volatile R&D environment. In this presentation, Dr. Kaitin will use Tufts CSDD data to document the current status of pharmaceutical R&D and explore new models of innovation.
To the $1,000 Genome — and Beyond
Kevin Davies, Ph.D., Author, The $1,000 Genome; Editor-in-Chief, Bio-IT World
The field of genome analysis has undergone a revolution in recent years. Next-generation sequencing technologies have dropped the cost of sequencing a human genome from about $1 million in 2007 to less than $10,000 in 2010, with new third- and fourth-generation technologies on the horizon. But will the arrival of the $1,000 genome have any meaningful impact on drug development and the practice of medicine? Kevin Davies, author of The $1,000 Genome will share his observations on the landmarks in next-generation sequencing. He will also highlight the challenges that remain in next-gen data generation, analysis and dissemination for the research and medical communities.
About the Conference:
The one scientific event for cutting-edge research, trends and analysis. The future holds great promise for molecular medicine, however the demand for results today is ever mounting, from both patients and businesses alike. The Molecular Med Tri-Con is the place to find the tools to turn ‘someday’ into ‘now’. ATTEND. DISCOVER. APPLY.
Molecular Med TRI-CON 2011 – a LIFE changing event