THURSDAY, AUGUST 23
DINNER, 6:30 - 9:00 PM
Leveraging Key Opinion Leaders (KOLs): Building a Bridge Between R&D and Commercialization of Companion and Non-Companion Diagnostics
Peggy Robinson, Vice President, Angle PLC
Charles Mathews, Principal, ClearView Healthcare Partners
Lawrence J. Worden, Principal, IVD Logix
Cabin John
Course Description:
All too often excellent diagnostic technologies languish during the transition from research settings into clinical practice. There is always scientific/technical risk but also a whole host of commercialization challenges that innovators face when bringing products to market including pricing/reimbursement, sales/marketing, clinical validation/evidence development, etc. Fortunately, the same KOLs who can help you conceptualize and develop great products can help you with these things as well. However, this only works if you have a well thought out KOL management strategy. This session will focus on best practices for smoothing the transition from bench to clinical laboratory with specific insights into companion diagnostic technologies.
In this session, we will explore:
- Key considerations for working with KOLs at each stage of the diagnostic life cycle (discovery, development, and commercialization)
- Understanding KOL wants/needs and potential roles
- How to cultivate and maintain a scientific advisory board that plays a positive practical role rather simply filling a general advisory role
- How to identify and map where potential KOLs that are interested in your topic area/technology area
- How to leverage KOLs to support payer coverage/reimbursement for novel assays (do’s and dont’s)
- Insights from pharma. Comparison of Pharma and Dx practices and how to apply the best parts of the pharma’s market development processes when working with a companion diagnostic
Biographies
Lawrence J. Worden, Principal, IVD Logix
Larry consults with clients on the design and implementation of studies, coordinates with the MDxI analytical staff to develop key findings and recommendations, and helps clients integrate these findings into their organizational goals and objectives. He has more than 30 years of experience in the field of medical/scientific market research, including; thirteen years of consulting with CaseBauer, an international business development and research firm specialized in the field of medical devices and diagnostic testing. The firm conducted pioneering work in the development of diagnostic assays and worked with the major IVD manufacturers in the design and development of automated analytical platforms for the clinical diagnostic and research markets; eleven years in medical, biotech, and pharmaceutical marketing research with the Health Industry Manufacturers Association (now AdvaMed), Luning Prak Associates, and IMS Health/Dun & Bradstreet; five years' operating experience with Becton Dickinson Corporate (legislative affairs) and Becton Dickinson Diagnostic Systems (marketing research). Larry has developed syndicated data services for the clinical diagnostic, diagnostic imaging, and medical/surgical markets that have become industry standards. He has authored numerous regulatory compliance manuals for the diagnostic and medical device industries and served as the biomedical industry liaison to the College of American Pathologists’ Workload Recording Committee. He is currently on the Board of Directors of the Diagnostic Marketing Association (DxMA) as the organization’s President-elect.
Charles Mathews, Principal, ClearView Healthcare Partners
Mr. Mathews has worked on a variety of diagnostic reimbursement projects involving the analysis, development, and implementation of coding, coverage, and payment strategies for both emerging and established innovators. This includes involvement in the commercialization of over 100+ different test products in the cancer, diabetes, cardiovascular disease, and infectious disease spaces. These tests range from simple point of care technologies to esoteric molecular approaches involving drug diagnostic combinations. He has knowledge gained by working not only with IVD platform and kit developers but also sole-source laboratories that are pursuing value-based pricing. He also has specific knowledge and expertise in the development of global market access plans for companion diagnostics. Mr. Mathews’ prior experience includes several years of working on health policy issues as a legislative aide on Capitol Hill. He also worked for the government affairs office of a biotechnology company and has worked on a National Institutes of Health sponsored clinical trial focused on genetic testing for Alzheimer’s disease. Mr. Mathews completed his undergraduate work at Colgate University and received a Master’s Degree in Public Policy at Duke University.
Peggy Robinson, Vice President, Angle PLC
Peggy Robinson is leading relationships with US key opinion leaders and responsible for US sales and corporate deals with major pharmaceutical and medtech companies. Prior to joining ANGLE, Peggy was the principal of BioMark Consulting, LLC, a boutique consulting firm focused on business strategies, marketing, strategic alliances, KOL and product development of new technologies, with an emphasis on cancer diagnostics, chronic diseases and companion diagnostics.