Commercialization Challenges and Opportunities for Diagnostics in Immuno-Oncology



(October 11, 2017) | Access Today

Sponsored by
Boston Healthcare Associates logo

Preview:  

 

Webinar Description:
The immuno-oncology testing paradigm is increasingly complex, moving beyond PD-L1 analysis via IHC to include mismatch repair, microsatellite instability, tumor mutational burden, and others. Some of the developments may come in the context of regulatory approval of therapies but some may be post-marketing innovations. This is presenting a new host of commercialization considerations and challenges for both drug and test innovators, including balancing test access and quality. There are also important questions about market access and evidence needs for these new tests. In this session we will explore the realities of possible test option and algorithm optimization and out some scenarios for how testing may evolve.

Learning Objectives:

  • Provide overview of developments in immuno-oncology diagnostics
  • Discuss possible challenges/issues with incorporation of a variety of test methods into routine clinical care
  • Highlight different test access, quality demonstration, and evidence development pathways
  • Recognize key reimbursement approaches/considerations for both companion and non-companion tests
  • Review several possible testing pattern scenarios and implications for innovators

Speaker:

Charles MathewsCharles Mathews, MPP
Vice President
Boston Healthcare Associates


Mr. Mathews has worked on a variety of reimbursement projects identifying public and private payer coverage channels, coding options, and pricing and payment possibilities for drugs, diagnostics, and medical devices. His specific area of expertise is in diagnostics, with a focus on value-based pricing for laboratory tests and molecular diagnostics, as well as with global companion diagnostic launch strategies. His experience further includes work with test and platform developers and laboratories, novel medical/surgical devices, drug/diagnostic combinations, and pharmaceutical product launches. Mr. Mathews’ prior experience includes working on health policy as a legislative aide on Capitol Hill. He has also worked for the government affairs office of Genentech and has participated in a National Institutes of Health sponsored clinical trial which focused on genetic testing for Alzheimer’s disease. Mr. Mathews has a master’s degree in public policy from Duke University and completed his undergraduate work at Colgate University.


(October 11, 2017) | Access Today