Session Abstract – PMWC 2020 Silicon Valley


Reimbursement of diagnostic tests are a core component of Precision Medicine. Convincing payers of the medical necessity of a new diagnostic test can be challenging. Timely access for patients with the most compelling unmet needs requires the reimbursement environment transition to a transparent value-based model using fit-for-purpose levels of evidence.

 Session Chair Profile

Ph.D., Independent consultant in Translational Sciences

Biography
John is a biotechnology translational medicine consultant with a comprehensive and deep understanding of the development and application of pioneering molecular procedures to the translation of research-grade biomarker assays into clinical-grade clinically adopted diagnostic tests. John oversaw the translation of an early stage research Next Generation sequencing test to a US government reimbursed and now widely adopted Laboratory Developed CLIA-CAP test for transplanted kidney rejection. He advises commercial translation efforts at Stanford University (SPARK) and University of California in San Francisco (CATALYST).


 Speaker Profile

M.D., Ph.D., Principal, Bruce Quinn Associates LLC

Biography
Dr. Bruce Quinn is an expert on health reform, innovation, and Medicare policy. A pathologist by training, he has worked on a wide range of federal health policy issues ranging from biopharma to genomics. After a career in academic medicine, he was a physician executive with Accenture, serving clients in both the biopharma and payer industries. After a stint as an executive with Medicare, he has been a full-time life sciences strategy consultant, serving clients of two major law firms, Foley Hoag LLP and Faegre Baker Daniels LLP. Since 2017, Dr. Quinn manages his own Medtech and biopharma consulting practice based in Los Angeles and San Francisco. His blog, Discoveries in Health Policy, current logs over 100,000 hits per year. Dr. Quinn has helped leading companies in both medical device and genomics negotiate with CMS agency on coding, coverage, and policy issues.


 Speaker Profile

Ph.D., Chief Scientific Officer, Covance, Sr VP, LabCorp

Biography
Dr Anderson has been with the LabCorp organization for 26 years and has held a variety of positions including director of operations for ViroMed Laboratories, director of operations for Monogram Biosciences, director of operations for the Center for Molecular Biology and Pathology, director of operations for Integrated Oncology and Genetics, national director of Research and Development, and global head of LabCorp Clinical Trials. Dr Anderson is a member of a variety of professional societies including the American Association for Cancer Research, the American Society of Clinical Oncology and the Association for Molecular Pathology. Dr Anderson’s research interests are in the development and applications for molecular diagnostics, including several examples of companion diagnostics and pharmacogenomics assays. He has authored more than 175 articles and abstracts published in such journals as Genetics, Proceedings of the National Academy of Sciences, Clinical Chemistry, the Journal of Infectious Disease, Human Pathology, American Journal of Obstetrics and Gynecology, Oncogene, the Journal of the National Cancer Institute, Clinical Cancer Research, Breast Cancer Research, BMC Cancer, the Journal of Molecular Diagnostics, Archives of Pathology and Laboratory Investigation and Expert Reviews in Molecular Diagnostics.


 Speaker Profile

M.D., Ph.D., Medical Director, MolDX; Chief Medical Officer, Palmetto GBA

Biography
Dr. Bien-Willner is the Medical Director of the MolDX program at Palmetto GBA, a Medicare Administrative Contractor (MAC). MolDX seeks to understand the molecular testing landscape to implement payer controls, coverage, and to set policy for affiliated MACs, which currently cover 28 states. He is a leader in the Precision Medicine space and practices as a Board-certified Anatomic Pathologist and Molecular Genetic Pathologist. Throughout his career, he has been active in research, development, and advancement of molecular diagnostic services, specifically next generation sequencing. He has worked closely with clinicians to develop clear clinical diagnostic and treatment pathways directing Precision Medicine programs for community cancer centers. Dr. Bien-Willner received his MD and PhD degrees from Baylor College of Medicine, with a PhD in Human Molecular Genetics. He completed his residency, fellowship, and attained a faculty appointment at Washington University in St. Louis prior to leadership roles in laboratory and biotech companies before joining Palmetto GBA.


 Speaker Profile

Director, Payment Policy Research and Analytics, Association of American Medical Colleges

Biography
Susan Xu is an expert on payment policy with 10+ years of experience in analyzing a wide range of Medicare payment systems, including inpatient, outpatient, and physician payment systems, pay for performance programs, and alternative payment models. At the Association of American Medical Colleges, she helps large academic medical centers better understand the changing reimbursement environment and the financial impact on their operation. She also collaborates with peer organizations and interfaces with government agencies to address various policy issues. Her policy experience also includes advising diverse health industry stakeholders about their policy, reimbursement, and regulation concerns at a health policy consulting firm and working on Medicaid payment issues at a state hospital association. Before launching her career into health policy, she worked in the field of biomedical engineering as a research scientist and also as a magazine journalist.