May 13, 2014
1 pm to 2 pm EDT

Sponsored by

Webinar Description:

Increasingly the FDA and payers are requesting clinical utility evidence as part of their approval and coverage processes for both CDx and IVDs. Precision will explore the implications of factors for clinical utility evidence development including the type of diagnostic test, regulatory status of the test, inclusion into the associated therapy’s label, and how it will be used to guide decision making. We will take a deeper dive into design features to be considered as you plan your study, to enable integration of regulatory and payer needs. We will explore examples of designs to address both needs and how they can affect the ROI on evidence development.

Learning Objectives:

• To understand the separate US FDA and payer expectations for clinical evidence
• To identify study design features that meet those separate expectations
• To explore overlaps in FDA and payer study designs to develop the clinical evidence
• To discuss the impact of incorporating features of those overlaps on ROI for evidence development

Speaker Information

Judi Smith, M.S., MT(ASCP)
Vice President, In Vitro Diagnostics and Quality
Translational and Regulatory Sciences
Precision for Medicine
www.precisionformedicine.com

David Parker, Ph.D.
Vice President, Market Access Strategy
Precision for Medicine
www.precisionformedicine.com

David Parker, Ph.D., is the Vice President of Market Access Strategy of Precision for Medicine. He has over 25 years experience in the healthcare industry, including 16 years of strategy consulting experience centered on the intersection of reimbursement, health economics, clinical science, and marketing strategy. His consulting encompasses all aspects of reimbursement, market access, and evidence development strategy with a particular focus on personalized medicine, molecular and advanced diagnostics, and medical devices.

Throughout his career, his work has resulted in numerous successful product launches, guided major investment and acquisition decisions, and driven favorable coverage and payment determinations by public and private payers alike. His consulting career was preceded by 11 years of increasingly responsible product and marketing management, strategic planning, and business development roles at biotechnology companies ranging from development-stage to units of Fortune 500 businesses. Dr. Parker is a frequent speaker and the author of peer-reviewed publications and book chapters in the biomedical sciences and health economics.

Dr. Parker received a Ph.D. in Cell and Developmental Biology from the Massachusetts Institute of Technology, where he was a National Science Foundation Fellow, and an A.B. with high honors from Princeton University.

Cost: No cost