Implementing Precision Medicine: Diagnostics Policy Considerations for Biopharmaceutical Innovators

The precision medicine landscape has experienced significant evolution in the past ten years, evolving from single gene assays to complex next-generation sequencing panels. During this period, the access landscape has evolved significantly, emerging from a traditional access environment with relatively few inputs to an exceedingly complex environment, with policy initiatives playing an increasingly pivotal role.

Recent and proposed changes to the policy environment directly affect market access for advanced diagnostics. These changes include but are not limited to:

• Medicare’s date of service policy
• Medicare’s national coverage determination for next-generation sequencing
• Federal legislative initiatives, including the VALID Act and VITAL Act
• FDA guidance, including class-based companion diagnostic labeling

The experts from Boston Healthcare Associates routinely leverage their expertise in precision medicine and policy to support diagnostic and biopharmaceutical clients as they navigate the policy environment. In this webinar, participants will learn about the need for diagnostics policy monitoring and engagement to support development and access for precision medicines.

Speakers

Joseph Ferrara, President and CEO, Boston Healthcare

Joe Ferrara has over 20 years of experience in life sciences consulting, working with biopharmaceutical, medical device, diagnostics and health care IT clients in market and business development strategy. He leads the global consulting team with practice areas in reimbursement and pricing, health economics, market analysis, and business development strategy. He has extensive experience in the development of novel business approaches designed to capture evidence-based value for innovation health care technologies. Ferrara writes and speaks extensively on the value of medical technology innovation, with particular focus on precision medicine, advanced diagnostics, and oncology informatics. Ferrara completed undergraduate studies at the University of Cincinnati and received his master’s degree from Harvard University.

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Adam Crowther, Senior Manager, Boston Healthcare

At Boston Healthcare, Adam Crowther contributes policy analysis and strategy development focusing on coding, coverage and payment for advanced diagnostics.  In his work, Crowther supports diagnostics innovators and pharmaceutical companies on US policy issues.  Crowther also leads Boston Healthcare’s internal policy monitoring activity, including monitoring of Medicare proposed and final rules, updates to private payer policies, and coding updates. Crowther holds a BA in History and Political Science from Denison University, and a Master’s in Public Policy from Duke University.

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