This session will provide an analysis of the IRA and its anticipated impact on novel therapeutics and regenerative medicines, particularly in the areas of R&D, pricing, and market access.

Panelists will explore the opportunities and challenges which the IRA presents for these novel biopharmaceutical treatments with a specific focus on the CMS’s role in approvals and reimbursement. Topics of discussion will include:

• An analysis of the key IRA provisions that pertain to novel therapeutics and regenerative medicines
• How the IRA influences R&D tax credits, grants, and other funding sources that could affect investment in these therapies
• Medicare drug price negotiation and the potential impact on the economic models for novel therapy development
• The implications of CMS formulary coverage for the development of novel therapeutics and regenerative medicines
• How changes in reimbursement policies may alter the pathway to commercialization
• The impact of the IRA on small startups versus large companies