Regenerative medicine access, particularly for rare diseases, remains a highly dynamic environment. Regulators, payers and HTAs are in the early learning curve, but HTAs are continually increasing their requirements. This means the cost of development will increase to address those requirements. The ability to gain fair access conditions will be driven by a robust, evidence-led, development plan and payment model. Therefore, integrating improved trial design combined with earlier inclusion of real world, health economic and patient reported outcome data, supported by a better understanding of the payer dynamic, will be a key competitive advantage. The medical affairs professional plays a pivotal leadership role in orchestrating the plan and the internal stakeholders contributing to it. In this plenary session, senior medical affairs leaders from the pharmaceutical industry and experts from the GenEra Consulting team will offer guidance on the regulator vs payer gap and describe how medical affairs professionals can develop and execute an integrated evidence and value strategy to meet market needs.
March 23 @ 09:45
09:45 — 11:15 (1h 30′)
Hyatt Regency New Orleans
Jameel Nazir, Mondher Toumi, Omar Dabbous