This unique training focuses on leveraging patient-centric Real-World Evidence (RWE) to accelerate the patient and market access of innovative and potentially transformative Orphan Medicinal Products (OMPs). Delegates will address the challenge of early market access based on fewer and less mature data, with the creation of an Early Value Proposition and a Patient-Centric Evidence Generation Plan that comprehensively support value demonstration, product positioning, and that meets stakeholders’ requirements.
Who should attend?
C-level executives, Senior business development strategists, Portfolio executives, Pricing and market access executives, Medical affairs executives, Marketing and commercial executives, Patient advocates, Epidemiologists, Outcomes researchers and health economists, Big data and RWE researchers, Clinical and regulatory executives interested in incorporating value and access early in development
- Opportunities and Challenges in Orphan Medicinal Products (OMPs)
- Rare Patient Empowerment & Involvement
- Real-World Evidence (RWE) Throughout the Value Chain
- Real-World Case Examples
- Early Value Proposition and Evidence Generation Planning
- Next-Generation OMP Market Access Strategies
- Why market access opportunities and challenges for OMPs are different from other drugs?
- How to collaborate with patients & caregivers in rare conditions to generate patient-meaningful outcomes?
- Leveraging applications of RWE for pricing and access success and throughout the lifecycle
- To mitigate payer uncertainty by addressing the challenge of early market access with accelerated approvals and fewer clinical data
- How to develop a next-generation market access strategy with a life-cycle full spectrum evidence generation plan that maximizes product value from launch to loss of exclusivity?
- To differentiate and succeed in the increasingly competitive rare disease space with a “fast to patient” approach