Members Forum: Integrated Evidence Planning to Accelerate Market Access

In this session, Eileen Mihas, Head of the Center for Patient Engagement at MDIC, will dive into MDIC’s EFS Explorer, including how the tool can improve site identification and readiness, increase transparency around site capabilities and operational considerations, and support more efficient study start-up.

Pablo Morales, MD, Chief Medical Officer, will build on that foundation with a discussion of integrated evidence planning across Regulatory, Clinical, Health Economics & Outcomes Research, and Commercial teams. Topics will include defining a cross-functional Target Evidence Profile that meets the needs of regulators, payors, providers, and patients; leveraging EFS to begin integrated evidence planning earlier in the product lifecycle; and using real-world data and lifecycle evidence generation to reduce redundancy, avoid delays, and accelerate reimbursement and adoption.

• Moving beyond siloed development by aligning Regulatory, Clinical, Health Economics & Outcomes Research, and Commercial teams around a unified evidence strategy
• Defining a cross-functional “Target Evidence Profile” that meets the needs of regulators, payors, providers, and patients
• Leveraging Early Feasibility Studies (EFS) as an opportunity to begin integrated evidence planning earlier in the product lifecycle, including consideration of clinical, regulatory, operational, patient, and downstream market-access needs
• Utilizing existing EFS resources and best practices to strengthen study planning and execution, reduce avoidable operational delays, and support more efficient progression from early feasibility through pivotal development and commercialization
• Highlighting the role of the EFS Explorer in improving site identification and readiness, increasing transparency around site capabilities and operational considerations, and supporting more efficient study start-up
• Leveraging real-world data and lifecycle evidence generation to reduce redundancy, avoid delays, and accelerate reimbursement and adoption