Integrated Evidence Generation Planning: Why Medical Affairs is a Critical Partner

Area of Science:

• Pharmaceutical Medicine
• Health Economics and Outcomes Research
• Regulatory Science

Background:

• Pharmaceutical companies face increasing pressure to demonstrate therapy value to diverse stakeholders.
• Traditional, siloed evidence generation approaches are insufficient in evolving healthcare systems.
• Integrated Evidence Generation Plans (IEGPs) are emerging as strategic imperatives.

Purpose of the Study:

• To present IEGP development as a collaborative and strategic process.
• To highlight how IEGPs demonstrate the holistic value of new therapies.
• To position Medical Affairs as leaders in IEGP development.

Main Methods:

• Cross-functional collaboration involving Medical Affairs, Market Access, and Clinical Development.
• Alignment of scientific, regulatory, and patient-centered objectives.
• Integration of evidence-generation activities across functions and geographies.

Main Results:

• IEGPs enable comprehensive evidence delivery throughout the product lifecycle.
• Strategic partnerships are vital for understanding evidence needs and achieving differentiation.
• Medical Affairs professionals are well-suited to lead IEGP initiatives.

Conclusions:

• IEGP development is a collaborative process essential for demonstrating therapy value.
• Medical Affairs, in partnership with other key functions, should lead IEGP initiatives.
• Holistic understanding of evidence needs is critical for bringing new medicines to patients.