Moderator
Jonathan Kowalski, MS, PharmD, Lumanity, Ladera Ranch, CA, United States
Speakers
Meena Venkatachalam, BSc, MSc, Lumanity, London, United Kingdom; Chris Leo Pashos, BS, MPP, PhD, Aregenx, Winchester, MA, United States
Pharma and biotech teams with established Integrated Evidence Generation Plan (IEGP) processes often find that “having a plan” isn’t the same as having a plan that is resilient to policy change, aligned across functions, and credible across markets. In this 30-minute session, the speakers will discuss why IEGPs are increasingly critical in today’s evolving global access and policy environment and how well-designed evidence strategies can support credible decision-making across markets.
The session will examine the IEGP lifecycle, from understanding the existing evidence base, to identifying and prioritizing evidence gaps and developing solutions to address these gaps—highlighting where HEOR should guide evidentiary priorities at each step. The discussion will also highlight three common, high-impact pitfalls seen in real-world IEGPs—and practical ways to avoid them:
- Policy blind spots: how failing to anticipate shifts such as the US Inflation Reduction Act (IRA) can derail evidence planning, and how to embed policy horizon scanning and scenario planning into IEGP design.
- Insufficient cross-functional integration: what happens when HEOR input is deprioritized versus Medical Affairs or Clinical, and how to formalize HEOR leadership and run structured cross-functional workshops that translate strategy into payer-relevant evidence.
- Ignoring country-specific nuances: why “one-size-fits-all” global plans break down (e.g., US IRA vs EU Joint Clinical Assessment timelines and evidence needs), and how to build modular IEGPs supported by local intelligence and regional HEOR liaisons.
Sponsored by Corporate Sponsor, Lumanity
Topic
Organizational Practices