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
Presentation Documents
Pharma and biotech teams with established Integrated Evidence Generation Plan (IEGP) processes often find that “having a plan” is not the same as having one that works by being resilient to policy shifts, aligned across functions, and decision-relevant in every key market. 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 & RWE 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:
- Siloed working: how function-led planning sidelines HEOR/RWE until after key evidence decisions - and how to establish HEOR/RWE-led, cross-functional governance and structured working sessions.
- Global-to-local misalignment: why global-first IEGPs miss country-specific requirements such as policy, evidence expectations, and timelines diverge (e.g., US IRA; EU JCA) - and how to build modular plans informed by local intelligence.
- Visibility and usability: how late, inconsistently applied IEGPs become retrospective documents - and how to operationalize a visible, durable working plan used throughout the lifecycle.
Sponsored by Corporate Sponsor, Lumanity
Topic
Organizational Practices