How does an evidence strategy hold up once policy, pricing rules, or legislation shift after the plan is already in motion.
The panel, "Evidence And Access Strategies That Hold Up Under Policy Pressure," runs Wednesday, September 16, in Room 122B. It brings together representatives from Viatris, AstraZeneca, Gilead and Novellia, a lineup spanning real-world evidence and outcomes research, franchise-level medical affairs, cross-portfolio market access, and the data side of evidence generation.
Diana Morgenstern leads real-world evidence and outcomes research at Viatris and will moderate the discussion.
Alan Yong oversees U.S. Medical Affairs for AstraZeneca's hematology and cell therapy franchise.
Harpreet Sandhu previously served as Executive Director of Market Access Strategy at Gilead, working across the company's full portfolio.
Shashi Shankar is co-founder and CEO of Novellia.
The panelists plan to cover four areas: how policy, pricing, and legislation shape strategy long before a product launches; how Medical Affairs and Government Affairs teams can align early enough to anticipate risk and inform evidence plans while they're still being built; how evolving regulations are changing what counts as sufficient evidence and what stakeholders expect to see; and how companies coordinate a cross-functional response when conditions shift faster than any single function can track alone.
Medical Affairs organizations have absorbed more of this risk in recent years. Evidence plans that once assumed a stable regulatory and pricing environment increasingly have to account for the ground shifting mid-plan. That puts VPs of Medical Affairs in the position of defending a strategy under conditions that haven't been set yet, a different problem than defending one built against a known target.
The session runs 1:15 to 1:55 PM on September 16 in Room 122B. Novellia will also host a booth, #1510, near the Medical Affairs Lounge.
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