Session (CTI)

This breakout session examines how the role of the real-world evidence (RWE) executive is evolving in response to rapid advances in artificial intelligence (AI) and continued skepticism from payers and health technology assessment (HTA) bodies. As AI-enabled tools increasingly automate core evidence-generation activities, RWE leaders must shift from primarily technical execution toward strategic interpretation, governance, and stakeholder engagement. At the same time, coverage, pricing, and appraisal decisions continue to prioritize randomized controlled trial evidence, limiting the influence of RWE. This session will define the emerging RWE executive profile, identify key leadership competencies, and frame practical considerations for ensuring AI-enabled RWE remains credible, decision-relevant, and fit for payer and HTA decision-making contexts. Moderator Doug Foster will introduce how artificial intelligence (AI) is transforming real-world evidence (RWE) generation and why payer and health technology assessment (HTA) skepticism toward observational evidence persists. He will frame the strategic challenge for RWE leaders as AI accelerates evidence production while decision-makers remain cautious about its use. The first panelist, Shuvayu Sen, will discuss the pharmaceutical executive perspective on how RWE leadership roles and priorities are evolving as AI automates traditional analytical work. The second panelist, Rachele Hendricks-Sturrup, will provide an academic and policy perspective on credibility expectations of regulators, HTA bodies, and payers, and whether AI-enabled methods can address concerns around rigor and transparency. The third panelist, Stephanie Reisinger, will present the technology perspective on operationalizing AI-enabled RWE at scale and its implications for evidence quality and trust. This panel (40–45 minutes of discussion with remaining time for Q&A) will offer RWE, HEOR, and market-access stakeholders practical insight into how the RWE executive role must evolve to remain relevant in payer and HTA decision-making.