Harnessing AI and RWE: Developing Integrated Evidence Strategies for Market Access in the IRA Era

Implementing an integrated evidence planning (IEP) approach to address current market access scenarios, including those posed by the Inflation Reduction Act (IRA), can lead to more efficient clinical development and improved commercial outcomes. In this session, we demonstrate how real-world evidence (RWE) can (and should) be integrated into evidence generation strategies throughout the product development lifecycle, and how AI-enabled solutions can enhance this process.Key topics include:1. The role of IEPs in comprehensive market access strategies2. Addressing market access and regulatory considerations in light of the IRA3. Utilizing RWE across all stages of development, to understand the landscape and perform patient segmentation4. AI-enabled access delivery models and their application to various client scenariosThrough practical case studies, we examine how RWE complements elements such as systematic literature reviews, network meta-analyses, cost-effectiveness modeling, and dossier preparation for health technology assessment can be planned for as part of the IEP framework and illustrate how AI can enable and enhance these components, leading to more efficient and higher-quality outcomes.The presentation will emphasize the importance of adopting a holistic approach from the outset of clinical development. We'll explain why IEPs are a crucial strategy for navigating the complex drug development pathway, with RWE serving as a core component and AI as an enabler for expedited, high-quality execution. By the end of this session, attendees will gain insights into creating comprehensive, IEPs that effectively incorporate AI-enhanced RWE to address evolving market access challenges related to the IRA. Sponsored by PAREXEL