As pricing pressures mount in the US, pharmaceutical companies are reassessing global launch strategies. This session looks to explore how geopolitical shifts - including US policy changes, EU pharmaceutical reform, and innovation agendas in the Middle East - are reshaping clinical development and access pathways for innovative therapies, with a focus on cell and gene therapies (CGTs), rare diseases, and personalized medicine. Regulators, industry leaders, and investors will examine evolving frameworks for clinical development, early access, health technology assessment (HTA), and pricing and reimbursement. Speakers will highlight early experiences with the EU HTA regulation and assess their implications for broader access strategies under legislative reforms in Europe, contrasted with emerging models in the Middle East.