Session (CTI)

Even when regulators, HTA bodies, and payers seek answers to many of the same scientific questions, evidence generation remains largely sequential, siloed, and awfully inefficient. This fragmentation creates avoidable translation loss between decision systems, triggers late evidence requests, and often requires sponsors to generate multiple versions of "decision-grade" evidence for different stakeholders. Drawing on insights from the ISPOR Strategic Dialogues pilot in the EU/EEA, this panel will examine whether Europe has reached an inflection point in evidence generation. With implementation of the EU HTA Regulation, the introduction of Joint Scientific Consultation (JSC), and increasing collaboration among regulators, HTA bodies, and innovators, is Europe creating the conditions for a more integrated approach to evidence planning across the product lifecycle? Panelists representing regulatory agencies, HTA, and industry will discuss whether JSC can serve as a building block for integrated evidence generation and how early scientific dialogue can evolve into coordinated evidence strategies that reduce duplication while respecting national decision-making. The discussion will explore what integrated evidence generation means for innovator companies as they rethink clinical development programs, real-world evidence strategies, and evidence packages to support multiple decision makers. Finally, the panel will consider whether Europe is uniquely positioned to become the global leader in integrated evidence generation, what barriers remain, and what practical steps are needed to translate alignment into more efficient evidence development, greater evidence reuse, and ultimately faster patient access to innovation.