Can Generative AI Aid Readiness for Joint Clinical Assessment (JCA)?

ISSUE:

The Joint Clinical Assessment (JCA) framework aims to streamline the approval of life science innovations in Europe by reducing redundant practices and harmonizing evidence requirements. This single, transparent process can spur pharmaceutical innovation and expedite patient access to approved therapies. However, the process’s complexity, including tight timelines and increased data demands, requires careful planning to avoid inefficiencies and delays. This panel will explore how generative AI can support the readiness for JCA, addressing timeline and scope challenges, and opportunities within this ambitious framework.

OVERVIEW:

Ramiro Gilardino will introduce the JCA framework, its objectives, and its potential impact on pharmaceutical innovation and patient access. He will also introduce the panelists and outline the session structure. Ipek Ozer-Stillman will discuss how the industry can prepare for the JCA, emphasizing the need for system efficiencies. She will summarize key challenges and necessary preparations for submitting the JCA dossier, highlighting opportunities for process optimization. Jag Chhatwal will share his perspective on the technology, highlighting how generative AI can be a game-changer to accelerate the JCA preparations. He will demonstrate the use of generative AI to conduct simulations of different PICO scenarios, highlighting specific examples and potential outcomes of implementing such AI-driven approaches. Diana Delnoij will share the Health Technology Assessment (HTA) perspective, discussing AI’s dual role in evaluating healthcare solutions and supporting HTA activities. She will emphasize the need for capacity building within HTA agencies to effectively harness AI technologies to meet state-of-the-art, scientifically valid, transparent methods required by HTA bodies. Finally, Ramiro will conclude the session by summarizing the key insights from the panel, outlining next steps for stakeholders, and moderating the Q&A session.

In conclusion, this panel will provide a comprehensive overview of how generative AI can enhance JCA readiness, offering actionable insights and strategies to navigate the complexities of this initiative.