Tuesday, October 7, 2025

15:15 - 16:00

SEVERO OCHOA ROOM

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Overview

Sponsor: ISCIII

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Clinical translation, the complex journey from laboratory discovery to widespread clinical practice, traditionally sees Health Technology Assessment (HTA) applied late, often post-regulatory approval. This limits its impact on early-stage development, where crucial decisions regarding technology design and research direction are made. Early HTA, however, advocates for integrating HTA principles throughout the entire translation pipeline, ensuring research aligns with real-world needs and maximizes patient benefit. This proactive approach is paramount for designing effective technology transfer roadmaps in biomedical research. By embedding HTA early, researchers can proactively address potential barriers to adoption, moving beyond mere efficacy to consider cost-effectiveness, ethical implications, and organizational feasibility. This facilitates the alignment of research activities with clinical needs, preventing the pursuit of technologies with limited translational potential. Early engagement with stakeholders, including patients, clinicians, and payers, ensures that innovations are relevant and acceptable, fostering a collaborative approach that enhances the likelihood of successful transfer. Moreover, early HTA informs strategic decisions regarding intellectual property, regulatory pathways, and reimbursement strategies, mitigating potential market access challenges. It supports the development of robust evidence generation plans, ensuring clinical trials are designed to address key uncertainties and generate data relevant to decision-makers. This roundtable will delve into the critical role of early HTA in shaping technology transfer roadmaps. We will count on the relevant opinions of experts in the field, who will provide diverse perspectives on the challenges and opportunities associated with integrating HTA early in the research and development process. Their insights will shed light on best practices, innovative approaches, and the potential for early HTA to drive more efficient and equitable translation of biomedical innovations.

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