Evidence transportability and HTA acceptance: Challenges, considerations and opportunities скачать в хорошем качестве

Evidence transportability and HTA acceptance: Challenges, considerations and opportunities

Evidence transportability and HTA acceptance: Challenges, considerations and opportunities with Meena Venkatachalam, Lumanity As companies seek to scale their real-world evidence (RWE) strategies globally, the question of evidence transportability, how well data generated in one setting applies to another, is increasingly in focus. In this interview, we speak with Meena Venkatachalam, Head of RWE Consulting, Lumanity about the frameworks, challenges, and opportunities of navigating evidence across borders, how HTA bodies are responding, and what practical strategies can help ensure acceptance of transported evidence. Questions 00:00: Introduction 00:32: To start, can you explain what evidence transportability is and why it has become such a critical issue for companies and HTA bodies today? 03:13: HTA bodies often express a preference for local data. Under what circumstances do you think non-local real-world evidence can be most valuable? 05:59: What are some of the main challenges when applying data from one country to another? 10:09: Could you share any practical examples where evidence transportability has made an impact? 12:18: Looking ahead, what strategies do you recommend for companies to successfully navigate evidence transportability and strengthen the case for acceptance by HTA bodies as well as regulators? Meena Venkatachalam Head of RWE Consulting, Lumanity Meena is the Real World Data ‘Luminary’ Consulting Lead at Lumanity. She leads a dedicated team that supports clients in identifying the most appropriate study designs for their RWE needs, expertly balancing requirements around data quality, timelines, budgets, and external stakeholder acceptance. Her group provides strategic guidance to ensure successful RWE applications for a variety of evidence generation needs, including clinical development, regulatory approval, HTA submissions, and post-launch use cases. Prior to joining Lumanity, Meena gained over 12 years of experience in HEOR consulting. During this time, she led a European economic modeling group focused on the development of cost-effectiveness models, indirect treatment comparisons, and HTA submissions. Her background in HEOR has equipped her with the expertise to develop comprehensive RWE strategies and economic models for diverse markets, including the United States, Europe, Canada, and the Asia Pacific region. Published as part of the Evidence Insights, "Beyond borders: the evolving role of evidence transportability", sponsored by Lumanity.