We are excited to be speaking at the 'Real-World Evidence in Health Technology Development' Event in Edinburgh in November/2025.
Join us, and our expert speakers, as we discuss the role of real-world (RWE) evidence in health technology development. RWE continues to gain prominence as a tool in health technology development with developers and regulators both looking to leverage the insights it can offer to support alternative pathways to market - whether it is through external control arms or post-launch evidence generation - there's a lot to be aware of. Despite this, the regulatory considerations around RWE are often misunderstood.
Hear live from The Cell and Gene Therapy Catapult
Title: The use of external control arms based on real-world data to support regulatory and HTA decisions: providing insights from case studies.
Date and time: Wednesday, 12th 2025 | 14:00 - 17:00
Speakers: Binu Gurung, Senior Health Economics and Market Access Manager & Tom Strakosch, Senior Health Economics and Market Access Manager
This session will explore the existing, and draft development guidelines for the use of external control arms based on real world data to support regulatory/HTA decision-making with the focus on the guidelines being developed by MHRA, EMA, and the FDA. This session will highlight where ECAs have been, or have potential to be used, as a key avenue for positive regulatory/HTA assessment outcomes of ATMP. Case studies will be utilised to initiate discussion on the challenges impeding the quality and consistency of RWE generation in the context of external controls.