With immature survival data, single-arm trials, and limited comparators common in early JCA submissions, real-world evidence is becoming a strategic necessity, not an afterthought. Learn how sponsors can plan and generate RWE that meets the methodological bar EU assessors expect.
The EU Joint Clinical Assessment is driving a new approach to evidence generation, where regulatory approval and market access considerations must be addressed together. Drawing on lessons from the first completed and discontinued JCA cases, this article explores how integrated evidence planning, comparative effectiveness evidence, proactive PICO management, and strategic use of real-world evidence can help organizations navigate evolving European requirements and support successful reimbursement and patient access outcomes.
Judy Lytle
Executive Director of Evidence Development Study Solutions
AI can support much more than drafting content. In Part 2 of our series, we explore practical tools that help teams organize information, improve communication, capture meeting insights, visualize complex concepts, and work more efficiently so experts can stay focused on what matters most.
Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.
With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.