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.
UBC Pharmacovigilance experts, Dobrochna Dolicka, Christopher Henry, Alix Garcia and Irene Navarro presented at DIA Europe 2025 on how AI can be used to streamline pharmacovigilance activities and how harmonization of guidelines can be enhanced in order to define a specific framework for gene therapy.
Psychedelic-assisted therapies are starting to emerge with potential as treatments for mental health conditions. Explore the evidence behind an increased interest in this use of substances such as psilocybin, MDMA, LSD, and DMT, and the future of research in this area.
Catherine Miller, MSN, CRNP, FNP-BC
Senior Project Manager, Safety, Epidemiology, Registries and Risk Management
Adherence is critical to ensuring patients receive full therapeutic benefit and effectively manage their disease, particularly for complex treatments such as injectables or infusions. Explore strategies to support patients and improve adherence in the blog.
Learn about the FDA's new guidance, the challenges of standardization, and how UBC is driving innovation in REMS implementation using modern APIs from UBC's VP of Data Intelligence and Program Analytics, Jim Shamp.
Discover UBC's insights from the Cell & Gene Meeting on the Mesa, the unique challenges patients face, and the importance of tailored support services to ensure successful treatment journeys
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.