In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
News|Podcasts|October 29, 2025
ACT Brief: AI Partnerships, Data-Driven Site Activation, and FDA Approval for Omvoh’s Single-Injection Regimen
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we spotlight how new OpenAI collaborations are transforming drug development, how AI is driving smarter site activation in global trials, and how the FDA’s approval of a single-injection Omvoh regimen enhances convenience for ulcerative colitis patients.
Welcome to another edition of the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry.
- We begin with the growing role of artificial intelligence in drug development. Thermo Fisher Scientific and Lundbeck both
announced new collaborations with OpenAI. Thermo Fisher will integrate OpenAI APIs into its Accelerator Drug Development platform and clinical research business, aiming to shorten clinical trial timelines and help sponsors identify low-potential therapies earlier. Meanwhile, Lundbeck will deploy ChatGPT across its global workforce to enhance R&D and commercial operations. Both moves reflect a broader wave of AI adoption across life sciences—building on recent partnerships from Medidata, BioRender, and Anthropic—further underscoring how AI is transforming every stage of the development process. - In our next story, we look at how AI and advanced analytics are helping expand global trial access. In a recent ACT
interview , Gen Li of Phesi explained how large-scale patient databases—covering hundreds of millions of records—can guide sponsors in identifying and activating new sites and investigators, particularly in lower-resource settings. By modeling patient populations early, sponsors can refine study design, anticipate control arm performance, and recruit qualified investigators faster. This data-driven approach improves trial efficiency while maintaining quality, allowing teams to meet patients where they are and reduce the barriers to participation in underserved regions. - Finally, the FDA has
approved a new single-injection, once-monthly maintenance regimen for Eli Lilly’s Omvoh in adults with moderately to severely active ulcerative colitis. The new formulation offers the same proven efficacy as the previous two-injection regimen, but with added convenience for patients managing long-term treatment. Backed by data from the LUCENT trial program, Omvoh has demonstrated durable remission, mucosal healing, and a consistent safety profile for up to three years. The simplified regimen is expected to launch in early 2026, marking another step forward in improving adherence and patient quality of life.
That’s all for today’s ACT Brief. Join us tomorrow for more insights shaping the future of clinical operations and drug development. Thanks for listening.
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