ACT Brief: Predictive Analytics Advance, Collaborative Data Standards Scale, and Moderna’s Flu Vaccine Review Moves Forward

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In Part 3 of a video interview with ACT, Angela Zubel of Debiopharm said faster clinical data monitoring is already achievable, with predictive models increasingly helping companies prioritize compounds most likely to succeed in later phases. She noted that forecasting outcomes from preclinical stages remains far more complex, especially for first-in-class therapies with limited historical data. Zubel added that stronger predictive analytics could eventually reduce reliance on less translational animal models in oncology.
• In its 2025 annual report, TransCelerate BioPharma highlighted expanded adoption of its Digital Data Flow initiative, with most member companies moving beyond pilot use. The consortium also released practical tools supporting implementation of ICH E6(R3) guidance and reported more than 200 health authority interactions worldwide. Leaders emphasized continued focus on reducing protocol complexity and scaling interoperable data standards across sponsors.
• Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna announced that its biologics license application for seasonal influenza vaccine candidate mRNA-1010 has been accepted for formal review. The agency assigned a PDUFA goal date of August 5, 2026, after Moderna revised its regulatory strategy. If approved, the mRNA-based vaccine could become available for adults 50 and older ahead of the 2026-2027 flu season.

That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.