ACT Brief: Real-Time Review Ecosystem Approach, AI Infrastructure Before Tools, and FDA Peptide Compounding Access

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

• In part four of his interview, Raviv Pryluk, CEO and co-founder of PhaseV, made the case that scaling real-time data review requires an ecosystem approach bringing regulators, sponsors, CROs, and technology vendors together in a shared learning environment rather than letting progress remain siloed. Transparent sharing of learnings across stakeholders is the prerequisite for broader adoption beyond current large-pharma pilots.
• In a new FAQ on AI in clinical trials, we examined how organizations seeing meaningful AI results have invested in unified data infrastructure and disciplined governance rather than cycling through pilots without foundation. Agentic AI in particular depends on connected processes, reliable data, and workflow integration; without these, autonomous agents amplify operational bottlenecks rather than reduce them.
• An FDA advisory committee voted to recommend six of seven unapproved peptides for compounding pharmacy access, advancing Health Secretary Kennedy's effort to bring widely used but legally ambiguous compounds out of unregulated markets into supervised pharmaceutical supply chains. The panel decision exposed fault lines over regulatory approach and raised concerns about newly appointed committee members.

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