In today's ACT Brief, we examine what patient-site relationships need most at DPHARM, how platform-based AI scales across workflows, and FDA's approval of a gene therapy for a rare childhood syndrome.
News|Podcasts|May 21, 2026
ACT Brief: Clinical Development Orchestration, Career Insights in Trials, and FDA Communication Gaps
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine how program-level orchestration is becoming critical to R&D success, reflections on meaningful work in clinical trials, and industry concerns about FDA communication and institutional knowledge loss.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In a new
article , Brian O'Dwyer of IQVIA analyzed 2025 productivity data showing late-stage improvements offset by rising end-to-end timelines at 10 years. Program-level orchestration—not individual trial execution—now determines success, with transition points between phases presenting the largest remaining opportunities to reduce delays and improve coordination across teams and partners. - In a new video
interview , Sam Hinsley, statistics manager at Phastar, reflected on her career in clinical trials and what it means to do work that genuinely makes a difference for patients and the broader research ecosystem. - In a new
interview from Pharmaceutical Executive, David Crean, chief business officer at MedicNova, described FDA communication as "well-intentioned but poorly executed" due to loss of institutional knowledge following leadership transitions. Early engagement through free INDs and pre-IND meetings is increasingly critical for companies seeking regulatory clarity before late-phase surprises.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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