ACT Brief: Governance vs. Execution in Pharma Modernization, AI Workforce Augmentation Planning, and Adaptive Trial Regulatory Shifts

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

• In a new contributed article, Brian Ongioni, founder of doubletheWHY, examined why pharma modernization stalls not from lack of ambition but from expanding governance layers that distance leadership from execution. Clear ownership, explicit decision rights, and proximity to implementation teams accelerate capability delivery more effectively than adding hierarchical layers focused on coordination.
• In part five of his video interview, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, introduced a practical augmentation scale for how AI agents will transform clinical trial roles over the next two years. Organizations need to begin workforce planning now to manage this shift effectively, moving beyond pilot thinking toward sustainable integration.
• In a new Drug Digest episode from Pharmaceutical Technology, experts from Abzena and Cellares discussed how evolving regulatory frameworks emphasize risk-based thinking and quality-by-design principles. Modern trial designs enable real-time data and informed decision-making while leveraging prior knowledge to accelerate development timelines without compromising safety standards.

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