In today's ACT Brief, we examine Veristat's acquisition of Certara's regulatory business, why reimbursement probability should inform development planning earlier, and how site selection misalignment drives downstream trial performance issues.

In today's ACT Brief, we explore organizational factors behind CRL decisions, methodological concerns with pooling amyloid antibody trial data, and how compounding addresses care gaps when commercial options fall short.

In today's ACT Brief, we explore practical community engagement strategies that drive representative enrollment, how sponsors should structure development plans around the plausible mechanism framework, and the organizational prerequisites for scaling AI effectively in drug development.

In today's ACT Brief, we explore practical steps sponsors can take to prepare for the plausible mechanism framework, how behavioral science addresses root causes of recruitment and diversity challenges, and FDA acceleration of psychedelic therapy reviews through executive order.

In today's ACT Brief, we explore how disease heterogeneity confounds natural history controls, the execution translation gap converting identified problems into action, and policy recommendations for strengthening FDA's accelerated approval pathway.

In today's ACT Brief, we explore biological and dosing considerations for basket trial designs, how human-relevant data earlier in development reduces late-stage failures, and FDA's shift toward single-trial approvals supported by real-world evidence.

In today's ACT Brief, we explore how FDA evaluates effectiveness for ultra-rare individualized therapies, the agency's enforcement push for mandatory trial result reporting, and Obsidian's merger backed by $350 million to advance next-generation TIL cell therapy.

In today's ACT Brief, we examine how protocol interpretation and source document preparation delay study startup, how the plausible mechanism framework accelerates individualized therapy timelines, and how real-time tracking technologies improve supply chain and sample integrity in decentralized trials.

In today's ACT Brief, we examine Thermo Fisher's expanded real-world data access through HealthVerity, how FHIR-based standards are finally enabling scalable eSource implementation, and FDA's second complete response letter for Replimune's oncolytic immunotherapy.

In today's ACT Brief, we explore industry perspectives on operational and methodological shifts defining 2026, how agentic AI will augment clinical trial roles over the next two years, and Roche's expanded partnership with C4 Therapeutics on next-generation antibody conjugates.