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In today's ACT Brief, we examine how biotech reaches inflection points on limited capital, how the FDA is restructuring early clinical development to reclaim US competitive standing, and a new combination therapy for treatment-resistant melanoma.

Acting CBER director Karim Mikhail outlines the structural barriers slowing Phase I trials in the US and details how the FDA's Expedited IND Pilot is designed to address them.

In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, reframes what "leaner" really means in practice—not cutting corners, but deploying fractional teams and strategic partners to reach inflection points faster on limited capital.

In today's ACT Brief, we examine why commercial readiness cannot wait until late-stage development, how operational trial infrastructure must precede AI optimization, and the execution gap between sponsor-built tools and site-level needs.

Real-time AI-enabled decision-making only accelerates development when trials have coordinated operational infrastructure for randomization, supply management, and workflows capable of responding to new insights without disrupting execution or compliance.

In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, makes the case that commercial strategy must now inform clinical development from the earliest stages—and what that means for indication selection, trial design, and endpoint choices.

In today's ACT Brief, we examine the most consequential risks facing early-stage biotech development, why recruitment spending targets the wrong funnel level, and industry deal speculation clarifications.

Under-enrollment isn't news to teams running oncology trials, and the instinct is to spend more on reach. The evidence, however, says the biggest leak is something else entirely and that most recruitment budgets focus on the least valuable part of the problem.

In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, identifies the funding gap and indication selection trade-offs as the most consequential risks facing early-stage programs today—and why great assets still fall behind when those decisions go wrong.

In this Q&A, Elizabeth Walsh, PMP, ACRP-CP, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, discusses the persistent misconceptions about sponsor accountability, why execution gaps originate long before study startup, and what genuine inspection readiness looks like when it is built in from the outset.

In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, explains how declining NIH funding, late-stage pharma acquisition strategies, and global operating pressures are forcing sponsors to move faster and more capital-efficiently toward clinical inflection points.

In today's ACT Brief, we examine the $500,000-per-day cost of execution delays and protocol variance at the point of care, why oncology real-world data requires hybrid clinical expertise with technology, and scaling challenges as trial data volumes continue to grow.

Real-world oncology data requires hybrid curation combining clinical expertise with technology to address variability in documentation, missing data, and complex concepts like lines of therapy that are often implicit rather than explicitly recorded in EHRs.