News

In today's ACT Brief, we examine the standardization gap that sits between raw data collection and real-time analysis, why regulatory unpredictability is pushing US biotechs to run early trials overseas, and FDA accelerated approval of a new immunomodulatory therapy.

In this Q&A, Raviv Pryluk, PhD, CEO and co-founder of PhaseV, discusses the data standardization bottleneck that sits between raw trial data and real-time analysis, what the FDA's continuous monitoring pilot will require to scale beyond large pharma, and why an ecosystem approach is the only path to making real-time trial oversight a practical reality.

A new survey of 37 US biotechnology executives finds broad preference for conducting first-in-human trials domestically, with regulatory unpredictability and clinical holds cited as the primary drivers of overseas migration.

In today's ACT Brief, we examine why data quality is the ceiling for all other trial modernization efforts, how CRAs are shifting from compliance monitors to data-enabled partners, and recognition of five rising industry leaders shaping pharma innovation.

Clinical research associates are evolving from compliance-focused manual monitors to data-enabled strategic site partners, but organizations need analytics training, clear operating models, and active change management to make the shift stick.

From point-of-care sample collection to real-world data curation, wearable device integration, and continuous review infrastructure, data quality is not a single problem in clinical trials—it is a layered challenge that manifests differently at every stage of development and demands a different set of solutions at each one.

In today's ACT Brief, we examine why protocol training completion doesn't ensure site execution readiness, how AI clinical monitoring drives measurable financial returns, and structural compliance failures behind rising FDA warning letters.

New eNPV modeling applied to operational data from an AI clinical monitoring agent finds ROI multiples as high as 82x, with time savings and monitoring cost reductions identified as the primary value drivers.

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joseph Kim, Chief Strategy Officer at ProofPilot, and Lauren Briggs, Chief Customer Officer at ProofPilot, about why completing training is not the same as being prepared to execute a protocol.

Clinical research coordinators face early burnout driven by gaps between job expectations and operational reality, inadequate mentorship structures, and fragmented technology environments that compound insufficient onboarding and deplete resources needed to sustain engagement.

AbbVie’s head of immunology clinical development, Kori Wallace, MD, PhD, discusses how combination therapies, translational science, and emerging immune-reset approaches could usher in a new era of treatment for inflammatory bowel disease and other autoimmune conditions.

In today's ACT Brief, we examine how to evaluate biotech incubators and accelerators beyond marketing, why clinical trial modernization requires point-of-care data collection, and a precision therapy entering registrational trials for a rare genetic epilepsy.

In this Q&A, Richard Graham, PhD, co-founder and chairman of the board at TruTechnologies, discusses why six decades of manual site-level processes continue to undermine clinical trial execution, what national initiatives like Operation TrialBlazer leave unaddressed, and why meaningful modernization has to start with data collected at the point of care.

In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, offers a frank breakdown of incubators, accelerators, and venture studios—and why biotechs need to ask harder questions about track records and exits before committing to any of them.

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 today's ACT Brief, we examine how declining NIH funding is reshaping biotech development strategy, why execution planning must begin at the business decision not at study startup, and why legacy R&D platforms are failing biologics complexity.

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.