This pilot episode of The Human Side of Clinical Trials introduces a framework from Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., exploring why operational failures in clinical trials often trace back to gaps in human readiness rather than process design alone.
In today's ACT Brief, we examine how eNPV modeling and real-world data finally put numbers on RBQM value, why static budgeting masks true site costs, and GSK advancing an mRNA flu vaccine candidate to late-stage testing.
In today's ACT Brief, we examine why operating model redesign must precede agentic AI deployment, how integrated platforms compress operations toward accountable teams, and BioNTech's decision to terminate a colorectal cancer mRNA trial.
In today's ACT Brief, we examine why 80% of sites operate on minimal cash reserves, how biomarker-informed enrollment risks excluding viable patient populations, and the growing role of predictive maintenance in preventing batch losses.
In today's ACT Brief, we examine how unpredictable payments damage site retention, why rapid AI deployment without validation creates regulatory risk, and China's growing dominance in early-stage drug discovery.
In today's ACT Brief, we examine where agentic AI delivers immediate wins in site payments, how botanical therapies can earn pharmaceutical credibility, and the connected financial systems reshaping trial operations.
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joel Stanley, CEO of AJNA BioSciences, about why botanical therapies need pharmaceutical-grade standardization and clinical evidence to earn physician trust and insurance coverage.
In today's ACT Brief, we examine why payment inconsistency persists despite industry awareness, why inspection readiness must be built throughout execution not assembled at submission, and FDA approval of the first disease-specific treatment for a rare blood disorder.
In today's ACT Brief, we examine how payment reliability has become a competitive differentiator at high-performing sites, what a truly strategic lean development model looks like, and a licensing deal for a next-generation obesity therapy combining Phase I data with preclinical validation.
In today's ACT Brief, we examine why AI architecture and ownership matter more than model sophistication in clinical development, how the FDA proposes to regulate generative AI-enabled medical devices, and a new leadership appointment at the agency
In today's ACT Brief, we examine which Phase I administrative processes are most ripe for AI automation, how sponsors should balance investor demands for real-time data against scientific rigor in capital-constrained trials, and a major CRO's expanded artificial intelligence partnerships.
In today's ACT Brief, we examine what actually drives the 6- to 12-month timeline reductions envisioned under Operation TrialBlazer, why trial modernization requires structural changes in sponsor-site collaboration, and a major biosimilars commercialization partnership.
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 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.
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.
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.
In today's ACT Brief, we examine new strategies for breaking efficacy plateaus in IBD through combination approaches, why clinical research teams lose talent at the early-career stage, and how FDA's Priority Review Voucher program is reshaping rare disease capital flows.
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 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.
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.
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.
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 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.
In today's ACT Brief, we examine how a gradual, win-driven strategy scales real-time monitoring adoption, why consumer wearables need rigorous fit-for-purpose validation, and an FDA committee's favorable vote on Replimune's oncolytic virus combination therapy.
In today's ACT Brief, we examine why real-time monitoring scales only through coordinated ecosystem efforts, how organizational failures not models explain weak AI results, and FDA's advisory panel peptide compounding decision.
In today's ACT Brief, we examine how sustainability is shifting from compliance to a procurement driver, what infrastructure gaps remain in FDA's real-time pilot model, and regulatory guidance targeting unnecessarily restrictive cancer trial criteria.
In this pilot episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Paulo Limgenco, VP of business operations and ESG strategy lead at YPrime, about how sustainability is shifting from a compliance checkbox to a factor that shapes vendor selection, client trust, and long-term business value.
In today's ACT Brief, we examine how data standardization must precede real-time monitoring deployment, why contracts cannot transfer sponsor oversight responsibility, and a strategic acquisition broadening immunology development.
In today's ACT Brief, we examine the data collection-to-analysis gap undermining continuous trial monitoring, why AI agents require foundational workflow infrastructure, and FDA approval of a novel ADHD treatment.
