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Applied Clinical Trials

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September 2 · 1 min
ACT Brief: RBQM Financial Value Quantification, Trial Budget Cost Visibility Gap, and GSK mRNA Flu Vaccine Phase III
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.
September 1 · 1 min
ACT Brief: Operating Model Change Before AI, Workforce Compression Through Integration, and Cevumeran Trial Termination
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.
August 31 · 1 min
ACT Brief: Site Cash Runway and Payment Infrastructure Priority, Biomarker Cut-Off Selection and Disparities, and Batch Failure Prevention Systems
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.
August 28 · 1 min
ACT Brief: Site Relationships and Payment Reliability, AI Adoption Without Governance Risk, and China's Biotech Innovation Rise
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.
August 27 · 1 min
ACT Brief: AI in Invoice Processing, Botanical Medicines and FDA Pathways, and Connected Trial Finance Systems
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.
August 26 · 37 min
Beyond Compliance: AJNA BioSciences' Joel Stanley on Bringing Botanical Medicine Through the FDA Pathway
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.
August 26 · 1 min
ACT Brief: Payment Infrastructure and Site Cash, Inspection Readiness Throughout Execution, and First Hemolytic Anemia Therapy
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.
August 25 · 2 min
ACT Brief: Payment Performance as Operational Brand, Speed and Discipline in Biotech Development Strategy, and Non-GLP-1 Obesity Candidate Licensing
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.
August 24 · 1 min
ACT Brief: AI Literacy and Ecosystem Adoption Requirements, CRO Operating Models Under Agentic AI Pressure, and Platform Collaborations in Vaccine and Antibody Discovery
In today's ACT Brief, we examine the three conditions required for AI-driven trial acceleration to work at scale, why agentic AI will force CRO operating model reckoning, and two major platform collaborations advancing discovery speed.
August 21 · 1 min
ACT Brief: Trial Failures as Administrative Problems, CRO Consolidation for Global Trial Reach, and FDA Approval of First FOP Treatment
In today's ACT Brief, we examine where trial failures actually originate and where AI delivers fastest wins, how CRO consolidation creates global operational scale, and the first FDA-approved treatment for a rare progressive bone disorder.
August 20 · 1 min
ACT Brief: AI Architecture and Model Ownership Due Diligence, FDA Framework for Generative AI Medical Devices, and Heidi Overton Nominated for FDA Commissioner
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.
August 19 · 1 min
ACT Brief: Phase I Back-Office Automation Priorities, Early Phase Data Interpretation Under Capital Pressure, and Syneos AI Ecosystem Expansion
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.
August 18 · 1 min
ACT Brief: TrialBlazer Timeline Reductions and Operational Demands, Structural Trial Collaboration and Site Integration, and Henlius-Sandoz Biosimilars Partnership
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.
August 17 · 1 min
ACT Brief: Data Standardization Bottleneck in Real-Time Monitoring, US Biotech FIH Trial Regulatory Frustration, and FDA Approval of Zenbexus for Multiple Myeloma
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.
August 14 · 1 min
ACT Brief: Data Quality as Foundational to Trial Modernization, CRAs Evolving to Strategic Site Partners, and 2026 Emerging Pharma Leaders Announced
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.
August 13 · 1 min
ACT Brief: Training Completion Versus Execution Readiness, AI Monitoring Agent Financial Value at Scale, and FDA Warning Letters and AI Oversight Gaps
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.
August 12 · 23 min
Beyond Compliance: ProofPilot's Joseph Kim and Lauren Briggs on Making Clinical Trial Training Actually Work
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.
August 12 · 1 min
ACT Brief: Efficacy Ceiling Breakthrough in Autoimmune Disease, Early-Career Retention and Burnout Prevention, and PRV Program Catalyzing Rare Disease Investment
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.
August 11 · 22 min
Breaking the Efficacy Ceiling in IBD and Beyond
Despite significant advances in treating inflammatory bowel disease (IBD) and other autoimmune conditions, many patients still fail to achieve lasting remission. In this Applied Clinical Trials podcast conversation, Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, examines the biological complexity behind this persistent “efficacy ceiling” and the strategies being explored to move beyond incremental gains. Speaking with Mike Christel, group managing editor, MJH Life Sciences, Wallace discusses the shift toward more stringent, tissue-based treatment targets; the potential of combining complementary mechanisms; and the ongoing search for biomarkers that can make precision medicine practical in immunology. She also explores the promise of B-cell depletion and in vivo CAR-T approaches designed to reset the immune system, potentially opening a path toward deep, durable drug-free remission.
August 11 · 2 min
ACT Brief: Substance Versus Branding in Biotech Support, Site-Level Execution Gaps and Point-of-Care Data, and KCNT1-Targeted Pediatric Epilepsy Program
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.

Showing 41–60 of 83 episodes