Applied Clinical Trials

1:34

ACT Brief: Trial Failures as Administrative Problems,...

Applied Clinical Trials ·

2026/08/21

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.

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1:41

ACT Brief: AI Architecture and Model Ownership Due...

Applied Clinical Trials ·

2026/08/20

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.

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1:46

ACT Brief: Phase I Back-Office Automation Priorities,...

Applied Clinical Trials ·

2026/08/19

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.

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1:57

ACT Brief: TrialBlazer Timeline Reductions and...

Applied Clinical Trials ·

2026/08/18

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.

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1:43

ACT Brief: Data Standardization Bottleneck in...

Applied Clinical Trials ·

2026/08/17

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.

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1:52

ACT Brief: Data Quality as Foundational to Trial...

Applied Clinical Trials ·

2026/08/14

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.

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1:52

ACT Brief: Training Completion Versus Execution...

Applied Clinical Trials ·

2026/08/13

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.

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23:05

Beyond Compliance: ProofPilot's Joseph Kim and Lauren...

Applied Clinical Trials ·

2026/08/12

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.

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1:42

ACT Brief: Efficacy Ceiling Breakthrough in...

Applied Clinical Trials ·

2026/08/12

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.

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22:57

Breaking the Efficacy Ceiling in IBD and Beyond

Applied Clinical Trials ·

2026/08/11

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

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2:06

ACT Brief: Substance Versus Branding in Biotech...

Applied Clinical Trials ·

2026/08/11

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.

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1:59

ACT Brief: Lean Development Through Fractional Teams...

Applied Clinical Trials ·

2026/08/10

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.

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1:42

ACT Brief: Commercial Strategy Shaping Early Clinical...

Applied Clinical Trials ·

2026/08/07

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.

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1:42

ACT Brief: Funding Gaps and Indication Decisions in...

Applied Clinical Trials ·

2026/08/06

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.

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1:52

ACT Brief: NIH Funding Reshaping Development...

Applied Clinical Trials ·

2026/08/05

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.

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1:57

ACT Brief: Trial Execution Cost Burden and Protocol...

Applied Clinical Trials ·

2026/08/04

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.

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1:38

ACT Brief: Real-Time Monitoring Through Quick Wins,...

Applied Clinical Trials ·

2026/08/03

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.

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1:39

ACT Brief: Real-Time Review Ecosystem Approach, AI...

Applied Clinical Trials ·

2026/07/31

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.

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1:59

ACT Brief: ESG as Commercial Selection Factor,...

Applied Clinical Trials ·

2026/07/30

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.

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20:44

Beyond Compliance: YPrime's Paulo Limgenco on Moving...

Applied Clinical Trials ·

2026/07/29

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.

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