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In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses whether recent trial design rejections signal a broader shift in FDA expectations or simply reflect changes in individual reviewers, emphasizing that current unpredictability may be more situational than systemic.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twins are helping clinical trials become more efficient, patient-centric, and capable of supporting innovative study designs over the next decade.

In this episode of the Applied Clinical Trials Brief, we spotlight a recent video interview with Luke Wilson of Thermo Fisher Scientific in which he shared insights on how data visibility, remote monitoring, and integrated systems can streamline inspections, improve patient safety, and keep decentralized trials compliant and on track.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI and digital twin technologies are being applied to improve data transparency, ensure reproducibility, and strengthen the reliability of clinical trial outcomes.

Results from a Phase II trial (NCT06640972) showed that patients treated with RDX-002 experienced significant reductions in postprandial triglycerides, less weight regain after GLP-1 therapy, and improvements in key cardiometabolic markers.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, explains why sponsors pursuing breakthrough or priority review designations must maintain rigorous trial design while building organizational agility.

Bringing some payment activities in-house while outsourcing others can help sponsors optimize clinical trial efficiency, reduce risks, and strengthen site relationships.

In the Phase III VAYHIT2 trial, ianalumab combined with eltrombopag significantly prolonged time to treatment failure and improved sustained platelet counts in patients with primary immune thrombocytopenia previously treated with corticosteroids, with a safety profile consistent with prior findings.

In this Phase III trial, the Padcev-Keytruda combination used as both neoadjuvant and adjuvant therapy significantly improved event-free and overall survival, as well as pathologic complete response, compared to surgery alone in cisplatin-ineligible patients with muscle-invasive bladder cancer.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how regulators are clarifying best practices for integrating AI and digital twins into clinical research.

The global Phase III EMPEROR trial (NCT06872125) will evaluate the safety and efficacy of zorevunersen, a novel antisense oligonucleotide designed to reduce seizures and improve cognitive and behavioral outcomes in children with Dravet syndrome.

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the previous week with a look into the FDA’s heightened scrutiny of trial design, the wind-down of federal mRNA vaccine programs, and how digital innovation is reshaping the clinical research landscape.

In this video interview, Meri Beckwith, Co-CEO of Lindus Health, examines how recent developments with Complete Response Letters have shifted industry perceptions of FDA breakthrough designation—highlighting that it offers faster review timelines and investor visibility, but not a higher likelihood of final approval.

In the Phase III ENVISION trial, Zusduri achieved a 24-month duration of response rate of 72.2% among patients with a complete response at three months, reinforcing its potential as a durable treatment option for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.

Results from the Phase III EPCORE FL-1 trial (NCT05409066) showed that patients treated with Epkinly (epcoritamab) in combination with Rituxan (rituximab) and Revlimid (lenalidomide) for relapsed or refractory follicular lymphoma demonstrated significant improvements in overall response rate and progression-free survival.

A unified technology approach improves study efficiency and data collection.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, shares key strategies for maintaining operational alignment and compliance in decentralized trials including unified data platforms, aligned SOPs, and clear governance and escalation pathways between sponsors and supply chain partners.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how digital twins provide patient-level predictions that enhance trial precision, reduce enrollment needs, and support AI-driven drug development.

Results from the Phase III ATTAIN-1 trial (NCT05869903) showed that the highest dose of orforglipron achieved an average weight reduction of 12.4% in patients with obesity or overweight.

In the Phase III TRIUMpH program, tegoprazan met primary endpoints and outperformed lansoprazole in maintaining healing of erosive esophagitis over 24 weeks, including in patients with the most severe disease.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, outlines the key barriers to real-time oversight in clinical trials and explains how integrated systems, built-in analytics, and live dashboards can empower clinops leaders to make faster, better-informed decisions.

Following positive Phase IIb TACTI-003 data, the FDA has endorsed further evaluation of Immutep’s efti-Keytruda combination in first-line recurrent/metastatic HNSCC patients with PD-L1 CPS <1, a population with few chemotherapy-free treatment options.

Jon Walsh, founder, chief scientific officer, Unlearn, explains how AI-designed therapies and digital twin technology are accelerating clinical trials, improving data precision, and reshaping early-phase drug development.

The US Department of Health and Human Services has terminated 22 mRNA vaccine research contracts under BARDA, signaling a shift toward alternative vaccine platforms and potentially more stringent oversight of trial design and funding.

The biotech company extends its Phase I trial (NCT06252220) of DA-1726 to eight weeks following encouraging early efficacy, safety, and weight loss data in patients with obesity.

In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, discusses how integrated systems and data transparency enable sponsors to meet evolving regulatory expectations and streamline FDA inspections through enhanced operational readiness.

As clinical trials become more complex, success depends on early collaboration, thoughtful protocol design, and practical strategies to manage risk, reduce delays, and support patients.

Company opts not to advance VX-993 into pivotal development after Phase II data show no statistically significant benefit over placebo in post-bunionectomy surgical pain relief.