What the Future Holds for Clinical Trials as AI and Digital Twins Become More Embedded
August 14th 2025Jon 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.
ACT Brief Episode 3: Breaking Down Data Silos to Accelerate Clinical Trials
August 13th 2025In 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.
Enhancing Clinical Trial Integrity Through AI and Digital Twin Technologies
August 13th 2025Jon 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.
FDA Review Changes and the Impact on Trial Design
August 12th 2025In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses recent Complete Response Letters issued to Replimune and Capricor, explaining how shifts in FDA reviewers can affect single-arm trial acceptance, especially in oncology settings where control groups may be deemed unethical.
ACT Brief Episode 2: FDA Oversight, Vaccine Funding Cuts, and the Digital Future of Clinical Trials
August 11th 2025In 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.
Rethinking the Value of FDA Breakthrough Designation
August 11th 2025In 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.
Genmab’s Epkinly Shows Major Survival Benefit in Relapsed, Refractory Follicular Lymphoma
August 8th 2025Results 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.
Best Practices for Operational Alignment in Decentralized Trials
August 8th 2025In 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.
Breaking Down Data Silos to Enable Real-Time Trial Oversight
August 7th 2025In 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.
FDA Supports Continued Development of Eftilagimod Alfa in PD-L1–Negative Head and Neck Cancer
August 6th 2025Following 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.
Using Digital Twins to Improve Efficiency and Accuracy in Clinical Research
August 6th 2025Jon 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.
How Integrated Systems Help Biotechs Stay Inspection-Ready
August 6th 2025In 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.
How Remote Monitoring Enhances Trial Efficiency and Patient Safety
August 5th 2025In this video interview, Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, explains how clinical operations teams can use remote monitoring and connected technologies to reduce site burden, respond faster to emerging data, and improve both patient safety and trial outcomes.
FDA Grants Priority Review to Breyanzi for Relapsed Marginal Zone Lymphoma
August 5th 2025Based on positive Phase II TRANSCEND FL data showing a 95.5% overall response rate, the FDA has accepted Bristol Myers Squibb’s sBLA for Breyanzi in relapsed or refractory MZL with a PDUFA date set for December 5, 2025.