In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site infrastructure, and how VeonGen has aligned with the FDA on a pivotal gene therapy trial design.
News|Podcasts|November 9, 2026
ACT Brief: APAC Inspection Findings, RBQM Key Risk Indicators, and Head and Neck Cancer Approval
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we examine why APAC inspection findings mirror those in the US and Europe, how key risk indicators should be read together, and how FDA granted accelerated approval to a subcutaneous antibody therapy for recurrent head and neck cancer.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In
part two of a video interview , James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explained that FDA inspection findings at APAC sites fall into the same categories, and at similar rates, as those in the US and Europe. The most common issues, such as informed consent versioning and incomplete source data, are not unique to the region. - In a
new contributed article , Vera Pomerantseva, director of product management for RBQM at eClinical Solutions, argues that a single key risk indicator is a symptom, not a full story. Reading indicators together can separate real site risk from a lack of oversight, such as a low deviation rate paired with many missed procedures. She also notes that normalization and conditional logic can keep those signals from misleading sponsors. - The
FDA granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy and an immune checkpoint inhibitor. The approval rests on a single-arm cohort of 102 patients in the OrigAMI-4 trial, where 42% responded and 15% had complete responses. Serious adverse reactions occurred in 39% of patients, and a Phase III confirmatory trial is under way.
That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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