ACT Brief: Data Standardization Bottleneck in Real-Time Monitoring, US Biotech FIH Trial Regulatory Frustration, and FDA Approval of Zenbexus for Multiple Myeloma

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In a new Q&A, Raviv Pryluk, PhD, CEO and co-founder of PhaseV, discussed the "dead time" delay between when data is collected and when it becomes analysis-ready for real-time monitoring. AI automation of data mapping and standardization to industry standards is beginning to compress this bottleneck, making continuous review operationally feasible at scale for sponsors beyond large pharma.
• A new survey of 37 US biotech executives found that 72% prefer domestic first-in-human trials but are hesitant due to regulatory unpredictability and clinical holds, causing 73% to cite delays and costs as reasons for overseas migration. When FDA review criteria are predictable, the US ranks first for 76% of companies, but historical practices have pushed development toward Australia and other jurisdictions.
• The FDA granted accelerated approval to Zenbexus for use with daratumumab and dexamethasone in multiple myeloma patients with at least one prior treatment, based on the Phase III trial showing 41% of patients achieved the deepest response measure compared to 21% with standard therapy. Zenbexus represents the first approved option in a new class of therapies designed to activate protein degradation in cancer cells.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.