FDA’s Inspection of An Academic Lab Used in Commercial Research
(Thursday, March 14, 2024) It is not uncommon for sponsors to use research labs in academic settings for specialized clinical tests not available commercially. However, the convenience of using such labs comes with its own challenges particularly when the sponsor does not follow common sense measures to ensure the quality and reliability of the tests conducted at these labs, a lesson learned the hard way by a sponsor, recently. Often clinical trials employ laboratory tests that are uncommon and/or highly specialized which may be available only at select academic research labs. It is also a common scenario that the laboratory tests needed for a clinical trial can be easily and conveniently conducted only at a lab run by a subject matter expert (SME) working with the sponsor. However, the convenience of the arrangement does not excuse the sponsor from enforcing Good Clinical Laboratory Practices (GCLP) on such labs. Not following GCLP could compromise the quality and reliability of tests conducted at these labs. Cassava Sciences, a biotechnology company in the Phase 3 clinical trial stage with its treatment for Alzheimer’s disease, used a lab at its SME, Dr. Hoau-Yan Wang, at the City University of New York (CUNY). An FDA audit of Dr. Wang’s lab found many issues with compliance with GCLP leading to FDA concluding that the data from all the tests conducted at Dr. Wang’s lab could not be trusted. The resulting fiasco potentially puts a question on Cassava’s Phase 3 clinical trial results. A review of the inspectional findings from the FDA audit shows ignorance of the most basic requirements of GCLP. The lab was using deficient quality matrices that are typical for an academic research lab but not acceptable for clinical trial test labs. To top that the lab was callous about its deficiencies when pointed out by the FDA inspectors. Initially, the lab refused the FDA audit claiming to be a research lab not subject to FDA regulations. When forced to comply, personnel gave the FDA inspectors silly answers to common questions about the reliability of the freezers used for storing samples, or that the lab personnel used their iPhones as timers for critical experiments. Most of the audit findings raised serious questions about the reliability and integrity of the results of the tests conducted by the lab. It is obvious from the FDA findings that the sponsor did not ensure the compliance of the lab with applicable regulations. Cassava’s investors hold it responsible for the debacle and rightfully so. Keeping its partner/vendors in compliance is a critical role of the sponsor that it goofed up. And it may pay a heavy price for it if the FDA rejects its data due to this. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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