On May 2, Algorithme Pharma, an early-stage clinical contract research organization (“CRO”) based in Laval, Canada, hosted a Science Symposium, “Innovative Solutions to Common Clinical & Bioanalytical Challenges“. First, Catherine Konidas, Vice President, Global Business Development, Algorithme Pharma, , presented a comparison of clinical trials in the U.S. versus Canada. The group explained the benefits of conducting Phase I clinical trials (early stage studies in healthy human subjects to determine a proposed therapy’s safety) in Canada. For each Phase I research to be conduced in Canada, Health Canada, the FDA equivalent regulatory agency, requires Health Canada forms including a clinical trial agreement (“CTA”), an investigator brochure, a protocol, informed consent, CTD summaries, and an overall quality summary. Unlike FDA, Health Canada does not require quality, non-clinical, and clinical reports (only summaries are required) as well as new related publications. In the opinion of Algorithme Pharma, these differences may save time. On the other hand, unlike FDA, Health Canada requires one CTA per clinical trial versus an open investigational new drug exemption for FDA that permits protocol amendments. Similar to FDA, there is a 30-day default for Health Canada to review a CTA, but in Algorithme Pharma’s experience, it usually takes 21 days before Health Canada reviews and permits each study to begin. Also, while an ethics committee review is required for approval, it can be conducted in parallel, which may also save time. In Algorithme Pharma’s experience, it usually takes 58 days via FDA’s procedures before a Phase I study may begin versus 33 days via Health Canada’s procedures, which may be of value for sponsors.
Dr. Fabio Garofolo, Vice President Bioanalytical Services, Algorithme Pharma, then discussed the benefits of conducting bioanalysis at a clinical site. According to Garofolo, liquid chromatography-mass spectrometry has been gaining popularity over traditional methods for large molecule quantification. He described the benefits of mass spectrometry for larger, biotechnology-type molecules and how the techniques compare using modern techniques for separation and quantification.