Sanofi Pharmaceutical Company’s First Clinical Trial Approved Through CATALIS Quebec’s FAST TRACK Evaluation Service
Following Novartis, Boehringer, and Roche, Sanofi is now CATALIS’ fourth pharmaceutical partner to pilot its FAST TRACK Evaluation Service.
Sanofi’s Phase I-ll study, which uses human subjects for the first time and is designed to assess the safety and the pharmacokinetic, pharmacodynamic, and antitumor activity of the SAR444200 regimen in participants with advanced solid tumours, was authorized by the CHU de Québec-Université Laval in 16 weeks thanks to CATALIS Quebec’s FAST TRACK Evaluation Service. Although regulatory delays doubled the target launch timeframe, the CHU de Québec-Université Laval managed to rank first among launched sites, ahead of 12 sites in 5 countries around the world.
“Our first experience with CATALIS’ FAST TRACK Evaluation Service was a huge success. For a Phase I trial in oncology, we reduced our average launch time by two-thirds and attained two global ‘firsts’: the first site to be launched and the first preselected patient! We look forward to future victories and even faster launches with CATALIS.” – Stéphanie Veyrun-Manetti, Sanofi Canada General Manager, Specialty Care and Country Lead, Canada
The approval of Sanofi’s study using the FAST TRACK Evaluation Service is the third success for the CHU Québec-Université Laval, which had positioned itself as Roche’s ProHer study’s first launched site in the world, a study which was also recently authorized through CATALIS’ FAST TRACK Evaluation Service.
“In early-stage clinical research, where windows of opportunity are often very small, minimizing delays is critically important. Thanks to CATALIS’ FAST TRACK Evaluation Service, the CHU de Québec-Université Laval was the first group in the world to launch the Sanofi TCD17240 study and thus offer an additional potential therapeutic avenue for people with cancer.” – Dr. Maxime Chenard-Poirier, hematologist and oncologist at the CHU de Québec-Université Laval’s research centre
Patients at the Core of the CATALIS Network’s Mission and FAST TRACK Evaluation Service
By accelerating the launch of industry-financed clinical trials conducted in Quebec, CATALIS and its partners hope to foster innovation in clinical trials and reduce the time it takes to develop treatments with the potential to improve many Quebecers’ lives.
“Coalition Priorité Cancer au Québec is pleased to see the acceleration of the approval time for a clinical trial designed to find innovative treatments that will potentially improve the lives of patients with tumours. We thank CATALIS’ FAST TRACK Evaluation Service for facilitating innovation.” – Eva Villalba, MBA, MSc, executive director of Coalition Priorité Cancer au Québec
CATALIS would also like to thank all its public and private partners for their trust, their involvement in developing innovative clinical research approval methods, and their commitment to implementing them in their institutions.
If you are a pharmaceutical company and are interested in learning more about this service, please write to us at: info@catalisquebec.com.
