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Two New Projects Approved Through CATALIS' New FAST TRACK Evaluation Service

Roche's Multi-centre ProHer Study

Thanks to CATALIS’ FAST TRACK evaluation service, Roche’s ProHer multi-centre study, which explores a new treatment method for patients with breast cancer, was approved in 10 weeks by the CHU de Québec-Université Laval. More specifically, this study seeks to discover patients’ preference for at-home administration of a fixed-dose combination of Pertuzumab and Trastuzumab for subcutaneous administrate at the early or locally advanced/inflammatory stage.

With the acceleration of this Roche study’s evaluation process, the CHU de Québec-Université Laval has ranked first among all the launched sites in the world, out of a total of 65 sites in 17 countries across the globe. This isn’t the CHU de Québec-Université Laval’s first successful experience with the FAST TRACK evaluation service. In September 2021, the CHU de Québec-Université Laval participated in the FAST TRACK evaluation service’s first-ever multi-centre study, in which it successfully enrolled the world’s first patient, ahead of more than 1,000 sites in 40 countries.

“I was thrilled to learn that we were able to significantly reduce the ProHer multi-centre study’s authorization time thanks to CATALIS’ FAST TRACK evaluation service. In a world where patient recruitment is competitive, the opportunity to join forces with our institutions to speed up our timeframes means that canadian patients have the opportunity to access innovative treatments through our clinical trials. We are working to achieve better outcomes for even more patients, and the FAST TRACK evaluation service is an essential component which allows us to fulfill our organization’s ambition.”

- Christina Archer, Former Clinical Operations Portfolio Leader, Hoffmann-La-Roche

Sanofi's Phase I - II Study in Advanced Solid Tumours 

Sanofi's Phase I-II 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.

Launch of Our New Personalized Support Service for Patients and Clinicians

CATALIS, under the banner "Clinical Research Quebec", is proud to announce the launch of the pilot project for its new personalized support service for patients and clinicians. This innovative, bilingual and free resource is dedicated to patients and caregivers of all ages and medical conditions. It offers them a human support in their search for a clinical trial that meets their specific criteria, while answering their questions about clinical trials.

the Personalized Support Service is already available in its pilot form to the Regroupement québécois des maladies orphelines (RQMO), the Amyotrophic lateral sclerosis society of Quebec (ALS-Québec), Muscular Dystrophy Canada (DMC), the Quebec Division of the Multiple Sclerosis Society of Canada and the Federation Of Quebec Alzheimer Societies. 

The Federation of Quebec Alzheimer Societies Joins the CATALIS Network

CATALIS is delighted to welcome the Federation of Quebec Alzheimer Societies to its partners' network, which now includes 14 patient associations. The organization's mission is to prevent and alleviate the consequences of Alzheimer's disease and major neurocognitive disorders by contributing to research, training, support and information. Since 1989, it has awarded more than $70 million worth of grants for research projects that are chosen not only by peer reviewers, but also by people with the disease and their caregivers.

"Without significant involvement in clinical research (projects, awareness, recruitment, funding), no innovative remedy can be developed and make a real difference in the lives of people with the disease. The last treatment was approved by Health Canada more than 15 years ago."

Nouha Ben Gaied, Director of Research and Development - Quality of Services for the Federation

 

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New Employees Join the CATALIS Team

 

Dorothy McKelvey - Operations Manager

 

Dorothy has a total of 39 years of experience in clinical research. During 11 years she supervised the adult and pediatric clinical research and regulatory activities of the Centre for Innovative Medicine of the MUHC, including 2 years as Acting Assistant Director of Operations. Previously, she managed the rheumatology clinical research of the RI-MUHC during 26 years and also worked as a clinical trial monitor at Nymox start-up for Phase III studies across the US. She has expertise in clinical trial start-up and has conducted numerous activities related to quality audits and monitoring. As Operations Manager at CATALIS, Dorothy will be responsible for the implementation, oversight and performance of the FAST TRACK Evaluation Service and will assist in the management of other operational activities of the organization.

 

Mireille Dessureault - Project Manager, Clinical Trials

 

Mireille holds two master’s degrees in science, one in molecular biology from the Université de Montréal, and a second in experimental medicine from McGill University. Over the past few years, Mireille has worked as a clinical research coordinator in hospitals, as well as a clinical trials coordinator in pharmaceutical settings. Having started working in the field of basic research during her studies, she then became interested in the clinical aspect of oncology research. Mireille has worked in the fields of sarcoma, breast cancer, colorectal cancer and melanoma, which makes her a versatile project manager who will certainly be useful during the CATALIS FAST TRACK Evaluation Service pilot project.

 

Kristina Amja - Patient and Healthcare

Professional Services Agent

 

Kristina holds a Master of Science in Chronic Pain from McGill University. Over the past few years, Kristina has been involved in a number of research projects related to patient partnership and patient experience in the healthcare system. Kristina also holds a Yellow Belt in Lean Six Sigma, a skill that will undoubtedly contribute to the development of CATALIS’ Quality Management and Continuous Service Improvement Program. Kristina also applies this knowledge in her volunteer activities with the office of Quality and Continuous Improvement at the Montreal Children’s Hospital, where she helps maintain quality improvement and optimize the quality of life of the users of this institution.

 

Salomé Cohen - Patient and Healthcare

Professional Services Agent

 

Salomé holds a Bsc in Biomedical Sciences from the University of Ottawa and a MSc in Public Health from the Université de Montréal. Before joining CATALIS, Salomé worked in public health in the fight against the COVID-19 pandemic, supervising case-contact tracing and managing outbreaks. Over the past few years, Salomé has also been involved in volunteer work for causes that she is passionate about, such as food security and environmental protection. Through her experiences, Salomé has developed a real desire to improve overall population health and access to healthcare. It is with a strategic approach and the ambition of contributing to facilitating access to clinical research that Salomé joins the CATALIS team.

 

Orosca-Maria Houmey Communications Coordinator

 

Orosca-Maria holds a master’s degree in Public Communication from Laval University and has benefited from qualitative education on both sides of the Atlantic, in Belgium and Canada. Passionate about her field of expertise, communication, she acquired multiple professional experiences in journalism, writing, digital marketing, and even scientific research when she took part in the project “Pawòl Famn”: Intersectionality and Francophone Journalism in Quebec. Lately, she developped her leadership skills by being involved in various organizations such as AIESEC. To positively impact the community, she wants to give meaning to her career. Orosca-Maria intends to make every effort to promote CATALIS’s mission in order to achieve strategic objectives and help position Quebec as a leading figure in clinical research.

CATALIS Is Hiring

 

QUALITY SYSTEMS AND TRAINING SPECIALIST (CLINICAL RESEARCH) 

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PATIENT AND HEALTHCARE PROFESSIONAL SERVICES AGENT 

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PROJECT MANAGER, CLINICAL TRIALS 

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CATALIS Quebec is a non-profit partnership dedicated to the advancement and operational excellence of clinical research in Quebec.

Since 2017, CATALIS Quebec has been carrying out a large-scale government mandate to optimize Quebec’s clinical research environment. The CATALIS network's efforts are focused on providing more Quebec patients with access to tomorrow’s therapies.

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