December 13, 2021
The Montreal Heart Institute (MHI) announces that it has won a request for proposals from the Fonds d’accélération des collaborations en santé (FACS). Pierre Fitzgibbon, Minister of Economic and Innovation, announced today a $9.35 million grant from the Government of Quebec to develop and deploy the project entitled Paradigm Shift in the Conduct of Clinical Trials.
Launched by Dr. Jean-Claude Tardif, Director of the MHI Research Centre and Professor of Medicine at the Université de Montréal, this major public-private partnership initiative, worth more than $21.7 million, aims to develop a digital platform for conducting virtual clinical trials that do not require in-person visits.
“Our teams at the Research Centre and the Montreal Health Innovations Coordinating Centre (MHICC) of the Montreal Heart Institute, as well as the team at Ecogène-21 are proud to mobilize a strong Quebec-wide network of public and private collaborators to lead this major initiative that addresses a critical need to transform traditional clinical trials,” said Dr. Tardif. “The use of new technologies in an integrated, patient-centred approach will allow patients to participate in clinical trials from the comfort of their own homes. This important paradigm shift will facilitate recruitment, retention and follow-up of participants while testing more potential therapies. Aimed at transforming the clinical trial environment in Quebec and around the world, this project has the potential to make Quebec a world leader in the field while accelerating value creation for our life sciences ecosystem, patients and healthcare system.”
The Paradigm Shift in Clinical Trials Project
The revolution in digital technologies and the pandemic environment have spurred new approaches to clinical trial conduct. This new reality allows for the responsible use of clinical data to reach out and educate the public on the importance of clinical research. The Paradigm Shift in the Conduct of Clinical Trials project will virtually conduct high-quality studies using innovative technologies for patient recruitment, retention and follow-up to achieve performance thresholds well beyond conventional approaches.
The virtual model will be used for clinical trials in cardiovascular and metabolic diseases, inflammatory diseases, cognitive disorders and dementia, rare diseases, infectious diseases and cancers. The approach will also strengthen registry studies. The Montreal Health Innovations Coordinating Centre (MHICC) of the Montreal Heart Institute and Ecogène-21 will serve as the research organizations coordinating the virtual clinical trials conducted under this initiative.
A Project Enabled by Major Public-Private Partnerships
The Fonds d’accélération des collaborations en santé (FACS) is a flagship measure of the Stratégie québécoise des sciences de la vie (SQSV) 2017-2027 of the Ministry of Economic and
Innovation, coordinated by the CQDM, that has the objective to support ambitious projects that stimulate public-private collaborations, strengthen the innovation chain and increase the maturity of Quebec SMEs (small and medium-sized enterprises).
In addition to the $9.35 million from the Government of Quebec, this project is enabled by more than $12.3 million in private partner investments, including 10 Quebec SMEs, Ecogène-21 and the Montreal Heart Institute Foundation. These private partners include IT and artificial intelligence companies such as Omnimed for the management of electronic medical records and patient portals, Kelvin Zero for the patient identity and data encryption and traceability between initiative databases and Perceiv AI for the analysis of megadata generated in clinical trials. The biopharma companies Ingenew Pharma and DalCor Pharmaceuticals are also working with the MHI in this major project.
Renibus Therapeutics and the investment firm InvHealth Capital are also partners. Finally, medical device companies Stratuscent, Optina Diagnostics and Labeo Technologies are also involved.
The project is also supported by several academic partners. These include Polytechnique Montréal, McGill University’s Centre for Genomics and Policy, Centre Hospitalier de l’Université de Montréal and its Centre of Excellence for Partnership with Patients and the Public, Université de Montréal’s Centre de médecine génique communautaire in Saguenay, Université de Montréal’s Beaulieu-Saucier Pharmacogenomics Centre at the MHI, Centre Hospitalier Universitaire de Sherbrooke, Maisonneuve-Rosemont Hospital, Centre Hospitalier Universitaire de Québec – Université Laval, as well as academic and family medicine groups in several Quebec region.
Other collaborators include Quebec Heart and Lung Institute, Montreal Clinical Research Institute, My Intelligent Machines and Imagem.
The Centre of Excellence for Partnership with Patients and the Public will mobilize patients and citizen partners in an advisory group to provide their perspectives and recommendations on the approaches developed and assess their accessibility and acceptability.
“Ecogène-21, a not-for-profit clinical research organization dedicated to access innovation for unmet medical needs, is proud to participate in the virtual clinical trials project. This exciting project will help increase access to clinical trials and act as an economic development catalyst for Quebec’s small and medium-sized enterprises working in biotechnology and in connected health solutions. Ecogène-21 will design, coordinate, and execute clinical studies to promote access to innovative treatments for people with rare or severe lipid diseases. In addition to fostering the development of connected solutions tailored to clinical research, various study drug delivery strategies will be tested across all studies in this project, including those carried out by MHI, in which we will develop medical drones in collaboration with the Civil and Commercial RPAS Niche of Excellence in Alma”, said Dr. Daniel Gaudet, Scientific Director of Ecogène-21 and the Centre de médecine génique communautaire in Saguenay.
“To improve care, together, we first need to provide patients with simple and effective access to clinical studies that are relevant to their care pathway so that they can contribute in an informed way to improving modern medicine. Quebec has created a powerful collaborative force between
patients, their care team, and researchers with this initiative. The health crisis has revealed the importance of clinical data to guide care. As a pioneer in the ‘electronic medical record’ and in managing millions of Quebecers’ clinical data, Omnimed will make available to patients the tools needed to accelerate clinical research in Quebec”, said Nicolas Beaudet, Scientific Director of Omnimed.
“We are delighted to collaborate with the Montreal Heart Institute and the many other partners who are part of this initiative. For us at Kelvin Zero, protecting citizens privacy and sensitive data are at the heart of our operations. This site-less clinical trials project will benefit from our innovative solution and ensure the protection of medical and personal records”, said Philippe Desmarais, CEO of Kelvin Zero.
“The significant costs of conventional clinical trials limit the creation and growth of biotech companies in Quebec, which too often results in their premature acquisition by foreign entities before they can generate value. Reducing costs by conducting virtual clinical trials will bring competitive advantages to Quebec through the creation and growth of biotech and biopharma companies”, said Pierre Laurin, President and CEO of Ingenew Pharma and InvHealth Capital.
About the Montreal Health Innovations Coordinating Center (MHICC):
The Montreal Health Innovations Coordinating Center (MHICC) is a leading academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4,500 clinical sites in more than 30 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing. www.mhicc.org