A CRO, or contract research organization, is a company that provides, on a contractual basis, services in the biomedical research field. Given their crucial role in the development of new treatments and technologies, as well as their economic importance, BIOQuébec and CATALIS, with financial support from the Ministry of Economy and Innovation, conducted a study of Quebec CROs to chart the sector’s impact and measure its growth, strengths, and needs.

studyreportGuest UserMay 9, 2023BIOOQuébecinnovation, study report, biopharmaceutical

Acasti Pharma Announces Positive Results for Pharmacokinetic Bridging Study, With Intravenous GTX-104 Meeting All Endpoints

LAVAL, Québec, May 18, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST) announced today that the top line results of its pharmacokinetic (PK) bridging study with IV GTX-104, the Company’s lead drug candidate for the treatment of Subarachnoid Hemorrhage (SAH), met all its planned study endpoints. The primary objective of the study was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy adult male and female subjects, while the secondary objective was to assess its safety and tolerability. The Company plans to submit these results to the US Food and Drug Administration (FDA), along with its proposed study design for the Phase 3 safety study which is on track to start in the second half of 2022. The safety study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting a New Drug Application to the FDA.

NewsGuest UserMay 26, 2022BIOOQuébecstudy report, FDA, quebec, innovation

A Framework for Action to Support Quebec’s Biopharmaceutical Innovations and Bolster Quebec’s Autonomy

BIOQuébec commissioned The JBL Group to produce a comprehensive account of the situation by first, rigorously documenting the Quebec healthcare system’s recommendation process for Quebec-based innovations and secondly, to develop, with industry partners, public policy proposals that would support the Quebec biopharmaceutical industry’s innovations and development. BIOQuébec’s review was prompted by a widespread perception among many members that Quebec-based drugs and biopharmaceutical industry products were unfavourably considered by the Quebec health and social services network.

studyreportGuest UserMay 24, 2022BIOOQuébecinnovation, study report, biopharmaceutical

Results of the Study on the Integration of Innovations – BIOQuébec Outlines a Framework for Action to Support Quebec’s Biopharmaceutical Innovations and Bolster Quebec’s Autonomy

Bromont (Québec), April 21 2022 — BIOQuébec is pleased to be releasing the results of a study on the integration of Quebec innovations into our healthcare system. It is also suggests courses of action to better support Quebec-based biopharmaceutical innovations during the entire process and strengthen Quebec’s autonomy.

press releaseCatherine LamontagneApril 22, 2022integration, innovation, study report

Study on Public Policies and Financing

The biotechnology and CRO industry issues 17 financing and public policy.

studyreportGuest UserNovember 14, 2019Public policies, Financing, study, study report

CROs in Québec

Their concentration, the nature of their involvement in research, and their economic power confirm that Québec’s CROs are a key element in the life sciences innovation chain.

studyreportCatherine LamontagneApril 3, 2017CROS, study report, socio-economic, development, province