AMSTERDAM and TUCSON, Ariz., April 26, 2023 /PRNewswire/ — Critical Path Institute (C-Path), an organization that generates regulatory-sanctioned methodologies and solutions to accelerate drug development, today released an annual summary of its activities in Europe to advance global regulatory science.
“We are pleased with the continued progress and development of our global efforts in the data science and regulatory spaces,” explained C-Path Europe Managing Director Cécile Ollivier, M.S. “As our work builds on the successes of C-Path’s 15-year presence in Europe, we look forward to strengthening partnerships in key areas with the greatest potential to accelerate global drug development in areas of high unmet need and benefit.” for public health.”
In 2022, the EMA issued two Qualification Opinions, one for the Type 1 Diabetes Consortium enrichment biomarkers for T1D prevention clinical trials and one for the Transplant Therapeutics Consortium iBox scoring system as endpoint secondary efficacy in clinical trials investigating new immunosuppressive drugs in kidney transplant patients.
In addition, the EMA issued two Letters of Support for the Critical Path for Parkinson Consortium’s Model-Based Clinical Trial Simulation Platform for Parkinson’s Disease and for the Duchenne Muscular Dystrophy Model-Based Clinical Trial Simulation Platform. Duchenne Regulatory Scientific Consortium.
These Rating Opinions and Letters of Support drive the ongoing transformation of drug development and trial design paradigms, bringing the total number of C-Path EMA Rating Opinions and Letters of Support to nine.
“It has been exciting to be a part of the growth of C-Path in Europe,” said Tomas Salmonson, MD, MSc, C-Path Board Member and former Chairman of the Committee for Medicinal Products for Human Use of the European Medicines Agency. Medicines (EMA). Cécile and the C-Path teams have worked hard over the last year to ensure that C-Path contributes to the advancements of the EMA’s Regulatory Science Strategy.”
C-Path has always been committed to providing the greatest opportunities for rapid improvement and benefits for global public health. Efforts led by C-Path to catalyze and accelerate TB drug development date back to 2010 and are currently focused on supporting two programs under the Innovative Medicines Initiative AMR Accelerator: : European Regimen Accelerator for Tuberculosis (ERA4TB) and the Academy and Industry United Innovation and Treatment for Tuberculosis (UNITE4TB).
In addition, as part of its International Neonatal Consortium, a global C-Path collaboration formed to forge a predictable regulatory pathway for evaluating the safety and efficacy of neonatal therapies, C-Path has received electronic patient record (EPR) data. fully anonymous from the UK National Neonatal Research Database (NNRD). This is the largest NNRD data transfer to date and the first time C-Path has received EPR data from the UK. This will contribute to a neonatal pilot project funded by a US Food and Drug Administration grant to better understand and find treatments for bronchopulmonary dysplasia, a chronic lung disease that commonly affects premature babies.
Overall, C-Path’s annual report highlights its continued commitment to advancing regulatory science and its efforts to streamline the drug development process through practical tools and solutions. C-Path looks forward to continuing collaboration and efforts on a global scale to fulfill its mission of accelerating the path to a healthier world.
About the Critical Path Institute The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 as a public-private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in building collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotechnology companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, The Netherlands, and C-Path Ltd. operates out of Dublin, Ireland with additional staff in many other locations. For more information, visit c-path.org.
Contact: Kissy Black C-Path 615.310.1894kblack@c-path.org
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