Critical Path Institute
Amsterdam and Tucson, Ariz. (ots /PRNewswire)
As an organization that develops regulatory-approved solutions and methodologies to accelerate drug development, the Critical Path Institute (C-Path) today released an annual review of its Europe-focused activities to advance global regulatory science.
“We are pleased with the progress and continued development of our global regulatory and data science efforts,” said Cécile Ollivier, MS, Managing Director of C-Path Europe. “As our work builds on the achievements of C-Path’s 15-year presence in Europe, we look forward to forging partnerships in key areas with the greatest potential to accelerate global drug development in areas of high unmet need and for public health benefits strengthen.
In 2022, the EMA issued two qualification opinions, one for the enrichment biomarkers of the Type 1 Diabetes Consortium for clinical trials on T1D prevention and one for that Therapeutics Consortium iBox Scoring System as a secondary efficacy endpoint in clinical trials investigating new immunosuppressive drugs in renal transplant patients.
In addition, the EMA has two letters of support for the Critical Path for Parkinson’s Consortium’s Model-based Clinical Trial Simulation Platform for Parkinson’s Disease and for them Duchenne Regulatory Science Consortium’s Model-based Clinical Trial Simulation Platform for Duchenne Muscular Dystrophy displayed.
These qualification opinions and letters of support encourage ongoing change in study design and drug development, bringing the total number of EMA qualification opinions for C-Path to nine and the same number of letters of support.
“It has been exciting to be part of C-Path’s growth in Europe,” said C-Path Board Member Tomas Salmonson, Ph.D., MS, and former Chair of the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use. “Cécile and the teams at C-Path have worked hard over the past year to ensure that C-Path advances the EMA’s Regulatory Science Strategy.”
C-Path has always strived to provide the greatest opportunity for rapid improvement and global public health benefits. C-Path-led efforts to advance and accelerate tuberculosis drug development dates back to 2010 and are currently focused on supporting two programs under the Innovative Medicines Initiative’s AMR Accelerator: European Regimen Accelerator for Tuberculosis (ERA4TB) and the Academia and Industry United Innovation and Treatment for Tuberculosis (UNITE4TB).
As part of the International Neonatal Consortiuma global C-Path collaboration aimed at creating a predictable regulatory pathway for evaluating the safety and efficacy of therapies for newborns C-Path fully anonymized Electronic Medical Record (EPR) from the UK’s National Neonatal Research Database (NNRD) receive. This is the NNRD’s largest data transmission to date and the first time C-Path has received UK EPR data. This will contribute to a neonatal pilot funded by a U.S. Food and Drug Administration grant to better understand and find treatments for bronchopulmonary dysplasia, a chronic lung disease that commonly affects preterm infants.
Overall, C-Path’s annual review underscores C-Path’s continued commitment to advancing regulatory science and efforts to streamline the drug development process through actionable tools and solutions. C-Path looks forward to continued partnerships and global efforts to fulfill its mission to accelerate the journey to a healthier world.
Information on the Critical Path Institute
The Critical Path Institute (C-Path) is an independent, non-profit organization founded in 2005 as a public-private partnership. C-Path’s mission is to advance the development of new approaches that advance medical innovation and regulatory science, accelerating the journey to a healthier world. As a global leader in forming collaborations, C-Path has formed 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 biotech companies. C-Path US is headquartered in Tucson, Arizona, where C Path in Europe is in Amsterdam, The Netherlands and C-Path Ltd. operates out of Dublin, Ireland and has additional employees in several other locations. For more information, see c-path.org.
Contact:
Kissy Black
C-Path
615.310.1894 [email protected]
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