In support of Critical Path Institute’s mission to catalyze innovation that accelerates the path to a healthier world, C-Path has announced the opening of its EU nonprofit headquarters in the Netherlands, which will focus on the development of existing and future activities in Europe.
C-Path is recognized globally as a leader in regulatory science, with extensive knowledge and experience in seeking and obtaining regulatory endorsement of drug development tools or novel methodologies in cooperation with the U.S. Food and Drug Administration, the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency. All C-Path regulatory-endorsed tools and methodologies are freely available to the broader scientific community.
The nonprofit’s headquarters in Amsterdam will extend and complement C-Path’s activities to improve public health, as well as share expertise, data, risks and costs to expedite advancements in global regulatory science by facilitating public-private partnerships with members from the biopharmaceutical industry, government regulatory agencies, academic institutions and patient groups in Europe.
“C-Path already has an established and longstanding presence in Europe,” said Tomas Salmonson, C-Path board member and former chair of the EMA Committee for Medicinal Products for Human Use. “We look forward to facilitating existing and new collaborations to productively support European Regulatory Science research programs and also contribute to the delivery of the EMA Regulatory Science Strategy to 2025.”
Since its inception in 2005, C-Path has worked to forge relationships and collaborations in Europe in tandem with U.S. efforts to facilitate global collaboration. Since then, C-Path has received a significant number of Qualification Opinions and Letters of Support from EMA and has a substantial track record of successful DDT and novel methodology endorsements by FDA, EMA and PMDA. These regulatory milestones have contributed to addressing different unmet needs in medical product development, which have transformed drug development in different areas (among others, tuberculosis, polycystic kidney disease, Alzheimer’s, Parkinson’s and irritable bowel syndrome).
“Advances in drug development are rapidly playing out on a global stage, and C-Path’s extensive background in accelerating the drug development and regulatory processes will fuel innovation for the development of novel approaches that can be endorsed by regulators in many countries,” said C-Path CSO Dr. Klaus Romero. “Working together with European organizations remains a key C-Path priority. We’re excited to have an office in Amsterdam, which we know will serve to enhance our collaborative efforts and speed the development of treatments for some of the world’s most complex health issues.”