AMSTERDAM and TUCSON, Ariz., July 19, 2023 /PRNewswire/ -- Today the Critical Path Institute (C-Path) announces the completion of the integration of C-Path Ltd. in Dublin, Ireland into the non-profit organization C-Path in Amsterdam, the Netherlands. This integration will allow C-Path to increase its activity in Europe and expand its global operations. C-Path operates in Europe as a non-profit organization that builds consensus among its stakeholders from around the world to improve public health. The organization shares experience, data, risks and costs to advance regulatory science.
"We are delighted to bring together the talented European teams as a unified organization. Doing so allows us to expand our presence in Europe and strengthen our global operations. With this integration, we will continue to build consensus among stakeholders and share expertise that drives global regulatory science. and data science that are improving public health around the world," said Cécile Ollivier, Managing Director of C-Path in Europe.
Shortly after its founding in 2005, C-Path began building relationships with European entities. In 2007, the C-Path Predictive Safety Evidence Consortium was the first collaboration to submit through pilot qualification procedures a package of evidence for seven biomarkers of renal safety to the US Food and Drug Administration, the European Medicines Agency (EMA) and the Japan Pharmaceutical and Medical Devices Agency. In May 2008, the EMA issued a statement of final conclusions for these biomarkers of nephrotoxicity. To date, the total number of C-Path EMA rating opinions is nine, with the same number of letters of support.
As part of the C-Path Data Collaboration Center (DCC), the Ireland team participates in global efforts. The DCC was founded to deliver secure, large-scale data solutions for medical research and to provide unsurpassed expertise in the selection, standardization, analysis, and sharing of medical data from around the world. DCC operates in neutral space with a focus on accelerating clinical research and improving treatments by maximizing the utility of medical data.
Since 2019, C-Path's work in Ireland has focused on two programs under the Innovative Medicines Initiative (IMI) AMR Accelerator: The European Tuberculosis Regimen Accelerator (ERA4TB) and the United Academy and Industry of Innovation and Tuberculosis Treatment (UNITE4TB). C-Path is the lead data management work package partner for these projects, where the Ireland-based data management team is collaborating with partners, resulting in 124 standardized data sources ( 93 preclinical and 31 clinical trial data sources) made available to consortium partners to support their research requirements. In addition to project-specific efforts on these TB initiatives, C-Path continues to maintain and expand the content of the TB Platform for Aggregation of TB Clinical Studies (TB-PACTS), which the global community of TB researchers may be formally accessed and used by TB to support its ongoing research activities.
"We acknowledge and appreciate the outstanding contributions of Patrick O'Meara, Head of the Data Team, and our Ireland-based data management team in advancing TB initiatives. Their collaborative efforts have played a critical role in supporting global regulatory strategies and driving advances in drug development," said Richard Liwski, CTO of C-Path. "We extend our thanks to Patrick and the team as we continue to make significant progress on these crucial efforts. We look forward to continuing to be involved in the growth and activities of C-Path European."
C-Path celebrates the successful integration and expansion of nonprofit operations in Europe. With this strengthened global presence, he remains committed to leading collaborations that accelerate drug development, advancing better treatments for people around the world.
About Critical Path Institute
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. As 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 and C-Path Europe is headquartered in Amsterdam, The Netherlands, with additional staff in many other locations. For more information, visit c-path.org.
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