TUCSON, Az. and BERLIN, March 13, 2023 (Newswire) – The Critical Path Institute (C-Path), an independent nonprofit, public-private partnership with the U.S. Food and Drug Administration (FDA) and Pirche AG, the global leader in AI-powered molecular matching and prediction analysis, announced a new collaboration that will see Pirche become the latest member of C-Path’s Transplant Therapeutics Consortium (TTC).
“TTC is excited to welcome Pirche to join our ongoing efforts to bring together the bio-pharmaceutical industry, diagnostic companies, academia, professional societies, and government and regulatory agencies, to accelerate innovation and application of new tools across pharmaceuticals, devices, and diagnostics for transplant patients.” said Amanda Klein, Executive Director of TTC.
Co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS), TTC represents an ongoing partnership between key stakeholders dedicated to advancing the regulatory science needs in transplantation. The iBOX, a composite biomarker panel developed to predict the probability of long-term kidney graft survival, represents one such advancement. The consortium’s primary initiative includes the qualification of the iBOX as a reasonably likely surrogate endpoint with FDA in order to address the unmet needs of kidney transplantation and bring innovative therapies to patients in a timely, efficient manner.
Regarding the new collaboration, Pirche CEO, Thomas Klein said, “We are thrilled to be a part of the TTC and to support the consortium in delivering for transplant specialists and patients. TTC offers an opportunity to collaborate with the transplant community and maximize learnings across the field.”
Dr. Klemens Budde, Pirche scientific advisor, TTC Member, and head of Transplant Nephrology at the Charité University Hospital in Berlin added, “Pirche and the PIRCHE epitope matching technology compliment the TTC’s objectives perfectly. Epitope matching improves immunologic risk assessment towards a personalized treatment and may further complement initiatives like iBOX for kidney transplantation.”
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and 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 forming 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 biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. Operates from Dublin, Ireland with additional staff in multiple other locations. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government source(s), totaling $11,196,634. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
The Transplant Therapeutics Consortium (TTC) was launched in April 2017 and co-founded by the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS). The TTC is a collaboration between the transplant community, including industry, academia, professional societies, and regulatory agencies, and is managed and supported by the Critical Path Institute (C-Path). It aims to accelerate the medical product development process for transplantation by identifying 1) areas that have hindered product development, 2) potential biomarkers, endpoints, quantitative tools, or process improvements as solutions to address those areas, and 3) appropriate pathways to achieve regulatory endorsement for developed solutions.
About Pirche AG
Pirche AG, headquartered in Berlin, Germany is a leading artificial intelligence company focused on establishing digital solutions in molecular medicine. We aim to provide clinical decision support for predictive medicine through AI-powered algorithms. With better matching we help clinicians to individualize care to bring a better quality of life to transplant patients. To learn more visit www.pirche.com.