C-Path and Eisai Data Sharing Collaboration to Include Lennox-Gastaut Syndrome Registry and Clinical Trial Data
TUCSON, Ariz., Nov. 2, 2022 — Critical Path Institute (C-Path) and the Eisai Co., Ltd. (Eisai) today announced a joint collaboration to significantly promote data sharing and incorporate Lennox-Gastaut Syndrome (LGS) clinical trial data, into C-Path’s Rare Disease Cures Accelerator-Data and Analytics Platform (RDCA-DAP®).
Lennox-Gastaut syndrome is a severe form of epilepsy with seizures occurring in early childhood, usually between ages 3 and 5. LGS affects an estimated 1 to 2 per million people. Often, due to uncontrolled seizures or falls, people with LGS have a death rate between 3% and 7% over 10 years after their diagnosis.
C-Path’s RDCA-DAP provides a centralized and standardized infrastructure to support and accelerate rare disease characterization targeted for clinical development. Additionally, the platform includes a framework that supports the rigorous conduct of natural history studies, with attention to established data quality standards, in order to be most useful to clinical trial design and regulatory review. It includes a robust, integrated database and analytics hub that allows for the aggregation of rare disease data from various sources and the efficient and effective interrogation of that data.
“This is another big win for patients and healthcare professionals hoping to accelerate drug development for LGS,” said Alexandre Bétourné. “We look forward to expanding the scope of Eisai’s datasets in RDCA-DAP as new studies generate additional clinical data. Over time, the integration of these data will lead to valuable discoveries, helping to improve clinical trial design for LGS and inform future work for related neurological disorders.”
From a small suburban R&D lab with a team of 15 researchers, to a global enterprise ranking among the top 20 in pharma worldwide, Eisai has become a global R&D based pharmaceutical company, adapting and evolving over the more than 80 years since it was first established in 1936. Today, it is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities.
Groups interested in contributing data to RDCA-DAP may visit, c-path.org/rdca-dap or email firstname.lastname@example.org. The platform is now OPEN and accepting applications for use; visit https://portal.rdca.c-path.org to apply and learn more.
About Critical Path Institute
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 Department of Health and Human Services (HHS) and is 55% funded by the FDA/HHS, totaling $17,612,250, and 45% funded by non-government source(s), totaling $14,203,111. 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.