European HeadquartersNews & Events
Advancing Adoption of Novel Safety Biomarkers into Drug Development through Voluntary Submission of Data at US FDA, EMA, and PMDA
Presenter – E Gribble Walker, M Brumfield, E H Dennis Conference – Society of Toxicologists 2013 Annual Meeting
FDA, IMI, and Patient Advocates to Present at CDISC 2012 International Interchange Formal Launch of CFAST – Collaboration between C-Path and CDISC
The Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path) announce the launch of the Coalition For Accelerating Standards and Therapies (CFAST), a follow-up to the partnership agreement signed earlier this year. The official launch of CFAST will take place at the CDISC 2012 International Interchange in Baltimore, Maryland (24-26 October 2012).
European Medicines Agency Deems Imaging Biomarker a Qualified Measure to Select Patients with Early Stages of Cognitive Impairment for Alzheimer’s Disease Clinical Trials
Based on a request for regulatory review by Critical Path Institute’s (C-Path) Coalition Against Major Diseases (CAMD), the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has issued a positive opinion on the use of magnetic resonance imaging (MRI) to measure hippocampal volume as a tool to enrich recruitment into regulated clinical […]
Critical Path Institute and Innovative Medicines Initiative Announce Formal Collaboration
Internationally renowned organizations share common commitment to advancing science that improves medical product development. Critical Path Institute and the Innovative Medicines Initiative (IMI) announced today that they have signed a Memorandum of Understanding to further the missions of both organizations.
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C-Path Successes
- >>First preclinical safety biomarkers (7) qualified by the FDA, EMA and PMDA
- >>First imaging biomarker for trial enrichment qualified by the EMA
- >>FDA and EMA reach landmark decisions on C-Path’s Simulation Tool for Alzheimer’s disease
- >>C-Path’s Alzheimer’s Disease Simulator Featured in the Wall Street Journal
- >>C-Path and CDISC partnership delivers therapeutic area standards
- >>FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
- >>EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- >>Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- >>C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- >>C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD