Critical Path Institute is a catalyst in the development of new approaches to advance medical innovation and regulatory science.
We achieve this by leading teams that share data, knowledge, and expertise, resulting in sound, consensus-based science. More…
Upcoming Events
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May 23, 2022 - May 24, 2022 Register Now | International 2022 Drug-induced Kidney Injury Biomarker Workshop
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Jun 15, 2022 Using Ontologies to Standardize Rare Disease Data Collection presented by Monarch Initiative
Past Events
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May 18, 2022 Generating Synthetic Longitudinal Data presented by Replica Analytics
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Apr 20, 2022 View Now | C-Path in Europe: Moving Global Regulatory Science Forward
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Apr 13, 2022 - Apr 14, 2022 13th Annual Patient-Reported Outcome Consortium Workshop
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Mar 16, 2022 View Now | AI-powered Real-world Simulations for Faster and Value-based Rare Disease Drug Development
Successes
- COA Qualification from FDA for Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD)
- Qualification of drug-induced kidney injury (DIKI) clinical safety biomarker, composite measure
- COA Qualification from FDA for the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
- C-Path receives COA qualification from FDA for the Symptoms of Major Depressive Disorder Scale (SMDDS)
- C-Path’s PKDOC Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD
- C-Path’s PKDOC Secures FDA Qualification for Enrichment Biomarker in ADPKD
- Regulatory Support For Autosomal Dominant Polycystic Kidney Disease Biomarker
- C-Path Opportunities Table
- EMA Qualifies ‘Hollow Fiber System’ For Anti-Tuberculosis Drug Development
- FDA and EMA issue first-of-their-kind Letters of Support for two Kidney Biomarkers
News
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May 16, 2022 The Critical Path for Parkinson’s Consortium Welcomes ESCAPE Bio
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Apr 28, 2022 C-Path to Lead Novel Pre-Consortium Framework for Optimizing the Rare and Orphan Medical Product Lifecycle
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Apr 14, 2022 Longtime Pharmaceutical Executive to Lead C-Path’s Sickle Cell Disease Consortium
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Apr 7, 2022 Doctor With Rare Disease And No Answers Decides To Find His Own Cure
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Apr 7, 2022 Castleman’s Disease: Behind the Mystery of Rare Disease
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Apr 5, 2022 New logo! Rare Disease Cures Accelerator-Data and Analytics Platform has a new look!