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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Apr 18, 2023 - Apr 20, 2023 April 18 – 20 | 2023 CDRC Annual Meeting
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Apr 19, 2023 - Apr 20, 2023 Register Now: 14th Annual Patient-Reported Outcome Consortium Workshop
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Apr 27, 2023 Register Now | Clinical Outcome Assessments: Does one size fit all?
Past Events
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Mar 15, 2023 View Now | CP-RND: An Introduction to the Patient Community
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Feb 22, 2023 Breaking Down Barriers in Support of Patients with Rare Diseases
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Feb 20, 2023 3rd PSTC Japan Safety Biomarker Workshop (presentations available)
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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Mar 14, 2023 C-Path Welcomes BioCentury Inc. Co-Founder Bernstein to Board of Directors
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Mar 8, 2023 C-Path Welcomes TransPerfect Life Sciences
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Feb 17, 2023 C-Path Stands with Bruce Willis, Neurodegenerative Disease Community After FTD Diagnosis
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Feb 15, 2023 Airway Therapeutics Joins C-Path’s International Neonatal Consortium
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Feb 14, 2023 Regulus Therapeutics Joins PKDOC
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Feb 7, 2023 Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) Joins PKDOC