Critical Path Institute, founded in 2005 in Tucson, Arizona, is an independent, nonprofit organization dedicated to bringing together experts from regulatory agencies, industry, and academia to collaborate and improve the medical product development process. More…
Upcoming Events
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Apr 21, 2021 WEBINAR | RDCA-DAP: Searching, visualizing and exploring data in the RDCA-DAP platform to identify data of interest for advanced analysis
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May 7, 2021 COVID-19 Mitigation Strategies in Pediatric Rare Disease Clinical Trials Virtual Workshop
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Jun 15, 2021 - Jun 16, 2021 Design of Clinical Trials in New-Onset Type 1 Diabetes: Regulatory Considerations for Drug Development
Past Events
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Apr 14, 2021 12th Annual Patient-Reported Outcome Consortium Workshop
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Mar 31, 2021 2021 PSTC Virtual Workshop
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Mar 10, 2021 View Now: IBD Biomarker Regulatory Science Webinar
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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Apr 14, 2021 CPTA Welcomes Triplet Therapeutics Chief Medical Officer as Industry Co-Director
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Apr 12, 2021 C-Path’s Alzheimer’s Disease Consortium Expands Data Repository
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Apr 8, 2021 CP-SCD Announces Pfizer Executive as its First Industry Co-Director
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Apr 6, 2021 C-Path Welcomes Dr. Ramona Belfiore Oshan as D-RSC Associate Director
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Mar 31, 2021 Cures Within Reach Names CURE ID as 2021 Patient Impact Awardee
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Mar 31, 2021 Introducing Dr. Alexandre Bétourné, RDCA-DAP Scientific Director