News
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July 26, 2018
First-ever biomarker qualified for Parkinson’s is a vital step toward improved clinical trials
FOR IMMEDIATE RELEASE Contact: Kissy Black 615.298.1144 kissyblack@lotosnile.com Tucson, AZ — July 26, 2018 – The Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), in partnership with Parkinson’s UK, announces that the European Medicines Agency (EMA) has issued a positive qualification opinion on an imaging test (biomarker) as a tool to enrich... - May 18, 2018
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May 7, 2018
C-Path Receives COA Qualification from FDA for the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
TUCSON, Ariz. – May 7, 2018 — Critical Path Institute‘s (C-Path) Patient-Reported Outcome (PRO) Consortium announces its second clinical outcome assessment (COA) qualification from the US Food and Drug Administration (FDA). The qualification of the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) for exploratory use represents another major milestone for the PRO Consortium and,... -
April 26, 2018
CPTR Newsletter – April 2018
CPTR Newsletter – April 2018 In this issue: ReSeqTB to be Adopted for WHO Surveillance of Drug-Resistant TB New Collaborations Expand TB-PACTS Database and Leverage Data for Analyses CPTR Workgroup Works to Advance Regulatory Qualification of LAM, a Promising New Biomarker TB-PBPK Model Progresses Toward EMA and FDA Qualification TB-ReFLECT Update: A Collaborative Effort... -
April 16, 2018
Helmsley Charitable Trust Awards Critical Path Institute a Grant to Focus on Crohn’s Disease Biomarkers
Tucson, AZ, and New York, NY – April 16, 2018 — The Leona M. and Harry B. Helmsley Charitable Trust has awarded Critical Path Institute (C-Path) a grant to support a Crohn’s disease biomarker pre-consortium. The pre-consortium will identify unmet needs for the use of biomarkers in developing new treatments for people with Crohn’s disease. Currently,...