News & Events
January 22, 2018
Critical Path Institute Receives Regulatory Support for Liver Injury BiomarkerTucson, AZ — January 22, 2018 — Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) has issued a Letter of Support for measurement of glutamate dehydrogenase (GLDH) as a biomarker of hepatocellular liver injury. The letter was awarded to C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC)...
January 17, 2018
C-Path welcomes Kay Holcombe to its Board of DirectorsJanuary 17, 2018 TUCSON, Ariz., January 17, 2018 — The Critical Path Institute (C-Path) is pleased to welcome Kay Holcombe to its Board of Directors. Recently retired as Senior Vice President for Science Policy at the Biotechnology Innovation Organization (BIO), Ms. Holcombe brings to the Board her extensive experience in health care and regulatory policy, a...
December 18, 2017
C-Path receives COA qualification from FDA for the Symptoms of Major Depressive Disorder Scale (SMDDS)Tucson, AZ – December 18, 2017 Critical Path Institute‘s (C-Path) Patient-Reported Outcome (PRO) Consortium announces its first clinical outcome assessment (COA) qualification from the US Food and Drug Administration (FDA) for the Symptoms of Major Depressive Disorder Scale (SMDDS). This qualification of the SMDDS for exploratory use represents a major milestone for the...
December 4, 2017
C-Path and FARA announce collaborative data aggregation project for Friedreich’s ataxiaTucson, AZ, and Downingtown, PA — December 4, 2017 — Critical Path Institute‘s (C-Path) Data Collaboration Center (DCC) and the Friedreich’s Ataxia Research Alliance (FARA) have announced that they will work together to develop an aggregated database of clinical data for Friedreich’s ataxia (FA). Use of this database will promote collaborative research to...
October 18, 2017
C-Path and CDISC Announce Therapeutic Area User Guide for Duchenne Muscular DystrophyOctober 18, 2017 TUCSON, Ariz., and AUSTIN, Texas – October 18, 2017 –Critical Path Institute (C-Path) and The Clinical Data Interchange Standards Consortium (CDISC) announce the open availability of a Duchenne Muscular Dystrophy Therapeutic Area User Guide (TAUG-DMD v1.0), which describes the most common clinical concepts relevant to Duchenne studies using the CDISC standard format. This format...