C-Path’s PSTC, D-RSC Receive Positive FDA Response for Drug-Induced Skeletal Muscle Injury Biomarkers

Safety biomarkers aim to provide an additional tool for detecting acute drug-induced skeletal muscle injury in phase 1 clinical trials.

TUCSON, Ariz., July 22, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) in the U.S. Food and Drug Administration (FDA) issued a positive response to the Letter of Intent (LOI) developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC), for a panel of four safety biomarkers of acute drug-induced skeletal muscle injury.

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C-Path’s PSTC, D-RSC Receive Positive FDA Response to Plan for Liver Safety Biomarker

Biomarker aims to provide an additional tool for detecting the onset of hepatic injury in clinical trials involving patients with inherited muscle disorders.

TUCSON, Ariz., July 21, 2020 — Critical Path Institute (C-Path) announced today that the Biomarker Qualification Program (BQP) at the Center for Drug Evaluation and Research (CDER) from the U.S. Food and Drug Administration (FDA) issued a positive response to the Qualification Plan (QP) for glutamate dehydrogenase (GLDH) as a safety biomarker for drug-induced liver injury (DILI), developed by C-Path’s Predictive Safety Testing Consortium (PSTC) and Duchenne Regulatory Science Consortium (D-RSC).

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C-Path Data Collaboration Center Analytics Team Wins Metadata Automation DREAM Challenge

TUCSON, Ariz., July 14, 2020 — Tucson-based Critical Path Institute (C-Path) today proudly announced that the analytics team from its Data Collaboration Center (DCC) program has won first place in the validation phase of the Metadata Automation DREAM Challenge, funded by the Cancer Moonshot℠ initiative. The mission of C-Path’s DCC program is to provide large-scale data collaboration solutions to support scientific research and advance medical innovation.Continue reading

C-Path Launches CURE Drug Repurposing Collaboratory to Accelerate Identification of New Uses of Existing Drugs to Treat Infectious Diseases, Including COVID-19

Clinicians to report novel uses of existing drugs through FDA-NCATS CURE ID Mobile App.

TUCSON, Ariz., June 23, 2020 — As millions of patients struggle with diseases that lack adequate treatments, there is a critical need to understand how existing drugs can be used in new ways to improve clinical outcomes. Health care professionals use drugs in novel ways as a potential life-saving intervention when no specific approved therapies are available. However, without the ability to share these experiences in a systematic manner, the clinical and research communities cannot benefit from lessons learned.Continue reading

C-Path’s Transplant Therapeutics Consortium Receives Acceptance of Letter of Intent for iBox Scoring System (Composite Biomarker Panel) as a Reasonably Likely Surrogate Endpoint

 

Biomarker aims to streamline the development of novel therapies intended to improve long-term outcomes for kidney transplant recipients.

 

TUCSON, Ariz., June 17, 2020 — Critical Path Institute (C-Path) announced today that its Transplant Therapeutics Consortium (TTC) has received a positive response to its Letter of Intent (LOI) from the U.S. Food and Drug Administration (FDA) detailing the decision to accept the Composite Biomarker Panel (iBox Scoring System) into the Center for Drug Evaluation and Research (CDER) Biomarker Qualification Program (BQP).Continue reading

C-Path and Provention Bio Announce Data Sharing Collaboration to Develop Advanced Drug Development Tools in Type 1 Diabetes

 

TUCSON, Ariz., and OLDWICK, N.J. May 13, 2020 — The Critical Path Institute (C-Path) and Provention Bio, Inc. (Nasdaq: PRVB) are proud to announce their collaboration to significantly improve the scientific community’s insight into type 1 diabetes (T1D) through Provention’s contribution of data from the Phase III Protégé study of teplizumab to the T1D Trial Outcome Measures Initiative (TOMI) integrated database. The Protégé study evaluated teplizumab on the preservation of beta cell function in newly onset T1D patients and generated the largest disease modifying interventional clinical trial dataset in T1D with more than 500 patients.Continue reading

C-Path Receives Letter of Support from EMA on Type 1 Diabetes Biomarker Initiative

 

 

TUCSON, Ariz., April 28, 2020 — The Critical Path Institute (C-Path) today announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to diagnose T1D: insulin autoantibodies, glutamic acid decarboxylase 65, and insulinoma antigen-2 autoantibodies as enrichment biomarkers for T1D clinical trials.Continue reading

C-Path Awarded FDA Contract to Enhance the Assessment of Clinical Outcomes in Pediatric Asthma Treatment Trials

Resulting novel drug development tools will support patient-focused drug development for children with asthma

 

 

TUCSON, Ariz., April 21, 2020 — The Critical Path Institute (C-Path) announced today it has been awarded a U.S. Food and Drug Administration (FDA) contract in support of ongoing development of novel clinical outcome assessments for pediatric asthma. C-Path’s Patient-Reported Outcome (PRO) Consortium will carry out this work through its Pediatric Asthma Working Group. Specifically, these assessments are intended to facilitate innovative patient-focused drug development and aid regulatory decision making by filling an unmet measurement gap.Continue reading