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



The decision support system is available free to medical professionals around the world.  

TUCSON, Ariz., April 20, 2020 — The Arizona Center for Education and Research on Therapeutics (AZCERT), a nonprofit dedicated to the safe use of medicines, is making MedSafety Scan®, a web-based decision support system, available free to medical professionals around the world, especially those treating high risk COVID-19 patients. MedSafety Scan can warn healthcare providers when their patients are prescribed drugs that place them at high risk of developing a potentially lethal cardiac arrhythmia known as torsades de pointes (TdP). MedSafety Scan also checks for potentially dangerous drug-interactions and suggests options for how to monitor the patient and reduce their risk of harm.Continue reading

Additional Warnings Issued for COVID-19 Possible Treatments

In the last 48-hours, there have been multiple reports warning the public about the medicines being tested as possible treatments for COVID-19. See below:

  1. Chloroquine treats malaria: Will it work against coronavirus? The side effects are risky, experts say
  2. AZ Couple took chloroquine phosphate – Man died; Woman in ICU
  3. Virus Drug Touted by Trump, Musk Can Kill With Just Two Gram Dose
  4. Which Covid-19 drugs work ? The first medical reports are in, but there’s no silver bullet for coronavirus infection yet.

At this time, there is no drug treatment that has been found to be effective in patients with COVID-19 and none has been approved by regulatory agencies to treat COVID-19. Several antivirals (including favipiravir, remdesivir, umifenovir and lopinavir/ritonavir) and antiinflammatory drugs (azithromycin) and antimalarials (chloroquine and hydroxychloroquine) are now being tested in clinical research for their potential benefit. Chloroquine, hydroxychloroquine and azithromycin) are known to prolong QTc and can cause potentially lethal arrhythmias (TdP). The combination of lopinavir and ritonavir is known to cause QT prolongation and is being followed to see if it also is associated with TdP arrhythmias. 

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C-Path Receives FDA Grant to Establish Rare Disease Clinical Outcome Assessment Consortium

TUCSON, Ariz., March 19, 2020 — The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has funded a cooperative agreement to establish a Rare Disease Clinical Outcome Assessment (COA) Consortium. The grant (U01FD006882)* was awarded to the Critical Path Institute (C-Path) with the National Organization for Rare Disorders (NORD) as a sub-awardee. The first step taken toward the establishment of the new consortium has been the creation of the Rare Disease Subcommittee within C-Path’s Patient-Reported Outcome (PRO) Consortium. The PRO Consortium will serve as an incubator for the maturation of a pre-competitive, multi-stakeholder consortium within C-Path’s COA Program.Continue reading

C-Path and Lundbeck Announce a Data Sharing Collaboration to Enable Development of Advanced Drug Development Tools in Alzheimer’s Disease

TUCSON, Ariz., March 18, 2020 — The Critical Path Institute (C-Path) and H. Lundbeck A/S (Lundbeck) are proud to announce that they will work together to significantly improve the scientific community’s insight in Alzheimer’s disease (AD) through Lundbeck’s contribution of a unique set of clinical trial data from more than 2,500 AD patients to the Critical Path for Alzheimer’s Disease (CPAD) consortium’s integrated database for qualified researchers across the globe to access.Continue reading

C-Path to Lead Multi-Stakeholder Engagement on FDA’s Proposed Novel Framework to Enhance the Pediatric Medical Device Ecosystem

TUCSON, Ariz., March 17, 2020 — The Critical Path Institute (C-Path) today announced it has been awarded a grant to conduct stakeholder engagement to garner insights, feedback and refinement of the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health’s (CDRH) proposed framework to enhance the pediatric medical device ecosystem and to develop a strategic plan for implementation. Funded by a cooperative agreement through the FDA, C-Path will work in collaboration with CDRH and other stakeholders to organize a workshop to brainstorm on the framework and strategic plan for building a viable ecosystem.Continue reading