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→

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→

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→

TUCSON, Ariz., April 30, 2020 — Tucson-based Critical Path Institute (C-Path) today announced the appointment of two new members to its Board of Directors: James W. Newman, CPA, former Executive Chairman of Victory Pharma, Inc. and Tomas Salmonson, Ph.D., M.Sc., former Chair of the Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA).

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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→

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→

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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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→