SafeTEC™ Drug Safety Technology Consortium Organizes Validation Project for In Vitro Early CardioToxicity Assay: Recruiting More Participants

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SafeTEC™ Drug Safety Technology Consortium, organized by One Million Solutions in Health (OMSiH), has announced a collaborative validation project sponsored by Axiogenesis, an innovator of stem cell technology to generate organ-specific human cell types for pharmaceutical drug discovery and toxicology testing.

drug safety technology consortium validation projects

SafeTEC™ (Drug Safety Technology Consortium)

The SafeTEC™ Drug Safety Technology Consortium, managed by One Million Solutions in Health (OMSiH), is announcing today a TEC Validation Project™ with Axiogenesis, an innovator of stem cell technology to generate organ-specific human cell types for pharmaceutical drug discovery and toxicology testing.

The collaborative project takes aim at identifying potential cardiac toxicity issues very early in the drug discovery process. Today, the standard to evaluate cardiotoxicity is to test early-stage compounds in animal species to assess possible liabilities in a chemical series. This test is costly, low-throughput, controversial to some, and often not predictive of the drug's effect in a human patient.

The SafeTEC™ consortium, comprised of biotech and pharmaceutical companies, is mandated to identify and evaluate promising drug safety technologies. Accordingly, SafeTEC™ will evaluate Axiogenesis’ technology in a controlled study and is looking for additional pharmaceutical and biotech partners to participate.

JOIN this TEC Validation Project™: Validate a new alternative to animal testing in human cardiac muscle cells
DATE: Thursday, December 15, 2016
TIME: 11:00am EST; 8:00am PST; 5:00pm CET
Click here to register

iPSCs are a Nobel Prize-winning technology that "reprograms" human adult cells into a stem cell state, allowing for subsequent differentiation into almost any cell type in the body, including the heart muscle (cardiac myocytes) or brain cells (neurons and glial cells). This important technology avoids the use of controversial embryonic stem cells, while maintaining the capability to produce unlimited quantities of human cell types for drug discovery and biomedical research.

"The cardiomyocyte impedance assay has been in place for several years in later stage toxicity testing, but has only recently been introduced to Chemists and Biologists supporting Lead Optimization prior to SAR," said Dr. Greg Luerman, US Technical Director at Axiogenesis.

"Identifying the 'bad actor' compounds very early in drug discovery will reduce late-stage surprises, thereby accelerating drug development and introducing safer therapies to patients sooner," said Dawn Van Dam, CEO of OMSiH. "We feel this industry collaboration project with Axiogenesis will speed the adoption of this technology within pharmaceutical development."

The project will commence soon, but there is still an opportunity for more members to join this non-profit consortium and observe the results of the study first-hand. Companies participating in the study have the benefit of assessing and contributing to a novel and disruptive technology, which could further optimize internal drug development procedures. Note: There is no fee for pharmaceutical or biotech companies that are approved for membership by the SafeTEC Steering Committee.

Join this TEC Validation Project™: Validate a new alternative to animal testing in human cardiac muscle cells
DATE: Thursday, December 15, 2016
TIME: 11:00am EST; 8:00am PST; 5:00pm CET
Click here to register

About SafeTEC™ and One Million Solutions in Health™
The SafeTEC™ consortium of pharmaceutical and biotech companies, which is managed by One Million Solutions in Health™ (http://www.onemillionsolutionsinhealth.org), is tasked with identifying new technologies that will improve the industry’s drug discovery process. SafeTEC operates in the pre-competitive drug safety space to find, evaluate and validate new technologies more quickly, with less time and money than if it was invested by individual companies.

Technologies that are being preferentially investigated focus on systems that provide mechanism of action data, for both therapeutic and/or adverse effects. Additionally, we are validating tools where the output from the assays will increase our understanding and can therefore be used in the early stages of compound selection and optimization. And, we are working to validate new technologies, e.g., organ-on-a-chip and in silico modeling tools. The 'honest broker' role of SafeTEC puts small technology companies and industry on common ground. The Consortium helps these companies meet industry requirements, identify gaps, and explain how you can optimize the value you are providing, thereby enhancing your commercial success.

About Axiogenesis
Axiogenesis is a leading provider of commercial-grade in vitro differentiated cell types (e.g., cardiac, neuronal) derived from human induced pluripotent stem cells (iPSCs), along with validated assays, which enable drug development. Assays for each cell type have been developed for advanced drug discovery, disease and tissue modeling, safety pharmacology, and in vitro toxicology applications.

Axiogenesis' innovative and proprietary cell types and assays accelerate and improve drug candidate selection, lower costs and thus increase overall drug development efficiency.

Media Contacts:
Dawn Van Dam
One Million Solutions in Health
dawn.vandam(at)onemillionsolutionsinhealth(dot)org
416-402-8274

Brian Murphy, MBA
Axiogenesis
brian.murphy(at)axiogenesis(dot)com
617-447-5319

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Brian Murphy
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