SBIR Phase II: Metabolomics of Human Embryonic Stem Cells to Predict Teratogenicity: An Alternative Developmental Toxicity Model

Award Information
Agency:
National Science Foundation
Branch
n/a
Amount:
$500,000.00
Award Year:
2011
Program:
SBIR
Phase:
Phase II
Contract:
1058355
Award Id:
n/a
Agency Tracking Number:
1058355
Solicitation Year:
2011
Solicitation Topic Code:
Phase II
Solicitation Number:
n/a
Small Business Information
504 S. Rosa Rd., Suite 150, Madison, WI, 53719-1256
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
Y
Duns:
794516695
Principal Investigator:
Paul West
(608) 204-0104
pwest@stemina.com
Business Contact:
Paul West
PhD
(608) 204-0104
pwest@stemina.com
Research Institution:
Stub




Abstract
This Small Business Innovation Research (SBIR) Phase II project will fund a continuation of breakthrough research, development and commercialization of an in vitro assay to help prevent birth defects. This innovative product is driven by a need to create a test for human developmental toxicity that is more accurate than current tests that use animals. False negative results from these animal assays have lead to unexpected cases of birth defects, such as observed with Thalidomide. This assay, performed on human embryonic stem cells, is more predictive of developmental toxicity than animal models (80% vs 60%) and unlike animal models, provides data about specific human biochemical pathways that are affected. This will fund research to 1) identify biomarkers of developmental toxicity present in three different human cell lines, 2) optimize automation systems, 3) create a web-based interface to be used by customers, 4) standardize and create quality control procedures and 5) take the initial steps required for validation of the assay by the European Centre for the Validation of Alternative Methods (ECVAM). Upon validation, the test will be required in Europe for assessing developmental toxicity of newly developed pharmaceuticals and may be further used for testing of environmental chemicals as well. The broader impacts of this research include 1) a global reduction in drug and chemical induced human birth defects 2) significant cost savings (up to $70 million per drug) for pharmaceutical companies allowing greater confidence in drug candidate selection and 3) a major global reduction in animal testing.

* information listed above is at the time of submission.

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