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
Contract: 1058355
Agency Tracking Number: 1058355
Amount: $500,000.00
Phase: Phase II
Program: SBIR
Awards Year: 2011
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
DUNS: 794516695
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 Paul West
 (608) 204-0104
 pwest@stemina.com
Business Contact
 Paul West
Title: PhD
Phone: (608) 204-0104
Email: 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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