Development of a human hepatocyte predictive pharmacology and toxicology system.

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,584,146.00
Award Year:
2013
Program:
SBIR
Phase:
Phase II
Contract:
2R44DK091104-02
Award Id:
n/a
Agency Tracking Number:
R44DK091104
Solicitation Year:
2013
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA12-088
Small Business Information
1115 5TH ST SW, CHARLOTTESVILLE, VA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
809452217
Principal Investigator:
BRIAN WAMHOFF
(434) 872-0198
wamhoff@hemoshear.com
Business Contact:
JAMES POWERS
(434) 872-0198
powers@hemoshear.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): There is a critical need to improve the accuracy of preclinical drug efficacy and toxicity screening and testing through the development of human hepatocyte (liver) in vitro culture systems that more effectively mimic the human in vivo environment. HemoShear is a biotechnology research company that utilizes patented methodologies to restore in vivo responsiveness to human primary cells in vitro. Under Phase I SBIR R43DK091104, we developed a predictive rat primary hepatocyte system that restores morphology, function, transport, metabolism and respond to drugs and growth factors at nearer to in vivo levels. The principles to develop the rat system, translated to human primary hepatocytes, restoring morphology, function, metabolism and drug response at in vivo drug levels achieved in humans. To our knowledge, there are no commercially available systems that can achieve this level of hepatobiology and in vivo responsiveness in human primary hepatocytes ex vivo. The purpose ofPhase II SBIR R44DK091104 is to further develop and validate a predictive primary human hepatocyte system for use in investigative toxicology, safety assessment and drug discovery with our commercial partners. Our Aims will achieve this using an integrated experimental, genomic and computational approach, screening more than 40 compounds in the system. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: There is a critical need to improve the accuracy of preclinical drug efficacy and toxicity screening and testing through the development of human hepatocyte (liver) in vitro culture systems that more effectively mimic the human in vivo response. HemoShear is a biotechnology research company that utilizes patented methodologies to restore in vivo responsiveness to human primary cells in vitro. The purpose of Phase II SBIR R44DK091104 is to further develop and validate a predictive primary human hepatocyte system for use in investigative toxicology, safety assessment and drug discovery with our commercial partners by screening more than 40 drugs in the system.

* information listed above is at the time of submission.

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