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Development of a human hepatocyte predictive pharmacology and toxicology system.

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2013 / SBIR
Agency Tracking Number:
R44DK091104
Solicitation Year:
2013
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA12-088
Small Business Information
HEMOSHEAR, LLC
HEMOSHEAR, LLC 1115 5TH ST SW CHARLOTTESVILLE, VA 22902-6465
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2013
Title: Development of a human hepatocyte predictive pharmacology and toxicology system.
Agency: HHS
Contract: 2R44DK091104-02
Award Amount: $1,584,146.00
 

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.

Principal Investigator:

Brian R. Wamhoff
434-872-0198
wamhoff@hemoshear.com

Business Contact:

James Powers
434-872-0198
powers@hemoshear.com
Small Business Information at Submission:

HEMOSHEAR, LLC
1115 5TH ST SW CHARLOTTESVILLE, VA -

EIN/Tax ID: 126197923
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No