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Software for Predicting Liver Injury from Biologics Drug Candidates Using Data from a Human Liver Microphysiology System

Award Number: R43TR003535
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 11/13/2021
PERIOD OF PERFORMANCE END DATE: 02/28/2022

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Software for Predicting Liver Injury from Biologics Drug Candidates Using Data from a Human Liver Microphysiology System - The goal of this project is to develop novel technology for predicting biologics-induced liver injury such as caused by anti-inflammatory biologics such as anti-IL6 receptor antibody (e.g., tocilizumab), and by growth factors such as neuregulin-1β isoform, glial growth factor 2 (GGF2), as well as by other biologics (e.g., checkpoint inhibitors). Biologics now account for more than half of the drugs in development, and have the potential to address many acute diseases, chronic diseases, and other unmet medical needs. Biologics-induced liver injury can manifest as focal hepatocyte necrosis, steatosis, and fibrosis. In some cases, liver transplantation is required for patients with biologics-induced liver injury. A significant problem is that while there is increased development and use of biologics, there lacks tools available for the assessment of biologics for the ability to cause biologics-induced liver injury. For example, because biologics are typically designed specifically for human targets, standard preclinical models used for small molecule drug development are inadequate for assessing the efficacy or safety of biologics. In this project, we will develop novel technology that will serve as a prototype for use in testing biologics (preclinical, clinical, or after-market) for potential to cause biologics-induced liver injury. In developing this new technology, we will also further develop the state-of-the-art human liver MPS (vLAMPS) to assess the liver effects of biologics from human liver cells in the liver acinus with the aim of using vLAMPS as the eventual key source of input data for BIOLOGXsym simulations. Additionally, we will perform validation of this new technology. Once validated, this system will serve as a prototype that can then be expanded for commercialization for use by our existing base of pharmaceutical company customers, regulatory agencies, and academic institutions for teaching and academic research use.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$1 )
2023	2021	SIMULATIONS PLUS INC	42505 10TH ST W STE 103	LANCASTER	CA	93534	LOS ANGELES	USA	National Center for Advancing Translational Sciences	002	2	8/21/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$1
2023	2021	DILISYM SERVICES, INC.	6 DAVIS DR	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	1/27/2023	NEW	-$1
2023	2021	DILISYM SERVICES, INC.	6 DAVIS DR	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	National Center for Advancing Translational Sciences	001	1	1/27/2023	NEW	$1
														Subtotal = -$1

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	DILISYM SERVICES, INC.	6 DAVIS DR	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	11/11/2021	NEW	-$144,614
2022	2021	SIMULATIONS PLUS, INC.	42505 10TH ST W	LANCASTER	CA	93534	LOS ANGELES	USA	National Center for Advancing Translational Sciences	001	2	11/13/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$144,614
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $251,076 )
2021	2021	DILISYM SERVICES, INC.	6 DAVIS DR	RESEARCH TRIANGLE PARK	NC	27709	DURHAM	USA	National Center for Advancing Translational Sciences	000	1	2/22/2021	NEW	$251,076
														Subtotal = $251,076

Grand Total All Awards = $251,075

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Software for Predicting Liver Injury from Biologics Drug Candidates Using Data from a Human Liver Microphysiology System

Award Number: R43TR003535

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 11/13/2021

PERIOD OF PERFORMANCE END DATE: 02/28/2022

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