Automation and validation of human on a chip systems for drug discovery

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44TR001326-03
Agency Tracking Number: R44TR001326
Amount: $2,963,140.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: 950
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-04
Award End Date (Contract End Date): 2021-08-31
Small Business Information
3259 PROGRESS DR RM 158, Orlando, FL, 32826-3230
DUNS: 079563251
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (607) 255-7577
Business Contact
Phone: (407) 900-5915
Research Institution
Project Summary AbstractOur overall strategy for Hesperos is to utilize microphysiological systems in combination with functional readouts to establish platforms capable of analysis of chemicals and drug candidates for toxicity and efficacy during pre clinical testingThis is a service based company that is developing low cost in vitro systems containing a novelpumplessmicrophysiological platform and serum free medium formulationThe pumpless integrated systemusing a rocking motion to pump the cellular mediumreduces the complexity and cost of the fluidic circuit design and simplifies set up and operation of the deviceThe system employs microelectrode arrays and cantilever systems that are integrated on chip to allow for noninvasive electronic and mechanical readoutsThese functional readouts greatly reduce the number of biomarkers to be monitored for cell health and function in our systemsWe have constructed physiological systems that represent human cardiacskeletal muscleneuronallivervasculatureblood brain barriergastrointestinal tract and neuromuscular junctionsNMJsVarious combinations of these organ modules can be integrated onto a single platform to examine interactions among organs due to interchange of drug metabolites or cell signaling molecules produced in response to drugsHesperos has worked withfirms using these multi organ systems for preclinical evaluation of drugs or toxicity tests on chemicalsHesperos received a Phase II grant from NCATS to apply advanced manufacturing technology to increase throughput and decrease the cost of the deviceWe have made major advances in our Phase II grant to the point where DrLili PorterNCATS SBIR Administratorand DrDan TagleProgram Manager of NCATS SBIR Programhave approved and encouraged Hesperos to submit a Phase IIB applicationTo move this technology to a level where it can be cost effective for routine applications in preclinical studies we propose a number of modifications to further reduce manufacturing cost and improve performance and reliabilityIn an attempt to validate the systemwe will partner with AstraZenecaRoche Pharma Researcha heart liver hemodynamic model to test for cardiac safetyand Bioverativto validate a Myasthenia Gravis model using an NMJ systemWe will determine if these systems can predict semi qualitative multi organ responses to those drugs and compare to human clinical data where availableThese studies will provide a basis for validation and qualification with the FDAAimwill make the use of theorgan system easier to incorporate into the workflow at pharmaceutical firms and should reduce the cost of use to significantly less than animal studies and provide the advantage of prediction of response in a human systemAimwill utilize Hesperos s systems to validate theseplatforms for FDA qualificationWhile the systems still have significant value to pharmaceuticalor food or cosmetic companieswithout FDA approvalFDA approval would greatly accelerate adoption of this technology Project Narrative Public Health RelevanceThe overall strategy for Hesperos is to build human on a chip systems to model integration of body organ modules such as the nervous systemcirculatory systemliver and skeletal muscle for toxicity testing as well as efficacy for diseasesHesperos offers this as a service to pharmacology companies for analysis of potential drug candidates as well as cosmetic and food organizations for testing of their compoundsThis system can be utilized in drug discovery and toxicity studies to decrease the cost of the drug development process which should lead to less expensive drugs for the public at large

* Information listed above is at the time of submission. *

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