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Validation of an In Vitro Human Airway Model for Regulatory Toxicity Testing

Award Number: U44ES014312
ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2005
PERIOD OF PERFORMANCE END DATE: 02/28/2021

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Validation of an In Vitro Human Airway Model for Regulatory Toxicity Testing - Results of Phase II research indicate that formal validation of the EpiAirway™ in vitro human bronchial tissue model for predicting toxicity of inhaled chemicals is an attainable goal. The proposed Phase IIB cooperative agreement project is intended to realize this goal by conducting formal ring trial validation studies that will be submitted to regulatory agencies and the Organization for Economic Co-operation and Development (OECD) in support of formal adoption for regulatory use. Aim 1 will develop the final validation plan in collaboration with an NIH Steering Committee (SC). In Aim 2, an expanded of set 75 chemicals will be tested in the lead project laboratory to verify the accuracy and relevance of the final prediction model. In Aim 3, training of the participating ring trial testing laboratories will occur. In Aim 4 the transferability, reproducibility, accuracy and relevance of the EpiAirway™ model and protocols will be established by conducting formal ring trials in 3 GLP compliant contract research laboratories. Preparing a final report of all study activities and submission of the study data to relevant US regulatory agencies and the OECD in support of adoption as a test guideline for regulatory use will be the goal of aim 5. The technology to be validated in the current Phase IIB proposal will be the first non-animal model for use in regulatory inhalation toxicity testing. Successful completion of the Phase II project will address a critical barrier to implementation of worldwide requirements for inhalation toxicity testing of chemicals, and provide a technical capability that is urgently needed but that does not presently exist. The validated model and testing protocol will be utilized worldwide by a wide variety of chemical manufacturers, consumer product manufacturers and industries which utilize chemicals to produce other products. Specific US federal agencies that may adopt and accept results of the validated test system include the Consumer Product Safety Commission (CPSC), the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA). The European Chemicals Agency (ECHA) will also be able to utilize data produced by the validated test system in support of hazard assessment in EU countries. Formal validation and adoption of the EpiAirway™ model and test system will generate commercial sales resulting from direct utilization by chemical manufacturers, consumer product manufacturers and regulatory agencies. Additional revenue will be generated by offering the EpiAirway™ Respiratory Toxicity test as a contract service that may be offered by numerous contract testing laboratories, including MatTek Corporation.


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: 2022 ( Subtotal = $0 )
2022	2019	MATTEK CORPORATION	200 HOMER AVE	ASHLAND	MA	01721	MIDDLESEX	USA	Environmental Health	000	6	1/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	MATTEK CORPORATION	200 HOMER AVE	ASHLAND	MA	01721	MIDDLESEX	USA	Environmental Health	000	6	11/6/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $241,361 )
2019	2019	MATTEK CORPORATION	200 HOMER AVE	ASHLAND	MA	01721	MIDDLESEX	USA	Environmental Health	000	6	3/22/2019	NON-COMPETING CONTINUATION	$241,361
														Subtotal = $241,361

Issue Date FY: 2018 ( Subtotal = $530,965 )
2018	2018	MATTEK CORPORATION	200 HOMER AVE STE 200	ASHLAND	MA	01721	MIDDLESEX	USA	Environmental Health	000	5	2/28/2018	NON-COMPETING CONTINUATION	$530,965
														Subtotal = $530,965

Issue Date FY: 2017 ( Subtotal = $431,027 )
2017	2017	MATTEK CORPORATION	200 HOMER AVE STE 200	ASHLAND	MA	01721	MIDDLESEX	USA	Environmental Health	000	4	2/28/2017	COMPETING CONTINUATION	$431,027
														Subtotal = $431,027

Grand Total All Awards = $1,203,353

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Validation of an In Vitro Human Airway Model for Regulatory Toxicity Testing

Award Number: U44ES014312

ORGANIZATION: NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 07/01/2005

PERIOD OF PERFORMANCE END DATE: 02/28/2021

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