Saturday, November 23, 2024 11/23/2024

Translational Center of Tissue Chip Technologies for quantitative characterization of MPS technologies

Award Number: U24TR002634
ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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A large percentage of drug candidates fail at the clinical trial stage due to a lack of efficacy and unacceptable toxicity, primarily because the commonly used preclinical models (in vitro cell cultures and in vivo animal models) provide limited information about how a drug will affect human physiology. The need for more physiologically relevant in vitro systems for preclinical efficacy and toxicity testing has led to a major effort to develop “Microphysiological Systems (MPS)” or “Tissue Chips (TC)” based on engineered human tissue constructs. The TC development process requires an initial assessment of viability and functionality, followed by an examination of the TC response to various stimuli, including drugs, toxins, and disease-related cues. These extensive development efforts take place mainly in the developer’s lab, and the reproducibility of the TC results are rarely assessed by an independent research group or transferred to industry partners for use in drug development. Although there is a need for more physiologically-relevant preclinical testing technologies, the transition of TC technologies from developer lab to industry remains challenging. Successful transfer and deployment of TC technologies requires systematic characterization and validation of the systems, preferably by an independent external testing facility. Therefore, we propose to continue filling this gap between tissue chip developers and industrial application of TC technologies with our Translational Center of Tissue Chip Technologies (TC2T), which will continue to provide unbiased testing and validation of MPS technologies as reflected in the current RFA. TC2T takes a holistic and mechanistic approach—based on quantitative systems pharmacology (QSP)— that combines quantitative experimental biology, computational biology, and biostatistics to characterize these complex systems and translation of experimental insights to clinical insights. Our TC2T team at MIT includes tissue engineers, experimentalists, and computational biologists and serves as the core of the testing center. This multidisciplinary team is highly experienced in TC technology testing and will be responsible for model- guided experimental design, experimental execution, data acquisition in collaboration with partner sites, data analysis, and reporting. TC2T will lead to transparent and unbiased TC testing to ensure adoption of well- characterized and independently validated TC platforms by the pharmaceutical industry to use in drug development and toxicology testing and government agencies to use in the regulatory decision-making process.


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: 2024 ( Subtotal = -$2,911 )
2024	2019	JAVELIN BIOTECH INC	299 WASHINGTON ST	WOBURN	MA	01801	MIDDLESEX	USA	National Center for Advancing Translational Sciences	000	2	8/2/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2019	JAVELIN BIOTECH INC	299 WASHINGTON ST	WOBURN	MA	01801	MIDDLESEX	USA	National Center for Advancing Translational Sciences	001	2	9/9/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$2,911
														Subtotal = -$2,911

Issue Date FY: 2023 ( Subtotal = -$89,604 )
2023	2019	JAVELIN BIOTECH INC	299 WASHINGTON ST	WOBURN	MA	01801	MIDDLESEX	USA	National Center for Advancing Translational Sciences	000	2	5/15/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$89,604
														Subtotal = -$89,604

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	JAVELIN BIOTECH, INC.	299 WASHINGTON ST	WOBURN	MA	01801	MIDDLESEX	USA	National Center for Advancing Translational Sciences	000	2	5/5/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2021	2019	JAVELIN BIOTECH, INC.	299 WASHINGTON ST	WOBURN	MA	01801	MIDDLESEX	USA	National Center for Advancing Translational Sciences	001	2	7/8/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	JAVELIN BIOTECH, INC.	299 WASHINGTON ST	WOBURN	MA	01801	MIDDLESEX	USA	National Center for Advancing Translational Sciences	001	2	3/9/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,519,257
2020	2019	JAVELIN BIOTECH, INC.	299 WASHINGTON ST	WOBURN	MA	01801	MIDDLESEX	USA	National Center for Advancing Translational Sciences	002	2	9/25/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2020	2018	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	National Center for Advancing Translational Sciences	000	1	3/9/2020	NEW	-$1,519,257
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1,435,688 )
2019	2019	JAVELIN BIOTECH, INC.	206 CHARLES ST	CAMBRIDGE	MA	02141	MIDDLESEX	USA	National Center for Advancing Translational Sciences	001	2	8/5/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,435,688
2019	2018	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	National Center for Advancing Translational Sciences	000	1	8/2/2019	NEW	$0
														Subtotal = $1,435,688

Issue Date FY: 2018 ( Subtotal = $1,519,257 )
2018	2018	MASSACHUSETTS INSTITUTE OF TECHNOLOGY	77 MASSACHUSETTS AVE	CAMBRIDGE	MA	02139	MIDDLESEX	USA	National Center for Advancing Translational Sciences	000	1	9/18/2018	NEW	$1,519,257
														Subtotal = $1,519,257

Grand Total All Awards = $2,862,430

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Translational Center of Tissue Chip Technologies for quantitative characterization of MPS technologies

Award Number: U24TR002634

ORGANIZATION: NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

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