Microphysiological Systems to Advance Precision Medicine for AD/ADRD Treatment and Prevention (U54 Clinical Trial Not Allowed)

Background
This Notice of Funding Opportunity (NOFO) invites U54 Cooperative Agreement applications aiming to establish multi-component Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Translational Centers for Microphysiological Systems (MPS) (AD/ADRD MPS Translational Centers). The overarching purpose of this Centers program is to develop 2D and 3D models of AD/ADRD as reproducible and scalable platforms that recapitulate key features of human AD/ADRD pathophysiology to be used as precision medicine research tools to investigate the complex biology of AD/ADRD and to accelerate multiple aspects of drug discovery and preclinical drug development. This NOFO is issued as an initiative tied to the implementation of several research milestones that are part of the AD/ADRD research framework to advance the development of precision medicines for AD/ADRD in support of the National Plan to Address Alzheimer’s and Related Dementias.

Grant Details
The overarching objective of this initiative is to create AD/ADRD MPS Translational Centers focused on establishing an infrastructure to develop standardized and deeply phenotyped 2D and 3D MPS models, establishing the translational validity of these MPS models to recapitulate the molecular and network perturbations identified in AD/ADRD, and ensuring rapid and broad distribution of the MPS models, data, and analytical methods for use in basic research and therapy development. The NOFO also outlines specific areas of research interest including the development of 2D and 3D culture system prototypes that recapitulate human AD/ADRD, including tissue chips that can contain multiple cell types and multi-organ systems, development of standardized protocols for validated and reproducible culture of cells in 2D and 3D microenvironments, extensive characterization and deep phenotyping of 2D and 3D MPS models, cross-validation of the molecular, cellular, and pathologic disease model phenotypic data with multi-modal human data, among others.

Eligibility Requirements
Eligible applicants include Higher Education Institutions, Public/State Controlled Institutions of Higher Education, Private Institutions of Higher Education, Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education), For-Profit Organizations (including Small Businesses), Local Governments, State Governments, County Governments, City or Township Governments, Special District Governments, Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized), Eligible Agencies of the Federal Government, U.S. Territory or Possession. Foreign Institutions are not eligible to apply. The NOFO also outlines required registrations for applicant organizations such as System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code for foreign organizations, Unique Entity Identifier (UEI), eRA Commons registration for organizations applying through Grants.gov.

Period of Performance
The project period can be up to five years with an earliest start date in February 2024. The application due date is June 2024 with a potential expiration date in February 2024.

Grant Value
NIA intends to commit up to $7 million in fiscal year 2025 to fund 2 awards. An application may request a budget of up to $2.5 million direct costs per year.