Key Dates

Related Announcements

RFA-TR-23-001 - Translational Centers for Microphysiological Systems (TraCe MPS) (U2C Clinical Trials Not Allowed)

Issued by

National Institute on Aging (NIA)

Purpose

The purpose of this Notice is to inform potential applicants that the National Institute on Aging (NIA) will hold pre-application, technical assistance webinars regarding applications for RFA-TR-23-001 on Tuesday, January 10, 2023 and Tuesday, January 24, 2023 from 3:00-4:30PM EST.

RFA-TR-23-001 invites U2C Cooperative Agreement applications aiming to develop, validate, and qualify microphysiological systems (MPS) as Drug Development Tools (DDTs) for Alzheimer’s disease (AD) and Alzheimer’s disease Related Dementias (ADRD) therapeutic development. The overarching purpose of this Centers program is to develop MPS that are fit-for-purpose and have specific context of use (CoU) that will satisfy regulatory criteria. The objectives are to establish translational centers focused on regulatory qualification of MPS with active input and engagement from key stakeholders and end users (e.g., NCATS Tissue Chip Consortium in collaboration with the U.S. Food and Drug Administration (FDA), pharmaceutical members, and academia).

Studies of interest include, but are not limited to, the following: i) establishing an enabling infrastructure to develop standardized and deeply phenotyped AD/ADRD in vitro models; ii) establishing the translational validity of these MPS models to recapitulate the molecular/network perturbations identified in AD/ADRD, including validation through the development of translatable biomarkers; iii) developing MPS technologies that allow for the testing of potential AD/ADRD therapies in a manner that incorporates disparities and differences in the specific pathogeneses across populations.

Central to this initiative is the rapid dissemination of MPS models to all qualified researchers for their use in basic research and preclinical therapy development, and the transparent reporting of research methodology and preclinical efficacy testing findings.

The purpose and objectives of the RFA will be reviewed during the webinars. Written questions submitted by participants either prior to or during the webinar will also be addressed. Potential applicants are strongly encouraged to submit questions prior to the webinars to zane.martin@nih.gov. Please indicate "U2C MPS Translational Centers Webinar" in the subject line of the email.

Potential applicants interested in participating in the webinar should register by sending an email to zane.martin@nih.gov at least one week prior to the event date. Please indicate "U2C Webinar Registration" in the subject line of the email. Call-in information will be provided once registration is received.

The webinar is optional and is not required for submission to the FOA.

Inquiries

Please direct all inquiries to:

Zane Martin, Ph.D.
National Institute on Aging (NIA)
Phone: 301-827-7130
Email: zane.martin@nih.gov