Funding News Edition: December 22, 2022 See more articles in this edition
Researchers seeking to better understand, prevent, and treat autoimmune diseases may want to consider participating in the NIAID Autoimmunity Centers of Excellence (ACE). Combining Basic and Clinical research programs, the objectives of ACE are to accelerate the discovery and translation of therapies for autoimmune diseases from lab to clinic.
Members of the Basic and Clinical programs will work closely together to fully develop and conduct the mechanistic studies in Clinical Projects and other studies of mechanism and pathogenesis. The ACE has conducted Clinical Projects in systemic lupus erythematosus, multiple sclerosis, rheumatoid arthritis, Sjögren's Syndrome, ulcerative colitis, scleroderma, and pemphigus vulgaris (partial list: ClinicalTrials.gov). The collaborative ACE Research Plan and annual progress reports of the current ACE are available on the public ACE website.
NIAID recently reissued two companion funding opportunity announcements (FOAs)—ACE Basic Research Program and ACE Clinical Research Program—which we briefly cover here. We encourage you to carefully read the FOAs for complete information.
Autoimmunity Centers of Excellence, Basic Research Program (U19, Clinical Trial Not Allowed)
Members of the Basic Research Program will conduct innovative studies of human autoimmunity within Principal Pilot and Collaborative Projects.
A Basic ACE Research application must include the following:
- Administrative Core—responsible for providing overall leadership to the Center, including management, coordination, and oversight for the Center activities.
- ACE Funds Management Core (AFMC)—administers two funds in support of the ACE consortia: the Clinical Project Fund for support of the Clinical Projects and the Collaborative Research Fund for support of the Collaborative Projects and additional studies required for achieving the aims of the ACE Research Agenda. An ACE awardee will be selected by NIAID to administer the AFMC, after the award.
- ACE Biorepository Core (ABC)—ABC will coordinate the collection and storage of samples from ACE Clinical Projects and provide them for use in mechanistic studies. An ACE awardee will administer the ABC, as selected by NIAID based on reviews and other criteria.
- Research Projects—Each ACE Basic Research Program must include a Principal Project, Pilot Project, and Collaborative Project. Refer to the FOA for details of each.
Award Budget, Project Period
U19 application budgets are not expected to exceed annual direct costs as follows:
- $200,000 for the Principal Project
- $150,000 for Collaborative Projects
- $75,000 for Pilot Projects
- $50,000 for Administrative Core
- $250,000 for ACE Funds Management Core (AFMC); one ACE will be awarded
- $250,000 for ACE Biorepository Core (ABC); one ACE will be awarded
Application budgets are not limited but need to reflect the actual needs of the project. The total project period must be 5 years.
Applications for this FOA are due by May 19, 2023, by 5 p.m. local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Direct your questions about this FOA to Dr. Stacy Ferguson, NIAID’s scientific/research contact at firstname.lastname@example.org or 240-627-3504. Questions related to peer review of U19 applications should go to Dr. James Snyder at email@example.com or 240-669-5060.
Autoimmunity Centers of Excellence, Clinical Research Program (UM1, Clinical Trial Required)
The Clinical Research Program develops and conducts Clinical Projects (i.e., clinical trials with integrated mechanistic studies) as well as Collaborative Projects investigating fundamental human immunology.
Members of the Basic and Clinical ACE will work together to design and conduct studies of autoimmune disease pathogenesis and mechanisms of action of immune-modulating interventions being tested in ACE clinical trials.
Clinical ACE Elements
UM1 application budgets are not expected to exceed annual direct costs as follows:
- $700,000 for each of two Clinical Projects (Primary and Alternate)
- $150,000 for Collaborative Projects
- $50,000 for Administrative Coordination
- $250,000 for ACE Funds Management Coordination (AFMC); one ACE will be awarded
- $250,000 for ACE Biorepository Coordination (ABC); one ACE will be awarded
Both Clinical Projects should be ready for implementation soon after award. The Primary and Alternate Clinical Projects must address different diseases and have different leaders, though both projects may be within one clinical specialty. The Clinical Projects will be phased for development based on peer review and programmatic assessment, independent of the designation Primary or Alternate; the prioritized clinical trial is expected to open within a year of award. Trials that continue or follow-up ongoing ACE Clinical Projects are encouraged. Neither Clinical Project may include mechanistic studies within industry-supported clinical trials.
Clinical Projects that are of particular interest to ACE include the following:
- Pathogenesis of human autoimmune disease
- Mechanisms responsible for the initiation, maintenance, or loss of immune tolerance
- Prevention of autoimmune disease
- Understanding existing therapies, including mechanism of action and why they may work better in subsets of patients
- Understanding sex-based differences in autoimmune disease
- Identification and evaluation of biomarkers for autoimmune disease status, including diagnosis, prediction or confirmation of remission or relapse, and measurement of therapeutic response or disease progression
Note: See the FOA for a list of projects that will be considered nonresponsive and not reviewed.
Application Due Date
Applications for this FOA are due by May 19, 2023, by 5 p.m. local time of the applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Direct your questions about this FOA to Dr. Stacy Ferguson, NIAID’s scientific/research contact at firstname.lastname@example.org or 240-627-3504. Questions related to peer review of UM1 applications should go to Dr. Kelly Hudspeth at email@example.com or 240-620-1627.
ACE: Available Funds, Anticipated Number of Awards
NIAID plans to commit $7.2 million to the ACE Program (Clinical and Basic) in fiscal year 2024, which includes approximately $3 million direct costs annually to support an ACE Clinical Project Fund and an ACE Collaborative Project Fund. Overall support will be divided between the Clinical and Basic programs. NIAID anticipates two to four U19 awards and two to four UM1 awards within the ACE Clinical Research Program.