Cooperative Program for Modeling Clinical Transplantation

The National Institute of Allergy and Infectious Diseases (NIAID) will support its mission through the Cooperative Program for Modeling Clinical Transplantation. Advancements of new therapeutics and success in human solid organ transplantation will require innovative and clinically translatable in-vitro and in-vivo systems to model local and systemic immune responses. This program seeks applications including new approach methods (NAMs) and/or refined mouse models that together will promote translation of new therapies to clinical practice. Potential NAMs include immune-competent microphysiological systems, organoids, ex-vivo perfused human organs, precision-cut tissue slices, and computational systems biology models. Applicants must propose models designed to overcome known obstacles to clinical translation in existing NAMS and/or mouse models, reduce reliance on nonhuman primates, and demonstrate relevance to clinical outcomes. Emphasis on data sharing will facilitate reproducibility and establishment of standards and best practices to achieve the program goals. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...