Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development

The NIH Blueprint for Neuroscience Research is interested in continuing to support the BluePrint Neurotherapeutics Network for Small Molecules (BPN-SM)- a program designed to help investigators advance promising small-molecule therapeutics toward clinical testing. The BPN-SM program supports drug discovery and development activities in investigators’ own laboratories while also providing access to NIH-supported subject matter experts and contract research organizations (CROs) with capabilities in medicinal chemistry, pharmacokinetics, toxicology, formulation development, GMP synthesis, and Phase I clinical testing. By integrating NIH resources with industry-standard expertise, BPN-SM advances investigator-initiated drug discovery while enabling investigators to retain and strengthen their intellectual property while gaining hands-on experience in translational drug development. The overarching goal of the program is to reduce the risk of scientific and therapy development sufficiently to enable external partners to take on late-stage development and ultimately bring new therapies to patients. In addition, this BPN program is specifically focused on small molecules and excludes biologics, because development, regulatory, and manufacturing considerations for each class of therapeutics differ substantially from each other. It will use a phased cooperative agreement mechanism which will enable the program to support innovative but higher-risk projects, with decisions of continued support being contingent on demonstrated feasibility of yearly milestones. A cooperative agreement framework is proposed because several key aspects of the program will involve collaborative activities between the investigators and NIH program staff, with substantial involvement beyond the normal scope of grant stewardship. The project principal investigator(s) and NIH program staff will work jointly with NIH-supported subject matter experts to coordinate and participate in all scientific and technical management aspects of the project. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop competitive projects and establish the cross-disciplinary collaborations necessary for success.

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;Non-domestic (non-U.S.) Entities (Foreign Institutions).

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...