See the Glossary for more terms.
Concepts represent early planning stages for program announcements, request for applications, or solicitations for Council's input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to the Opportunities and Announcements portal.
NB: Council approval does not guarantee that a concept will become an initiative.
For the published request for applications, see the January 27, 2015, Guide announcement, Systems Biology and Antibacterial Resistance (U01).
For the published request for applications, see the November 14, 2014, Guide announcement, Nontraditional Therapeutics That Limit Antibacterial Resistance (R21/R33).
Request for Applications
Contact: Michael Schaefer
Objective: To provide support for preclinical development of selected candidate therapeutics that target host-encoded functions required for infection, replication, virulence, proliferation, and/or pathogenesis of infectious diseases.
Description: This initiative will support milestone-driven projects focused on advancing candidate host-targeted therapeutics through the product development pathway. These milestones include standard investigational new drug (IND)-enabling activities required for therapeutic products, such as cGMP production of active pharmaceutical ingredient (API), identifying an acceptable drug product formulation, successful execution of GMP toxicology studies, completion of proof-of-concept efficacy studies in appropriate models of disease, and preparation of IND and design of future clinical plans.
Emphasis of this initiative will be on developing novel therapeutics that target host-encoded functions required for infection, replication, virulence, proliferation, and/or pathogenesis of infectious microbes of priority to the Division. Therapeutics of interest for this initiative include small molecules or biopharmaceuticals such as monoclonal antibodies, nucleic acids, or peptides to be used as monotherapy or in combination, or as adjunctive therapy with other drugs.
Examples of host-targeted approaches to be supported by this initiative include inhibition of host-encoded functions critical for pathogen infection, replication, virulence, proliferation, or pathogenicity; modulation of host immune response; modulation of host response to reduce disease pathology (e.g., inflammation); and modulation of host metabolism to reduce nutrients critical for pathogen survival.
Of particular importance for novel host-targeted therapeutics will be a detailed consideration and description of the most appropriate clinical and regulatory path to product registration, including addressing potential hurdles such as demonstration of pathogen susceptibility and therapeutic efficacy using nonstandard in vitro assays and disease models. Responsive projects will include preliminary data establishing proof-of-concept for a single selected candidate therapeutic and plans to progress that candidate through preclinical development. Participation of industrial laboratories is expected to facilitate appropriate and validated product development activities.
Broad Agency Announcement
Contact: Alexandra Buck
Objective: To advance the translation of promising therapeutic products against biothreat pathogens and emerging infectious diseases from lead candidate to first-in-human clinical trials.
Description: This initiative will support the necessary development activities to carry a lead candidate product through Phase I clinical testing. Special emphasis will be placed on therapeutics that may fill gaps in our armamentarium, such as therapeutics for filovirus and emerging influenza strains, with particular importance placed on therapies that address antimicrobial resistant pathogens and limit the emergence of antimicrobial resistance.
Activities will be supported that encompass focused nonclinical development and clinical evaluation (through Phase I only) of treatments to address unmet needs to position new therapies toward advanced development and eventual licensure. Offerors must have already identified a promising candidate therapeutic agent and will propose a comprehensive product development plan for moving their therapeutic candidate through human clinical trials.
For the published request for proposals, see the August 15, 2014, Solicitation of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals.
Last Updated January 28, 2015
Last Reviewed January 28, 2015