Concepts represent early planning stages for program announcements, requests 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 Find a Funding Opportunity.
NB: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
- In Vitro Assessments for Antimicrobial Activity
- Nonclinical Services for the Development of Interventional Agents for Infectious Diseases
- Evaluation and Testing Services for Vaccines and Other Biologics for Infectious Diseases
- Manufacturing and Characterization for Vaccines and Other Biologics for Infectious Diseases
- Systems Biology: The Next Generation for Infectious Diseases
- International Research in Infectious Diseases, Including AIDS
In Vitro Assessments for Antimicrobial Activity
Request for Proposals—proposed FY 2018 initiative
Contact: Tiffany Chadwick
Objective: To provide a variety of in vitro screening services to the research community to assess antimicrobial activity (antiviral, antibacterial, antifungal, antimycobacterial, and/or antiparasitic) of new or existing compounds.
Description: These contracts will provide screening for antimicrobial activity against a variety of pathogens, including newly emerged, highly pathogenic, and/or drug-resistant strains. Most often the in vitro screening service is the first step requested by product developers with potential therapeutics. Specifically, a compound is initially tested in vitro against a broad bacterial, fungal, or viral in vitro panel. This broad in vitro testing is an efficient way to screen large numbers of compounds. For many compounds it is a way to indicate, at an early stage for a relatively modest cost, whether a compound has promise. For those compounds showing promise, secondary, in vitro screens allow further exploration of clinical potential.
Nonclinical Services for the Development of Interventional Agents for Infectious Diseases
Request for Proposals—proposed FY 2018 initiative
Contact: Edward Ryan
Objective: To advance the development of therapeutic candidates and diagnostics for infectious diseases and biological toxins by providing services to the research community to advance the preclinical development of therapeutic agents.
Description: The purpose of this initiative is to provide the research community with services for activities commonly associated with preclinical development of therapeutic agents, including those activities required for submitting investigational new drug applications. Services include small molecule synthesis, medicinal chemistry, preclinical safety, toxicology and pharmacokinetic studies, and good manufacturing practice manufacture of drug substance and drug product in a variety of formulations and delivery forms.
Evaluation and Testing Services for Vaccines and Other Biologics for Infectious Diseases
Request for Proposals—proposed FY 2018 initiative
Contact: Aileene Lewis or Michael Welsh
Objective: To establish a service program for the research community that provides capacity for evaluating and testing candidate vaccines and other biologics for infectious diseases and/or related toxins.
Description: Under this initiative, DMID will have the capability to evaluate and test candidate vaccines or related biologics with the associated methods, processes, and documentation of sufficient quality to satisfy regulatory requirements to enable clinical evaluation. Specific activities that will be supported include a suite of services for activities commonly associated with testing and evaluating infectious diseases vaccines and other products, encompassing activities required for submitting Biologic License Application and/or investigational new drug applications. Task areas that will be supported include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification, and validation of immune assays, 3) immunogenicity and efficacy testing, 4) nonclinical and clinical sample testing, and 5) safety/toxicology studies.
At a minimum, existence of the vaccine and/or its related component as a bench-grade product and preliminary proof-of-concept efficacy data will be required for consideration. Examples of the types of candidate products include: (a) synthetic peptides, (b) recombinant subunits, (c) vector-based vaccines, (d) virus-like particles/replicons, and/or (e) nucleic acid-based vaccines. Adjuvants and delivery systems may also be supported. In addition, challenge materials such as agents for preclinical, nonclinical, and clinical trials will be supported. A companion initiative will support manufacturing and characterization services for vaccines and other biologics for infectious diseases.
Manufacturing and Characterization for Vaccines and Other Biologics for Infectious Diseases
Request for Proposals—proposed FY 2018 initiative
Contact: Lauren Tipton
Objective: To establish a service program for the research community that provides capacity for the manufacturing and characterization of vaccines and other biologics for infectious diseases and/or related toxins.
Description: This initiative seeks to provide support for constructing, developing, and manufacturing vaccines and biologics for infectious diseases. It will support the development of methods, processes, and documentation of sufficient quality to satisfy regulatory requirements to enable Phase I/II clinical evaluations, as well as those activities required for submitting Biologic License Application and/or investigational new drug applications. Task areas that will be supported include:
- Administrative and technical management along with training and workshops
- Feasibility studies including product development plans and early product screening, optimization, and construction of product candidates
- Process development such as assay development, reagent development, pilot and/or engineering runs, as well as storage and stability studies
- cGMP manufacture of master cell banks, master virus seeds, bulk drug substance, final drug product, as well as storage and stability studies
- Quality and regulatory management including site visits, critical stage reviews and audits, and final study report audits
Examples of the types of products supported include vaccine and biological products; cellular and viral banks; product components including adjuvants, and delivery systems such as needle free patches; critical reagents for product development and assay development; and challenge material. The quality of these products will span early research and development grade material through current Good Manufacturing Practices compliant products for Phase I/II clinical trials. A companion initiative will support evaluation and testing services for vaccines and other biologics for infectious diseases.
Systems Biology: The Next Generation for Infectious Diseases
For the published request for applications, see the November 16, 2016 Guide announcement, Systems Biology: The Next Generation for Infectious Diseases (U19).
International Research in Infectious Diseases, Including AIDS
Program Announcement With Special Receipt, Referral, and/or Review Considerations—proposed FY 2018 initiative
Contact: Polly Sager
Objective: To support the development of local scientific expertise and to increase research capacity at NIAID international sites in resource-constrained countries.
Description: This initiative will support small grants in eligible (resource-constrained) foreign countries for infectious diseases research, especially among investigators and institutions at international sites where NIAID has significant investment in research and/or infrastructure. Research should focus on infectious diseases, including AIDS, that are of particular interest to the local country. Collaborative projects involving investigators and institutions from international sites and the U.S. are particularly encouraged.