June 2016 DMID Council-Approved Concepts

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

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

For the published request for proposals, see the March 10, 2017 solicitation, Manufacturing and Characterization 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

For the published program announcement, with special receipt, referral, and/or review considerations, see the January 27, 2017 Guide announcement International Research in Infectious Diseases, Including AIDS (R01).

Content last reviewed on March 13, 2017