September 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

Development of Medical Countermeasures for Biothreat Agents, Antimicrobial-Resistant Infections, and Emerging Infectious Diseases

Broad Agency Announcement—proposed FY 2018 initiative

Contact: George Kennedy

Objective: To advance the development of promising candidate therapeutic, vaccine, and diagnostic products for biothreat agents, antimicrobial-resistant infections, and emerging infectious diseases.

Description: This initiative is designed to advance high-priority, promising candidate therapeutics; vaccines and vaccine technologies; and diagnostics toward appropriate regulatory agency approval/licensure/clearance through a focused, milestone-based development approach for NIAID Emerging Infectious Diseases/Pathogens-Category A, B, and C Priority Pathogens. It is anticipated that specific area(s) of focus will be announced annually.

The types of activities that are envisioned for therapeutics and vaccines may include:

  1. Nonclinical research and development, including safety and efficacy testing
  2. Lead candidate optimization
  3. Developing manufacturing/technology platforms/processes, manufacturing/synthesis of current good manufacturing practices (cGMP) pilot lots, and conducting extended product stability studies
  4. Development and qualification of characterization and release assay development, and qualification and advanced candidate characterization
  5. Preparing and submitting investigational new drug (IND) applications to FDA
  6. Conducting a Phase 1, Phase 1/2, and/or Phase 2 clinical trial
  7. Post-Phase 1 development activities to enable eventual licensure

For diagnostics, the types of activities may include:

  1. Optimizing diagnostic assay(s), control reagents, and/or instruments
  2. cGMP manufacturing of diagnostic reagents, control reagents, and/or instrument
  3. Extended product stability studies
  4. Performing studies required for FDA 510k clearance or Pre-Market Approval (PMA) of the diagnostic
  5. Preparing and submitting a 510k or PMA application to FDA
  6. Evaluation studies to assess the diagnostic’s impact on patient outcomes and/or healthcare costs

Examples of potential topics that could be solicited:

  • Therapeutics
    • Novel strategies to treat drug-resistant pathogens
    • Broad-spectrum antivirals to treat influenza and emerging viral diseases
    • Anti-toxin products
  • Vaccines
    • Vaccines against pathogens that are urgent or serious antimicrobial-resistant threats
    • Vaccines for post-exposure prophylaxis indications with an emphasis on rapid immune response and sterilizing immunity
    • Technology gaps that slow progression to clinical testing
    • Delivery technology platforms
    • Technologies to increase vaccine stability and decrease cold chain requirements
    • Novel vaccine “plug-and-play” technologies to:
      • Enable multivalent and/or universal vaccine approaches
      • Facilitate the rapid generation of effective vaccine candidates against emerging infectious diseases
      • Enable platform development in support of continuous manufacturing initiatives including process efficiencies and surge production capabilities
  • Diagnostics
    • Rapid, sensitive, specific, simple, and cost-effective diagnostic products capable of:
      • Addressing antimicrobial resistance by identifying causative pathogen(s) and determining the antimicrobial sensitivity of the pathogen(s)
      • Detecting novel and/or emerging pathogens
      • Assessing a patient’s stage of disease
      • Using validated biomarkers to predict a patient’s outcome
      • Identifying potential patients/subjects most likely to be evaluable in pivotal efficacy trials for therapeutics

Partnerships for the Development of Tools To Advance Therapeutic Discovery for Select Antimicrobial-Resistant Gram-Negative Bacteria

For the published request for applications, see the November 16, 2016 Guide announcement, Partnerships for the Development of Tools To Advance Therapeutic Discovery for Select Antimicrobial-Resistant Gram-Negative Bacteria (R01).

Partnerships for Development of Vaccines To Prevent Mycobacterium tuberculosis Infection and/or Tuberculosis Disease

For the published request for applications, see the October 5, 2016 Guide announcement, Partnerships for Development of Vaccines to Prevent Mycobacterium tuberculosis Infection and/or Tuberculosis Disease (R01).

Development of Multipurpose Prevention Technologies: A Strategy for the Prevention of STIs

For the published request for applications, see the December 7, 2016 Guide announcement, Development of Multipurpose Prevention Technologies: A Strategy for the Prevention of Sexually Transmitted Infections (STIs) (R61/R33)​​.​

 

Content last reviewed on December 8, 2016