2027 NIAID DMID Omnibus Broad Agency Announcement: Development of Medical Interventions for Infectious Diseases

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INTRODUCTION: The National Institute of Allergy and Infectious Diseases (NIAID), one of 27 institutes of the NIH, an agency within the Department of Health and Human Services (DHHS); conducts and supports research to understand, treat, and ultimately prevent the myriad infectious, immunologic, and allergic diseases that threaten the health and longevity of human lives.Through a variety of research grants and contracts, NIAID’s Division of Microbiology and Infectious Diseases (DMID) specifically supports extramural research to develop new medical interventions against infectious disease threats to include drug-resistant pathogens. NIAID/DMID intends to use this BAA to help address goals articulated in a number of strategic plans, such as in the Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan (https://aspr.hhs.gov/PHEMCE/2024-PHEMCE-SIP/Pages/default.aspx), as well as current prioritized antimicrobial resistant threats identified by national death and infection estimates as determined by the Centers for Disease Control and Prevention’s (CDC) to prevent and control antimicrobial resistance (https://www.cdc.gov/antimicrobial-resistance/data-research/threats/index.html). In addition, NIAID/DMID intends to use this BAA to encourage projects that align with the NIH priorities of enhancing rigor & reproducibility, improving biosafety and biosecurity, and the use of complementary non-animal testing methods where appropriate. This Broad Agency Announcement (BAA) is soliciting proposals to advance the research and development of promising candidate therapeutics, vaccines, and diagnostics for infectious diseases in each of three (3) Research Areas described below and more thoroughly discussed in the attached BAA Solicitation. An offeror should carefully review the content of the BAA Solicitation No. HHS-NIH-NIAID-BAA2026-1 for the comprehensive information regarding all requirements, the technical objective of each Research Area of this BAA Solicitation, instructions regarding the proposal submission, and a description of the evaluation and award process. Please note, due to the competitive nature of the BAA Solicitation, the NIAID is unable to offer advice or feedback regarding an offeror’s specific technical approach. Offerors should exercise their professional judgment when compiling their proposals in line with the requirements and specifications of the BAA Solicitation. Research Area 001 - Vaccine Candidates: The objective is to develop vaccine candidates through an early phase clinical trial that use a needle free (i.e., alternative to classical needle and syringe, see below for description) route of delivery to protect against infections caused by viral pathogens that include but are not limited to respiratory and vector borne viruses. The scope of this vaccine research area includes the preclinical development of a needle free vaccine candidate, IND enabling studies, limited process development, Good Manufacturing Practice (GMP) compliant manufacturing, regulatory submissions to the U.S. Food and Drug Administration (FDA) and conduct of a Phase 1 or early Phase 2 clinical trial. The scope of work must include a clinical trial. Offerors must propose a single vaccine candidate for protection against a specific viral pathogen. The vaccine candidate may provide a breadth of protection against other viral strains or viruses. A strong justification is required to support (1) the proposed vaccine antigen and platform for the disease indication, (2) the use of a clinically relevant adjuvant (if needed), and (3) a clinically relevant needle free route of delivery. Research Area 002 - Therapeutic Candidates: The objective is to develop safe, effective, new therapeutic products that will improve patient outcomes against serious infectious diseases for which there are no approved therapeutics, or for those that are refractory to treatment despite appropriate antimicrobial therapy or due to pathogen…

Idioma deste anúncio: English. O título e a descrição são apresentados tal como a entidade adjudicante os publicou.

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