Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, 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 Opportunities & Announcements.
Note: Council approval does not guarantee that a concept will become an initiative.
Table of Contents
Fiscal Year (FY) 2025 Division of Microbiology and Infectious Diseases (DMID) Concepts
- Interventional Agents Safety and Pharmacokinetic Services
- Interventional Agents Chemistry Services
- Evaluation and Testing Services for Vaccines and Other Biologics for Infectious Diseases
- Vaccine (and Other Biologics) Manufacturing Services for Infectious Diseases
- Centers of Excellence for Translational Research
Interventional Agents Safety and Pharmacokinetic Services
Request for Proposals—proposed FY 2025 initiative
Contact:
Jonathan Bryan
jonathan.bryan@nih.gov
240-669-5180
Objectives: To provide a broad range of in vitro and in vivo preclinical services to offer gap-filling support for nonclinical therapeutic development.
Description: The purpose of this concept is to continue to provide the research community with services for activities commonly associated with preclinical development of therapeutic agents, including those activities required for the submission of investigational new drug applications. Services include product development planning, in vitro ADMET, in vivo PK, and safety and toxicology.
These services are intended to provide information to fill discrete gaps in the product development pathway, not to support a comprehensive product development program. These services will be available to investigators in academia, not-for-profit organizations, industry, and government worldwide, subject to DMID priorities and resources.
Interventional Agents Chemistry Services
Request for Proposals—proposed FY 2025 initiative
Contact:
Jonathan Bryan
jonathan.bryan@nih.gov
240-669-5180
Objective: To provide a broad range of chemistry and manufacturing preclinical services to offer gap-filling support for nonclinical therapeutic development.
Description: The purpose of this concept is to continue to provide the research community with chemistry and manufacturing services commonly associated with preclinical development of therapeutic agents, and in support of submission of investigational new drug applications. Services include medicinal chemistry synthesis, process optimization, preparation of toxicology batches, formulation development, GMP manufacturing of drug substance and drug product, and release and stability testing. These services are intended to provide materials and information to fill discrete gaps in the product development pathway, not to provide a comprehensive product development program. These services will be available to investigators in academia, not-for-profit organizations, industry, and government worldwide, subject to DMID priorities and resources.
Evaluation and Testing Services for Vaccines and Other Biologics for Infectious Diseases
Request for Proposals—proposed FY 2025 initiative
Contact:
Michael Welsh
welshmi@mail.nih.gov
240-669-5132
Objective: To provide a suite of preclinical, nonclinical, and clinical assays services for vaccines and other biologic products.
Description: Under this renewal initiative, DMID will continue to 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 required for regulatory submissions such as Investigational New Drug (IND), EUA (emergency use authorization), and Biologic License Applications (BLA). Task areas that will be supported include:
- Development, qualification, and validation of immunological and infection assays and nonclinical and clinical sample testing.
- Immunogenicity and efficacy testing up to BSL3 and 4.
- General safety/toxicology studies including neurological/reproductive studies.
In addition, challenge materials including agents for preclinical, nonclinical, and clinical trials will be supported. These services are intended to provide information to fill discrete gaps in the product development pathway, not to support a comprehensive product development program. Services will be available to investigators in academia, nonprofit and not-for-profit organizations, industry, and government agencies worldwide, subject to DMID priorities and resources.
Vaccine (and Other Biologics) Manufacturing Services for Infectious Diseases
Request for Proposals—proposed FY 2025 initiative
Contact:
Andrew Cherry
cherryan@niaid.nih.gov
240-669-5138
Objective: To provide product development and manufacturing support of novel candidates from proof-of-concept stage through Phase I/II clinical studies.
Description: Through this initiative, DMID will provide gap filling services to optimize, develop, and manufacture products for use in investigational new drug (IND)-enabling and Phase I/II clinical studies. Products include vaccines, other biologics, challenge material, adjuvants, associated delivery systems, and other critical reagents that span BSL2-4. This gap filling support will be separated into 4 distinct task areas:
- Task Area 1 will include Product Development Plans (PDPs) and Feasibility Studies as well as other documentation and planning activities. This task area will provide specific product assessments and development plans that are of value to both the product innovators and NIAID.
- Task Area 2 will encompass Development and Manufacturing Services and includes process development, manufacture of non-GMP and IND-enabling material. Product optimization is included in this task area.
- Task Area 3 will include cell line optimization, manufacture of pre-master banks and manufacture of master banks. This task area will include appropriate quality oversight and regulatory support for Chemistry, Manufacturing, and Controls (CMC) and ICH Quality (Q6) activities.
- Task Area 4 will include manufacture of engineering lots and GMP material for Phase I/II clinical trial material, and human challenge material. Note that this task area will include appropriate quality oversight and regulatory support for CMC and ICH Quality (Q6) activities.
Note that these services are intended to fill discrete gaps in the product development pathway and are not intended to support a comprehensive product development program. Based on DMID priorities and resources, these services will be available on a worldwide basis to appropriate organizations including academia, non-profit and not-for-profit organizations, industry, and public/private partnerships.
Centers of Excellence for Translational Research
Request for Applications—proposed FY 2025 initiative
Contact:
Judy Hewitt
jhewitt@niaid.nih.gov
240-627-3274
Objective: To expand the pipeline of medical countermeasures against bacteria or fungi with known and emerging resistance as identified in the CDC’s 2019 Biggest Threats Report by supporting translational research activities to advance basic discoveries into preclinical development and the product development pathway.
Description: This initiative will support multidisciplinary translational research centers focused on generating, validating, and advancing medical countermeasures (therapeutics, immunotherapeutics, vaccines, vaccine technologies, and medical diagnostics) against bacteria or fungi with known and emerging [drug] resistance. Each center will conduct interdependent research and development activities organized around a specific research gap and/or theme. Emphasis will be placed on integration of current research knowledge and infrastructure with highly innovative and synergistic approaches to facilitate countermeasure development that addresses related constraints or barriers to product development, licensure, and usage. Clinical trials will not be supported under this program.