January 2026 DAIDS 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 NIAID initiatives, go to Explore NIH Grant Opportunities.

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year (FY) 2028 Division of AIDS (DAIDS) Concepts

HIV/AIDS Clinical Trials Network Leadership and Operations Centers

For more information, go to View Grant Opportunity for HIV/AIDS Clinical Trials Network Leadership and Operations Centers. Note: Information is tentative and subject to change.

Request for Applications—proposed FY 2028 initiative

Contact:
NIAID DAIDS SPOB

Objective: The primary objective of this notice of funding opportunity (NOFO) is to advance NIH’s mission by supporting four Clinical Trials Networks (CTNs) by establishing Leadership and Operations Centers (LOC) that will provide scientific leadership and operational support for a coordinated, multidisciplinary research network to advance HIV/AIDS prevention, treatment, and implementation research designed to end the HIV epidemic. This NOFO will solicit applications for four LOCs to provide scientific leadership, research prioritization, and conduct studies in a CTN.

A LOC will develop the research agenda in one of these areas: 1) HIV therapeutics/cure and prevention/treatment for HIV-associated comorbidities in adults; 2) HIV prevention/treatment in maternal/adolescent/pediatric populations; 3) biomedical HIV prevention strategies for adults/adolescents; and 4) immune-based prevention for HIV and HIV-associated diseases. CTNs will conduct HIV implementation research, improving uptake of evidence-based prevention and treatment strategies across the lifespan.

High impact LOC studies will produce crucial findings significantly benefiting Americans with or at-risk of HIV and HIV-associated diseases.

Description: NIAID’s HIV/AIDS Clinical Trials Networks provide research and infrastructure resources to support coordinated, multidisciplinary efforts to advance HIV research. The objectives will primarily be addressed through clinical trials and associated clinical research. Each Clinical Trials Network will be constituted by a LOC coupled with the Statistical and Data Management Center (SDMC), and Laboratory Center (LC), Clinical Trials Units (CTUs), and their affiliated Clinical Research Sites (CRSs). The SDMC, LC, and CTUs will be supported under separate initiatives, and will solicit applications under separate NOFOs.

It is expected that each network will maintain and support clinical trial capacities to include digital health tools and remote/decentralized trial capabilities to expand access and participation as needed for successful trial implementation.

Each application must address the scientific agenda for only a single network. The scientific agendas for the four Network LOCs include:

HIV/AIDS Adult Therapeutics Clinical Trials Network

The main goal of the NIAID Adult Therapeutics Clinical Trials Network is to advance HIV/AIDS adult therapeutics research. This Network will address questions for treatment and cure of people living with HIV (PLWH), including implementation science and research to improve treatment of HIV-related comorbidities and co-infections (e.g., tuberculosis, viral hepatitis) and aging. These are high-priority research areas for NIAID/DAIDS and co-funding NIH ICs and will have the greatest impact on PLWH.

Capitalizing on its robust research infrastructure, the LOC together with its associated LC and SDMC will establish and strengthen collaborations with other NIH ICs, NIAID/DAIDS networks, and external groups, and leverage its resources to achieve the above objectives. It’s expected that the Network will conduct some clinical studies at international sites to ensure trial feasibility, maximize efficiency, and ensure validity of research findings, which will ensure the research undertaken by this network is of greatest benefit to Americans who suffer from (or are at risk of) these diseases.

HIV Maternal, Adolescent, and Pediatric Clinical Trials Network

The main goal of this Network will be to support research strategies that address scientific knowledge gaps in populations living with or at high risk of acquiring HIV and focus on evaluating novel and optimized treatment interventions; evaluating HIV post-natal prophylaxis strategies towards eliminating vertical HIV transmission; achieving ART-free remission; advancing tuberculosis treatment and prevention; and strengthening research on brain and mental health and other comorbidities. In general, research efforts should leverage implementation sciences strategies that inform integration and scale up of evidence-based interventions in routine settings, or end-user preference-focused, state-of-the-art socio-behavioral sciences that complement investigational product evaluation and can facilitate their future adoption and uptake.

Appropriate pediatric-friendly formulation development and innovative trial design and statistical methodologies should be leveraged, as appropriate. The LOC will implement sound processes for efficient review of research concepts, ensuring that those most likely to be impactful are selected for performance at clinical research sites. Research in international settings is necessary to enable efficient and well-powered trials that provide timely answers to scientific questions relevant to achieving perinatal/pediatric elimination in the United States and will directly contribute to improving the lives of American children and mothers living with or affected by HIV.

HIV Prevention Research Clinical Trials Network

One of the main goals of the HIV Prevention Trials Network is to undertake implementation science studies to improve real world roll out and uptake of promising new prevention strategies and products. This work will require partnerships with implementers. Another main goal of the Network should focus on ensuring an appropriate level of effort on clinical development of new HIV prevention products. To achieve these goals, there will need to be a mix of both domestic and international site collaboration. Although the ultimate goal is to improve the lives of U.S. residents, it will take additional international sites with higher HIV incidence to definitively answer the scientific questions and deliver health improvements to U.S. citizens. The Network must develop processes to efficiently move ideas from concept stage through full protocol development and implementation. Broad solicitation of scientific ideas, appropriate review processes, and project management are key components to drive the science forward.

Immune-Based Prevention Trials Network (IBPTN)

The main goal of the IBPTN is to support early- and late-phase clinical trials to assess safety, tolerability, immune correlates of protection, and efficacy of immune-based preventative countermeasures, such as monoclonal antibodies and vaccines, against HIV, TB, and sexually transmitted infections relevant to people living with or at risk of acquiring HIV. Early countermeasure concepts will advance through iterative, discovery medicine approaches to evaluate immune-based strategies, such as inducing broadly neutralizing antibodies against HIV. Additionally, the LOC will prioritize implementation science to improve the administration and acceptability of these countermeasures. Research will be conducted domestically and internationally in regions with high disease burden, enabling faster, more cost-effective trials across populations to generate data on varied pathogen strains, with the goal of accelerating countermeasure development to protect U.S. communities.

Operationally each NIH HIV/AIDS Clinical Trials Network should:

  • Implement and maintain standardized processes, forms, and project management functions across the Network to allocate and track project resources and allow trans-network coordination and reporting. Protocol-based project plans, including timelines and resources, will allow better forecasting of Network activities.
  • Foster the incorporation of new researchers as appropriate within the context of conducting the Network's research agenda.
  • Integrate community participation in Network activities, from scientific agenda to protocol development and community engagement; support for site community advisory boards; and support of community training and educational needs needed for the success of the research agendas.

HIV/AIDS Clinical Trials Network Laboratory Centers

For more information, go to View Grant Opportunity for HIV/AIDS Clinical Trials Network Laboratory Centers. Note: Information is tentative and subject to change.

Request for Applications—proposed FY 2028 initiative

Contact:
NIAID DAIDS SPOB

Objective: To establish Laboratory Centers (LCs) that will provide a framework for laboratory leadership, structure and activities that contribute to the development of the Network’s research agenda, and to execute the laboratory component of the Network’s clinical research. The LCs will be expected to work closely with the respective Leadership and Operations Centers (LOCs) to contribute to their scientific agenda and develop the lab component of study protocols. In collaboration with the NIAID Laboratory Quality Assurance contract resources, the LCs will evaluate and qualify laboratories proposed by Clinical Trials Units (CTUs)/Clinical Research Sites (CRSs), with final selection of the laboratories by the LCs and the DAIDS Clinical Laboratory Oversight Team (DCLOT). LCs will ensure that analyte testing procedures are appropriately qualified or validated according to risk-based endpoint determination, and the phase and purpose of clinical trial. The LCs will also coordinate with the Statistical and Data Management Centers (SDMCs) to achieve reliable laboratory data capture and export as well as specimen tracking.

Description: The NIAID HIV/AIDS Clinical Trials Networks provide research and infrastructure resources to support coordinated, multidisciplinary efforts to advance HIV research. The objectives will primarily be addressed through clinical trials and associated clinical research. The Clinical Trials Network will be constituted by a LOC coupled with the SDMC, and LC, the CTUs, and their affiliated CRSs. Each LOC, as well as the SDMC, LC, and CTUs will be supported under separate initiatives, and will solicit applications under separate notices of funding opportunities (NOFOs).

This initiative will establish LCs to provide a framework for laboratory leadership, structure, and activities that contribute to the development of the respective Network’s research agenda and demonstrate an ability to execute the laboratory component of Networks’ clinical research. This initiative will expect an LC to:

  1. Implement, coordinate, and oversee laboratory testing in support of the Network research agenda in U.S. and non-U.S. laboratories, including: 
    • Clinic-based laboratories associated with CRSs for local specimen processing and testing (e.g., HIV rapid tests, urine hCG).
    • CRS-affiliated clinical laboratories, commercial labs, and/or centralized local and regional laboratories for routine clinical testing (e.g., safety tests and diagnostic tests).
    • Central/specialized/endpoint laboratories (e.g., immunology, virology, pharmacology, TB) that use a variety of modern analytic tools (e.g., high-throughput systems biology approaches to study tissue, cells, and plasma/serum coupled with detailed clinical phenotyping; next generation sequencing techniques, immunophenotyping, imaging techniques, quantitative molecular methods for measuring HIV reservoirs).
  2. Ensure, in collaboration with DAIDS-funded laboratory quality assurance contracts (pSMILE, VQA, IQA, CPQA, TBQA, EQAPOL) the ongoing reliability and integrity of protocol-mandated laboratory testing and standards of laboratory operations to allow for product advancement decisions or the approval of registrational studies by U.S. and non-U.S. regulatory entities. Laboratories will be expected to comply with DAIDS requirements, as applicable, including participation in External Quality Assurance schemes to assess ability to perform tests accurately, CLIA certification, and/or compliance with Good Clinical Laboratory Practices (GCLP). (We will include hyperlinks to our requirements in the published NOFO).
  3. In collaboration with protocol teams, sites, and DAIDS, support reliable specimen chain of custody, address shipping challenges, and provide for local and centralized short- and long-term storage of study samples obtained from study participants. The LC, in collaboration with Network Leadership, will promote access to stored specimens for future research by the broader scientific community.
  4. Ensure that the LC’s electronic information systems are appropriate, validated, and verified to capture laboratory data and track specimens according to all regulatory standards.
  5. Support the development and evaluation of novel assays, using diverse specimens, for implementation in trial protocols and in ancillary studies (e.g., assays to measure the HIV viral reservoir, diagnostics and prognostic biomarkers, with focus on point-of-care testing, for pulmonary and extrapulmonary TB; identification of immunologic and virologic biomarkers associated with HBV clearance and immune control; identification of immune profiles that correlate with maturation of B cell bNAb precursors to potent bNAbs; protective T cell responses; determinants of vaccine durability; assays to measure levels of antiviral drugs and biologics; diagnostics to distinguish HIV vaccine-induced positivity from HIV infection; HIV incidence assays/algorithms to measure impact of prevention tools).
  6. In collaboration with the NIAID Laboratory Quality Assurance contract resources, the LCs will evaluate and qualify laboratories proposed by CTUs/CRSs, with final selection of the laboratories by the LCs and the DCLOT. This approach may include central, local, and regional laboratories, when applicable and feasible, that support an efficient, flexible, and cost-effective laboratory structure, that can enable rapid activation of Network protocols in response to evolving global and regulatory needs and complexities.
  7. Plan to increase the LC capacity and capabilities to meet NIAID future unanticipated needs related to emerging infectious diseases of national and global significance.
  8. Develop an approach for coordinating laboratory oversight activities when other networks or institutions (e.g., NICHD) jointly participate in the conduct of a protocol.
  9. Develop and implement an approach to ensure reliable testing in back-up laboratories when needed and develop and implement an approach for the timely acquisition of external specialized laboratory expertise when needed to support study protocols.
  10. Work closely with the SDMC and LOC to contribute to its scientific agenda and review the lab components of study protocols; and coordinate with the SDMC(s) to achieve reliable laboratory data capture and export as well as specimen tracking.
  11. Establish central testing in support of multiple Network studies when common assays are employed and harmonize lab-related requirements and processes in support of the Networks (e.g., laboratory approval process).

HIV/AIDS Clinical Trials Network Statistical and Data Management Centers

For more information, go to View Grant Opportunity for HIV/AIDS Clinical Trials Network Statistical and Data Management Centers. Note: Information is tentative and subject to change.

Request for Applications—proposed FY 2028 initiative

Contact:
NIAID DAIDS SPOB

Objective: To establish Statistical and Data Management Centers (SDMCs) that will provide statistical expertise and data management leadership for clinical research in support of NIH’s HIV/AIDS Clinical Trials Networks. Each SDMC will support coordination of the design, conduct, study data monitoring, and analysis of clinical research to advance a chosen scientific agenda. Each SDMC will provide the infrastructure and ongoing support critical to operational and regulatory aspects of data management necessary to ensure data quality and integrity while meeting all NIH, U.S. federal, and international standards for clinical research, including clinical trials. The scope of data management responsibilities includes clinical and laboratory data including immunologic, virologic, and both host and pathogen genomic data, management of data related to the inventory and use of specimen repositories.

Each SDMC will be responsible for the development and maintenance of validated and verifiable data collection systems, data forms and formats, and generic and protocol-specific instruments, and will be responsible for determining how statistical methodologies and/or database systems and structures will be adopted and adapted to accommodate the Network’s research needs and others when required. It is important to note that the level of data validation is dependent on clinical trial protocol objectives. Each SDMC will work closely with a chosen Leadership and Operations Center (LOC) to support continual reporting of operational status by protocol and clinical research sites, to permit projections and reallocation of clinical research resources, and to use data tracking systems. Together with the LOC and Laboratory Center (LC), the SDMC will assist in monitoring the performance of all key elements of the Network to ensure efficient development, implementation, and completion of clinical research and the publication of study results. The SDMC will be expected to work closely with the LOC(s) to contribute to the scientific agenda, develop and review study protocols, develop composite protocol budgets and project plans for data management operations with Clinical Trials Unit (CTU)/Clinical Research Site (CRS) leaders, and coordinate with the LC(s) to achieve reliable laboratory data capture and export.

Description: NIAID’s HIV/AIDS Clinical Trials Networks provide research and infrastructure resources to support coordinated, multidisciplinary efforts to advance HIV research. The objectives will primarily be addressed through clinical trials and associated clinical research. The Clinical Trials Network will be constituted by a LOC coupled with the SDMC, and LC, CTUs, and their affiliated CRSs. Each LOC, as well as the SDMC, LC and CTUs will be supported under separate initiatives, and will solicit applications under separate notices of funding opportunities.

The SDMC initiative will support:

  • Innovative research to foster novel data management and statistical methodologies to address the research challenges of aligned LOC agendas.
  • Alignment of statistical and data activities with Network scientific agendas.
  • Harmonization of processes/requirements, where possible, both within the Network supported by an SDMC and across all funded SDMCs.
  • Implementation and maintenance of validated and verified data capture, integration, storage, retrieval, and tracking systems, including systems to fulfill NIAID/DAIDS requirements for trial master files.
  • Implementation of processes for assessing risks in clinical data, i.e., data review and analysis for detection of potential issues.
  • Compliance with Clinical Data Interchange Standards Consortium (CDISC) requirements, including:
    • Clinical Data Acquisition Standards Harmonization (CDASH)
    • Analysis Data Model (ADaM)
    • Study Data Tabulation Model (SDTM)
    • Compliance with standards of FDA and other regulatory authorities, as appropriate
  • Established processes for ensuring the validity, reliability, and accuracy of clinical research data.
  • Fulfillment of NIH mandated data sharing processes.
  • Documentation of all research-related statistical and data activities performed according to regulatory standards through standard operating procedures.

The SDMC will have the primary responsibility of data transmission for a Network LOC to NIH and NIAID data systems.

Each SDMC must comply with current applicable federal regulations located at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm and http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html (e.g., 21 CFR 11, 21 CFR 50, 56, 312, 612 and 812 as applicable, 45 CFR 46 and/or similar statutes), including U.S. Public Law 110-85 or the Food and Drug Administration Amendments Act of 2007, as well as local regulations as applicable.

Each SDMC must adhere to current globally accepted standards, including the following:

  1. International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 R3 Good Clinical Practice, located at: https://www.ich.org/page/efficacy-guidelines.
  2. Compliance with coding to M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries, located at: https://www.ich.org/page/multidisciplinary-guidelines.
  3. Compliance with coding to the World Health Organization drug reference dictionary, WHODrug Global), protocol-specific requirements, and all applicable NIH/NIAID/DAIDS policies and procedures.
  4. Compliance with current industry standards for clinical data management, current example – Clinical Data Interchange Standards Consortium (CDISC) located at: https://www.cdisc.org.

Provisions to maintain compliance with changing industry standards and regulations must be in place, at no additional cost to the U.S. government.

HIV/AIDS Clinical Trials Units

For more information, go to View Grant Opportunity for HIV/AIDS Clinical Trials Units. Note: Information is tentative and subject to change.

Request for Applications—proposed FY 2028 initiative

Contact:
NIAID DAIDS SPOB

Objective: NIAID seeks to advance the NIH mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center, and Laboratory Center working with Clinical Trials Units (CTUs), to advance prevention and treatment research on HIV and HIV-associated diseases. CTNs will conduct randomized controlled clinical studies at CTUs testing innovative strategies and conduct implementation research targeted to end the HIV epidemic. This notice of funding opportunity (NOFO) will solicit applications for CTUs providing scientific expertise to conduct these clinical trials and implementation research studies. Each CTU will include an administrative hub and domestic and/or international Clinical Research Sites (CRSs) to promote efficient utilization of resources and infrastructure. CTUs conduct multiple clinical studies, from more than one CTN, and can access, recruit, and retain relevant study participants. International studies produce crucial findings significantly benefiting Americans with or at-risk of HIV or HIV-related diseases.

Description: NIAID HIV/AIDS Clinical Trials Networks provide research and infrastructure resources to support coordinated, multidisciplinary efforts to advance HIV research. The objectives will primarily be addressed through clinical trials and associated clinical research. The Clinical Trials Network will be constituted by Leadership and Operations Center (LOC) coupled with the Statistical and Data Management Center (SDMC), and Laboratory Center (LC), the CTUs, and their affiliated CRSs. Each LOC, as well as the SDMC, LC and CTUs will be supported under separate initiatives, and will solicit applications under separate NOFOs.

The focus of this initiative is to support coordinated CTUs for domestic and international HIV/AIDS clinical research. Each CTU will include an administrative hub and one or more domestic and/or international CRSs. The CTUs will provide clinical and scientific expertise to conduct clinical research, and provide laboratory, pharmacy, and local data management resources, as well as robust community engagement activities. Each CTU will have responsibility for overseeing and evaluating clinical trial conduct at the sites, ensuring compliance with policies and procedures, as well as adherence to regulations. The CTU will also be responsible for ensuring optimal resource allocation at the CRS to conduct the clinical protocols.

Each CTU will be linked to separately funded Network awards for leadership and operations, statistics and data management, and laboratory services.

  • Each CTU will be composed of 1 to 8 experienced CRSs. A CRS is a discrete entity where clinical research protocols are implemented. The CRS must have demonstrated access to an appropriate clinical trial population based on demographics, incidence and prevalence of HIV/AIDS, and other relevant population characteristics.
  • The CRS must:
    • Be staffed by trained, qualified professionals capable of conducting clinical research in accordance with Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) standards, local and/or national regulatory requirements, and other applicable NIH requirements.
    • Be directed by a CRS leader with experience and qualifications to oversee all HIV/AIDS Network clinical activities at the CRS.
    • Have a main clinic location with appropriate infrastructure and equipment to conduct clinical research activities, although the CRS may include more than one location where clinical research activities are conducted.
    • Have a community advisory board and other community engagement strategies to meaningfully engage with the community in which the CRS works.
    • Be staffed by trained, qualified professionals with experience in good data management practices.
    • Perform quality management functions at all levels of the CRS to ensure research activities are conducted at the highest standards of quality and compliance.

All CTU activities will be compliant with current applicable federal regulations located at: https://www.ecfr.gov/current/title-21 and https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html.

CTU activities must adhere to current globally accepted standards, including the following:

  • International Conference on Harmonization (ICH) E2, Clinical Safety Data Management, ICH E3 Clinical Study Reports, ICH E6 Good Clinical Practice, located at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219488.htm.
  • Compliance with coding to M1 MedDRA Terminology and ICH M5, Data Elements and Standards for Drug Dictionaries, located at: https://www.ich.org/page/multidisciplinary-guidelines.
  • Compliance with coding to the World Health Organization Drug Dictionary, protocol-specific requirements, and all applicable NIH/NIAID/DAIDS policies and procedures.
  • Compliance with current industry standards for clinical data management, current example – Clinical Data Interchange Standards Consortium (CDISC) located at: https://www.cdisc.org. Provisions to maintain compliance with changing industry standards must be in place, at no additional cost to the government.
  • NIAID is seeking ‘research ready’ CRSs that have demonstrated experience conducting IND-level clinical research and have demonstrated access to the appropriate clinical trial participant populations for studies.
  • There are no changes to the overall goals of this initiative to provide appropriate scientific and technical expertise as well as clinical research infrastructure to support NIAID’s research priorities.

Immunology Quality Assessment (IQA) Program

Request for Proposals—proposed FY 2028 initiative

Contact:
Callie Prassinos

Objective: To provide a critical resource to evaluate and enhance the ability of laboratories (Labs) to participate in NIAID-funded and collaborative trials by:

  1. Monitoring the ability of Labs to reliably perform study-specified immunological tests, freeze viable peripheral blood mononuclear cells (PBMCs), and process leukopaks.
  2. Comparing, optimizing, standardizing, and validating immunological assay methodologies for implementation in NIAID-supported studies.
  3. Helping Labs meet sponsor and regulatory requirements for good clinical laboratory practices (GCLP).

Options to increase level of effort to support unanticipated increases in demand related to additional Labs, as well as performance of late-stage assay validation and/or immunological assay testing of clinical samples in a CLIA-certified laboratory, are also within the scope of the contract.

Description: This initiative will:

  1. Obtain or prepare proficiency testing (PT) panels of coded samples to be shipped to approximately 40 non-U.S. CD4 Labs in 15 countries, receiving test results from Labs, analyzing and grading performance, issuing performance reports, and guiding Labs in the investigation of root causes of poor performance to correct and prevent deficiencies. As needed, provide PT oversite support to other immunological tests incorporated in NIAID-supported studies.
  2. Monitor the ability of approximately 60 U.S. and 40 non-U.S. PBMC freezing Labs in approximately 12 countries to reliably freeze viable PBMCs, as well as monitor the ability of approximately 15 Labs to reliably process leukopaks or tubes containing large numbers of PBMCs. Frozen samples will be shipped from Labs to the IQA for thawing and determining cell viability and viable yields. The IQA will analyze and grade performance, issue reports, and provide Labs with guidance to correct and prevent poor performance.
  3. Conduct at the IQA, or facilitate multi-lab, studies to compare, optimize, and standardize immunological assay methodologies, for eventual implementation in NIAID-supported studies.
  4. Prepare and/or obtain quality control materials (QCMs), including those from well-characterized donors, to support proficiency testing, assay evaluations, and other IQA activities.
  5. Provide support to PBMC freezing Labs and to specialized immunology Labs for conducting laboratory operations according to good clinical laboratory practices (GCLP). This will include review of GCLP Lab audit reports (audit done by another contractor), capturing audit findings, and providing guidance to Labs to resolve deficiencies.
  6. Maintain a 508 and FISMA-compliant web-based information repository that includes Lab-specific documents such as records of resolution of each Lab's audit findings and performance in proficiency testing panels. The IQA will provide each participating Lab with controlled access to its own documents and provide NIAID and other NIAID-designated entities with controlled access to all documents. The IQA will provide a public web-based resource library that includes guidance documents and standard operating procedures for various laboratory procedures.
  7. As necessary, enable expansion of the program (through contract options) to provide support to additional Labs and support for the development and quality assurance of assays and methods related to emerging viral pathogens.
  8. Options will also be included to provide in-house late-stage assay development and validation, as well as testing of samples from NIAID-supported clinical trials, in a CLIA certified laboratory.

Preclinical Services for HIV Therapeutics

Request for Proposals—proposed FY 2028 initiative

Contact:
Callie Prassinos

Objective: To provide preclinical resources to support the discovery and preclinical development of therapeutic agents for HIV infection and associated co-infections (e.g., TB, Hepatitis B and C). The goal is to further the development of promising compounds and biologics by providing resources to investigators who have not yet identified a corporate sponsor to support studies that will help move products towards regulatory submission and clinical trials.

Description: The contracts will allow NIAID to provide specific support of drug discovery and product development for next-generation therapies to meet the evolving needs of the Division of AIDS’ Basic Sciences and Therapeutics Research Programs in six task areas:

Task Area 1. In Vitro Testing and Screening Resource for HIV Therapeutics

This task area will provide drug discovery and lead development tools to the HIV-1 research community to 1) develop assays and models that are physiologically relevant for inhibiting HIV replication; 2) conduct in vitro evaluation of potential therapeutics for efficacy, toxicity, and safety pharmacology in cell-based and specialized cell- or target-based assays; 3) adapt selected assays to a high throughput format and perform high throughput screening (HTS) of chemical compound libraries; 4) perform hit-to-lead progression studies on promising compounds; and 5) conduct mechanism of action studies on lead compounds. This task area will also include the development of new approach methodologies (NAMs) and 3D-assays to study HIV infection and pathogenesis and evaluate new therapeutic agents for HIV efficacy.

Task Area 2. Synthesis of Therapeutic Agents for Infectious Diseases

This task area will include support for the synthesis of promising therapeutic agents for the treatment of HIV and other infectious diseases. The synthesis contract will have the capacity to synthesize chemicals in small- and large-scale amounts, in compliance with current FDA Good Manufacturing Practice (GMP) regulations, if necessary, in quantities needed for testing in either in vitro screens, animals, or early Phase I clinical studies.

Task Area 3. Efficacy Models for HIV, HBV, and HCV

This task area will support NIAID DAIDS drug discovery and evaluation programs by providing contract resources to evaluate the efficacy of potential interventions (therapeutics, cure strategies, pre-exposure prophylaxis) in efficacy models of HIV, HBV, and HCV, including established small animal models and NAMs. The contractor will provide a discovery and development tool for external investigators to facilitate the rapid translation of in vitro findings to an in vivo setting. Proof of efficacy in an animal model or NAM is now recognized as an important complement to traditional in vitro activity assessments for identifying promising agents. The animal models employed will include immunodeficient mice engrafted with human tissues of fetal or non-fetal origin that can be infected with well-characterized clinical isolates of HIV-1, HBV, or HCV and support both systemic and mucosal routes of infection. Conventional small animal models will also be supported as well as other newly developed small animal models.

Task Area 4. Efficacy Models of M. tuberculosis Infection

This task area will support NIAID DAIDS drug discovery and evaluation programs by providing a contract to evaluate the efficacy of potential interventions (therapeutics, cure strategies, pre-exposure prophylaxis) in efficacy models of M. tuberculosis infection, including established small animal models and NAMs, that will also include both pulmonary and extrapulmonary TB, such as TB meningitis. The contractor will provide a discovery and development tool for external investigators to facilitate the rapid translation of in vitro findings to an in vivo setting. Proof of efficacy in an animal model or NAM is now recognized as an important complement to traditional in vitro activity assessments for identifying promising agents.

Task Area 5. Formulation Development and Manufacture of Clinical Dosage Forms

This task area will include services for the development of new formulations and clinical dosage form manufacture, and activities of packaging, labeling, and shipping final versions of these products intended for evaluation in clinical trials. Services will also include support for the development of analytical assays, with the capability to conduct studies compliant with the applicable GLP or GMP regulations. Targeted formulations to be developed include tablets, capsules, lyophilized powders, solutions, suspensions, aerosols, nanomaterials, etc., for oral, intravenous, subcutaneous, intramuscular, or intranasal delivery. Potential therapeutics may include both small molecules and biologics.

Task Area 6. Preclinical Pharmacology and Toxicology Services

This task area will support preclinical development and IND-enabling animal and NAM studies of promising candidates to assess their pharmacological properties, safety pharmacology, acute, repeated dose, and chronic toxicity, immunotoxicity, as well as genetic and reproductive toxicity. Services will also include bioanalytical method development and bioanalytical testing to support the studies described above. This task area will also include in vitro evaluation of promising therapeutics agents for safety and metabolism during preclinical development and may include established in vitro assays at clinically relevant concentrations, hollow-fiber cell culture, 3-dimensional culture, organon-a-chip technology and experimental NAMs. The contractor will have the capacity to conduct GLP and non-GLP studies as appropriate.

Potential therapeutic agents to be developed may include small molecules, polymers, biologics (e.g., peptides, oligonucleotides, antibodies), cellular and genetic drug products (e.g., CAR-T cells), or products with nanomaterials in their finished dosage form. The services will also provide support to facilitate regulatory submissions and intellectual property applications by the investigators who have requested evaluation of their products. The data to be developed under this initiative are intended to support various decisions by the investigator/sponsor and the FDA.

NIAID Specimen Repository

Request for Proposals—proposed FY 2028 initiative

Contact:
Callie Prassinos

Objective: To continue the critically needed comprehensive services of the NIAID Specimen Repository (NSR), which will continue to 1) secure, receive, catalog, process, aliquot, store, and disburse human biological specimens from subjects participating in DAIDS-sponsored cohort studies and clinical networks; 2) provide adequate cold storage facilities; 3) remain current on novel procedures for optimized storage of clinical specimens and be able to use state-of-the-art technology to ensure specimen integrity from receipt to storage in the freezers and from freezers to shipment containers for outgoing shipments; 4) provide (or utilize the current) computerized Specimen Inventory Database Management System (SIDMS) that supports the repository's functions; and 5) develop, perform, and maintain Quality Assurance (QA)/Quality Control (QC) Program for the NSR facility, operations, stored biospecimens, shipping materials, and personnel in accordance with all applicable federal, state, and local regulatory requirements.

Description: This initiative will serve and support current and future vaccine and epidemiological cohort study groups referred to as Study Groups. The NSR will support the following ongoing NIAID Study Groups: the Women's Interagency HIV Study (WIHS); the Multicenter AIDS Cohort Study (MACS); the MACS/WIHS Combined Cohort Study; and the HIV Vaccine Trials Network (HVTN). The NSR also will maintain specimens from other NIAID-sponsored studies that have been completed. The NSR will support the short, moderate, and long-term specimen storage needs of the Study Groups. Retrieval and distribution of specimens is guided by the scientific priorities of the Executive or Advisory Committees of Study Groups. These specimens include peripheral blood mononuclear cells, serum, plasma, tissue specimens, and other bodily fluids or substances such as cervicovaginal lavage (CVL), semen, saliva, urine, feces, hair, mucosal, autopsy and biopsy materials, and whole blood spots dried on filter paper. Support will be provided through receipt or shipment of specimens to multiple laboratories that are either part of the Study Group (referred to as Sites) or laboratories collaborating with the Study Groups (referred to as external research groups).

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