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NB: Concepts represent early planning stages for PAs, RFAs, or RFPs for Council 's input. Council approval does not guarantee that a concept will become an initiative.
If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIH Funding Opportunities Relevant to NIAID.
Table of Contents
Cooperative Research Partnerships for Development of Antimicrobials and Diagnostics for Drug-Resistant Bacteria and Parasites
Request for Applications
Contact: Suman Mukhopadhyay
Phone: 301-451-3032
Email: mukhopadhyays@mail.nih.gov
Objective: This program will support translational research on select drug-resistant bacterial and parasitic diseases, and focuses primarily on the development of novel diagnostic and therapeutic approaches.
Description: This initiative will support collaborative, multidisciplinary projects that seek to develop new therapeutics and/or diagnostics for select infectious diseases. Projects that characterize novel therapeutic or diagnostic targets are encouraged provided they focus on product discovery and include downstream product development steps. Research on broad-spectrum antimicrobials, platformed diagnostics, and truly novel drug classes is particularly encouraged.
Projects should focus on NIAID Category A, B, or C bacterial pathogens and/or other bacteria or parasites where drug resistance is a significant and/or rapidly growing clinical problem. Projects addressing eligible drug-resistant pathogens for which limited therapeutic options are available are also encouraged. Examples of eligible non-category A, B, or C pathogens include but are not strictly limited to Clostridium difficile, Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumanii, Pseudomonas aeruginosa, and Enterobacter spp.
Antimicrobial Drugs: This initiative will support projects focused on discovery and early development of new or improved antimicrobial agents, including small molecule inhibitors, therapeutic antibodies, and peptides. Broad-spectrum drugs and/or drugs targeting novel mechanisms are encouraged.
Adjunctive Therapeutics: Projects seeking to develop adjunctive pharmacologic approaches to specifically target and prevent drug resistance during therapy are encouraged. Such approaches need not be geared to a specific pathogen, but rather should directly target known mechanisms of resistance in order to extend the clinical utility of existing antimicrobials.
Diagnostics: This initiative will support development of rapid point-of-care diagnostics to quickly identify pathogens and their resistance profiles. Multiplexed diagnostics, as well as those able to provide diagnostic information on potential presymptomatic carriers are particularly encouraged.
Cooperative Research Partnerships for Biodefense Food- and Water-borne Diseases
Request
for Applications
Contact: Melody Mills
Phone: 301-435-2876
Email: millsm@niaid.nih.gov
Objective: This program will support translational research on food- and water-borne diseases, focusing primarily on the development of broad spectrum therapeutics and diagnostics.
Description: This initiative will support collaborative, multidisciplinary projects that utilize broad spectrum approaches to design and develop products to diagnose or treat multiple diseases caused by NIAID Category A, B, or C food- and water-borne prokaryotic or eukaryotic pathogens or toxins. NIAID has identified three key strategies (broad spectrum activity, broad spectrum technology, and broad spectrum platforms) for biodefense research; thus, this program promotes the development of multiplex diagnostics and broad spectrum drugs. Partnerships between researchers from different disciplines and industrial laboratories will be strongly encouraged to facilitate discovery, design, and/or development of new products. Clinical trials will not be supported by this program.
Diagnostics: This program calls for the design and development of rapid, sensitive multiplex diagnostics that can differentiate diarrheal pathogens in a single clinical specimen. The focus may be on either previously identified pathogen- or host-specific targets or novel approaches to identify and validate new targets, technologies, or multiplex platforms amenable to large-scale production and validation for clinical diagnosis and point-of-care use. Diagnostics for the protozoan pathogen, Toxoplasma gondii, are not part of this program.
Therapeutics and Immunotherapeutics: The development of new or improved therapeutics may focus on known targets (including antimicrobial resistance mechanisms) or the identification of new targets based on, for example, microbial physiology, immune responses, genomic/proteomic approaches, structural characterization, and components or pathways common to the targeted pathogens. The design of novel drugs or immunotherapies should include lead compound identification and optimization and pre-clinical efficacy testing in animal models. Emphasis will be placed on projects that focus on development of broad-spectrum therapeutics or platforms for discovery of novel targets.
Cooperative Research Partnerships for Biodefense Viral Pathogens
Request for Applications
Contact: Mark Challberg
Phone: 301-402-8668
Email: mchallberg@niaid.nih.gov
Objective: This program will support translational research on NIAID Category A, B, or C viral pathogens, focusing primarily on the development of broad spectrum therapeutics and diagnostics.
Description: This initiative will support collaborative, multidisciplinary projects that utilize broad spectrum approaches to design and develop products to diagnose or treat multiple diseases caused by NIAID Category A, B, or C viral pathogens. NIAID has identified three key strategies (broad spectrum activity, broad spectrum technology, and broad spectrum platforms) for biodefense research; thus, this program promotes the development of multiplex diagnostics and broad spectrum drugs. Partnerships between researchers from different disciplines and industrial laboratories will be strongly encouraged to facilitate discovery, design, and/or development of new products. Clinical trials will not be supported by this program.
Diagnostics: This program calls for the design and development of rapid, sensitive, and specific diagnostics which may focus on previously identified pathogen- or host-specific targets or novel approaches to identify and validate new targets. Emphasis will be placed on technologies or multiplex platforms amenable to large-scale production and validation for clinical diagnosis and point-of-care use.
Therapeutics and Immunotherapeutics: The development of new or improved therapeutics should focus on known targets or the identification of new targets based on viral biology, immune responses, genomic/proteomic approaches, structural characterization, etc. The design of novel drugs or immunotherapies should include lead compound identification and optimization and pre-clinical efficacy testing in animal models. Emphasis will be placed on therapeutics for viral hemorrhagic fevers and encephalitides and on drugs which have broad-spectrum activity arising from novel target/mechanisms and broad-spectrum platforms.
Partnerships for Development of Vaccines for Selected Pathogens
Request for Applications
Contact: Lillian Van De Verg
Phone: 301-451-3754
Email: lvandeverg@niaid.nih.gov
Objective: To engage academia and industry in the development of vaccines against select non-biodefense pathogens (cytomegalovirus, respiratory syncytial virus, Staphylococcus aureus, Pseudomonas aeruginosa, Clostridium difficile) that have a significant impact on public health.
Description: This new initiative will advance vaccine development by supporting:
- Improvement of existing candidates - alternate formulation; stabilization; immunopotentiation, through regimen optimization and novel adjuvants.
- Evaluation of novel vaccine strategies - recombinant DNA; reverse genetics leading to live attenuated strains and vectors; chimeras and mono- or multi-valent subunits.
- Advanced preclinical studies - safety and host response; efficacy in animal models; toxicology studies; correlates of immunity and surrogate endpoints (e.g., protection of the fetus for CMV).
Development of Therapeutics for Biodefense
Broad Agency Announcement
Contact: Suzanne Dawkins
Phone: 301-451-3698
Email: sdawkins@niaid.nih.gov
Objective: To evaluate platform technologies, as they are applied to the development of therapeutic countermeasures for biodefense, for their capability to provide broad advances in technologies that may be widely applicable to drug development.
Description: This initiative is designed to advance high priority promising candidate therapeutics toward the product stage by a focused, development-based approach that is consistent with all applicable federal regulations and guidelines for the conduct and oversight of developing therapeutics to be tested in human subjects. The government is particularly interested in supporting the development and evaluation of treatments with broad spectrum activity, broad spectrum technologies, and broad spectrum development platforms.
The types of activities that are envisioned to be funded may include the following:
- Non-clinical research and development;
- Lead optimization;
- Development of manufacturing processes, manufacturing/synthesis of cGMP pilot lots, and conduct of extended product stability studies;
- Preparation and submission to the FDA of investigational new drug (IND) applications and conduct of a Phase 1 clinical trial; and
- Post-Phase I Biological License Application (BLA) or new drug application (NDA) enabling activities.
Hepatitis C Cooperative Research Centers
Request for Applications
Contact: Rajen Koshy
Phone: 301-496-7051
Email: rkoshy@niaid.nih.gov
Objective: To perform clinically-relevant research to elucidate the mechanisms involved in spontaneous clearance of acute hepatitis C virus (HCV) infection, and the frequent progression to chronic persistence; and, thereby, to provide the rationale for immunotherapeutic strategies against HCV.
Description: Previous research has provided insights into host immunological responses to HCV infection and described some of the important differences between clearance of acute infection and chronic persistence. However, this has not been sufficient to allow the development of successful therapy against HCV suggesting that many of these differences are only markers of a given clinical outcome and that true effectors remain undiscovered.
This project is intended to stimulate the field into developing innovative ideas that would cast fresh light on the capability of the immune system to eliminate HCV infection. This includes elucidating key molecular pathways involved in cellular immunity, clarifying the role of the antibody response, and addressing the neglected question of how the adaptive responses are integrated with the innate immune responses.
The clinical outcome of HCV infection is also affected by factors such as race, virus genotype, mode of infection, and co-infection with HIV or liver parasites. A proper understanding of virus clearance or persistence will require the study of different infected population groups. Therefore, this project will require that the significance and clinical relevance of laboratory observations be determined in the appropriate cohorts of humans infected with HCV.
NIAID Partnerships with Product Development Public- Private Partnerships
Request for Applications
Contact: M. John Rogers
Phone: 301-402-8304
Email: jrogers@niaid.nih.gov
Objective: To establish collaborative relationships with Public-Private Partnerships (PPPs) so that NIAID and PPPs, acting in concert, can accelerate research and development of new diagnostic, preventive, therapeutic, and control strategies for high-priority infectious diseases of global importance for which commercial markets currently provide insufficient incentive for corporate investment.
Description: This initiative seeks to build on NIAID's investments in various emerging and re-emerging diseases, malaria, tuberculosis, dengue, sexually transmitted infections, parasitic diseases, diarrheal diseases, or other diseases that predominantly affect the poor and disenfranchised, and may also be termed “neglected diseases.” NIAID will enter into cooperative agreements with PPPs to support projects on various aspects of preclinical development (e.g., target validation, process development, formulation, toxicology, etc.) and targeted aspects that would facilitate or enhance clinical development (e.g., diagnostics, pretrial infrastructure assessment and development, epidemiologic surveillance in anticipation of clinical trials, trial monitoring, etc.).
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