September
2009 DMID Council-Approved Concepts
NB: Concepts represent early planning stages for PAs, RFAs, or solicitations 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
Partnerships for Biodefense
Request for Applications
Contact: Michael Schaefer
Phone: 301-451-3758
Email: MSchaefer@niaid.nih.gov
Objective: To support mid-stage development of vaccines, therapeutics, adjuvants, and diagnostics for biodefense and emerging infectious diseases, including all activities beyond lead candidate identification (e.g., safety evaluation, stability testing, manufacturing, development, etc.), diagnostic assay development, or initial development of diagnostic platform technology.
Description: This program will support collaborative efforts and multidisciplinary approaches to advance candidate products or platform technologies through the product development pathway. Partnerships between researchers from different disciplines and industrial laboratories will be strongly encouraged to facilitate mid-stage development of new products. Clinical trials will not be supported under this program.
Therapeutics and Immunotherapeutics: Mid-stage development of new or improved therapeutics should focus on validated leads and/or targets (including antimicrobial resistance mechanisms). Emphasis will be placed on drug development including broad-spectrum activity arising from novel target/mechanisms and broad-spectrum platforms.
Diagnostics: Mid-stage development of rapid, sensitive, and specific diagnostics should focus on previously identified pathogen- or host-specific targets or novel approaches to validate new targets or technologies amenable to large-scale production and validation for clinical diagnosis and point-of-care use.
Vaccines: Mid-stage development of vaccine candidates or vaccine delivery systems should focus on specific characterized immunogens. In addition, vaccination enhancement strategies, such as temperature stabilization or enhanced immunogenicity, are also encouraged. These projects are expected to include proof-of-concept in animal models, pre-clinical evaluation, and scale-up production under Good Manufacturing Practices (GMP) to provide sufficient quantities for pre-clinical FDA-required animal studies.
Adjuvants: Mid-stage development of adjuvants should focus on validated lead candidates. These projects are expected to include strategies for screening adjuvant activity, pre-clinical evaluation, and scale-up production under GMP to provide sufficient quantities for pre-clinical FDA-required animal studies.
Partnerships for Next Generation Biodefense Diagnostics
Request
for Applications
Contact: Maureen Beanan
Phone: 301-451-3247
Email: beananm@mail.nih.gov
Objective: The objective of this initiative is to support research that will facilitate the development of the next generation of non-nucleic acid amplification-based medical diagnostics that are anticipated to greatly improve a clinician's ability to rapidly diagnose and treat infectious diseases caused by priority pathogens.
Description: This program will stimulate collaborative efforts and multidisciplinary approaches for early stage development of novel, emerging, innovative, rapid, easy-to-use, sensitive, and specific technologies for use in a clinical setting to pre-symptomatically and/or post-symptomatically diagnose infectious diseases caused by priority pathogens. The technologies may focus on pathogen or host-specific targets, and projects should assess the potential of the early stage technology for large-scale production and utilization for diagnosis of infectious diseases in clinical settings, including public health laboratories, hospital-based clinical microbiology laboratories, and/or point-of-care use. Appropriate early stage technologies include non-invasive, in vivo molecular imaging modalities and methods, breath analysis approaches, nanotechnology-based integrated microfluidic platforms, and other emerging technologies.
Partnerships between researchers from clinical and basic science disciplines and industrial laboratories will be strongly encouraged to facilitate early stage development of the novel technologies required for the next generation of medical diagnostics products. Clinical trials will not be supported under this program. Currently NIAID supports numerous PCR and isothermal nucleic acid amplification-based biodefense infectious disease diagnostics platforms which are in the mid-to-late stage of product development. However, new technologies are required for developing the next generation of infectious disease diagnostics.
Partnerships for Development of New Therapeutic Classes for Select Viral and Bacterial Pathogens
Request for Applications
Contact: Leslye Johnson
Phone: 301-496-7051
Email: ljohnson@niaid.nih.gov
Objective: The goal of this initiative is to stimulate the development of urgently needed therapies for selected pathogens of public health importance.
Description: This initiative will advance the development of new therapeutic classes for C. difficile, N. gonorrhea, and hepatitis B virus (HBV). It will promote new antimicrobial strategies based on recently generated biological and genomic data, and will support early to mid- stage product development, including all activities beyond target and candidate identification (e.g., selection and optimization of lead candidate, medicinal chemistry, assay validation, safety evaluation, stability testing, manufacturing, development, etc.)
Examples of novel therapeutic approaches include, but are not limited to:
- Modulation of virulence factors (e.g., attachment, invasion, toxin production, biofilm formation).
- Blocking antimicrobial resistance mechanisms (e.g., efflux pumps).
- Blocking of metabolic pathways (e.g., acquisition of essential nutrients such as iron).
- Elimination of viremia by targeting novel sites on replication pathway (e.g., HBV cccDNA, the nucleocapsid, relevant host factors, etc.).
- Amplification of immune responses that lead to resolution but do not harm the host.
Vaccine and Therapeutic Development Services
Request for Proposals
Contact: Edward Ryan
Phone: 301-496-0612
Email: ryanes@niaid.nih.gov
Objective: To advance the development of vaccine and therapeutic candidates for infectious diseases and biological toxins.
Description: This initiative will provide a variety of IND-, BLA-, and NDA-enabling activities including manufacturing (GMP, process development, formulation, stability, etc.), pharmacology, immunogenicity, toxicity testing, product development planning, and assay development and validation. These preclinical services are intended to fill gaps in the product development path, not to support a comprehensive product development program. Services are available to investigators in academia, not-for-profit organizations, industry, and government worldwide. This program is part of DMID's new consolidated, integrated approach to the provision of product development services.
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