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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
Phase I Clinical Trial Unit for Therapeutics Against Infectious Diseases
For the published initiative, see the March
1, 2007, solicitation.
Request for Proposals
Contact: David Lisle
Phone: 301/451-2617
Email: dl115q@nih.gov
Objective: To provide a DMID clinical resource with the capability
and expertise to undertake Phase I clinical trials for therapeutics.
Description: Under this initiative, Phase I clinical trials of
promising candidate therapeutics will be conducted. In collaboration
with program staff, the contractor will be responsible for design, implementation,
conduct, and completion of all clinical trials.
Pharmacological
Approaches to Combating Antimicrobial Resistance
For the published initiative, see the April
6, 2007, Guide announcement.
Request
for Applications
Contact:Christine Sizemore
Phone: 301/435-2857
Email: csizemore@niaid.nih.gov
Objective: To encourage partnerships between antimicrobial pharmacologists
and infectious disease researchers to apply pharmacokinetic and pharmacodynamic
principles to the development of in vitro and animal models that will
enhance our understanding of the emergence of antimicrobial drug resistance.
Description: Through this initiative, academic or industry scientists
will be encouraged to submit creative proposals for research on existing
antimicrobial regimens using in vitro and animal models that are based
on human pharmacokinetics with the expectation that these studies will
lead to a better understanding of the contribution of PK/PD correlates
to the development and/or avoidance of drug resistance. These studies
are also expected to result in improved animal models of infection and
drug treatment and are expected to inform the discovery and development
process for new drug candidates. Once validated in human clinical trials,
PK/PD optimized drug therapies have the potential to also extend the
clinical utility of antimicrobial agents against drug resistant infections.
Development
of Therapeutic Agents for Select Biodefense Pathogens
For the published initiative, see the July 11, 2007, solicitation.
Broad Agency Announcement
Contact: Suzanne Dawkins
Phone: 301/451-3698
Email: sd33r@nih.gov
Objective: To advance promising candidate therapeutics for select
high priority biodefense viral and bacterial pathogens, with a special
emphasis on therapeutics with broad spectrum activity or that address
antimicrobial resistance.
Description: The objective of this initiative is to focus on
the development of promising candidate therapeutics for:
- Smallpox
- Filoviruses: Ebola and Marburg
- Anthrax
- Gram negative bacteria (broad spectrum)
- Influenza
Current treatments for these diseases are either nonexistent, of limited
utility, or threatened by the emergence of antimicrobial resistance or
intentional engineering to increase virulence or decrease drug susceptibility.
Development of each candidate is through a staged focused approach that
is consistent with all applicable federal regulations and guidelines
for the conduct and oversight of developing therapeutics to be tested
in animals and human subjects. Plans for advancing therapeutic candidates
and products through the product development path shall be proposed,
implemented, and
funded in stages with specific decision points and gates and well defined
criteria for determining the merit and feasibility of advancing to the
next stage.
The types of activities that are envisioned to be funded 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 Food and Drug Administration
of Investigational New Drug applications and conduct of Phase
1 or 2 clinical trial; and
- Post-Phase 1 Biological License Application or New Drug
Application enabling activities.
Indo-U.S.
Vaccine Action Program Small Research Grant Program
For the published initiative, see the November
22, 2006, Guide announcement.
Program Announcement
Contact: Edward McSweegan
Phone: 301/402-8370
Email: emcsweegan@niaid.nih.gov
Objective: To support collaborative research projects that ultimately
reduce the burden of infectious diseases of importance in India, the
U.S., the South Asian region, and globally.
Description: Under this initiative, investigators may propose
collaborative studies that will result in new and improved approaches
to combating some infectious diseases of importance in India, the U.S.,
the South Asian region, and globally. Any area of basic, translational,
clinical, or epidemiological research may be proposed under this program.
Examples of possible research topics include, but are not restricted
to:
- Discovery, demonstration of the proof of principle, development
of novel manufacturing processes, evaluation of the safety and efficacy,
and demonstration
of the effectiveness of the use of new and improved vaccines to
prevent:
- HIV/AIDS
- Tuberculosis
- Pandemic and interpandemic influenza
- Dengue and Dengue Hemorrhagic Fever (DHF)
- Development of adjuvants.
- New manufacturing and vaccine delivery technology.
- Effectiveness of the introduction of new and improved vaccines into
public health immunization programs.
- Epidemiology of disease in the human population.
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