NIAID Funding News - October 5, 2016 | NIH: National Institute of Allergy and Infectious Diseases
NIAID Funding News - October 5, 2016
Feature Articles
Maximize Research Funds and Fill Gaps With NIAID Resources
Opportunities and Resources
Are You Up for the Challenge...Competition?
An Opportunity to Examine the Role of T-Cell Epitopes in Allergic Diseases
Small Businesses: Apply Now for I-Corps™ Entrepreneurship Immersion Program
In The News
Number of Archived Mouse Germline Mutations Jumps Ten-Fold
NIH Issues Multiple New Policy Requirements for Clinical Trials
News Briefs
NIAID to Host Workshop for Transitioning Career Development Awardees
Complete NIAID Website Tree Test to Help Us Improve Site Navigation
NIH Posts Q&A Following HHS SBIR Contract Webinar
Consider the Latest Set of Grand Challenges From the Gates Foundation
Big Data To Knowledge Program Launches an Online Lecture Series
Advice Corner
Tips for Writing a Strong Multiple PI Leadership Plan
Reader Questions
Can I propose a clinical trial using the R21 activity code?
How can I tell if my research is eligible for a small business Fast-Track award?
New Funding Opportunities
See the list
Feature Articles
Maximize Research Funds and Fill Gaps With NIAID Resources
NIAID offers an array of resources to help investigators translate basic research findings into products to diagnose, treat, or prevent immune-mediated and infectious diseases.
Our Tools, Datasets & Services are available to you as an investigator in academia, a nonprofit organization, industry, or government in the United States or worldwide, whether funded by NIH or not.
Resources save you time and money by fulfilling a research need, such as obtaining a reagent, using state-of-the-art analytical tools to examine datasets, or accessing preclinical services. For small businesses especially, NIAID resources can be critical in advancing research.
Though most resources are free, you may need to pay production or shipping and handling costs in some cases. Before placing an order or requesting a service, verify eligibility and cost details on the resource’s website or touch base with the listed point of contact.
How To Find Resources
To identify potential resources, search Tools, Datasets & Services by function—such as bioinformatics or technology transfer and intellectual property—or by NIAID program division. If you cannot find an appropriate resource, ask Institute program staff in your area of science whether we offer the service you’re seeking. For assistance, see When To Contact an NIAID Program Officer.
Explore Your Options
For a sampling of NIAID’s broad range of resources, see the following division-specific lists.
Division of AIDS (DAIDS)
Databases, reagents, efficacy evaluations, and animal models are just some of the available resources; also consult HIV/AIDS Research Resources.
Chemical Synthesis, Analytical Chemistry, and Preclinical Services—Offering limited support for academic investigators who are moving products toward FDA licensure, these resources include evaluation of lead compounds and drug candidates in cell culture and animal models, drug formulation, and animal pharmacology and toxicology. To learn more, contact Dr. Joseph Fitzgibbon(link is external).
Comprehensive Resources for HIV Microbicides and Biomedical Prevention—Obtain preclinical product development services to help advance your promising non-vaccine biomedical prevention product or multipurpose prevention technology into clinical testing. Contact Dr. James Cummins(link is external) to request access to the following:
Preclinical gap-filling services
HIV animal models supporting product development
Bioanalytical support services
Product manufacturing
Scientific, quality, and regulatory support services
Treatment of HIV Disease In Vivo Efficacy Evaluations—This service evaluates products in humanized mouse efficacy models. To be accepted as a candidate, your product must already demonstrate a potent and selective activity profile against HIV in vitro. Direct inquiries to Dr. Brigitte Sanders(link is external).
In Vitro Screening Resource for HIV Therapeutics and Topical Microbicides—If your project requires in vitro efficacy testing of anti-HIV therapeutics and topical microbicides, this popular service may be able to help. For details, contact Dr. Roger Miller(link is external).
Long Acting/Extended Release Antiretroviral Resource Program(link is external)—Gain access to research results and resources and to subject matter experts in developing longer-acting antiviral drugs.
NIH AIDS Reagent Program(link is external)—Select from a catalog of critical research reagents and resources that are available at no cost to qualified investigators.
Quantitative Viral Outgrowth (QVOA) Service Resource—This new resource offers standardized assays that quantitate latent reservoirs of HIV. Address questions to Dr. Betty Poon(link is external).
Division of Allergy, Immunology, and Transplantation (DAIT)
Delve into DAIT’s extensive databases and other highlighted resources below. For more options, see Allergy, Immunology, Transplantation Research Resources.
Human Immunology Project Consortium(link is external) (HIPC)—This network of researchers defines, analyzes, and correlates molecular profiles of varied human immune responses induced by infection or vaccination. Use ImmuneSpace(link is external), a data management and analysis engine, to explore and analyze HIPC-generated datasets using advanced computational tools. To learn more, see “Mine Immunology Data on New ImmuneSpace Website” in our February 10, 2016 issue.
Immune Epitope Database(link is external) (IEDB)—Search this heavily used resource for experimental data characterizing antibody and T-cell epitopes studied in humans, nonhuman primates, and other animal species. The IEDB website provides tools to predict and analyze epitopes.
Immunological Genome Project(link is external) (ImmGen)—Participating laboratories generate data on gene expression and its regulation in the immune system of the mouse. You can request individual normalized datasets from ImmGen or download raw datasets from the National Center for Biotechnology Information(link is external).
Immunology Database and Analysis Portal (ImmPort)—DAIT’s primary database supports the exchange of scientific data in all areas of immunological research. After registering on the portal, gain access to ImmPort’s shared research and clinical data, as well as its analytical tools.
Mutagenetix(link is external)—This database of phenotypes and mutations produced in mice includes links to major repositories from which you can order stocks. See our news article below “Number of Archived Mouse Germline Mutations Jumps Ten-Fold.”
NIH Tetramer Core Facility(link is external) (TCF)—Processing more than 300 requests each month, TCF produces and distributes major histocompatibility complex tetramers and related reagents for detecting T-cell responses to viruses, bacteria, parasites, tumors, auto-antigens, and other model antigens.
Nonhuman Primate Reagent Resource(link is external) (NHP)—For researchers using nonhuman primate models, NHP identifies, develops, characterizes, and produces reagents for monitoring or modulating immune responses.
Division of Microbiology and Infectious Diseases (DMID)
Among the comprehensive resources provided by DMID are reagents, bioinformatics and genomics, and preclinical services to facilitate product development. For a complete listing of DMID’s resources, refer to Microbiology and Infectious Diseases Resources.
Animal Models of Infectious Disease—Resources are available to develop and refine animal models, conduct in vivo screening, and perform efficacy testing. Touch base with the appropriate DMID contact to discuss your preliminary data.
BEI Resources Repository—Select from a wide array of organisms and reagents to support microbiology and infectious diseases research. This popular repository also provides tools and information.
Bioinformatics Resource Centers—Public data repositories provide access to genomic and other diverse data sets generated from NIAID-funded Centers. These Centers provide publicly available datasets, bioinformatics and data analysis tools, and workspaces and training related to the following pathogens, including host-related data:
All bacterial species
All viral families including influenza virus
All eukaryotic pathogen species including fungi
Invertebrate vectors of human pathogens
Genomic Centers for Infectious Diseases—Participating centers sequence, assemble, and annotate the genomes of microorganisms from the NIAID Emerging Infectious Diseases/Pathogens list, related organisms, and hosts, and support next-generation sequencing and related technologies. In addition to providing high-throughput genomic technologies for sequencing, metagenomics and microbiome analysis, and microbial and targeted human genotyping, the Centers support the development of next-generation sequencing and related genomic technologies.
In Vitro Assessment for Antimicrobial Activity—This program tests antimicrobial activity of products against microbial pathogens and vectors, such as the Zika virus. You must have appropriate preliminary data to support advancing the product to be studied.
Therapeutics and Vaccine Development—A broad range of services facilitate the preclinical development of therapeutics and vaccines. Services include, but are not limited to, lead identification and development and medicinal chemistry work for therapeutics and safety and toxicity testing, as well as pilot and Current Good Manufacturing Practice manufacture work for vaccines.
World Reference Center for Emerging Viruses and Arboviruses (WRCEVA)—Providing reagents and supporting investigations of virus outbreaks across the globe, WRCEVA identifies and characterizes arboviruses and other suspected emerging viruses spread by insects and animals.
Opportunities and Resources
Are You Up for the Challenge...Competition?
A recently announced Challenge Competition could be for you if you can deliver what it seeks: in vitro diagnostic tests that would help health care providers better identify antibiotic-resistant bacteria and make more informed decisions on appropriate antibiotic use and infection prevention.
The Challenge is cofunded by NIAID and the Biomedical Advanced Research and Development Authority (BARDA) of HHS's Office of the Assistant Secretary for Preparedness and Response.
The Antimicrobial Resistance Diagnostic Challenge* website is administered by Capital Consulting Corporation (CCC).
*Shortened to "Challenge" in this article.
Challenge Steps
In addition to registering and submitting a letter of intent (for more on those, see below), the Challenge has the following steps, as explained in greater detail in the Submission Requirements section on the Challenge(link is external) website.
In Step 1 (Theoretical), you'll provide a description of your proposed in vitro diagnostic test. See the Participation Requirements(link is external). Judges will select semi-finalists to proceed to the next step.
Note: You may skip this step and submit an entry for Step 2 as long as you follow the Participation Requirements. By going this route, you miss a chance at being chosen a Step 1 semi-finalist and winning the associated prize amount (see Prize Descriptions, below).
In Step 2 (Delivery of Prototype and Analytical Data), you will submit data and a prototype device that support the ability of your diagnostic device to meet the target product profile for analytical and performance characteristics in nonclinical testing as well as confirm analytical performance.
Note: You may still submit for Step 2 if you were not among the Step 1 semi-finalists or, as we mentioned above, you did not submit for Step 1.
If you are a Step 2 semi-finalist, you will proceed to Step 3 (Performance Testing in CLIA-Certified Laboratories) and provide sufficient prototypes and other materials for testing in two independent Clinical Laboratory Improvement Amendments(link is external)-certified laboratories.
Proposal Information
Proposed in vitro diagnostic tests should:
Be novel, innovative, accurate, rapid, and cost-effective.
Be appropriate for outpatient and/or inpatient settings.
Demonstrate a clinically significant advance in diagnostic test performance and address gaps or deficiencies in current capabilities that may include ease of use, time to result, significant advances in sensitivity and specificity, and ability to process a broad range of specimen types.
Allow health care providers to:
More rapidly identify or detect the specific etiology drawn from a differential diagnosis of a particular clinical syndrome caused by any of the 18 drug-resistant bacteria listed in Table 3 of the National Action Plan for Combating Antibiotic-Resistant Bacteria(link is external)pdf.
More rapidly identify or detect and characterize antibiotic susceptibility of at least one of the 18 drug-resistant bacteria listed in Table 3 of the National Action Plan for Combating Antibiotic-Resistant Bacteria(link is external)pdf.
Detect biomarkers that would inform patient management decisions, such as need for antibiotics or severity of infection.
Do not propose solutions that describe existing, well-established, or currently supported approaches, especially commonly used strategies—unless you can show that 1) potentially clinically significant, quantifiable advances are achievable and/or 2) the methods and measures are used in unique combinations that have not been previously tested together for detecting or diagnosing drug-resistant bacteria.
Registration
To participate in the Challenge competition, you must register. Go to New User Registration(link is external) on the Challenge(link is external) website.
Letter of Intent
You must submit a letter of intent by December 23, 2016, for Step 1.
Use the AMR Diagnostic Challenge Letter of Intent Form(link is external)pdf. It has instructions on saving and submitting the form, which you will do throughAntimicrobial Resistance Rapid Point of Care Diagnostic Letter of Intent (link is external)on the Challenge.gov(link is external) website.
Prize Descriptions
The amount of prizes is as follows:
Step 1: Up to $50,000 per semi-finalist (maximum of 20 semi-finalists)
Step 2: Up to $100,000 per semi-finalist (maximum of 10 semi-finalists)
Step 3: Equal to or greater than $18 million to be divided among a maximum of three awardees based on the number of prizes awarded to Step 1 and 2 semi-finalists from a total pool of $20 million.
Judges will determine the number of prizes for the Step 1 and 2 semi-finalists and Step 3 winner(s).
Deadlines
The submission deadline for Step 1 is January 9, 2017, at 11:59 p.m. Eastern Time. For other key dates, see the Challenge Timeline on the Challenge(link is external) page.
More Details
For additional information, read the September 8, 2016 Guide notice(link is external) as well as the October 3, 2016 Guide notice(link is external) that clarifies and corrects several components of the Challenge.
If you have questions about the Challenge, contact NIAID’s Dr. Robert W. Eisinger(link is external).
An Opportunity to Examine the Role of T-Cell Epitopes in Allergic Diseases
Apply to a new funding opportunity announcement (FOA) if you can propose research to study the role of allergen epitope-specific T-cell responses in the pathogenesis and treatment of allergic diseases using allergen epitope-specific reagents.
Examples of responsive research projects include:
Novel T-cell epitope identification, characterization, and validation of important food allergens and aeroallergens that have not yet been studied
New Phase I and small-scale Phase II clinical trials. If proposed, these clinical trials must focus on immune-based therapies or interventions involving experimental allergen exposure.
Projects proposing to use or develop novel sample sparing technologies that can enhance research in children and infants
The initiative’s ultimate goal is to use T-cell epitopes either as biomarkers predicting disease development and severity or as therapeutic targets for immune tolerance.
This FOA will be funded through a U19(link is external) cooperative agreement, which means there will be substantial NIAID staff involvement. To learn more about this type of award, refer to “Just for "U": A Closer Look at Cooperative Agreements” in our May 4, 2016 issue.
Research Requirements
For this FOA, you will propose an Administrative Core and two or three highly synergistic Research Projects centering on the common theme of epitope validation. You may also propose optional Clinical, Data Management and Analysis, or additional Scientific Cores.
All projects in your application must focus on human disease and may involve subjects with allergic rhinitis, asthma, or food allergy. Human specimens from outside studies can be used if high-quality clinical phenotyping was performed and all information is available to the applicant investigators.
If you propose a clinical trial (see NIH Definition of Clinical Trial(link is external)pdf) as part of this project, the proposed work must clearly define the central role of T-cell epitope analyses in the study hypothesis, design, and mechanistic assays.
Read the September 7, 2016 Guide announcement(link is external) for full information on research objectives and scope, as well as types of projects that will be considered nonresponsive.
Application Details
Your application budget is limited to $600,000 in annual direct costs. The maximum project period is five years.
Applications are due by March 3, 2017. Apply early to allow adequate time to correct any errors found in your application during the submission process.
Direct questions to Dr. Michael Minnicozzi(link is external), the FOA’s scientific/research contact.
Small Businesses: Apply Now for I-Corps™ Entrepreneurship Immersion Program
Your small business may do outstanding biomedical research, but if you’re unable to position your innovations in the market place and implement a successful commercialization plan, your business won’t realize its full potential.
To help grow and develop the entrepreneurial skills of small business grantees, NIH will sponsor the enrollment of nearly 50 organizations into its Innovation Corps (I-Corps™) program. The program uses a hypothesis-driven method of customer discovery to help participants learn the issues associated with technology commercialization. Each team will conduct a large number of interviews (i.e., 100+) with potential customers, strategic partners, and other third-party stakeholders, sharing feedback and lessons learned with the other participants.
The I-Corps™ training course also includes a three-day kick-off workshop, six four-hour Web-Ex courses, and a two-day final Course Closeout/Lessons Learned session.
To apply, your organization must be an active NIH or CDC Small Business Innovation Research or Small Business Technology Transfer Phase I grantee, as the program is supported through administrative supplements to the current grant. Your application budget cannot exceed $50,000 in direct costs.
I-Corps™ recommends that your small business’s team consist of a chief-level corporate officer, an industry expert, and a program director/principal investigator. Each team member should plan to spend at least 20 hours per week on I-Corps™ activities and learning exercises for the duration of the eight-week program.
The program will be split into two cohorts, one beginning February 5, 2017, and the other beginning April 23, 2017. The application due dates are November 1, 2016, and January 9, 2017, respectively.
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