The In Vitro Assessment for Antimicrobial Activity program provides capability in a broad range of in vitro assessments to evaluate promising candidate countermeasures for antimicrobial activity against microbial pathogens and vectors, including those derived from clinical specimens.
Main Areas of Focus
Services include screening products for antimicrobial activity and developing and performing or providing the following in vitro assays:
- Bacteria and fungi: minimal inhibitory concentration, minimal bactericidal concentrations, post antibiotic effect, hollow fiber pharmacokinetic modeling, disruption of biofilms,
- Viruses: inhibition of viral replication and infectivity, hollow fiber pharmacokinetic modeling
- Parasites and vectors: inhibition of parasite replication, maintaining vector cells
- Toxins: enzyme kinetics, neutralization and binding assays
- In Vitro Models that Mimic In Vivo Exposure: techniques that recreate dynamic pharmacokinetic profiles and measure the impact on pathogen growth
- Development of New Techniques to Culture Difficult to Grow Pathogens
These services are intended to fill critical gaps for researchers working toward product development.
Who Can Use This Resource
- Investigators, academia, not-for-profit organizations, industry, or governments worldwide may request services.
- Investigators do not need to be a grantee of NIAID or another Institute or Center at the National Institutes of Health.
- Investigators must have appropriate preliminary data to support advancing the product you wish to have studied to the requested stage of the product development pathway.
How To Get Started
Step 1 – Discuss the potential request informally
Email firstname.lastname@example.org to discuss your preliminary data and the suitability of your proposed studies for support. Your request will be evaluated as follows:
- Are the proposed studies within the Division of Microbiology and Infectious Diseases (DMID)/NIAID mission?
- Are the proposed studies within the scope of and/or technology provided by awarded contracts?
- Are a sufficient quality and/or quantity of product available?
- Is the proposed work supported by other funding sources/available from other sources?
- Has the requestor previously used DMID resources for assessment of the same or similar product? (Repeat use of DMID resources may be undertaken with strong justification.)
- Are preliminary data adequate to support the request to advance the product to the next step in the product development pathway?
- What is the likelihood that services will contribute significantly to the eventual development and/or evaluation of a product of high quality?
- What is the purported public health impact?
- What improvements in health benefits are offered beyond current measure(s)?
- Does the requestor have a plan for advancing the product beyond completion of the services requested?
Informal requests are reviewed and approved at the branch/office level, where they are considered in relation to branch/office priorities.
Step 2 – Submit a formal proposal (by invitation only)
- If your proposal is judged to be promising, DMID staff will invite you to submit a formal request for approval through the DMID Preclinical Services for Researchers site. DMID staff will provide instructions for establishing the NIH account required to access this site, instructions for submitting your request, and a brief description of what to expect next.
- Formal requests are reviewed and approved by the DMID senior leadership, where they are considered in relation to division priorities.
- Requestors must update DMID staff on all on-going studies and development status involving submitted compound(s).
- Requestors must also provide abstracts, draft publications, press releases, and other materials prior to submission to journals, conferences, or other public release of information.
- Communications should acknowledge the role that access to preclinical services provided by the In Vitro Assessment for Antimicrobial Activity program played in furthering the research being reported.
Assurance to Requestors
- A Non-Clinical Evaluation Agreement (NCEA), with an attached Service Request Form (SRF), between NIAID and the requestor will be required. The NCEA protects the requestor’s intellectual property and ensures confidentiality. The contract establishes confidentiality for all information flowing from NIAID to the contractor. Therefore, additional material transfer agreements between the requestor and the contractor are not needed.
- All information provided to the contractor will be treated as confidential.