Interventional Agent Development Services

Lead Identification and Development

• Design lead optimization schemes (LOS) and generate chemical analogues
• Synthesize, resynthesize, or acquire compounds/interventional agents or chemical analogues for in vitro and in vivo studies
• Analyze structure activity relationships (SAR)
• Custom synthesize radio labeled compounds for in vitro and in vivo studies
• Optimize lead series to improve specific physiochemical or pharmacological properties
• Synthesize prodrug derivative(s)

Chemistry and Manufacturing

• Develop analytical methods to characterize interventional agents
• Develop and manufacture cGMP-qualified materials for preclinical and Phase I/II clinical use
• Conduct formulation studies
• Support cGMP-compliant stability program

In Vitro and In Vivo Preclinical Safety, Toxicology, and Pharmacokinetics

• Develop analytical methods to characterize interventional agents
• Perform preclinical microbiological, safety, biokinetics and toxicity studies, such as in vitro microbiological assays
• Perform in vitro and in vivo pre-clinical safety, toxicology, and biokinetics studies, including:
  • Maximum tolerated dose and no observed adverse effect levels (NOAEL)
  • Acute and sub chronic toxicity
  • PK, Bioavailability, ADME
  • Genotoxicity, carcinogenicity, reproductive toxicity testing
  • Biotransformation assays conducted in vitro
  • Cytotoxicity, immunotoxicity
  • Behavioral pharmacology
  • Cell permeability

Preclinical Development, Planning, and Evaluation

• Develop preclinical and/or product development plans
• All of these services support the development of products directed against the full range of pathogens, including bacteria, viruses, parasites, fungi, and other agents such as toxins and prion proteins. Services will be conducted at the appropriate regulatory compliance level dependent on the stage of product development.

• 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.

Please contact the appropriate staff contact in the Division of Microbiology and Infectious Diseases (DMID) to discuss the preliminary data required in order to derive meaningful data from the studies you propose.

Step 1 – Discuss the potential request informally

Contact the appropriate staff contact in the Division of Microbiology and Infectious Diseases to discuss your preliminary data and the suitability of your proposed studies for support. Your request will be evaluated as follows:

1. Are the proposed studies within the DMID/NIAID mission?
2. Are the proposed studies within the scope of and/or technology provided by awarded contracts?
3. Are a sufficient quality and/or quantity of product available?
4. Are the proposed studies in compliance with animal welfare regulations?
5. Is the proposed work supported by other funding sources/available from other sources?
6. 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.)
7. Are preliminary data adequate to support the request to advance the product to the next step in the product development pathway?
8. What is the likelihood that services will contribute significantly to the eventual development and/or evaluation of a product of high quality?
9. What is the purported public health impact?
10. What improvements in health benefits are offered beyond current measure(s)?
11. 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 the DMID staff on all on-going studies and development status involving submitted compound(s).
• Requestors must also provide abstracts, draft publications, press, 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 Therapeutic Development Services program played in furthering the research being reported.

• A Non-Clinical Evaluation Agreement (NCEA), with an attached Service Request Form (SRF), between NIAID and the requestor shall 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.