Therapeutic Development Services - Interventional Agents

Preclinical Development, Planning, and Evaluation

• Develop preclinical and/or product development plans

Chemistry and Manufacturing

• Synthesize non-GMP grade bulk intermediates, compounds, or therapeutic agents.
• Synthesize chemical analogs of a given lead compound or scaffold in singleton or library format in quantities sufficient for biological and biochemical testing.
• Route optimization, including route design, reaction optimization and production of a demonstration batch, to enable late-stage diversification of a medicinal chemistry route or large-scale synthesis of a target compound or therapeutic agent.
• Formulation development for clinical or advanced preclinical studies
• Current Good Manufacturing Practices (cGMP)-compliant synthesis of Drug Substance (DS), cGMP-compliant manufacturing of Drug Product (DP) consistent with relevant FDA guidelines
• DP stability testing required during clinical trials 

Preclinical Safety and Pharmacokinetics (GLP and non-GLP)

• GLP and non-GLP, in vitro and in vivo pre-clinical safety, toxicology, and biokinetics studies, including:
  • Cytotoxicity, immunotoxicity, Genotoxicity, carcinogenicity, reproductive toxicity, ion-channel testing
  • Pharmacokinetics, Bioavailability, ADME
  • Biotransformation assays
  • Acute and sub chronic toxicity
  • Maximum tolerated dose and no observed adverse effect levels (NOAEL)
  • Behavioral pharmacology

• 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.