What Services Does this Resource Provide?
The Biopharmaceutical Product Development Services program provides services to facilitate preclinical development of materials that are derived from biotechnology processes, such as monoclonal antibodies and derivatives of monoclonal antibodies; recombinant proteins; peptides; nucleic acid based vectors (siRNA, plasmids); and live, modified-live and/or attenuated entities.
Services include
- Product development planning and evaluation
- Assay development and product release testing
- Process development and formulation
- GMP manufacturing
- Regulatory CMC documentation support
See examples of services within each of these categories.
A suite of services is provided to 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.
Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development. Preliminary data to support program participation are required.
Eligibility Criteria and Preliminary Data Required
You may request services if you are an investigator in academia, a not-for-profit organization, industry, or government worldwide. You need not be a grantee of NIAID or another National Institutes of Health Institute or Center. However, you 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 to discuss the preliminary data required in order to derive meaningful data from the studies you propose.
Assurances to Requestors
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.
Application and Approval Process
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:
- Are the proposed studies within the 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.
Requestor Requirements
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.