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.
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.
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.
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.
Step 1 – Discuss the potential request informallyContact 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:
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.
Last Updated April 20, 2016