Therapeutic Development Services - Biopharmaceutical Products

Product development planning and evaluation

• Assess feasibility of development program and preparation of Phase I/II clinical materials
• Develop Product Development Plan for candidate products

Assay development and product release testing

• Develop and validate analytical methods for product characterization
• Perform comparability studies, redevelop or improve existing assays

Process development and formulation

• Carry out process development, characterization and production of biopharmaceutical products for use in preclinical and Phase I/II clinical studies
• Generate master and working cell/viral banks
• Develop GMP-suitable and scalable process
• Conduct formulation optimization studies
• Complete stability indicating assays throughout process development and pilot manufacture

GMP manufacturing

• Prepare Master Production Records
• Manufacture biopharmaceutical products in compliance with FDA cGMP regulations
• Perform QC release testing and execute stability testing program

Regulatory CMC documentation support

• Support interactions with FDA at pre-IND and IND stages
• Provide the required documentation for IND submission (e.g., Chemistry, Manufacturing and Controls (CMC) Information; Master Files)

Services will be conducted at the appropriate regulatory compliance level dependent on the stage of product development. These services support the development of products and diagnostic reagents directed against the full range of pathogens, including bacteria, viruses, parasites, fungi, and other agents such as toxins and prion proteins.

• Investigators in academia, a not-for-profit organization, industry, or government worldwide may request services
• Investigators need not be a grantee of NIAID or another National Institutes of Health Institute or Center
• 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

Note: Resources are limited and intended to fill critical gaps and are not to be the sole source of product development.

Step 1 – Discuss the potential request informally

Contact the appropriate staff contact in the Division of Microbiology and Infectious Diseases (DMID) 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. Is the proposed work supported by other funding sources/available from other sources?
5. 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.)
6. Are preliminary data adequate to support the request to advance the product to the next step in the product development pathway?
7. What is the likelihood that services will contribute significantly to the eventual development and/or evaluation of a product of high quality?
8. What is the purported public health impact?
9. What improvements in health benefits are offered beyond current measure(s)?
10. 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.