Services for Researchers

Services for the Preclinical Development of Therapeutic Agents

Application Process

Step One

The request must include:

• A description of the overall product development plan.
• Background and significance (including why the service requested fits into the overall development plan for the product).
• Preliminary data that supports the request to advance the product through provision of contract services.
• A list of other support that NIAID or other Federal agencies are providing, including funded and pending grant applications and a brief description of what activities are covered.
• Description of the overall plan for advancing the product beyond completion of the services requested.

The request also includes information on:

• Desired delivery time and justification, for example filing IND
• Special IP requirements
• Good Laboratory Procedure(GLP)/Good Manufacturing Procedure (GMP) requirements
• Involvement of select agents and other biohazard materials
• Defined deliverables
• A detailed description of the specific studies requested, including
• Compliance level for each
• How the test article or other critical reagents will be provided
• If required assays have been developed and to what stage of qualification and/or validation
• If the requesting institution will provide technology transfer packages for supporting assays or will perform the assays themselves
• If for synthesis, inclusion (electronic) of compound structures, as well as any synthesis schemes already developed

B. The Program Officer, with the Branch Chief, establishes branch priority.

Step Two

The Investigator, Program Officer and Project Officer work together to refine the request and associated costs. A member of the DMID Office of Regulatory Affairs is recruited as a member of the team as needed regarding GLP/GMP requirements, the value of GLP/GMP, and the readiness of products to advance to the level of the requested service(s).

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