Examples of Co-Development Goals

Example A) Early Testing of Collaborator's Agent
Input	Result
Contributor Contribution	Provides agent for testing Files IND with the Food and Drug Administration
NIH Contribution	Conducts preclinical research and Phase I studies in adult and/or pediatric patient populations at the NIH Clinical Center Provides data in support of a new Investigational Drug (IND) application
Successful Outcome and/or Product	Evaluation of a new agent including safety, tolerability, pharmacokinetics, immunogenicity, etc. IND for agent

Example B) Research Collaborations for Evaluating Devices/Equipment
Input	Result
Collaborator Contribution	Places equipment in an NIH facility for testing by NIH scientists for a limited time Offers onsite training sessions and technical support for NIH scientists interested in using the equipment May provide equipment upgrades, accessories, reagents/disposables, and maintenance related to technology
NIH Contribution	Conducts a variety of pilot studies to test the technology and compares results to the other methods Assists in validating assays and methods Provides data and other feedback for equipment and methods improvements
Successful Outcome and/or Product	Improved product

Example C) Research Collaborations for Co-Development of New Antibodies
Input	Result
Collaborator Contribution	Designs and develops antibodies Provides agreed upon quantity of product to NIH
NIH Contribution	Chooses target proteins for antibody development Validates using a wide variety of available cell systems Provides validation data to company
Successful Outcome and/or Product	Develops custom antibodies Publish information about new antibodies Create new antibody product

Example D) Clinical Testing of Agents Leading to New Therapeutics
Input	Result
Collaborator Contribution	Provides or synthesizes the agent Conducts preclinical and clinical studies in collaboration with NIH and other institutions Works with NIH to develop data needed for FDA approval
NIH Contribution	Provides or synthesizes the agent Conducts preclinical studies for the agent Develops or contributes to better formulation or alternative administration methods Conducts clinical trials through its network of clinical centers including NIH Clinical Center
Successful Outcome and/or Product	FDA approval of agent Product on the market Other clinical trials for additional indications