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Examples of Co-Development Goals

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Example A). Early Testing of Collaborator's Agent

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

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

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

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


Monday, December 18, 2017