The PIVOT consortium collaborates with pharmaceutical research teams to test agents for which there is potential activity against one or more childhood cancers. Agents tested by PIVOT are generally ones that have already entered clinical evaluation or for which a decision for clinical development has been made.
The industry partner must provide relevant information about the targeted agent to guide model selection and experimental design. A sufficient quantity of agent for testing must be supplied as well. There are no costs to the industry partner for the testing.
Collaborating industry partners must be willing to negotiate a Material Transfer Agreement (MTA) with NCI for the proposed testing based on the model MTA that has been developed by NCI for the PIVOT consortium and that all PIVOT Testing Centers have accepted.
PIVOT Preclinical Testing Procedure
- An industry representative submits the PIVOT new agent consultation request form below
- A representative of the Coordinating Center reaches out to the individual listed on the form to schedule a follow up meeting to discuss the targeted agent(s)
- Following agreement by the PIVOT Steering Committee to proceed with testing, a Research Plan is developed in consultation with the collaborating company
- The mutually acceptable Research Plan is incorporated into an MTA, and an MTA is executed with NCI
- The PIVOT Coordinating Center works with the industry partner to provision the agent to the appropriate Testing Centers
- In vivo testing and data analysis is performed by the PIVOT consortium
- A final study report is generated and provided to the industry partner (typically within 8-12 months of the start of a study)
- A manuscript is drafted by PIVOT following study completion
Discussion with one of the NCI programs lead for PIVOT prior to requesting a consultation meeting is encouraged (but not required):
- Malcolm A. Smith, MD PhD (Malcolm.Smith@nih.gov)
- Beverly Teicher, PhD (Beverly.Teicher@nih.gov)
All inquiries are confidential.