1. UMBRELLA CRADAS: AN EASIER PATH AN EASIER PATH Suzanne M. Frisbie, Ph.D. Unit Supervisor Technology Transfer Center National Cancer Institute National Institutes of Health

2. Summary Description of new NCI Umbrella CRADA Description of new NCI Umbrella CRADA Issues to consider when using this approach Issues to consider when using this approach Tips on setting up the process Tips on setting up the process Outcomes Outcomes

3. Why Something New? CRADA negotiations time and resource intensive CRADA negotiations time and resource intensive Multiple agreements with same company Multiple agreements with same company Revisiting of previously agreed upon terms for new CRADAs Revisiting of previously agreed upon terms for new CRADAs Adding PI to existing CRADA not always practical: Adding PI to existing CRADA not always practical: –Disagreements and competition –Funding –Projects not compatible

4. What is an Umbrella CRADA? CRADA that encompasses a broad research topic and large number of PIs Such as: Development of Agent X for Treatment of Cancer (20 PIs) – Basic research, preclinical, and clinical trials

5. New Umbrella CRADA Structure CRADA w/RP based on carefully drafted template to encompass large amount of research and large number of PIs CRADA w/RP based on carefully drafted template to encompass large amount of research and large number of PIs Legal language same as non-Umbrella Legal language same as non-Umbrella Simple internal MTAs to: Simple internal MTAs to: –track agent within NCI –track data and subject invention obligations –Conflict of Interest reviews Flexibility to add cmpds. within same class from same company Flexibility to add cmpds. within same class from same company

6. Roles of TTC and Scientists Scientists: makes request makes request discuss projects & how each PI fits into pipeline for agent development discuss projects & how each PI fits into pipeline for agent development discuss funding & personnel discuss funding & personnel interact w/Co. & TTC to draft RPs for MTAs interact w/Co. & TTC to draft RPs for MTAs Each PI fills out Ethics review forms Each PI fills out Ethics review formsTTC: asks Sci. Div. Dir. if Umbrella asks Sci. Div. Dir. if Umbrella negotiates CRADA w/Co. negotiates CRADA w/Co. make sure each PI approved by Ethics make sure each PI approved by Ethics coordinates w/PIs to execute internal MTAs & sends copy to Co. (Sci. Div. Dir. & TTC sign MTAs) coordinates w/PIs to execute internal MTAs & sends copy to Co. (Sci. Div. Dir. & TTC sign MTAs) internal MTAs tracked in database internal MTAs tracked in database Status updates sent routinely to Sci. Div. Dir. Status updates sent routinely to Sci. Div. Dir.

7. Issues to Consider When Using This Approach Drafting first RP template was biggest challenge; how to be generic yet focused. Drafting first RP template was biggest challenge; how to be generic yet focused. First Co. concerned that negotiation of legal language would take longer – once have track record easier to convince. First Co. concerned that negotiation of legal language would take longer – once have track record easier to convince. Buy-in from Sci. Div. Director or someone who has authority to organize and make decisions regarding scientific priorities and funding important for success. Buy-in from Sci. Div. Director or someone who has authority to organize and make decisions regarding scientific priorities and funding important for success. Approval of CRADA Subcommittee (committee reviewing and approving CRADAs) was important in setting up process. Approval of CRADA Subcommittee (committee reviewing and approving CRADAs) was important in setting up process.

8. Tips on Setting Up the Process Since drafting the RP template is challenge, it may help if Tech. Transfer Specialist drafts, then sends to each PI potentially involved to see if the PI thinks that any research they could possibly want to do is covered. Since drafting the RP template is challenge, it may help if Tech. Transfer Specialist drafts, then sends to each PI potentially involved to see if the PI thinks that any research they could possibly want to do is covered. Discussions with people involved are very important throughout the process to reassure everyone (PIs, Co., Sci. Director, CRADA approval committee) that the new approach will be easier for them, more efficient, and will address their policy concerns as well as what they are used to. Discussions with people involved are very important throughout the process to reassure everyone (PIs, Co., Sci. Director, CRADA approval committee) that the new approach will be easier for them, more efficient, and will address their policy concerns as well as what they are used to.

9. Anticipated Outcomes Multiple CRADAs for same agent or with same Co. for different agents within a class are minimized Multiple CRADAs for same agent or with same Co. for different agents within a class are minimized Negotiation of legal language takes same amount of time as for non-umbrella CRADA Negotiation of legal language takes same amount of time as for non-umbrella CRADA Drafting RP is easier than a non-umbrella CRADA since based on a template. Drafting RP is easier than a non-umbrella CRADA since based on a template. Possibility of RP overlapping another CRADA RP minimized (avoids ambiguity of deciding which CRADA governs in the event of invention etc.) Possibility of RP overlapping another CRADA RP minimized (avoids ambiguity of deciding which CRADA governs in the event of invention etc.) New metrics needed New metrics needed

10. Advantages to Scientific Program Sci. Div. Dir. only “CRADA” PI Sci. Div. Dir. only “CRADA” PI Consolidation of scientific efforts for a particular agent for a more unified approach Consolidation of scientific efforts for a particular agent for a more unified approach More impact by “speaking with one voice” More impact by “speaking with one voice” More administrative and financial resources available at the Sci. Div. Dir.’s level vs. individual PIs More administrative and financial resources available at the Sci. Div. Dir.’s level vs. individual PIs More effective communication between PIs and between PIs and companies More effective communication between PIs and between PIs and companies

11. Advantages to Company Company does not need to negotiate multiple CRADAs for multiple PIs and multiple projects Company does not need to negotiate multiple CRADAs for multiple PIs and multiple projects Company can interact with just one NCI negotiator Company can interact with just one NCI negotiator Company may be more likely to supply agent for lower priority projects Company may be more likely to supply agent for lower priority projects Funding requests can be combined Funding requests can be combined

12. Unanticipated Outcomes Stimulated PIs to conduct more research and use a unified approach to a scientific problem Stimulated PIs to conduct more research and use a unified approach to a scientific problem Scientific program needed to hire new staff to manage the scientific projects Scientific program needed to hire new staff to manage the scientific projects Sci. Div. Dir. decides whether each clinical CRADA should be Umbrella or not. Now deciding same question for nonclinical areas. Sci. Div. Dir. decides whether each clinical CRADA should be Umbrella or not. Now deciding same question for nonclinical areas. NIH Subcommittee’s review is streamlined NIH Subcommittee’s review is streamlined

13. Statistics 7 Umbrella CRADAs executed since 3/2008 7 Umbrella CRADAs executed since 3/2008 29 internal MTAs executed 29 internal MTAs executed 17 internal MTAs pending 17 internal MTAs pending

14. Summary Description of NCI Umbrella CRADA Description of NCI Umbrella CRADA Issues to consider when using this approach Issues to consider when using this approach Tips on setting up the process Tips on setting up the process Outcomes Outcomes

15. Contact Information Technology Transfer Center, NCI Phone: 301-496-0477 Web site: http://ttb.nci.nih.gov http://ttb.nci.nih.gov