UMBRELLA CRADAS:UMBRELLA CRADAS: AN EASIER PATHAN EASIER PATH

Suzanne M. Frisbie, Ph.D.Suzanne M. Frisbie, Ph.D.Unit SupervisorUnit Supervisor

Technology Transfer Center Technology Transfer Center National Cancer InstituteNational Cancer Institute

National Institutes of HealthNational Institutes of Health

Summary Summary

• Description of new NCI Umbrella Description of new NCI Umbrella CRADACRADA

• Issues to consider when using Issues to consider when using this approachthis approach

• Tips on setting up the processTips on setting up the process

• OutcomesOutcomes

Why Something New?Why Something New?

• CRADA negotiations time and resource intensiveCRADA negotiations time and resource intensive

• Multiple agreements with same companyMultiple agreements with same company

• Revisiting of previously agreed upon terms for Revisiting of previously agreed upon terms for new CRADAsnew CRADAs

• Adding PI to existing CRADA not always practical:Adding PI to existing CRADA not always practical:– Disagreements and competitionDisagreements and competition– FundingFunding– Projects not compatible Projects not compatible

What is an What is an Umbrella CRADA?Umbrella CRADA?

CRADA that encompasses a broad CRADA that encompasses a broad research topic and large number of research topic and large number of PIsPIs

Such as: Such as: Development of Agent X for Treatment Development of Agent X for Treatment of Cancer (20 PIs) – Basic research, of Cancer (20 PIs) – Basic research, preclinical, and clinical trialspreclinical, and clinical trials

New Umbrella CRADA New Umbrella CRADA StructureStructure

• CRADA w/RP based on carefully drafted template to CRADA w/RP based on carefully drafted template to encompass large amount of research and large encompass large amount of research and large number of PIsnumber of PIs

• Legal language same as non-UmbrellaLegal language same as non-Umbrella

• Simple internal MTAs to:Simple internal MTAs to:– track agent within NCItrack agent within NCI– track data and subject invention obligationstrack data and subject invention obligations– Conflict of Interest reviews Conflict of Interest reviews

• Flexibility to add cmpds. within same class from Flexibility to add cmpds. within same class from same companysame company

Roles of TTC and ScientistsRoles of TTC and ScientistsScientists:Scientists:

• makes requestmakes request

• discuss projects & how discuss projects & how each PI fits into pipeline each PI fits into pipeline for agent development for agent development

• discuss funding & discuss funding & personnelpersonnel

• interact w/Co. & TTC to interact w/Co. & TTC to draft RPs for MTAsdraft RPs for MTAs

• Each PI fills out Ethics Each PI fills out Ethics review formsreview forms

TTC:TTC:

• asks Sci. Div. Dir. if Umbrellaasks Sci. Div. Dir. if Umbrella

• negotiates CRADA w/Co.negotiates CRADA w/Co.

• make sure each PI approved make sure each PI approved by Ethics by Ethics

• coordinates w/PIs to execute coordinates w/PIs to execute internal MTAs & sends copy internal MTAs & sends copy to Co. (Sci. Div. Dir. & TTC to Co. (Sci. Div. Dir. & TTC sign MTAs)sign MTAs)

• internal MTAs tracked in internal MTAs tracked in databasedatabase

• Status updates sent routinely Status updates sent routinely to Sci. Div. Dir.to Sci. Div. Dir.

Issues to Consider When Issues to Consider When Using This ApproachUsing This Approach

• Drafting first RP template was biggest challenge; how Drafting first RP template was biggest challenge; how to be generic yet focused.to be generic yet focused.

• First Co. concerned that negotiation of legal language First Co. concerned that negotiation of legal language would take longer – once have track record easier to would take longer – once have track record easier to convince.convince.

• Buy-in from Sci. Div. Director or someone who has Buy-in from Sci. Div. Director or someone who has authority to organize and make decisions regarding authority to organize and make decisions regarding scientific priorities and funding important for success.scientific priorities and funding important for success.

• Approval of CRADA Subcommittee (committee Approval of CRADA Subcommittee (committee reviewing and approving CRADAs) was important in reviewing and approving CRADAs) was important in setting up process.setting up process.

Tips on Setting Up the Tips on Setting Up the ProcessProcess

• Since drafting the RP template is challenge, it may Since drafting the RP template is challenge, it may help if Tech. Transfer Specialist drafts, then sends to help if Tech. Transfer Specialist drafts, then sends to each PI potentially involved to see if the PI thinks that each PI potentially involved to see if the PI thinks that any research they could possibly want to do is any research they could possibly want to do is covered.covered.

• Discussions with people involved are very important Discussions with people involved are very important throughout the process to reassure everyone (PIs, Co., throughout the process to reassure everyone (PIs, Co., Sci. Director, CRADA approval committee) that the Sci. Director, CRADA approval committee) that the new approach will be easier for them, more efficient, new approach will be easier for them, more efficient, and will address their policy concerns as well as what and will address their policy concerns as well as what they are used to.they are used to.

Anticipated Outcomes Anticipated Outcomes • Multiple CRADAs for same agent or with same Co. for different Multiple CRADAs for same agent or with same Co. for different

agents within a class are minimizedagents within a class are minimized

• Negotiation of legal language takes same amount of time as for Negotiation of legal language takes same amount of time as for non-umbrella CRADAnon-umbrella CRADA

• Drafting RP is easier than a non-umbrella CRADA since based Drafting RP is easier than a non-umbrella CRADA since based on a template.on a template.

• Possibility of RP overlapping another CRADA RP minimized Possibility of RP overlapping another CRADA RP minimized (avoids ambiguity of deciding which CRADA governs in the (avoids ambiguity of deciding which CRADA governs in the event of invention etc.)event of invention etc.)

• New metrics neededNew metrics needed

Advantages to Scientific Advantages to Scientific ProgramProgram

•Sci. Div. Dir. only “CRADA” PISci. Div. Dir. only “CRADA” PI

• Consolidation of scientific efforts for a Consolidation of scientific efforts for a particular agent for a more unified approachparticular 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 More administrative and financial resources available at the Sci. Div. Dir.’s level vs. available at the Sci. Div. Dir.’s level vs. individual PIsindividual PIs

•More effective communication between PIs More effective communication between PIs and between PIs and companiesand between PIs and companies

Advantages to CompanyAdvantages to Company

•Company does not need to negotiate multiple Company does not need to negotiate multiple CRADAs for multiple PIs and multiple projectsCRADAs for multiple PIs and multiple projects

•Company can interact with just one NCI Company can interact with just one NCI negotiatornegotiator

•Company may be more likely to supply agent Company may be more likely to supply agent for lower priority projects for lower priority projects

•Funding requests can be combinedFunding requests can be combined

Unanticipated OutcomesUnanticipated Outcomes• Stimulated PIs to conduct more research and use a Stimulated PIs to conduct more research and use a

unified approach to a scientific problemunified approach to a scientific problem

• Scientific program needed to hire new staff to manage Scientific program needed to hire new staff to manage the scientific projectsthe scientific projects

• Sci. Div. Dir. decides whether each clinical CRADA Sci. Div. Dir. decides whether each clinical CRADA should be Umbrella or not. Now deciding same should be Umbrella or not. Now deciding same question for nonclinical areas.question for nonclinical areas.

• NIH Subcommittee’s review is streamlinedNIH Subcommittee’s review is streamlined

StatisticsStatistics

• 7 Umbrella CRADAs executed since 7 Umbrella CRADAs executed since 3/20083/2008

• 29 internal MTAs executed29 internal MTAs executed

• 17 internal MTAs pending17 internal MTAs pending

Summary Summary

• Description of NCI Umbrella Description of NCI Umbrella CRADACRADA

• Issues to consider when using Issues to consider when using this approachthis approach

• Tips on setting up the processTips on setting up the process

• OutcomesOutcomes

Contact InformationContact Information

Technology Transfer Center, NCITechnology Transfer Center, NCIPhone: 301-496-0477Phone: 301-496-0477Web site: Web site: http://ttb.nci.nih.gov