1. Shortening the Pre-Clinical Research Cycle at the Clinical Discovery Laboratory Galen Chan Anand Singhania Fern-Anita Stalling February 23, 2011

2. Agenda Our Understanding Approach Recommendations Conclusion

3. Clinical Discovery Laboratory (CDL) What it does? Facilitate clinical and applied research Assistance with budget preparation Assistance with PACUC protocol preparation Assistance with execution of research and study Organization structure Part of Medical Discovery Unit (MDRU) but reports to both MDRU and Department of Veterinary Clinical Sciences

4. Clinical Discovery Laboratory (CDL) Primary Issues Scheduling of the study Difficult to coordinate between the animal housing, CDL facility and investigator’s availability Delays due to schedule conflicts result in funding loss and cancellation of studies Opportunity cost losses when the CDL is inefficient or underutilized Challenges Time and resource required to scheduled a study and the causes of delays are not recorded currently Requirements of all units (PACUC, Animal Housing, and delays caused by passage through other units are amplified at the CDL level)

5. Clinical Discovery Laboratory (CDL) Causes of delays in executing a study Delays in account set up, mainly due to prolonged contract negotiations Animal housing schedule is dependent on account set-up Internal CDL facility capacity and availability of CDL investigators

6. Pre-Clinical Research Cycle Duration Yellow: Sponsored Program Services (proposal submission, award management, contracting) Orange: Purdue Animal Care and Use Committee (approval of research activities) Red: Animal Housing (animal requisition, animal housing scheduling) Blue: CDL (assistance with budget preparation, assistance with PACUC protocol preparation, assistance with execution of study: technical support, facility and equipment, peri-operative housing) Day 0 Day 5 Day 10 Day 15 Day 20 Day 25 Day 30 Day 35 Contract PreparationPreparation and Completion of Award Notice PACUC Approval Process Additional Review by PACUC Animal Requisition Form Meet with CDL Manager Complete Work Request FormScheduling of Study

7. Agenda Our Understanding Approach Recommendations Conclusion

8. Resources & Research Interviews –Dr. Gert Breur, Director of CDL –Dr. Harm HogenEsch, Associate Dean for Research and Graduate –Dr. John Turek, Assistant Dean of Research –Dr. Peter Constable, Professor & Head, Department of Veterinary Clinical Sciences - pending –Deb Cessna, Director of Financial Affairs - pending –Suzie Inskeep, Business Manager - pending Documents –CDL Future –Notice to Proceed and Instructions –Purdue Clinical Discovery –Purdue SPS Handbook –“Shortening of the Pre-Clinical Duration”

9. Agenda Our Understanding Approach Recommendations Conclusion

10. Application of Project Management Framework Structural Changes –Reorganize reporting structure –Hire an inter-group liaison Provide temps/interns for administrative duties as necessary –Begin implementation of Project Management Software –Begin automation of processes Initiation –Investigator must provide all dates that he/she is available for the study up front in documentation form Planning & Design –Shared calendar accessible by all groups Monitor & Control –Report on variance between days budgeted and actual days needed Initiation Planning & Design Monitor & Control Executing Closing Project Development PhasesRecommendations

11. Agenda Our Understanding Approach Recommendations Conclusion

12. Next Steps & Conclusion Communication –For the study: heads of the various associated departments must be aware and buy in to the project –For the process: better communication is needed between the various groups that are involved in the process Improved financial management –Better knowledge of the process will reduce the lost time associated with scheduling and rescheduling studies –Better control of the process will allow for more studies and create a more competitive research facility