Shortening the Pre-Clinical Research Cycle at the Clinical

Discovery Laboratory

Galen ChanAnand Singhania

Fern-Anita Stalling

February 23, 2011

Agenda

• Our Understanding

• Approach

• Recommendations

• Conclusion

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

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)

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

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 Preparation Preparation and Completion of Award Notice

PACUC Approval Process Additional Review by PACUC

Animal Requisition Form

Meet with CDL Manager Complete Work Request Form Scheduling of Study

Agenda

• Our Understanding

• Approach

• Recommendations

• Conclusion

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”

Agenda

• Our Understanding

• Approach

• Recommendations

• Conclusion

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 Phases Recommendations

Agenda

• Our Understanding

• Approach

• Recommendations

• Conclusion

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