ISCT Lab Practices Committee Who are we & What do we do?

Initial Efforts ( ) Identify potential committee members Establish an effective means of communication Identify areas of focus Develop working relationship with other ISCT committees Develop MISSION Statement

Mission Statement (2003) To help develop, standardize and disseminate accepted laboratory practices for clinical applications of cellular therapy To participate in the translation of novel cell therapy products from the laboratory to the clinic To encourage and foster the participation of laboratory practitioners in all aspects of the society

Education Standardization of common Standard Operating Procedures and Practice Encourage society membership amongst technical staff Scheduling of Teleconferences  Review and discuss practical operational topics  Discuss various lab’s approach to common issues  Develop consensus amongst various labs where applicable Actively participate in society’s conferences  Technical Breakfast  Round Table Discussion Groups  In-service training with “wet” lab demonstrations

Regulatory Development QA Issues  Audits  Documentation Control  Facility Cleaning QC Issues  In-house vs. Out-sourcing of test  Environmental Monitoring  Participation in method comparisons RA Issues  Laboratory Involvement in clinical trails development and execution  Documentation to meet cGCP

Staffing Requirements Job Descriptions  Adequate for the technical task  Graduated levels for advancement opportunities  Enhance recruitment efforts Staffing ratios and overlapping positions  Cross-check functionality  Pro-active audits  Multi-tasking across divisions of labor – how to share positions Certification

Developmental Research Translation of developmental research into cGMP environment  Understanding of development issues and scientific technology  Scale-up and Close-up issues cGCP and how it applies to the laboratory staff  Successful protocol implementation  Process and time integration

cGMP Facility Operations Actively participate in construction process  Work-flow  Shared equipment & spaces  Multi-purpose units Optimal cleaning processes Changeover policies Gowning standardization Validation

Next Steps Active integration into society’s growth and expansion Pioneering and implementing new procedures  Streamline processes  Improve resource utilization  Efficient scale-up  Development of closed system Cost Management