Details
Cell and gene therapies hold huge promise for addressing unmet medical needs but developing safe and effective therapies come with unique challenges. Come hear from a panel of experts on topics critical to achieving long-term success.
The discussion will include:
Pre-phase I
- - CMC strategy
- - Pharm/tox requirements
Working with the FDA and other regulatory agencies
- - Expanded access strategies
- - Accelerated development designations
- - “Right to try” considerations
Site selection
- - Site infrastructure
- - Investigator and staff experience
Planning for breakthrough designation
- - Impact on monitoring team
- - TMF readiness
- - Getting sites ready for inspection
Integrated and synchronized clinical supply chain management
- - Chain of custody
- - Cell processing plan
- - Import/export requirements
FDA Bioresearch Monitoring Program (BIMO)
- - Accuracy and reliability of clinical trial data
- - Compliance with regulations
- - Protection of Study Subjects