Beyond BMT: Regulating Your Lab's Cell Therapies Across Medical Specialties
Saturday, June 1, 2024 11:30 AM - 12:30 PM
Room 205-207
Regulation & Policy
Roundtable
Moderator
Assess existing and potential standards and accreditation requirements for centers supplying cell therapies across diverse medical specialties.
Key Learning Objectives
1. Discuss regulatory standards governing who can serve as PIs or sponsors of cell therapy clinical trials.
2. Share experiences from centers supplying in-house manufactured IECs and MSCs to multiple diverse medical specialties.
3. Think about qualification of study PIs who want to use cellular therapies processed by academic GMP laboratories.
- Ashley Krull, PhD, W.W. Williams Cellular Therapy Laboratory, The Ohio State University, Unites States
- J. Kaitlin Morrison, PhD, UNC Lineberger Comprehensive Cancer Center, United States
- Kathryn Bushnell, BS, MT (ASCP), Children's National Hospital, United States
- Michael Gustafson, PhD, Mayo Clinic Arizona, United States
- Monica Shaw, MBA, MT(ASCP), Mayo Clinic, United States
Assess existing and potential standards and accreditation requirements for centers supplying cell therapies across diverse medical specialties.
Key Learning Objectives
1. Discuss regulatory standards governing who can serve as PIs or sponsors of cell therapy clinical trials.
2. Share experiences from centers supplying in-house manufactured IECs and MSCs to multiple diverse medical specialties.
3. Think about qualification of study PIs who want to use cellular therapies processed by academic GMP laboratories.
J. Kaitlin Morrison
Executive Director, UNC Lineberger Clinical Research & Assistant Professor of Medicine- Hematology
UNC Lineberger Comprehensive Cancer Center
Panelist
Executive Director, UNC Lineberger Clinical Research & Assistant Professor of Medicine- Hematology
UNC Lineberger Comprehensive Cancer Center
Panelist