The FACT Education Committee and Immune Effector Cell Task Force have developed a series of webinars on Immune Effector Cellular Therapy. Six webinars are planned throughout 2020 and include the following topics:
The State of FACT Immune Effector Cell Therapy Accreditation Today presented by Dr. Patrick Hanley
Wednesday, March 4, 2020
11:00 am ET, 16:00 GMT
Dr. Patrick Hanley, Director of GMP for Immunotherapy at Children’s National Health System Blood and Marrow Transplant Program, will present the State of FACT Immune Effector Cell Therapy Accreditation Today. Dr. Hanley will discuss the growth and expected direction of IEC Accreditation and describe the major concepts addressed the FACT IEC Standards. He will also explain various methods of compliance, as well as compare requirements between FACT and commercial manufacturers.
Labeling and Chain of Custody for IEC Products presented by Dr. Sarah Nikiforow
Wednesday, April 22, 2020
11:00 am ET, 15:00 GMT
Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will present Labeling and Chain of Identity and Custody for IEC Products. Dr. Nikiforow will review the IEC Standards related to labeling and chain of identity and custody and explain FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside. In addition, she will describe how ISBT 128 coding and labeling can be used with commercial cellular therapy products.
Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier
June 17, 2020
11:00 am ET, 15:00 GMT
Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, will present Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program. Dr. Bachier will begin by discussing the requirements for transplantation and immune effector cellular therapy. He will highlight opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan, and provide steps that can be taken to incorporate immune effector cellular therapy into a transplant program.
Other sessions within this series include:
- Bringing a Stand-Alone Immune Effector Cell Therapy Program into FACT Compliance (Date/time TBD)
- IEC Inspector Training (Date/time TBD)
- Data Reporting and REMS Compliance (Date/time TBD)