2024 Inspector Training @ ISCT Vancouver

2024 Inspector Training @ ISCT Vancouver

FACT's inspector training course will be held on May 28, 2024, in conjunction with the International Society for Cell & Gene Therapy (ISCT) Conference in Vancouver, BC, held May 29 - June 1, 2024, at the Vancouver Convention Centre, West Building. Connecting with global experts from academic, regulatory, and industry in the cell and gene therapy field. Earn AMA PRA Category 1 Credit™ for attending! Inspector trainees and Inspectors can register today for this great training event.

image

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Illinois State Medical Society (ISMS) through the joint providership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accredited by the ISMS to provide continuing medical education for physicians. This live activity is designated for a maximum of 8.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Joseph Schwartz, MD, MPH

Senior Medical Officer, Director of Transfusion Medicine

FACT/H. Lee Moffit Cancer Center & Research Institute

Dr. Joseph Schwartz is the Director of Transfusion Medicine Services at the Moffitt Cancer Center in Tampa, FL. Dr. Schwartz is the Chair of the FACT Technology Committee and Co-Chair of the FACT Cellular Therapy Accreditation and Cord Blood Bank Accreditation Committees. In addition, he is a member of the FACT Standards Steering and Education committees. In the past, he served on the FACT Board of Directors. Dr. Schwartz has participated as an Apheresis and Marrow Collection, Cord Blood Banking, and Cord Blood Collection Inspector since 2006. Dr. Schwartz recently joined FACT as the Senior Medical Officer

No Disclosures.

Phyllis I. Warkentin, MD

Chief Medical Officer

FACT

Dr. Phyllis Warkentin is a founding member of the Foundation for the Accreditation of Cellular Therapy (FACT), a member of the FACT Board of Directors, and the FACT Chief Medical Officer. She is a Pathology, Microbiology, Immunology, and Pediatrics professor at the University of Nebraska Medical Center, Omaha, NE, and the Medical Director of the Nebraska Medicine Blood and Marrow Transplant Marrow Collection Program. She has authored over one hundred scientific publications in transfusion, transplantation, and cellular therapy. She is a graduate of the University of Minnesota Medical School, Minneapolis, MN, board certified in pediatric hematology/oncology and transfusion medicine.

No Disclosures

Alex Babic MD PhD

Medical Director

Saint Louis University Blood and Marrow Transplant Program

Dr. Alex Babic is an Associate Professor of Internal Medicine at St Louis University Medical School. He is the Director of the Cellular Therapy Laboratory and Collections at St Louis University Medical Center. From 2013 until 2018, he was also the Medical Director of St Louis Cord Blood Bank. Since 2016, he has served as FACT Inspector and, since 2019, as a member of the FACT Education Committee. In 2020, he became a member of the FACT Accreditation Committee. His focus is on evaluation and optimization of outcomes of cell collection and processing

No Disclosures

Wanxing Cui, MD PhD

Director

Medstar Georgetown University Hospital Cell Therapy Manufacturing Facility

Dr. Wanxing Cui leads the Cell Therapy Manufacturing Facility at MedStar Georgetown University Hospital, blending a diverse background in academia, industry, and healthcare in the realm of cell therapy. His medical odyssey began in Shenyang, China, transitioning from a surgical residency to earning a Ph.D. from Kyoto University, where he focused on bioartificial pancreas development. As director of an FDA-registered facility accredited by both the Association for the Advancement of Blood & Biotherapies (AABB) and the Foundation for the Accreditation of Cellular Therapy (FACT), Dr. Cui plays a crucial role in the Pancreatic Islets and Hematopoietic Progenitor Cells Transplantation programs at his institution. His distinguished career in pancreatic islet transplantation spans over 27 years, marked by more than 70 peer-reviewed publications and several biotechnological patents. Dr. Cui serves as an AABB assessor and a FACT inspector, upholding the highest quality practices in the field. Parallel to his work with AABB, Dr. Cui is also engaged with the International Society for Cell & Gene Therapy (ISCT). Here, he contributes to the iPSC Joint and Lab Practice Committees, offering his expertise in innovative cellular therapies. Committed to mentorship, Dr. Cui supports the professional growth of upcoming experts through his involvement in ISCT's Professional Education Program (PEP) and AABB's Early Stage Professionals (ESP) programs. His interdisciplinary expertise and impactful contributions position him as an invaluable member of the AABB CTSCC committee, driving progress in cell therapies.

No Disclosures.

Scott Koepsell, MD PhD

Medical Director, Division of Transfusion and Transplantation Support Services

University of Nebraska Medical Center

Dr. Koepsell is a Pathology, Microbiology, and Immunology Professor at the University of Nebraska Medical Center. He is the medical director for the Biologic Production Facility and Apheresis Services at Nebraska Medicine.

TOPIC: Assessing Risk

___________

Dr. Koepsell disclosed that he had a previous financial relationship that ended in the last 24 months for consulting and speaking with Alexion and for research funding and consulting with Werfen.

Nadim Mahmud, MD PhD

Professor / Director, Clinical Cell Therapy Laboratory

University of Illinois Hospital and Health Sciences System Blood & Marrow Transplant Program

Dr. Nadim Mahmud is a Professor in the Department of Medicine in the Division of Hematology and Oncology at the University of Illinois College of Medicine, Chicago. He is also the Clinical Stem Cell Laboratory Director for UI Hospital Blood & Marrow Transplant Program. He has more than 22 years of experience in hematopoietic stem cell biology and stem cell transplantation. He also has extensive experience in studies of hematopoietic stem cell biology and blood cell regeneration, both in human and animal models, which includes bone marrow failure following myeloablative radiation or chemotherapy. Dr. Mahmud has a broad background in medicine, stem cell biology, and transplantation and is currently serving as PI or co-investigator on several university and NIH-funded grants. His clinical laboratory is responsible for processing, storing, and releasing stem cell grafts for administration to patients undergoing bone marrow transplantation or other cell-based therapy. Dr. Mahmud’s laboratory has pioneered a novel way to augment the number of transplantable blood-forming stem cells present in an umbilical cord blood graft by using chromatin-modifying agents and has been awarded a US patent for this work. Dr. Mahmud’s research lab has the expertise in developing leukemia patient-derived xenografts (PDX) to test the in vivo function of efficacy of isoform-selective HDAC inhibitors in leukemia. Dr. Mahmud also serves as the principal investigator for the UIC Hembank, a repository of banked hematologic malignancy samples with detailed clinical and molecular annotation. Dr. Mahmud serves on the FACT (accreditation body) Board of Directors and the FACT Global Affairs Committee chair. He is also a FACT Executive Committee member and serves on the editorial board of the premier cell therapy journal Cytotherapy.

TOPIC: Summary of Results

No Disclosures.

Nic Prokopishyn, PhD

Cellular Therapy Lab Director

Foothills Medical Centre

Nic Prokopishyn received her PhD in Biochemistry and Cell Biology from the University of Saskatchewan. After completing a PhD, Nic moved to the USA, working in Houston, TX, and Philadelphia, PA. Her research in the US involved the early stages of utilizing gene repair/editing technologies for blood stem cell gene therapy of diseases, including sickle cell disease and hemophilia. Dr. Prokopishyn returned to Canada as Director of the Cellular Therapy Lab (CTL) at APL in Calgary in 2007. At CTL, she is responsible for all clinical blood and marrow transplant products, the standard of care and commercial clinical trial cellular therapy products, and CTL-manufactured cellular therapy products. She holds appointments as a clinical assistant professor in the Departments of Hematology and Pathology/Lab Medicine. Dr. Prokopishyn is is the chair of Standards for FACT. In CTL, Dr. Prokopishyn focuses on providing innovative, novel cellular therapy products for clinical application in our transplant and cellular therapy patients, such as liver cells for the treatment of neonatal patients with urea cycle disorders, participation in the first blood stem cell gene therapy clinical trial in Canada, generating the first alpha-beta depleted T cell haploidentical transplant product for clinical use. Manufacturing of POC CAR-T cells to treat various diseases.

No Disclosures.

Zlatibor Velicokvic, PhD

Facility Director

Royal Perth Hospital,

Zlatibor Veličković is the Facility Director at Cell & Tissue Therapies Western Australia (CTTWA) at Royal Perth Hospital. He has over 20 years of experience in cell and gene therapy manufacturing, with expertise in GMP facility management, quality systems, regulatory compliance, and translational research. He holds a PhD in Immunogenetics and has an academic appointment as Adjunct Associate Professor at UWA. He has published numerous peer-reviewed articles and delivered invited talks worldwide. He serves on multiple professional committees related to cell/gene therapy manufacturing, regulation, and workforce development.

No Disclosures.

image
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Illinois State Medical Society (ISMS) through the joint providership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accredited by ISMS to provide continuing medical education for physicians. This live activity is designated for a maximum of 8.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
  • Registration Closed

Key:

Complete
Failed
Available
Locked
Registration
You must be an Inspector or Inspector Trainee to register for this course. You must register to access.
Continuing Medical Education Credit
Critical information must be reported to the state and licensing boards for CME credit to be provided. You must register to access.
Live In-Person Event
FACT's inspector training course will be held on May 28, 2024, in conjunction with the ISCT Annual Meeting scheduled for May 28-31, 2024, at the Vancouver Conference Center, Vancouver, Canada to discover the latest advancements in the field of Cellular Therapy. Inspector trainees and Inspectors can register today for this great training event! Earn AMA PRA Category 1 Credit(TM) for attending! You must register to access.
Video
Inspector Insight Story: What to Do and Not Do When Inspecting. Watch the video to move on to the next component. You must register to access.
FACT Inspector Training Evaluation
An evaluation is required to complete your training and receive your certificate. Please provide feedback on the FACT Inspector Training in conjunction with the ISCT Annual Meeting on May 28, 2024. You must register to access.
Certificate
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Illinois State Medical Society (ISMS) through the joint providership of Edward-Elmhurst Health and FACT. Edward-Elmhurst Health is accredited by the ISMS to provide continuing medical education for physicians. This live activity is designated for a maximum of 8.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. You must register to access.