FACT Cellular Therapy Inspector Training

Presenters

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Walid Almashaqbeh

Suzanne Birnley, MS, MBA
Accreditation Services Manager
Foundation for the Accreditation of Cellular Therapy


Suzanne is passionate about immunology and her research thesis focused on T cell homeostasis and interleukin-2.  She managed an academic research lab for a decade prior to joining the FACT team in Accreditation Services as a Coordinator, and now as the Accreditation Services Manager. She is the former FACT Staff Liaison for the Cellular Therapy Accreditation Committee, and participated as a staff member in the Seventh Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.  Suzanne is in the process of developing a training program for new FACT Coordinators.

 

Patrick Hanley, PhD
Director of GMP for Immunotherapy
Children's National Health System Blood and Marrow Transplant Program 


Dr. Hanley is the Chief and Director of the Cellular Therapy Program and an associate professor of pediatrics at Children’s National Hospital and the George Washington University, respectively. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, and testing of novel cellular therapies and is responsible for seeking partnerships and commercialization of promising cell and gene therapies. 

Dr. Hanley serves on the board of directors and as the chair of the education committee of the Foundation for the Accreditation of Cellular Therapy (FACT) and is an active cellular therapy and cord blood inspector. He co-founded and served as the inaugural co-chair of the Early Stage Professionals committee and currently serves as the co-chair of the Immuno-Gene Therapy committee of the International Society of Cell and Gene Therapy (ISCT). He is the commissioning editor of the journal Cytotherapy 

Joseph Lynch

Joseph Lynch, MD
Director, Bone Marrow Transplant Program
The Center for Bone Marrow Transplantation at Geisinger Medical Center

Joseph P. Lynch MD currently serves as the Director of the Blood and Marrow Transplantation Program of Geisinger Health System. Dr. Lynch joined Geisinger in August of 2018. Prior to his tenure at Geisinger he served as the Director for the Blood and Marrow Transplantation Program at Saint Francis Hospital in Tulsa Oklahoma from 1999-2018. During his tenure at Saint Francis, he also served as the President of the Medical Staff of Saint Francis Hospital.

 

Dr. Lynch has served on the Board of Directors of the Community Oncology Alliance since 2010. In addition, he has served as a certified Inspector for FACT since 2000. He currently serves on the FACT Education Committee.

 

Donna Salzman

Donna Salzman, MD
Professor of Medicine 
The University of Alabama Adult and Pediactric Bone Marrow Transplantation and Cell Therapy Program

 Dr. Donna Salzman is the Interim Director of the Blood and Marrow Transplantation and Cell Therapy Program at the University of Alabama at Birmingham. The transplant program is celebrating its 30 year anniversary and she has been a part of this program since 1995. She is the medical direcctor for the adult program and is the director of the Quality Program.

Dr. Salzman has served on the FACT Board of Directors and is a member and past Chair of the Education Committee, member of the Clinical Program Standards Committee and Grievance Committee. She is a FACT Inspector for the FACT Clinical Hematopoietic Cellular Therapy and Marrow Collection, and very active in FACT inspector workshops.

Jean Sanders, MD
Fred Hutchinson Cancer Research Center
FACT Consultant 

Dr. Sanders' to eliminate cancer as a cause of human suffering and death shaped the treatment of pediatric
transplant patients nationwide. She devoted her career to determining which transplant treatments work best in children, investigating the long-term health effects of stem cell transplantation, providing compassionate care, and teaching more than 90 doctors.


Although retired from clinical service in 2012, her groundbreaking clinical research has advanced the field of pediatric bone marrow transplantation and improved the survival and quality of life of many children undergoing this lifesaving procedure. In addition to authoring more than 300 scientific publications, Sanders has chaired multiple cooperative research group studies and served as adviser for many medical and scientific organizations including the Children’s Oncology Group, the National Childhood Cancer Foundation, the American Academy of Pediatrics and National Institutes of Health.

As a FACT inspector, Jeans has performed 42 FACT inspections, 36 in cellular therapy and 6 cord blood banks. 

Bipin Savani

Bipin Savani, MD
Professor, Processing Facility Medical Director
Vanderbilt University Medical Center

Dr. Savani's area of specialization is in the treatment of hematological malignancies, stem cell transplantation/cellular therapy, and his primary field of research is in the long-term follow-up after transplantation/cellular therapy, including regimen-related toxicity/supportive care, and outcomes analysis of hematological malignancies, transplant and cellular therapy recipients. Dr. Savani has published over 500 peer-reviewed articles, reviews, book chapters, editorials, perspectives and commentaries in the field of hematological malignancies, stem cell transplantation and cellular therapy. He has served as a FACT inspector for Clinical & Marrow Collection Facilities and Immune Effector Cells since 2011.
 

Phyllis I. Warkentin, MD

Phyllis I. Warkentin, MD
FACT Chief Medical Officer
University of Nebraska Medical Center 

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 Professor of Pathology/Microbiology and Pediatrics at the University of Nebraska Medical Center, Omaha, NE, and the Medical Director of the Nebraska Medicine Biologics Production Facility. She has authored over one hundred scientific publications in the field of transfusion, transplantation, and cellular therapy. She is a graduate of the University of Minnesota Medical School, Minneapolis, MN, and is Board certified in Pediatric Hematology/Oncology and Transfusion Medicine.

 

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