FACT Inspection & Accreditation Virtual Workshop

Presenters

Nicole Aqui

Nicole Aqui, MD
Associate Professor of Clinical Pathology & Laboratory Medicine
Chief, Transfusion and Apheresis Services 
Department of Pathology and Laboratory Medicine
Hospital of the University of Pennsylvania

Dr. Nicole Aqui is an Associate Professor of Pathology and Laboratory Medicine, Vice Chair for Inclusion, Diversity and Equity, and Section Chief for Transfusion and Apheresis Services at the University of Pennsylvania. Prior to joining the faculty at Penn, she completed postdoctoral fellowship, studying the effects of T cell immunotherapy on immune reconstitution after transplant. Dr. Aqui is nationally recognized expert in apheresis, having co-authored evidence-based guidelines for the use of therapeutic apheresis in clinical practice. She is an active member of several societies, including the American Society for Apheresis, where she serves on the Board of Directors. Her research focuses on optimizing collections for HPC transplantation and immune effector cell therapy. Dr. Aqui’s clinical practice focuses on improving care of sickle cell patients transitioning to adult care.

Dr. Aqui is a member of the FACT Education and Cellular Therapy Accreditation, and FACT-JACIE IEC Standards Subcommittee. She serves as FACT Collection Inspector.

Suzanne Birnley

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.

Charles Branson

Charlie Branson, MS
Manager
Biologics Production Facility, Nebraska Medicine, The Nebraska Medical Center

Mr. Branson has nearly 20 years of experience in both the academic and industry cell therapy arenas.  Currently, he oversees operations for the Biologics Production Facility, a GTP/GMP compliant cellular therapy manufacturing and processing facility, and the newly started Nebraska Medicine apheresis program which received initial FACT accreditation in Feb. 2019.  Both of these facilities are independently FACT accredited and support Nebraska Medicine’s comprehensive BMT & IEC programs.

He is an active FACT processing facility inspector for both minimally and more than minimally manipulated products of any cell type and is looking forward to performing apheresis collection facility inspections in the near future.

Paul Eldridge

Paul Eldridge, PhD
Scientific Director 
Levine Cancer Institute Transplant and Cellular Therapy Program

Dr. Eldridge is the Standards Chair of the FACT Board of Directors and the FACT Executive Committee, as well as the Chair of the Cellular Therapy Standards, Cellular Therapy Standards Steering, Cord Blood Bank Collection Standards, and Cord Blood Bank Steering Committees and member of others.  

Dr. Eldridge serves as a FACT Inspector for Processing: Minimal manipulation of HPC, and Processing: More than minimal manipulation of any cell type.  

Liz Ferraro

Elizabeth Ferraro, CTBS
Quality Management Coordinator

Biologics Production Facility, Nebraska Medicine, The Nebraska Medical Center

Elizabeth Ferraro has been the Quality Management Coordinator for the Nebraska Medicine Apheresis Program since its inception in November 2018.  Prior to joining the Apheresis team, she worked in tissue banking and pharmaceuticals for 25+ years in Quality roles. She is also certified LEAN practitioner and energetic problem-solver.  

In July 2018, Elizabeth relocated from Chesapeake, VA to Omaha, NE, to move closer to family. 

Alisa Forsythe

Alisa Forsythe
IT Business Analyst
Foundation for the Accreditation of Cellular Therapy


Alisa Forsythe currently serves as the IT Business Analyst for FACT. Alisa constantly seeks to improve lives and processes with technology. With over 13 years of experience, she has overseen countless projects for FACT, the Department of Defense, and other smaller organizations. Since she joined FACT she has spearheaded the new FACT Accreditation Portal effort and is currently working to release the next major version. 

Brian Jones

Brian Jones, SBB (ASCP)
Clinical Quality Manager, Cellular Therapies
Vitalant Cell Therapies Lab, Phoenix

Brian Jones has spent the last 20 years in a variety of clinical laboratory positions which include infectious disease marker testing, complex serological workups, and advanced cellular therapies. He is currently applying this knowledge in his role as the Cell Therapy Quality Manager for Vitalant, where he is responsible for quality oversight of 8 HPC collection sites, 2 class 351/361 HCTP labs servicing 11 transplant centers, and a cord blood bank. Brian has been a FACT inspector for six years and currently serves on the FACT Inspector Development Committee.

Tom Leemhuis

Thomas Leemhuis, PhD

Laboratory Director, Cellular Therapies
Hoxworth Blood Center, University of Cincinnati Academic Health Center

Dr. Tom Leemhuis is an Associate Professor of Pediatrics at the University of Cincinnati and the Laboratory Director for Hoxworth Blood Center’s Cell Therapy laboratory.   His laboratory performs a variety of minimal manipulation and more than minimal manipulation cell processing procedures for two pediatric and two adult transplant programs, including the  manufacture of cell therapy products for local Investigator-Sponsored clinical trials, and providing support for immune effector cell infusions. Dr. Leemhuis has been a processing facility FACT inspector since 2001.

Sara Murray

Sara Murray, BSc, DAS
Quality and Accreditation Manager
Northwest Marrow Transplant Program at Oregon Health and Science University
Legacy Good Samaritan Hospital & Medical Center and Doernbecher Children's Hospital

Sara Murray has been with the Northwest Marrow Transplant Program at Oregon Health & Science University (OHSU) in Portland, Oregon for seventeen years.  She managed the Cellular Therapy Laboratory for fifteen of those years. Two years ago, Sara moved into the Quality Management Accreditation role for the OHSU maintaining and improving the existing Quality Management System with an innovative and effective approach.   She is a FACT Inspector and has been for 15 years, serving on FACT committees during her tenure. Her energy and passion for the work that she does is devoted to supporting OHSU’s Clinicians and transplant teams in providing the highest quality of care to patients in the dynamic world of Cellular Therapy.

Federico Rodriguez Quezada, SBB, MLS(ASCP)

Stem Cell Lab Coordinator
UF Health Shands Hospital 

Federico Rodriguez Quezada has over 30 years of experience in immunohematology and cellular therapy fields and has held different positions during his career: Medical Technologist, Sales Specialist, Laboratory Supervisor, Education Coordinator, Laboratory Manager, Technical Director, Coordinator and recently as a Consultant.

His experience includes all aspects of manufacturing, regulatory requirements and compliance, process design, process improvement and quality management systems in the Cellular Therapy field, including bone marrow, cord blood and peripheral blood.

He has provided guidance to laboratories and institutions worldwide, including the United States, Europe, Latin America and the Middle East. Federico was FACT/NetCord inspector, and AABB inspector for Cellular Therapies from 2005 until 2012.

Joseph Schwartz, MD, MPH

Joseph Schwartz, MD, MPH
New York Presbyterian Hospital/Weill Cornell Medical Center
Bone Marrow and Hematopoietic Stem Cell Transplant Program

Dr. Joseph Schwartz is the Director of Transfusion Medicine and Cellular Therapy at Columbia University where he oversees the Blood Bank, the Apheresis unit and the Cell Therapy facility at the Columbia University Medical Center campus of the New York Presbyterian Hospital. Dr. Schwartz serves on the FACT Board of Directors, is Chair of the FACT Technology Committee, Chair of the FACT HLA Typing Accreditation Committee, and Co-Chair of the FACT Cellular Therapy Accreditation & Cord Blood Bank Accreditation Committees. In addition, he is a member of the FACT Common Standards Steering, Education, Grievance, and Professional Relations Committees. Dr. Schwartz has participated as a Marrow Collection, Apheresis Collection, Cord Blood Banking, and Cord Blood Processing Inspector for 14 years. 

Joan Sevcik Joan Sevcik, RN, BSN, MHSA
Director, HPC Apheresis Clinical Operation
Vitalant

Joan Sevcik is the Director of Clinical Apheresis for the North East Division at Vitalant. She oversees the Therapeutic Apheresis program as well as the FACT accredited collection sites at the University of Pittsburgh (adult and Pediatric), University of Illinois Hospital in Chicago and Johns Hopkins in Baltimore (allogeneic collections only). Joan has worked in therapeutic apheresis since 2002 in multiple roles.

Joan has been a FACT Inspector since 2016 and is a member of the Standards Committee.

Olive Sturtevant, MHP, MT(ASCP), SBB/SLS
Administrative Director, Cell Manipulation Core Facility
Dana-Farber Cancer Institute

Olive is currently the Senior Administrative Director of the Connell & O'Reilly Families, Cell Manipulation Core Facility at Dana Farber Cancer Institute in Boston Massachusetts.  Prior to this postion she served as the Quality and Regulatory Director the Cell Therapy Programs at DFCI for the first 15 of her 20+ years at DFCI. She has been very active in FACT, and has served as the co-chair for the Cellular Therapy Quality standards for several editions now. Olive is also actively involved on quality and regulatory committees for several professional organizations, and is the Chair for the ISCT CTLM (Cell Therapy Liaison Meetings).

Dr. Leon Su

Leon Su, MD, MBA, FCAP, FASCP
Medical Director, Stem Cell Collection
University of Chicago

Dr. Leon Su is a specialist in clinical pathology and blood banking/transfusion medicine. He is currently the Medical Director of Apheresis and Coagulation Laboratory at Phoenix Children Hospital. Dr. Su has been a FACT Apheresis Collection Medical and Facility Director since 2014 and a FACT apheresis collections inspector since 2016.  He is currently a member of the FACT Technology Committee and a regular volunteer speaker for FACT Workshops.  

Priti Tewari Priti Tewari, MD
Associate Professor
The University of Texas M.D. Anderson Cancer Center Children's Cancer Hospital 

Priti Tewari is Associate Professor of Pediatrics at the Children’s Cancer Hospital at MD Anderson Cancer Center within the Section of Pediatric Stem Cell Transplantation & Cellular Therapies.  She has been a FACT inspector for Clinical/IEC Programs for several years and more recently she has been actively involved in the FACT Education Committee.  She also serves as the Pediatric Hematology-Oncology & Advanced Fellowship Program Director at her institution.

Phyllis I. Warkentin, MD

Phyllis I. Warkentin, MD
FACT Chief Medical Officer
University of Nebraska Medical Center 
Apheresis & Cord Blood Presenter

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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