FACT Inspection and Accreditation Virtual Workshop

Presenters

Nicole Aqui, MD
Associate Professor of Clinical Pathology & Laboratory Medicine
Vice Chair for Inclusion, Diversity, and Equity
Residency Program Director
Chief, Transfusion and Apheresis Services 
Department of Pathology and Laboratory Medicine
Hospital of the University of Pennsylvania

Apheresis Presenter

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.

Alex Babic, MD

Alex Babic, MD
St. Louis University Blood and Marrow Transplant Program
Apheresis Presenter

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 FACT Education Committee. In 2020, he became a member of FACT Accreditation Committee.  His focus is on evaluation and optimization of outcomes of cell collection and processing. 

 

Charlie Branson, MS

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

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.

Bigitte D'Avanzo

Brigitte D'Avanzo
CQA, Audit manager
Héma-Québec
Cord Blood Presenter

Brigette D’Avanzo has 14 years experience in a highly regulated environment conducting internal audits, process audits, and supplier audits for all product lines and services offered by Héma-Québec.  She is responsible for the coordination of all regulatory inspections and a certified auditor by the American Association of Quality. 
Andrew Deeming

Andrew Deeming
Quality Manager
BMDI Cord Blood Bank 

Cord Blood Presenter

A career rich in Quality began when Andrew Deeming completed a BSc (Med Sci) at La Trobe University in Melbourne, Australia. He started at the Australian Red Cross Blood Service (ARCBS), where he worked in Processing for 2.5 years before moving into Quality Management for 4.5 years. Within Quality, he was a Quality Systems Officer, Acting Quality Advisor, and Acting Quality Manger for Victoria/Tasmania. Andrew was involved in an average of one internal and one external audit each month required by the numerous collection sites of the ARCBS across the states of Victoria and Tasmania.
As the Quality Manager at the BMDI CBB for the last 9 years, he has coordinated the preparation and response to three FACT inspections. Andrew has redesigned the internal audit program for the BMDI CBB and he has trained others in internal audit process as auditors. At ISCT London, Andrew co-designed and presented a poster on the AusCord combined supplier audit program.

Ngaire Elwood, PhD

Ngaire Elwood, PhD
Director
BMDI Cord Blood Bank

Co-Chair & Cord Blood Presenter

Associate Professor Ngaire Elwood is the Director of the BMDI Cord Blood Bank and Head of the Cord Blood Stem Cell Research Program at the Murdoch Children’s Research Institute in Melbourne, Australia.  A/Prof Elwood is Vice-President of the Board of Directors for FACT. She has been a FACT Cord Blood Bank Inspector since 2008 and serves on many FACT committees, including the FACT CB Accreditation Committee, FACT CB Standards Committee, FACT Education Committee and FACT Regenerative Medicine Task Force. A/Prof Elwood is a Non-Executive Director of the National Stem Cell Foundation of Australia, Chair of the AusCord Network of public cord blood banks and was the Australia New Zealand Regional Vice President for the International Society for Cell & Gene Therapy (ISCT) (2018-2020). She has more than 30 years’ experience in the field of cellular therapy, cord blood, stem cells and leukaemia and is passionate in promoting words’ best practice in cellular manufacturing and the application of cellular therapies.

Diane Fournier, PhD

Diane Fournier, PhD
Manager, Stem Cell Laboratory
Scientific Director
Héma Québec Cord Blood Bank
Cord Blood Presenter 

With training in microbiology and immunology, Dr. Diane Fournier worked as a Research Scientist at the National Research Council of Canada for 10 years before joining Héma-Québec in 2008. Dr. Fournier is a member of the FACT Cord Blood Bank Accreditation Committee and the FACT Education Committee. She is an active FACT Cord Blood Processing Inspector. 

Dr. Dennis Gastineau

Dennis Gastineau, MD
Medical Director, Human Cellular Therapy Lab
The Blood and Marrow Transplant Program at Mayo Clinic Arizona 
President of the Foundation for the Accreditation of Cellular Therapy

Dr. Dennis Gastineau established the Human Cellular Therapy Laboratory in the Division of Transfusion Medical at Mayo Clinic's campus in Rochester, Minnesota and established a sister laboratory, the Nyberg Human Cellular Therapy Laboratory, at Mayo Clinic's campus in Phoenix / Scottsdale, Arizona. Dr. Gastineau is the President of the FACT Board of Directors and the FACT Executive Committee and is a member of the FACT Cellular Therapy Accreditation, Clinical Outcomes, Education, and Finance Committees. He also serves as a FACT Inspector for Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, and Marrow Collection. 

Phillip Johnson, MMEdSc(Path)

Phillip Johnson, MMEdSc(Path)
Director/Scientific Director 
Queensland Cord Blood Bank at the Mater
Cord Blood Presenter

Phillip Johnson is the Director / Scientific Director at Queensland Cord Blood Bank at the Mater and the Director of the Cellular Therapy Unit of Mater Pathology. He is a member of the FACT Cord Blood Bank Processing, Selection and Release Standards Subcommittees, the FACT Quality Management Committee, and the FACT Cord Blood Accreditation Committee. He is a FACT Cord Blood Bank, Collection and Processing Inspector. 
 

Dr. Kim Kasow

Kim Kasow, DO
Director, Pediatric Bone Marrow Transplant Program, Marrow Collections Medical Director
UNC Bone Marrow Transplant and Cellular Therapy Program
Cord Blood Moderator

Dr. Kim Kasow directs both clinical care and clinical research efforts in transplant at UNC. One of her primary interests is providing hematopoietic cell transplantation to patients with sickle cell disease.

She is a current member of the FACT Board of Directors, chair of the FACT Finance and Quality Management Committees, and Vice-chair of the FACT Technology Committee. Dr. Kasow is also a member of the Cellular Therapy Accreditation and Clinical Program Standards Committees. Dr. Kasow has served as a Clinical Hematopoietic Cellular Therapy, Clinical Immune Effector Cellular Therapy, and Marrow Collection FACT inspector since 2006.

Guy Klamer, PhD

Guy Klamer, PhD
Director
Sydney Cord Blood 
Cord Blood Presenter

Guy Klamer obtained his Bachelor of Science and Doctor of Philosophy (Medicine) from the University of New South Wales in Australia. Following graduation from his PhD candidature, he began working as a postdoctoral scientist at the Children's Cancer Institute Australia studying novel small molecule inhibitors as therapies for Graft-versus-Host Disease. In 2014, he joined the Sydney Cord Blood Bank as Quality Manager to be involved in the manufacturing of clinical therapeutics. In this position, he was responsible for the Quality Management System, incorporating non-conformance reporting, internal auditing, document control, and process improvement. In 2019, Guy was promoted to Director of the Cord Blood Bank. In this new role, Guy is responsible for the operations of the bank including collections, processing, storage, and administration for transplantation.

Gesine Kögler, PhD 
Jose Carreras Cord Blood Bank and GMP Facility Director
University of Duesseldorf Medical Center
Cord Blood Lunch Leader

Dr. Gesine Kogler is a professor of Immunology in Medicine at the Medical Center of the Heinrich Heine University of Duesseldorf. She is the head of the Stem Cell Processing Laboratory and stem cell research unit with the GMP-facility (including production permission-license- for unrelated cord blood and other cellular human therapeutics) at the Medical Center. Since 2004, she has served as a member of the FACT Accreditation Committee and has been the co-chair of the Cord Blood Processing Standards Committee since 2008. She specializes in cord blood hematopoietic and non-hematopoietic cells including the transition from research to the clinic with documentation in more than 150 scientific publications.

Linda Peltier, PhD, RN

Linda Peltier, PhD, RN
Project Manqager
McGill University Health Centre
Cord Blood Presenter

Critical care nurse for many years, Dr. Peltier obtained her doctorate degree in experimental medicine at McGill University. She implemented the Clinical Research Cord Blood bank at McGill University Health Center in addition to the second Public Cord blood bank of Canada. Dr. Peltier is the laboratory manager of a Cellular Therapy Laboratory where she is collecting, processing and infusing cells from cord blood, cord tissue, adipose tissue and dendritic cells. She is an instructor for a Graduate Certificate program in Regenerative Medicine at McGill Univeristy. Dr. Peltier has served as a FACT Inspector since 2007.

Robyn Rodwell, PhD

Robyn Rodwell, PhD
Cord Blood Presenter

Recently retired Director/Scientific Director of the Queensland Cord Blood Bank At The Mater, Dr.  Rodwell is a cord blood bank inspector for FACT, Vice-chair of the FACT Education Committee, member of the FACT Inspector Development Committee and was on the Steering Committee for development of the 7th Edition of the NetCord-FACT international cord blood standards. In addition to her clinical work, Dr Rodwell has been involved in education, holding appointments as Adjunct Associate Professor Queensland University of Technology. 
Joseph Schwartz, MD, MPH

Joseph Schwartz, MD, MPH
Director Transfusion & Cellular Therapy
New York Presbyterian Hospital/Columbia University Medical Center
Co-Chair and Apheresis Presenter

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. 

Renee Smilee, BSMT(ASCP), CQIA (ASQ)

Renee Smilee, BSMT(ASCP), CQIA (ASQ)
Performance Improvement Lead
H. Lee MOffitt Cancer Center & Research Institute
 
Apheresis Presenter

With over 26 years of cellular therapy experience in laboratory, apheresis, quality, and clinical trial research, Renee Smilee is the Performance Improvement Lead at H. Lee Moffitt Cancer Center & Research Institute. Her involvement with the ISCT over the last 20 years has included memberships on the laboratory and regulatory committees and the Advisory Board. Renee is a member of the FACT Inspector Development Committee and has been an Apheresis Collection Inspector and Processing Inspector for 22 years. 
Dr. Leon Su

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

Dr. Su is the Medical Director of Apheresis and the Section Chief of Transfusion Medicine at the Phoenix Children’s Hospital. Dr. Su is a member of the ASFA Clinical Applications Committee. He is a FACT Apheresis Collection Inspector. 

Michele Sugrue, MS, MT(ASCP)SBB

Michele Sugrue, MS, MT(ASCP)SBB
Coordinator, Research Programs
UF Health Shands Hospital
Apheresis Presenter

Michele Sugrue serves on the ISCT Laboratory Practices Committee and is a Contributing Editor for the ISCT Telegraft Editorial Board. She is a member of the FACT Cellular Therapy Collection Facility Standards Committee, Education Committee and the Inspector Development Committee. Michele has served as a FACT Apheresis Collection and Processing Inspector since 1998.

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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