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Apheresis Optimization in Gene and Immunotherapy Development in Non-Mobilized Patients and Donors

Please note: AABB reserves the right to make updates to this program.

Live Program Date: Thursday, February 23, 2017 – On-Demand Available
Master Program Number: 113 (see program format numbers below under Registration)

Educational Track: Technical/Clinical
Topic: Cellular Therapies
Intended Audience: Physicians, Scientists, Technologists, Nurses, Managers/Supervisors, CEOs, CFOs, Laboratory Staff, Medical Directors
Teaching Level: Intermediate

Director/Moderator: Mark Flower, Senior Manager, Global Strategic Marketing with Terumo BCT, Lakewood, CO
Speakers: Andrew Fesnak, MD, Director, Cell Manufacturing and Development, Clinical Cell and Vaccine Production Facility, University of Pennsylvania, Philadelphia, PA; Chrissy Anderson, Associate Director of Cell Procurement, Bluebird Bio, Cambridge, MA; Sanjin Zvonic, MD, Senior Director, Business Leader, Clinical & Commercial Manufacturing, PCT Caladrius, Allendale, NJ

Learning Objectives

After participating in this educational activity, participants should be able to:

  • Discuss the impact of clinical indication on leukapheresis collections in gene and immunotherapy setting.
  • Address clinical, technical and operational actions designed to optimize apheresis and minimize variability in collected products.
  • Discuss strategies employed to address collection process in various settings including hospitals, blood centers and across regional differences.
  • Review the present state of apheresis collections, logistics and manufacturing processes.
  • Share lessons learned and insights that can be applied in centers performing leukapheresis procedures for cell based gene and immunotherapies to optimize apheresis collections.

Program Description

Over the last few years we have witnessed significant growth in the number of clinical trials for cell based gene and immunotherapies. The clinical results have many suggesting that 2 or 3 of these therapies may reach the commercial stage within the next three years. Apheresis is critical first step in the development of many of these products. The need for good quality products that balance yield and purity has brought the topic of optimized apheresis collections into the spotlight. The impact of commercial availability may impact the need for apheresis products and those who collect, deliver and process them. This program will bring together three important perspectives; the clinician, the immunotherapy developer and the contract manufacturing organization. Speakers will discuss use of currently available apheresis devices to collect leukapheresis products from non-mobilized patients/donors – addressing the variables that can affect quality and quantity of cells collected, and the downstream effects on manufacturing processes.

Registration

   Program #
Single Viewer: On-Demand Register17EL-4070-113
Group Viewing: On-Demand Register17EL-8070-113

Speaker Biographies

Mark Flower is the Senior Manager, Global Strategic Marketing with Therapeutic Systems business unit at Terumo BCT.  In his current role, he interacts and consults with a number of cell, gene and immunotherapy developers and manufacturers; particularly those developing therapies from apheresis and bone marrow products.  With over 12 years experience in the field of stem cell collection, isolation, cell processing and manufacturing, he has launched and maintained commercial responsibility for multiple devices and technologies in the emerging and exciting therapeutic area of immuno-oncology.

Dr. Andrew Fesnak is an attending physician in Transfusion Medicine at the Hospital of the University of Pennsylvania, where he completed his clinical pathology residency and transfusion medicine fellowship. He now shares clinical responsibility for the blood bank and apheresis unit. Dr. Fesnak also works in the Clinical Cell and Vaccine Production Facility at the University of Pennsylvania where he oversees translation of preclinical cell therapy work to clinical manufacture.

Chrissy Anderson is a registered nurse with a baccalaureate degree in nursing from the University of Oklahoma, who has worked in the field of apheresis for over 27 years, in various roles including management, training and education, quality improvement, and research and development.  She also is an ASCP certified Hemapheresis Practitioner of 23 years, one of ~500 individuals in the world with this status. She is currently working for bluebird bio as Associate Director of Cell Procurement. Prior to that her past employment includes Carter BloodCare in Dallas/Fort Worth where she served as Director of Clinical Apheresis for 11 years, Parkland Hospital, Dallas, TX, MD Anderson Cancer Center, Houston, TX, and the Oklahoma Blood Institute, Oklahoma City, OK. In between these jobs, she spent 10 years as clinical specialists for Terumo, Fresenius, and Kaneka. Her ASFA achievements include Past President of ASFA, recipient of the SHS Allied Health Award in 2011, Presidential Award in 2013, and Lecturer Award in 2015.  She has also served on the board of World Apheresis Association in the past as the Allied Health Liaison. Her areas of interest include cell therapy, sickle cell awareness, and pediatric apheresis.  Last but not least she reports, “I am proud to be an apheresis nurse!”

Dr. Sanjin Zvonic earned his Doctorate in Cell and Molecular Biology at Louisiana State University, in the laboratory of Dr. Jacqueline Stephens, studying adipose tissue functions in the context of metabolic disease development. Continuing on to a post-doctoral position in Dr. Jeffrey Gimble's lab at Pennington Biomedical Research Center, Dr. Zvonic contributed to the development of methodologies for the isolation and culture of human adipose stem cells (ASC) from several sources, and later utilized ASCs to develop a human in vitro model for circadian biology studies. He then joined Dr. Darwin Prockop's group at Tulane University, where he directed the technology transfer and development of bone marrow-derived MSC manufacturing and analytical methods in the in-house GMP production facility.

In 2009, Dr. Zvonic joined PCT, where he focused on client engagement and technology transfer into PCT, giving him a comprehensive understanding of cell therapy development, manufacturing and commercialization requirements and strategies. In 2014, he joined Novartis Cell and Gene Therapy Unit, where he focused on the development and commercialization of Novartis C/GT pipeline products. In 2016, Dr. Zvonic returned to PCT, with a focus on driving the growth and development of PCT's clinical and commercial manufacturing business lines.