Critical components for developing & managing expansive, high-performing collection networksPublished: April 1, 2019
The success of a cell or gene therapy depends on the collection of high-quality starting material, which in turn relies heavily on apheresis and collection professionals receiving applicable, highly-specialized training and ongoing support and protocol management for each unique product. With the rapid growth in cell therapy clinical trials, proven experience and shared knowledge of the apheresis infrastructure and cell therapy industry is essential to the development and management of high-performing collection networks.
Watch this On Demand webinar with Amy Hines and Richard Smith of Be The Match BioTherapies, and expert guest panellists:
- Joseph Vitale, PhD, Hitachi Chemical Advanced Therapeutics Solutions, LLC
- Sanjin Zvonić, PhD, WindMIL Therapeutics
- Richard J. Smith, Be The Match BioTherapies, United Kingdom
At the end of this On Demand webinar viewers will have a strong understanding of:
- The importance of high-quality starting material for the success of a new cell and gene therapy, challenges associated with cell collection and the resource burden currently impacting collection center infrastructure
- The necessity of standardized cell collection processes to obtain consistent, compliant and high-quality cell starting materials
- Proven strategies for the effective and efficient qualification and onboarding of collection sites
- Efficiencies that can be gained by leveraging partners with established relationships in the apheresis and collection environment
The On Demand webinar attendance is free of charge.
Amy Hines, BSN, RN, Director, Collection Network Management, Be The Match BioTherapies
In her role, Amy oversees the performance of apheresis and marrow collection centers and cell therapy labs in the network, and ensures their on-going compliance with FDA and International standards and criteria, industry best practices, and appropriate regulatory and accrediting entities. She joined NMDP/Be The Match in 2013 and managed the NMDP/Be The Match apheresis and marrow collection center network of more than 90 apheresis centers and 80 marrow collection centers. Amy has nearly 20 years of experience in the cellular therapy field. Her career in this field began as a stem cell transplant registered nurse at Spectrum Health/Helen DeVos Children’s Hospital in Grand Rapids, Mich., in 1999. Over the course of 12 years in Grand Rapids, Amy held a wide range of positions including Staff Nurse on a 15-bed pediatric unit, Transplant Coordinator, Program Manager, Clinical Research Coordinator of the Children’s Oncology Group (COG), and finally Program Administrator for the pediatric and adult stem cell transplantation programs.
Richard J. Smith, New Business Development Consultant, Be The Match BioTherapies
Richard Smith is a Clinical Scientist, educated and trained at Southampton University Hospitals NHS Trust in the department of Haematology and Serology. In 1989, he joined the Senior Lecturer in Southampton University Faculty of Haematology to establish and manage the Steve Mills Stem Cell Transplant Laboratory. From 2002 to 2017, Richard Smith worked as Global Senior Scientist with the Department of Scientific and Clinical Affairs at Terumo BCT, In this role he supported a portfolio of medical devices including clinical apheresis devices, and a range of ex vivo cell processing devices including hollow fibre bioreactors, equipment for cell washing, and elutriation used in engineering and manufacturing. He worked with transplant physicians, engineers, scientists and apheresis practioners to design and implement study protocols including first in human and pre-registration activities through to post-market surveillance work. He established and managed performance databases and had responsibility to teach, train, support and optimize performance outcome for technologies used in stem cell transplant and cellular engineering. He was a regular presenter at academic and industry sponsored events and webinars and supported and co-authored more than fifty peer-reviewed publications and posters Richard Smith now works as an Independent Consultant specializing in delivering scientific support focused on the role of apheresis in Immunotherapy and as a diagnostic tool for liquid biopsy of circulating tumour cells. He continues to publish and present on a variety of cell separation and processing technologies.
Joseph Vitale, PhD, Director, Account Management, Hitachi Chemical Advanced Therapeutics Solutions, LLCas
Dr. Vitale is responsible for driving the client experience and providing strategic solutions to our clients’ clinical and commercial challenges. He has a unique holistic view of the industry with experience in various cell therapy industry disciplines, ranging from process development, manufacturing, supply chain and software.
Joe had previously worked at HCATS as a Senior Biomedical Engineer for the company’s Center for Innovation and Engineering, where he developed, and tech transferred several T-cell immunotherapy programs. Prior to re-joining HCATS, he worked at TrakCel, a cell therapy supply chain software company, as the Director of Process Engineering, where he acted as the organization’s cell therapy subject matter expert. Prior to his post-doctoral fellowship in Hematology and Medical Oncology at Mount Sinai, he earned a PhD in Cell Biology and Molecular Medicine from Rutgers University.
Sanjin Zvonić, PhD, Vice President, Process Science and Manufacturing, WindMIL Therapeutics
Established leader in development and manufacturing of cell-based therapeutics. Cell and molecular biologist with a strong technical/scientific background in physiology, stem cell biology, and cell therapy CMC development.
After earning his Doctorate in Cell and Molecular Biology Dr. Zvonić continued on to a post-doctoral position at the Pennington Biomedical Research Center where he 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 transitioned onto a second post-doctoral role 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. Zvonić 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. Zvonić returned to PCT, with a focus on driving the growth and development of PCT’s clinical and commercial manufacturing business lines while integrating into Hitachi Chemical.
In his current role at WindMIL Therapeutics, Dr. Zvonić leads the development of WindMIL’s core technologies and pipeline products, while concurrently contributing to the organizational growth and development.