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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Challenges of cell collections for cell therapy manufacturing: what do we want in the bag?

Wednesday, 24 June 2020. 08:00 PDT; 11:00 EDT; 16:00 BST; 17:00 CEST

Sponsored by:

Terumo logoCell collections destined for cell therapy manufacturing present many challenges to the manufacturer. A physician and two cell collection and manufacturing experts will share their perspective and experience related to starting material consistency, process challenges and bottlenecks, implications for the final product and key considerations for optimization. We will discuss different collection protocols to better define the starting material requirements and relevance to the cell and gene therapy manufacturer. We’ll also cover other factors that contribute to a robust and reproducible cell collection to meet manufacturing requirements.

Attendees will:

Elizabeth Valdez

Elizabeth Valdez, RN, MSN, Global Product Support and Training Specialist, Terumo BCT

Elizabeth Valdez is a Global Product Support and Training Specialist for the Therapeutic Systems team at Terumo BCT, manufacturer of the Spectra Optia® Apheresis System. She develops, maintains and conducts global training for Spectra Optia and other Terumo BCT products. Prior to working at Terumo BCT, Elizabeth was an Apheresis RN specializing in pediatric apheresis. She has conducted many educational sessions on the care of pediatric patients in the apheresis clinic and continues to look for avenues to educate clinicians about apheresis.

Krishnendu Roy

Krishnendu Roy, PhD, Director, NSF Engineering Research Centre for Cell Manufacturing Technologies (CMaT); Director, Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M); Georgia Tech and Emory University

Dr. Roy’s research interests are in the areas of scalable cell manufacturing, immunoengineering, stem-cell engineering, and controlled drug and vaccine delivery technologies, with a particular focus in biomaterials. In recognition of his seminal contributions to these fields, Dr. Roy has been elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and Fellow of the Biomedical Engineering Society (BMES). In addition, Dr. Roy has received numerous awards and honors, including Young Investigator Awards from both the Controlled Release Society (CRS) and the Society for Biomaterials (SFB), the NSF CAREER award, and the Global Indus Technovator Award from MIT, among others.

He serves on the editorial boards of the Journal of Controlled Release, the European Journal of Pharmaceutics and Biopharmaceutics, the Journal of Immunology and Regenerative Medicine, and AIChE Journal of Advanced Manufacturing and Processing. He is also a member of the Forum on Regenerative Medicine of the National Academies of Science, Engineering and Medicine (NASEM) and a board member of the newly established Standards Coordinating Body (SCB) for Cell and Regenerative Therapies.

Jim Beltzer

Jim Beltzer, PhD, Senior Manager, Global Strategic Medical Affairs, Terumo BCT

Jim earned his PhD in Biochemistry at Purdue University and did his post-doctoral fellowship at the Biocenter in Basel, Switzerland. He worked at several start-up biotechnology companies in the Boston area and at Corning Life Sciences prior to joining the Cell Processing team at Terumo BCT. He has more than twenty five years of research and development experience in a broad range of disciplines.

Sandeep Soni

Sandeep Soni, MD, Associate Professor (Clinical) of Pediatrics, Lucile Packard Children’s Hospital Division of Stem Cell Transplant and Regenerative Medicine; Medical Director, Clinical Trial Office Cell and Gene Therapy Center for Definitive and Curative Medicine, School of Medicine, Stanford University

Dr. Soni received his MBBS degree from the University of Delhi, India, and had fellowship training at Hadassah University Hospital, Jerusalem, Israel and MD Anderson Cancer Center, Houston, TX. His clinical research focuses on stem cell transplant and gene therapies for hemoglobinopathies and rare genetic disorders. He currently works at Lucile Packard Children’s Hospital at Stanford University in the Stem Cell Transplant department.

Dr. Soni is involved in gene therapy trials, both gene-insertion and gene-editing strategies from academia and industry, and his translational research focus is on understanding the mechanisms related to the efficacy of gene therapy for genetic disorders.

Melinda CaltabianoMelinda Caltabiano, Director, Apheresis Operations, Dendreon

Melinda Caltabiano joined Dendreon in 2017 as Director of Apheresis Operations overseeing Dendreon’s expansive apheresis collection network throughout the United States. She ensures patients have convenient access to cell collection in their communities to facilitate their cancer treatment. She is also partnering with her Dendreon colleagues in China to help grow their apheresis network and bring Dendreon’s life-extending cancer treatment to Asia for men suffering from prostate cancer. Prior to joining Dendreon, Catalbiano spent more than 20 years at New York Blood Center as Director of Clinical Services.

She also served in the United States Peace Corps in Slovakia for two years working on local environmental projects and youth development programs. Currently, she serves as Secretary of the Board of Directors for Be The Match and sits on the Diversity and Healthcare Disparities Advisory Group. She holds a bachelor’s degree from Manhattan College and a master’s degree in public administration from New York University’s Robert F. Wagner Graduate School of Public Service.

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