Inaugural ECGT Town Hall - International Society for Cell & Gene Therapy

ABOUT THE TOWN HALL

Ethics sits at the centre of cell and gene therapy development, influencing trial design, consent, patient access, pricing and public confidence across every jurisdiction in which these products are developed and delivered. The ISCT Ethics of Cell and Gene Therapy (ECGT) Committee invites you to its inaugural town hall.

The session will open with an overview of the committee, covering its origins, mission, achievements to date and the major projects planned for the period ahead. This will be followed by presentations from ISCT’s Vice-Presidents on the global ethical challenges to safe and effective cell and gene therapy, reflecting perspectives from across regions, sectors and stages of development.

The session will then be given over to an open discussion. Attendees will be asked which priority topics the committee should address first, from equitable access and unproven therapies to consent in vulnerable populations and cross-border access care etc. A question-and-answer session will close the meeting.

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KEY LEARNING OBJECTIVES

By the end of this session, attendees will be able to:

Describe the origins, mission and remit of the ISCT Ethics of Cell and Gene Therapy Committee, and identify the major projects it has planned for the period ahead.
Recognise the principal ethical challenges currently affecting the safe and effective development and delivery of cell and gene therapies at a global level, including how these vary across regions, sectors and stages of development.
Evaluate how ethical considerations intersect with practical decisions in trial design, informed consent, patient access, pricing and public trust.
Contribute informed input to the committee’s forward agenda, and understand the routes available for continued engagement with the committee’s work.

TOWN HALL CHAIRS

Joseph (Yossi) Schwartz , MD, MPH
ISCT Regional Secretary, North America
Senior Medical Officer
Foundation for Accreditation of Cellular Therapy
United States

Dr. Schwartz received his MD from the Technion – Israel Institute of Technology and his MPH from Columbia University Mailman School of Public Health. Upon completion of his training, he pursued a decades-long career in promoting excellence in the field of Transfusion Medicine, Apheresis & Cellular Therapy across a multitude of facilities including Columbia University Irving Medical Center, Moffitt Cancer Center and recently joined FACT as their Senior Medical Officer. In these capacities, He amounted many years of experience directing Transfusion Medicine, Apheresis & Cellular Therapy Services. Throughout his tenure in the field, Dr. Schwartz became an active member of the professional and academic community. He had been involved in many professional organizations including AABB, CAP, ISCT, and ASCP to name few. He served as the president of ASFA in 2018-2019 and is currently the Immediate Past-President of the World Apheresis Association. He served on the writing committee of ASFA’s Therapeutic Apheresis guidelines for five editions. Furthermore, he promoted quality and standardization through dissemination of the FACT-JACIE international standards for cellular therapy. For these efforts and many more, he Have had earned many honors including the AABB Hemphill Jordan Leadership Award (2019), ASFA’s Presidential Award (2021), Francis Morrison lectureship Award (2023), and Lecturer award (2024).

Mikey Creane, PhD
ISCT Regional Treasurer, Europe
Translational Research Manager
HAON Life Science
Ireland

Dr. Creane obtained his BSc in Physiology, MSc in Regenerative Medicine, and PhD in Translational Cell Therapy in University of Galway, Ireland between the years of 2005-2016. After his postdoctoral research training, he worked for many years as a Research Fellow and Programme Manager in the Regenerative Medicine Institute in University of Galway where he worked on translating stromal cell therapies from laboratory studies to first in human testing. Dr Creane also worked as Strategic Lead for the Centre for Cell Manufacturing Ireland which is an academic Good Manufacturing Practices facility located at University of Galway. In 2024 he joined HAON Life Science, a Dublin-based biotech company developing a novel cell therapy for Neonatal Hypoxic-Ischemic Encephalopathy. As Translational Research Manager at HAON Life Science. Dr Creane has been leading the preclinical development of HAON’s cell therapy platform, overseeing studies to support its progression toward clinical testing.

Beth Roxland, JD, MS
Member, ISCT Ethics of Cell and Gene Therapy (ECGT) Committee
Bioethics and Principal Consultant
Roxland Consultants Ltd.
United States

Beth E. Roxland is a seasoned Attorney & Bioethicist with multifaceted experience across Industry, Law, Government & Academia. She founded an independent consultancy (Roxland Consultants Ltd.) to leverage her unique expertise to provide comprehensive but practical support and advice to life-science, biotechnology & research entities, law firms, hospitals & healthcare practitioners, venture capital & financial institutions, and professional & patient associations confronting complex legal, ethical, operational & communications challenges in the scientific and medical arenas. Beth is also a practicing attorney, specializing in litigation, regulation, policy, public health & pandemics, risk & crisis management, and insurance. Beth is a frequent public speaker & author, and serves on several academic, medical and research oversight boards, and occupies leadership roles in professional societies.

SPEAKERS

Bruce Levine, PhD

Chair, ISCT Ethics of Cell and Gene Therapy (ECGT) Committee
Founding Director, Clinical Cell and Vaccine Production Facility
Barbara and Edward Netter Professor in Cancer Gene Therapy
University of Pennsylvania
United States

Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 30 issued US patents and co-author of >200 manuscripts and book chapters with a Google Scholar citation h-index of 99. He is a Co-Founder of Tmunity Therapeutics, and of Capstan Therapeutics both spinouts of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, the National Marrow Donor Program/Be The Match ONE Forum 2020 Dennis Confer Innovate Award, serves as Immediate Past-President of the International Society for Cell and Gene Therapy, and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.

Sowmya Viswanathan, PhD

ISCT Regional VP, North America
Senior Scientist, Schroeder Arthritis Institute
Associate Professor, Division of Hematology, Department of Medicine
University Health Network/University of Toronto
Canada

Dr. Viswanathan is a Scientist at the Osteoarthritis Program, Division of Orthopedic Surgery, Schroeder Arthritis Institute and the Krembil Research Institute (University Health Network) and an Associate Professor at the Institute of Biomedical Engineering and at the Division of Hematology, Department of Medicine (University of Toronto). Her research is focused on using anti-inflammatory approaches to target osteoarthritis (OA), including i) using proprietary enhanced mesenchymal stromal cells (MSCs) to modulate inflammatory responses and ii) reprograming monocytes/macrophages to more inflammation resolving subtypes using small molecules and gene edited iPSCs. Dr. Viswanathan’s lab is translation of cellular and immunotherapies into clinical investigations. Dr. Viswanathan is a co-Principal Investigator of a recently completed trial using autologous MSCs to treat OA patients, a North American first. Dr. Viswanathan’s publication was cited as the most downloaded paper in Stem Cells Translational Medicine in 2019, and also garnered The Arthritis Society’s Top 10 Research Advances in 2019. Dr. Viswanathan is also investigating the role of synovium and monocytes/macropahges in osteoarthritis pathogenesis, with the intention of developing a macrophage-based adoptive transfer immunotherapy. Dr. Viswanathan is the recipient of the Biologics Association’s Summit Research Award (2021) for research in this area. An in vitro model developed in the lab demonstrates the role of synovium on cartilage degradation and was cited as one of the Top 10 Research Advances of The Arthritis Society in 2021. Currently, she is leading international efforts to standardize MSC nomenclature and create reference materials for MSC research. Dr. Viswanathan sits on the Standard Council of Canada’s Mirror Committee for International Organization for Standardization (ISO TC276) on Analytical Methods and Bioprocessing, and is on the steering and working committee of an international Standards Coordinating Body (SCB). Dr. Viswanathan is a formal liaison between ISO TC276 and the International Society of Cell and Gene Therapy (ISCT). In addition, Dr. Viswanathan is Associate Editor of Cytotherapy, the official journal for ISCT. As a translational scientist, Dr. Viswanathan serves as a national regulatory and cell manufacturing consultant for projects across Canada. At the Cell Therapy Program at the University Health Network, Dr. Viswanathan has overseen clinical translation of over 13 cell-based therapies into Health Canada approved clinical investigations; these include immunotherapies, therapies for lysosomal storage disorders and acute kidney failure. Dr. Viswanathan chaired the Cell Therapy Stakeholder Group, a bilateral group that engages Health Canada on cell therapy related policy issues from 2015-2021.

Dominique Farge, MD, MSc, PhD
ISCT Regional VP, Europe
Professor of Internal Medicine
Hospital Practitioner
Paris University/St-Louis APHP University Hospital
France

Dr. Dominique Farge is full time Professor of Internal Medicine and Hospital Practitioner at St-Louis APHP University Hospital, Paris-Cite University France since 1995 and adjunct Professor at McGill University, Canada since 2017. She has worked for the past 30 years in hematopoietic stem cell transplantation (HSCT) and other immune cell therapies, notably mesenchymal stroma cell (MSC) and CART Cell, for patients with autoimmune diseases (AD) at the French and European levels and also in Canada nad worldwide. Her current activities are focused on clinical and translational research programs and education in stem cell therapies (HSCT,MSC, CARTs) for AD patients. As former Chair of the Auto-immune Diseases (AD) Working Party of the European Bone Marrow Transplant Association (ADWP EBMT), she fostered the cooperation among transplant and AD specialists to initiate and promote EBMT retrospective registry studies and prospective studies using HSCT in SSc, SLE, MS and Crohn’s disease. She was and is involved and coordinated several European and International guidelines for the use of HSCT and innovative therapies (MSC and CART) in AD. She founded the French MATHEC network dedicated to stem cell therapy in auto-immune diseases, labelled and funded by the French Health Ministry as a Center of Reference for Rare Autoimmune Diseases and stem cell therapies (www.mathec.com). Since 2017, she is active member the International Society of Cell Therapy (elected member to the ISCT Board of Directors 2019-21; Regional Vice-President elect Europe 2023-2025;Regional Vice-President Europe 2025-2027;) with major focus on contributing to develop ISCT visibility on clinical trials and by developing online education globally in order to facilitate knowledge transfer based on the three pillars from the ISCT (www.isctglobal.org) She is presently PI or COPI of 3 ongoing clinical phase I-II trials using AT-MSC or UC-MSC in Scleroderma and CoVID patients. She is author or coauthor of 550 peer-reviewed articles (H-Index 85) and Co-Editor of the book – Hematopoietic Stem Cell Transplantation and Cellular Therapies for Autoimmune Diseases, Book 651 pages, edited by Burt R.K, Farge D., Ruiz M., Saccardi R., Snowden JAD, First Edition published 2022, Taylor & Francis Group LLC, CRC Press.

Pawan Gupta, MBBS, MD, DNB, PhD
ISCT Regional VP, Asia
President, Medical & Regulatory Affairs
Stempeutics Research
India

Dr. Pawan joined Stempeutics in October 2008. Before joining Stempeutics, he was an Associate Professor, Dept of Pathology, Haematopathology & Transfusion Medicine, Armed Forces Medical College, Pune. He had served the Armed Forces for 24 years and he has a vast experience in Pathology, Haematopathology, Transfusion Medicine and Stem Cells. In the Armed Forces, he was awarded Chief of Army Staff Commendation Card twice and the GOC-in-C commendation card once. He is a trained Hematologist from All India Institute of Medical Science, New Delhi. He also has worked in Stem Cells Institute, University of Minnesota in 2006 and trained in both Hemaotpoietic stem cells and adult bone marrow derived stem cells. He was the Dean, Manipal Institute of Regenerative Medicine from Oct 2008 to Mar 2011. Currently he is in charge of the clinical development program in Stempeutics. He has more than 50 publications both in International and National journal to his credit. Dr Gupta is an MD (Pathology) (AFMC, Pune), Diplomate of National Board of Examination (Pathology) and PhD (Haematology - AIIMS)

Siok Tey, MBBS(Hons), PhD, FRACP, FRCPA
ISCT Regional VP, ANZ
Group Leader, Translational Cancer Immunotherapy Laboratory
QIMR Berghofer Medical Research Institute, Royal Brisbane & Women's Hospital
Australia

Andrés Caicedo, PhD
ISCT Regional VP, South and Central America
Professor and Director of Research Laboratory
Universidad San Francisco De Quito, USFQ
Ecuador

Dr. Andrés Caicedo is a distinguished scientist in the field of Biomedicine, having earned his Ph.D. with honors in 2013 from the University of Montpellier, where he also completed specializations in Regenerative Medicine and Management. As a Professor-Researcher at the School of Medicine of the San Francisco University of Quito since 2016, Dr. Caicedo spearheads the Biomedical Discovery Team and the Dragon BioMed Initiative, demonstrating a commitment to innovation in advanced cell-based therapies and biomarker application. His notable contributions to the field were internationally recognized when he was selected as an Innovator Under 35 in Latin America by MIT Tech Review in 2017, specifically for his groundbreaking study, "MitoCeption." This accolade was complemented by his victory in the 2017 Innovation Call “Ecuador Changes the World” for AEI, further underscoring his influence on biomedical research. Dr. Caicedo has a prolific portfolio of scientific publications and patents, underscoring his expertise and ongoing quest for novel therapeutic agents. In 2023, his leadership and vision were further endorsed as he was elected Vice President of the International Society for Cell & Gene Therapy (ISCT) for the South and Central American region and honored with the organization’s prestigious Trailblazer award. Dr. Caicedo's career is marked by a relentless pursuit of excellence and a passion for positioning USFQ as a vanguard institution in regenerative medicine.