Program
ISCT 2021 New Orleans VIRTUAL focuses on six key topic areas in translational science, as well as key issues in regulation and industry
SCIENTIFIC PROGRAM
TRACK I
Mesenchymal Stromal Cells
TRACK II
Commercialization
TRACK III
Exosomes
TRACK IV
Stem Cell Engineering & Bone Marrow Transplantation
TRACK V
Tissue Engineering & Regenerative Medicine
TRACK VI
Immuno & Gene Therapies
REGULATORY PROGRAM
GRP Workshop • Regulatory Sessions
INDUSTRY PROGRAM
Corporate Symposia • Roundtables • Global Showcase • Tutorials
Use the drop-down menu below to select a program track to follow.
You may also search by keywords by using the search box below.
- Filter by Topic, Schedule, and More
- Plenary
- Track I - Mesenchymal Stromal Cells
- Track II - Commercialization
- Track III - Exosomes
- Track IV - Stem Cell Engineering & BMT
- Track V - Tissue Engineering & Regenerative Medicine
- Track VI - Immuno & Gene Therapies
- Regulatory Sessions
- Corporate Symposia
- Corporate Tutorials
- Global Showcase
- Pre-Recorded Sessions
COVID-19: Understanding the Path Forward for Mesenchymal Stromal Cell Therapies
MAY 26 - 08:00 EDT
In 2020, MSC therapies offered ‘a new hope’ for treating COVID-19. At the ISCT 2020 Virtual Meeting, ISCT explored the scientific rationale and growing list of MSC trials for COVID-19 induced acute respiratory distress syndrome (ARDS). One year later, our panelists return to provide an update on the very latest results from ongoing MSC trials for COVID-19, and to discuss how we can apply this new knowledge to address the ongoing hurdles to MSC therapeutic development.
Presenters:
Chair
Jacques Galipeau, MD
University of Wisconsin-Madison
USA
Maroun Khoury, PhD
Cells for Cells – REGENERO
Chile
Patricia Rocco, MD, PhD
Federal University of Rio de Janeiro
Brazil
Anthony Ting, PhD
Athersys
USA
Abstract Presentation
Tomer Bronshtein, PhD
Bonus BioGroup Ltd.
Israel
Abstract Presentation
Duncan Stewart, MD
Ottawa Hospital Research Institute
Canada
Integrating Science, Regulatory Oversight, and Commercialization for the New Wave of Cell & Gene Therapies
MAY 26 - 13:30 EDT
Forecasts demonstrate that approvals-wise, we are looking at 10-20 items being considered per year by 2025. For some time now, we have been lining up to build the research and the knowledge needed for cell and gene therapies to flourish... The questions we can ask now pivot towards how approval should be approached, how reimbursement might look, how patients can get access to therapies, and so on.
Presenters:
Chair
Bruce Levine, PhD
University of Pennsylvania
USA
Co-Chair
Shabnum Patel, PhD
Stanford University
USA
Peter Marks, MD, PhD
FDA Center for Biologics Evaluation and Research
USA
Arie Belldegrun, MD
Allogene Therapeutics
USA
Matthew Porteus, MD, PhD
Stanford University
USA
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"First in Man" Exosome Trials
MAY 27 - 08:00 EDT
Human trials of exosome therapeutics mark the arrival of true clinical translation. Understanding manufacturing and regulatory challenges is critical to ensure a smooth translational path forward. The panel considers the translation of current preclinical data and lessons learned from research to date to examine where consensus is needed, and how it can be developed.
Presenters:
Co-Chair
Sai-Kiang Lim, PhD
Institute of Molecular & Cell Biology
Singapore
Co-Chair
Maurizio Muraca, MD, PhD
University of Padova
Italy
Massimo Dominici, MD
University of Modena and Reggio Emilia
Italy
Eva Rohde, MD
Paracelsus Medical University
Austria
Andrew Hoffman, DVM, DVSc
University of Pennsylvania
USA
BMT vs Gene Therapy vs No Cell Therapy: Accessibility, Cost, and Outcomes
May 27 - 13:30 EDT
The panel begins with clinical updates exploring the latest data in gene therapy and alternative donor BMT for treating hemoglobinopathies, followed by a moderated debate with leading experts to understand accessibility, cost, endpoints, and outcomes of the currently available therapies for thalassemia and sickle cell disease.
Presenters:
Co-Chair
Jaap Jan Boelens, MD, PhD
Memorial Sloan Kettering
USA
Co-Chair
Sandeep Soni, MD
CRISPR Therapeutics
USA
Alexis Thompson, MD, MPH
Ann & Robert H. Lurie Children's Hospital of Chicago
United States
Suradej Hongeng, MD
Ramathibodi Hospital, Mahidol University
Thailand
Selim Corbacioglu, MD
University Children's Hospital Regensburg
Germany
Matthew Porteus, MD, PhD
Stanford Medicine
USA
Deepa Manwani, MD
The Children's Hospital at Montefiore
USA
Charting the Future - Safe and Effective Translation in Tissue Engineering and Regenerative Medicine
MAY 28 - 08:00 EDT
Successfully translating tissue engineered and regenerative medicine products requires orchestration of numerous disciplines to realize the potential to repair, replace, and regenerate organs and tissues. This panel examines the state of the art, and key lessons from, stem cell therapy and 3d printing research, proposing a path forwards towards safe translation.
Presenters:
Co-Chair
Ranieri Cancedda, MD
Università degli Studi di Genova
Italy
Co-Chair
Giuseppe Orlando, MD, PhD
Wake Forest University
USA
Anthony Atala, MD
Wake Forest Institute for Regenerative Medicine
USA
Graziella Pellegrini, PhD
University of Modena and Reggio Emilia
Italy
Rocky Tuan, PhD
Chinese University of Hong Kong
Hong Kong
Debating Applications of CAR-T/NK cells: Perspectives on Autologous versus Allogeneic Therapies
MAY 28 - 13:30 EDT
Leading experts in the field outline the benefits and challenges of autologous versus allogeneic sources of immune effector cells, drawing on their experiences in driving novel technologies within each setting. The panel will discuss how progress is contingent on addressing issues related to manufacturing, efficacy, regulatory approvals, cost, patient access, pricing, and
availability of therapies to underserved populations. Through this discussion, the panel aims to build consensus that supports decisions for the optimal uses of cellular immunotherapy sources.
Presenters:
Chair
Michael Gustafson, PhD
Mayo Clinic Arizona
USA
Rayne Rouce, MD
Baylor College of Medicine
USA
Wen Bo Wang, PhD
Fate Therapeutics
USA
MSC-Derived EVs: Cell Therapy without Cells
MAY 26 - 10:00 EDT
Pre-clinical and clinical studies have established that mesenchymal stromal cells (MSCs) yield therapeutically beneficial effects via paracrine action, and that extracellular vesicles (EVs) shed from MSCs contribute to this activity.
However, while efforts are underway to develop MSC-EVs as a standalone therapeutic, many questions remain regarding best practices to achieve a successful outcome.
In this session, key opinion leaders in the field discuss efforts to develop standards to isolate and characterize MSC-EVs (Dr. Sai-Kiang Lim), address critical issues related to how MSC source and particle size influence cargo content (Dr. Bas van Balkom), and evaluate the value of pre-clinical models to assess MSC-EV potency (Dr. Claudia dos Santos).
Therefore, the session is of high value for researchers and clinicians engaged in the study of MSC-EVs and pursuing their use in an experimental clinical therapy.
Presenters:
Chair
Don Phinney, PhD
Scripps Research Institute
USA
Bas von Balkom, PhD
University Medical Center Utrecht
Netherlands
Claudia dos Santos, MD
University of Toronto
Canada
Sai-Kiang Lim, PhD
Institute of Molecular & Cell Biology
Singapore
Debating MSC Tissue Sources: Biological and Manufacturing Considerations
MAY 26 - 11:30 EDT
Adipose and bone marrow derived MSCs have met marketing approval in Europe and Japan. The interest in umbilical-cord derived MSCs as an investigational therapy is flourishing and iPS-derived MSCs have emerged as a plausible inexhaustible defined source.
Are there intrinsic biological and manufacturing properties which identify clear front-runner in the off-the-shelf use of MSC and how to evaluate these properties in a clinical perspective?
Presenters:
Chair
Karin Tarte, PharmD, PhD
University of Rennes
France
Frank Barry, PhD
National University of Ireland Galway
Ireland
Ivan Martin, PhD
University Hospital Basel
Switzerland
Melanie Generali, PhD
University of Zurich
Switzerland
Abstract Presentation
Kristina Thamm, PhD
denovoMATRIX
Germany
Abstract Presentation
Martha Arango-Rodriguez, PhD
FOSCAL
Colombia
Understanding Regulatory Requirements for Potency Assays
MAY 26 - 15:30 EDT
Marketing approval for MSCs requires the establishment of validated identity and functional attributes for uniform manufacturing as well as to help understand clinical responses in any given indication.
• Will in vitro cell-based assays suffice to meet the bar?
• Is a matrix of functional assays required?
• Do these assays need to correlate with clinical outcomes?
• Can there be consensus amongst international regulators on what these requirements may be for MSC-based therapeutics?
A gap analysis is discussed.
Presenters:
Chair
Sowmya Viswanathan, PhD
University Health Network
Canada
Steven Bauer, PhD
U.S. Food and Drug Administration
USA
Mauro Krampera, MD
University of Verona
Italy
Eleuterio Lombardo, PhD
Takeda
Spain
Abstract Presentation
Pallab Pradhan, PhD
Georgia Tech
USA
Abstract Presentation
Razieh Rabani
University Health Network
Canada
Lessons & Recommendations for Clinical Trials of MSCs for Musculoskeletal Diseases in 2021
MAY 26 - 17:00 EDT
This session will explore the state of the art in MSC sourcing and fabrication for disease–specific clinical therapies for musculoskeletal disease. The specific experience of three effective teams in Europe, Japan and Taiwan will be used to catalyze in depth discussion of key challenges for: 1) reproducible product fabrication, characterization and quality control, 2) effective disease-specific targeting, design and execution of rigorous clinical trials for musculoskeletal disease, and 3) both enabling and inhibiting region-specific differences in regulatory environment.
Goals: To provide an authoritative overview of the current status of clinical assessment of culture expanded MSCs in Musculoskeletal Disease.
Methods: Leaders from across the globe are asked to address key strategic and practical issues that have driven and limited current approaches and progress, including:
- Cell Sourcing – Fabrication, Certification
- Disease Setting and Patient Selection
- Delivery Strategies
- Clinical Outcome Assessment
- Evidence to Date from Completed Studies
Presenters:
Co-Chair
Christian Jorgensen, MD, PhD
Centre Hospitalier Universitaire de Montpellier
France
Co-Chair
George Muschler MD
Cleveland Clinic
USA
Oscar Lee MD, PhD
China Medical University Hospital
Taiwan
Norimasa Nakamura, MD, PhD
Osaka University
Japan
Felipe Prósper, MD, PhD
Universidad de Navarra
Spain
Allogeneic Therapies – What really is a healthy donor?
MAY 26 - 10:00 EDT
Donor derived cell-based starting materials are fundamental to cell and gene therapies and play a key role in in all aspects from manufacturing to product and patient safety. But what defines a healthy donor and how much characterization is enough?
As allogeneic therapies continue to grow and advance clinically, it will be critical for both therapeutic developers and regulators to harmonize on the requirements and balance safe versus sustainable.
This session will highlight the current state of the industry and debate the outstanding questions impacting harmonized clinical translation and global commercialization.
Questions for consideration:
• What constitutes a healthy donor or healthy enough?
• Starting materials are tested for specified release criteria and with an expectation for these to be defined, but what is realistic?
• What are the characterization requirements (viral testing of the donor to that of the cell-based product for example)?
• There is a need to generate data, but how much is actually enough?
• How do we align to ask the right questions?
Presenters:
Session Chair
Dominic Clarke, PhD
HemaCare, a Charles River Company
USA
Hanh Khuu, MD
U.S. Food and Drug Administration
USA
David Sourdive, PhD
Cellectis
France
James Trager, PhD
Nkarta Therapeutics
USA
Christopher Bravery, PhD
Consulting on Advanced Biologicals Ltd
United Kingdom
The Economic Impact on Healthcare and the Future of Advanced Cell & Gene Therapy
MAY 26 - 15:30 EDT
Despite the unprecedented difficulties of the pandemic, it is still an exciting time for Cell and Gene Therapy (CGT). Currently there is over one thousand ongoing clinical trials in the field. There is a buzz about the potential for advanced CGT products to decrease healthcare costs and deliver patient value, but cost and patient access are still significant issues that may require innovative funding models. Strong clinical results are attractive for investors in CGT companies, but limited examples of commercial success thus far may still present a barrier to accelerating investment.
The session will cover:
• The state of cell and gene therapy, focusing on investment and financing
• Strategic business development for the commercial model of CGT including clinical manufacturing and product design
• Development of strategies for reimbursement and how to define the value of these innovative therapies
Presenters:
Co-Chair
Julie Allickson, PhD
Wake Forest Institute of Regenerative Medicine
USA
Co-Chair
Patrick Rivers, MBA
Aquilo Capital
USA
Reni Benjamin, PhD
JMP Securities LLC
USA
Matthew Durdy
Cell and Gene Therapy Catapult
UK
Stephanie Farnia MPH
Nimitt Consulting
USA
Advancing the translational process through automation & equipment that deliver successful scale up/out in cell therapies
MAY 26 - 17:00 EDT
Successful translation of cell based therapy relies heavily on a combination of research, process development, and manufacturing. What have the successes of early commercial CAR-T products and late stage cell therapies taught us? What hurdles did the industry have to overcome, and how will new technologies impact the translational process? How has the definition of “automation” changed, and what does industry need and need?
Presenters:
Chair
John McMannis
Cellenkos
USA
Jason Foster, MBA
OriBiotech
UK
Fabian Gerlinghaus
Cellares
USA
Martin Giedlin
PACT Pharma
USA
Megan Suhoski Davis PhD
University of Pennsylvania Perelman School of Medicine
USA
Drug Delivery: The Therapeutic Power of Engineered EVs
MAY 27 - 10:00 EDT
EVs are part of an ancient intercellular communication system we recently have become aware of. They transmit complex signals in physiological and pathophysiological situations, in a targeted manner. Thus, EVs provide the ideal shuttle for drug delivery. To this end it is a challenge in the field to unravel the EVs tropism and to develop strategies for EV loading. In this session, sophisticated technologies are introduced for the genetic engineering and targeting of EVs as shuttle systems for biotherapeutics.
Presenters:
Chair
Bernd Giebel, PhD
University of Duisburg-Essen
Germany
Chulhee Choi, MD, PhD
KAIST Institute
South Korea
Samir El Andaloussi, PhD
Karolinska Institute
Sweden
Le Thi Nguyet Minh, PhD
National University of Singapore
Singapore
Abstract Presentation
Jiajun Shi
National University of Singapore
Singapore
Abstract Presentation
David Bernal, PhD
University of Murcia
Spain
Extracellular Vesicles as Future Therapeutics and Indicators of Cardiac Disease
MAY 27 - 11:30 EDT
Extracellular vesicles (EV) are a potent component of the secretome, and as such have been harnessed recently as therapeutics and biomarkers of cardiovascular disease. The objective of this session is for attendees to appreciate the wide biological and therapeutic potential for EV to improve our understanding and management of cardiovascular disease, in both humans and naturally occurring companion animal disease models.
Presenters:
Co-Chair
Andrew Hoffman, DVM, DVSc
University of Pennsylvania
USA
C0-Chair
Dominique de Kleijn, PhD
UMC Utrecht
Netherlands
Saumya Das, MD, PhD
Massachusetts General Hospital
USA
Eduardo Marban, MD, PhD
Cedars-Sinai
USA
Vicky Yang, DVM, PhD, DACVIM
(cardiology)
Tufts University
USA
Abstract Presentation
Federica Marinaro, MSc
Centro de Cirujia de Minima Invasion Jesus Uson
Spain
Abstract Presentation
Marta Monguió-Tortajada, PhD
Germans Trias i Pujol Research Institute
Spain
EVs for Infectious Diseases and Preparedness for Future Pandemics
MAY 27 - 17:00 EDT
Description Forthcoming
Presenters:
Chair & Speaker
Kenneth Witwer, PhD
John Hopkins University School of Medicine
USA
Lorena Martin-Jaular, PhD
Institut Curie
France
Yong Song Gho, PhD
Pohang University of Science and Technology
South Korea
Abstract Presentation
Michael Bellio, PhD
Organicell Regenerative Medicine Inc.
USA
Traceability and Labeling for Cell-based Therapies and Regenerated Tissues
MAY 27 - 15:30 EDT
Effective traceability, unique identification and standardized labeling are all important ways to enhance safety of clinical product during manufacturing, release and distribution to the patient. The need for traceability is well recognized but the complexity of the traceability pathway for medical products of human origin (MPHO) is poorly understood. ISBT 128 is the global standard for the terminology, identification, coding and labeling of MPHO, which includes cell-based products, regenerated tissues and many other products of human origin (including blood, cell, tissue, milk, and organ products). It provides international consistency to support the transfer, traceability and transfusion/transplantation of these products. The session will provide an overview of traceability for MPHO, and highlight recent developments of ISBT 128 to support standardized labeling of collection products for further manufacture, and the availability of product description codes to support nonproprietary names and novel products in clinical trials. In addition to the presentations, a round-table forum will provide an opportunity for delegates to pose questions to the panel.
Presenters:
Co-Chair
Lizette Caballero, BSc, MLS(ASCP)CM
The Janssen Pharmaceutical Companies of Johnson & Johnson
USA
Co-Chair
Paul Ashford, MSc
ICCBBA
United Kingdom
Martin Hildebrandt, MD
Technische Universität München
Germany
Julie Allickson, PhD
Wake Forest Institute of Regenerative Medicine
USA
Dilemmas in Transplantation for Acute Myeloid Leukemia
MAY 27 - 10:00 EDT
We live in an exciting time for the treatment of acute myeloid leukaemia. After decades of frustration, recent progress in the understanding of the pathogenesis of AML, coupled with novel therapeutic innovations, are rapidly changing the options available to patients. While allogeneic transplantation remains central to the treatment of high-risk AML, clinicians are now faced with difficult decisions when trying to optimise care for such patients. How should chemotherapy be used to optimise disease status prior to transplant? Which alternative donor should be chosen for patients with high-risk AML lacking a matched donor? Are maintenance strategies or novel cell therapies relevant post-transplant? These dilemmas will be discussed by five exciting speakers in this clinically oriented session, which will include a debate and ample room for audience participation.
Presenters:
Co-Chair
Duncan Purtill, MD
Fiona Stanley Hospital
Australia
Co-Chair
Robert Wynn, MD, MB BChir, MRCP FRCPath
Central Manchester University Hospitals NHS Foundation Trust
UK
Juliet Barker, MBBS
Memorial Sloan Kettering Cancer Center
USA
Charles Craddock, CBE, FRCP (UK), FRCPath, DPhil
University of Birmingham
UK
David Curtis, MBBS, PhD, FRACP, FRCPA
Monash University
Australia
Kanya Rajangam, MD, PhD
Nkarta Therapeutics, Inc.
USA
PTCy vs T-Cell Depletion vs Cord Blood: Debating the Best Stem Cell Sources for Treating Non-Malignant Diseases
MAY 27 - 11:30 EDT
Hematopoietic stem cell transplantation is curative for many nonmalignant disorders, including primary immune deficiency disorders (PIDD), primary immune regulatory disorders (PIRD), hemoglobinopathies, inherited bone marrow failure syndromes (IBMFS), and metabolic disorders. Historically, success has been limited by the scarcity of fully matched donors. More recently, the use of alternative donors, including mismatched family members, unrelated bone marrow and peripheral blood, or unrelated cord blood, has dramatically expanded the donor’s availability. During this session experts in the field will debate about the use of different stem cell sources and will discuss alternative strategies of in vivo and ex vivo graft manipulation strategies with a special focus on the use of PT-Cy versus alpha/beta T-cell depletion.
Presenters:
Co-Chair
Alice Bertaina, MD, PhD
Stanford Medical School
USA
Co-Chair
Carmem Bonfim, MD, PhD
Federal University of Paraná
Brazil
Amy DeZern, MD, MHS
John Hopkins Medicine
USA
Orly Klein, MD
Lucile Packard Children's Hospital Stanford
USA
Arina Lazareva
Great Ormond Street Hospital
UK
Parinda Mehta, MD
Cincinnati Children's Hospital
USA
State of the Art in Cord Blood Transplantation: Banking, Expansion and Future Horizons
MAY 27 - 15:30 EDT
Cord Blood (CB) has unique properties and advantages, including a strong anti-tumor effect. This session will focus on how the use of cryopreserved cord blood cells is changing from the standard transplant to engineered stem cells and T cells directed to viral or disease specific targets. The future of cord blood banking and the new strategies to overcome the main limitations of the stem cell content (including the results of phase II and phase III clinical trials) will be discussed to provide a broad overview of new cord blood applications
Presenters:
Co-Chair
Allistair Abraham, MD
Children's National Hospital
USA
Co-Chair
Annalisa Ruggeri, MD, PhD
San Raffaele Hospital
Italy
Catherine Bollard, MD, MBchB
Children's National Hospital
USA
Sandra Cohen, MD
Université de Montréal
Canada
May Daher, MD
MD Anderson Cancer Center
USA
Mitchell Horwitz, MD
Duke University
USA
Sergio Querol, MD, PhD
Banc de Sang i Teixits
Spain
Andromachi Scaradavou, MD
Memorial Sloan Kettering Cancer Center
USA
Simple Milestones of Immune Reconstitution are Modifiable by Conditioning and Predict Outcomes of Transplant
MAY 27 - 17:00 EDT
The talks in this session will highlight different components of effective immune reconstitution after hematopoietic stem cell transplant. Thymic dependent and thymic independent pathways for T cell reconstitution as well as novel validated milestones of T cell immune reconstitution will be discussed. The important contribution of the innate immune system to protection from infection and relapse after transplant will be discussed in the second segment.
Presenters:
Chair & Speaker
Susan Prockop, MD
Memorial Sloan Kettering Cancer Center
USA
Kenneth Weinberg, MD
Stanford Children's Health
USA
Marcel van den Brink, MD, PhD
Memorial Sloan Kettering Cancer Center
USA
Jurgen Kuball
UMC Utrecht
Netherlands
Tamara Laskowski, PhD
MD Anderson Cancer Center
USA
New Horizons for Cell Therapies to Treat Cardiovascular Diseases
MAY 28 - 10:00 EDT
A few years ago, great expectations were set around the clinical potential of cell therapy for the treatment of ischemic heart disease. Initial excitement, derived from encouraging preclinical data, resulted in a rapid translation into clinical research. The puzzling outcome of the first clinical trials mitigated the initial enthusiasm both among cardiologists and the various stakeholders. However, some more recent clinical studies suggest that perhaps, especially in the most severe patients, the correct use of reparative strategies could be of help. These latest results will be presented, and possible future strategies discussed during this session.
Presenters:
Chair
Massimiliano Gnecchi, MD, PhD
University of Pavia
Italy
Jozef Bartunek, MD, PhD
Hartcentrum OLV Aalst
Belgium
Stephan Janssens, MD, PhD
Leuven University
Netherlands
Giulio Pompilio, MD, PhD, FESC
Centro Cardiologico Monzino IRCCS
Italy
Networks and Dynamics in the Clinical Translation of Safe and Effective Cellular Therapies for Musculoskeletal Diseases
MAY 28 - 11:30 EDT
This session takes a broad perspective on the translation of safe and effective cellular therapies for musculoskeletal disease. The presentations and following forum will explore the current dynamics between biomedical innovation, clinical literature, clinical research networks, professional societies, physician practices, and patient education.
Dr. Guilak, a leading bioengineer and past president of the Orthopaedic Research Society, will define the state of clinical translation in the key area of cartilage tissue replacement.
Dr. Piuzzi, an orthopaedic surgeon and clinical-scientist, will define the current evidence for the clinical efficacy (derived from systematic reviews and RCTs) of cellular injection therapies for osteoarthritis, osteonecrosis, tendonopathy and fracture non-union.
Dr. Maloney, past president of the American Academy of Orthopaedic Surgery and current Chair of the AAOS Clinical Registry Program will illuminate the investments being made to develop digital reporting tools and widespread professional adoption of clinical registries as a resource for rigorous longitudinal assessment and comparison of implants, surgical techniques, as well as cellular “biologic” therapies that are currently regulated by the FDA under 361 exemptions as HCT/Ps.
Presenters:
Chair
George Muschler, MD
Cleveland Clinic
USA
William J Maloney, MD
Stanford University
USA
Farshid Guilak, PhD
Washington University School of Medicine
USA
Nicolas Piuzzi, MD
Cleveland Clinic
USA
Abstract Presentation
Jesil Kasamkatill, MSc
University Hospital Basel
Switzerland
Abstract Presentation
Judith Krieger, MSc
Fraunhofer Institute
Germany
Fabrication and Transplantation of Neural Cells and Tissues
MAY 28 - 15:30 EDT
This session will explore the state of the art in sourcing and fabrication of neurons for disease–specific clinical therapies. The specific experience of four highly productive teams will be used to catalyze in depth discussion of key challenges for 1) reproducible cell product fabrication, characterization and quality control, 2) effective disease-specific targeting and cell delivery strategies, 3) design and execution of rigorous clinical trials, and 4) key technical challenges or gaps that must be addressed to enable more effective development and translation of cell therapy for neurological tissue regeneration.
Presenters:
Chair & Speaker
Budd Tucker, PhD
University of Iowa Health Care
USA
Molly Shoichet, FRS
University of Toronto
Canada
Clive Svendsen
Cedars-Sinai Medical Center
USA
Cell and Biomaterials based Technologies in GI Bioengineering: Approaching the Bedside
MAY 28 - 17:00 EDT
The session features three speakers. Paolo De Coppi will speak about the application of extracellular matrix-based scaffolds as a platform for the bioengineering of the pediatric esophagus. Ekaterine Berishvili will illustrate how a combinatorial approach harnessing stem cell engineering, gene editing and placenta extracellular matrix-based biomaterials may foster progress in beta cell replacement for type 1 diabetes. Geraldine Mitchell will elucidate on progress in the bioengineering of the vascular network of complex tissues. Overall, this session will offer an overview of the state of the art of tissue engineering technologies as they may be applied to GI medicine.
Presenters:
Co-Chair
Rachele Ciccocioppo, MD
University of Verona
Italy
Co-Chair
Vincenzo Cardinale, MD, PhD
Sapienza University of Rome
Italy
Paolo De Coppi
Great Ormond Street Hospital for Children
UK
Ekaterine Berishvili, MD, PhD
University of Geneva
Switzerland
Geraldine Mitchell, MBChB
St. Vincent's Hospital Melbourne
Australia
Abstract Presentation
Pradyut Paul, PhD
University of Wisconsin-Madison
USA
Lymphodepletion and Biomarkers in Cell Therapy
MAY 28 - 10:00 EDT
Description Forthcoming
Presenters:
Co-Chair
Jaap Jan Boelens, MD, PhD
Memorial Sloan Kettering
USA
Co-Chair
Michael Scordo, MD
Memorial Sloan Kettering
USA
David Teachey, MD
Children's Hospital of Philadelphia
USA
Cameron Turtle, MBBS, PhD
Fred Hutchinson Cancer Research Center
USA
Abstract Presentation
Vanessa Fabrizio, MD, MS
Duke University
USA
Novel Allo-Engineering Approaches and Progress in Off-the-Shelf Products
MAY 28 - 11:30 EDT
This session will discuss various approaches to allogeneic cell products, including off-the-shelf virus-specific T cells, allogeneic CAR T cells, and allogeneic gamma delta T cells. What makes this session unique is that parts of it will focus on genetic approaches to evading immune rejection and increasing persistence while others will present on non-gene therapy-based approaches to allogeneic therapies and why they are an appealing alternative to autologous cell and gene therapies.
Presenters:
Co-Chair
Patrick Hanley, PhD
Children’s National Hospital
USA
Co-Chair
Margaret Lamb, MD
Children’s National Hospital
USA
Maksim Mamonkin, PhD
Baylor College of Medicine
USA
Jason Dubovsky, PhD
Atara Biotherapeutics
USA
Lawrence Lamb, PhD
IN8Bio, Inc.
USA
Abstract Presentation
Michelle Cox, M.S.
Mayo Clinic
USA
Abstract Presentation
Cristina Ferreras, PhD
IdiPAZ
Spain
Progress in In-Vivo Gene Therapies
MAY 28 - 15:30 EDT
To help attendees learn and understand fundamentals of AAV virology as it applies to in vivo gene therapy applications. We will also cover the current state of the art AAV technologies being applied preclinically as well as clinically in both the CNS and blood disorders.
Following the seminar, the participant will be able to:
• Explain and understand the current state of field of AAV gene therapy.
• Discuss the potential for AAV gene therapies to be applied to both brain and blood disorders.
Presenters:
Co-Chair
Sandeep Soni, MD
CRISPR Therapeutics
USA
Co-Chair & Speaker
Nicole Paulk, PhD
University of California San Francisco
USA
Krystof Bankiewicz, MD, PhD
Ohio State University
USA
Lindsey A. George, MD
University of Pennsylvania
USA
Cell Therapy and the Spleen: Modulating Therapeutic Outcomes After Inflammatory Crises or Injury Onset
MAY 28 - 17:00 EDT
Regardless of organ system (CNS, Cardiopulmonary, Severe body trauma), after onset of severe injury to these systems, the peripheral immune system is engaged and, in most cases, results in a secondary “pathophysiological hit” subsequent to the initial injury, resulting in enhanced secondary damage at the site of initial injury.
The engagement of the peripheral immune system in the acute time frame after initial injury onset, results in increased activation and infiltration of leukocytes, myeloid cells, neutrophils and increased levels of inflammatory cytokines.
Presenters:
Co-Chair
Robert Mays, MD
Athersys, Inc.
USA
Co-Chair
Charles S. Cox, MD
University of Texas Medical School
USA
Sangeeta S. Chavan, PhD
Feinstein Institutes for Medical Research
USA
Richard Maziarz
Oregon Health & Science University
USA
Sean Savitz
University of Texas Medical School
USA
Translating Cellular Therapies from Bench to Clinic – The Critical Role of GMP-compliant, Scalable Cell Engineering Technology
MAY 26 - 10:00 EDT
Increasingly sophisticated approaches to cellular engineering, including CRISPR-mediated gene editing and expression of disease-targeting receptors, require corresponding advances in cellular delivery technologies.
Aside from the high manufacturing costs of viral vectors, demand for non-viral methods is driven by the diversity of cell types (e.g,, T cells, NK cells, stem cells) and loading agents (e.g., RNPs, mRNA, transposons) that are central to many engineered cellular therapies. Moreover, aggressive development timelines combined with strict standards for safety and therapeutic potency create a need for cell modification protocols that translate seamlessly from the research lab into the clinic, accommodating a broad range of processing scales without compromising cell viability or loading efficiency.
This Industry Symposium brings together leading researchers and clinicians to discuss their experiences with translating and scaling non-viral approaches to engineered cellular therapies.
Defining Intelligent Scale Up and Scale Out. How Small Decisions Have Major Implications for Intelligent Scale Up And Out
MAY 26 - 15:30 EDT
Join a stellar panel of industry leaders as they speak about how you can define and plan for intelligent scaling of cell and gene therapies. Drawing on insights from academic, industry, facility design, and tool providers, this panel will explore a variety of decision points researchers and drug developers face when scaling up and scaling out. Please participate in the live polling and feel free to contribute questions during the Q&A session at the end!
Standardization of cell and gene therapy starting materials
MAY 27 - 10:00 EDT
Corporate Symposium hosted by Cytiva
Description Forthcoming
Corporate Symposium - hosted by Miltenyi Biotec
MAY 27 - 11:30 EDT
Corporate Symposium hosted by Miltenyi Biotec
Description Forthcoming
Current and future state of CAR-T cell therapy manufacturing- Closing, automating and preparing for the allogeneic revolution
MAY 27 - 15:30 EDT
Description Forthcoming
Presenters:
Session Chair
Xavier De Mollerat Du Jeu, PhD
Director, Product Management, Cell and Gene Therapy, Thermo Fisher Scientific
USA
Sean Chang, PhD
Product Manager, Cell and Gene Therapy
Thermo Fisher Scientific
USA
Evan Zynda, PhD
Staff Scientist, Cell Biology
Thermo Fisher Scientific
USA
David Shaw, PhD
Principal Scientist and Group Leader, Cell Therapy Process Development, Genentech
USA
Ben Schilling, PhD
Process Engineer
Caribou Biosciences
USA
Corporate Symposium - hosted by Penn Medicine
MAY 27 - 17:00 EDT
Corporate Symposium hosted by Penn Medicine
Description Forthcoming
Corporate Symposium - hosted by Terumo
MAY 28 - 10:00 EDT
Corporate Symposium hosted by Terumo
Description Forthcoming
Presenters:
Lei Yu, MD, PhD
Founder, Shanghai Unicar-Therapy Biomed-Pharmaceutical Technology Co.,Ltd,
China
Corporate Symposium - hosted by Roche
MAY 28 - 11:30 EDT
Corporate Symposium hosted by Roche
Description Forthcoming
Corporate Tutorial by bioMérieux & Accellix
Available On-Demand on May 26
Corporate
Corporate Tutorial hosted by bioMérieux & Accellix
Description Forthcoming
Corporate Tutorial by Pall
Available On-Demand on May 26
Corporate Tutorial hosted by Pall
Description Forthcoming
Corporate Tutorial by Bio-Techne
Available On-Demand on May 26
Corporate Tutorial hosted by Terumo
Description Forthcoming
A Case Study: Streamlining Digital Transformation and Reducing Data and Process Silos in Biologics
Available On-Demand on May 26
Biologics manufacturing and new classes of precision therapeutics, including cell and gene therapies, require a new category of companion informatics that automates and digitalizes complex manufacturing, quality management, and clin-ops processes. This digital transformation can reduce time to market, reduce development costs, and streamline the scaling and development of these medicines. This discussion will feature an in-depth discussion on digital transformation for advanced therapeutics including biologics manufacturing, and a case study with a leading CDMO company.
Corporate Tutorial by RoosterBio
Available On-Demand on May 26
Description Forthcoming
Scalable Xeno-free Production of MSC-Derived EVs in Single-use Bioreactors
Available On-Demand on May 26
Learn how EVs are robustly produced from various hMSC (BM, AT & UCM) using a scalable serum-/xeno-free microcarrier-based culture platform, employing a single-use bioreactor and human platelet lysate culture supplement (UltraGROTM-PURE).
Achieving production of clinical EV doses will require cost-efficient, scalable, GMP ex-vivo expansion systems. Here we present a readily scalable, xeno-free MSC-EV expansion approach in a microcarrier-based bioreactor using human platelet lysate supplement;
• Producing MSC-derived EVs from various human tissue sources; bone marrow (BM), adipose tissue (AT), and umbilical cord matrix (UCM)
• Experience in a Vertical WheelTM Bioreactor
• Results using xeno-free UltraGROTM-PURE (FDhPL) supplement
Presenters
Claudia Lobato de Silva, PhD
University of Lisboa
Portugal
Miguel de Almeida Fuzeta, PhD Candidate
iBB, IST, U. Lisboa
Portugal
Available On-Demand on May 26
Global Showcase Session by:
New Jersey Innovation Institute | BioCentriq
Description Forthcoming
T & NK Cell Culture: Novel Substitute for Human AB Serum
Available On-Demand on May 26
BioLegend is a global trusted partner of premier research institutions, biotechnology, and pharmaceutical companies. Our cutting-edge tools provide reproducible results in immunology, oncology, neuroscience, stem and proteogenomics.
During this presentation, learn:
• To show how serum replacements can benefit the immunotherapy field.
• About our new product, Cell-Vive™ T-NK Xeno-Free Serum Substitute, GMP. Designed to work in combination with multiple basal media, Cell-Vive™ performs similarly or better than human AB serum, for both T and NK Cells.
Presenter:
Vanda S. Lopes, PhD
Scientist III
BioLegend
USA
Available On-Demand on May 26
Global Showcase Session by:
BioLife Solutions
Description Forthcoming
Everything is rethinkable - robust and scalable manufacture of human cells via cellular reprogramming
Available On-Demand on May 26
Application of cellular reprogramming supported by our opti-ox technology, enables precise and scalable manufacturing of human cells for therapeutic applications.
Learning Objectives:
• Introduction to novel technology that allows consistent, fast and scalable manufacturing of human cells from hiPSCs.
• Understanding the role of transcription factors in cell reprogramming.
• How this applies to cell therapy.
Presenter
Mark Kotter, MD
CEO & Founder
bit.bio
UK
Available On-Demand on May 26
Global Showcase Session by
Catalent
Description Forthcoming
What’s Next for AAV-based Gene Therapy?
Available On-Demand on May 26
Learn how Catenion can support you to look into the complexity of AAV-based gene therapy and identify new indications that fit the unique technological profile of your gene therapy platform
Learn about:
• Overview of AAV-based gene therapy, including challenges and potential solutions
• Therapeutic Expansion – Learn how to conduct a systematic database-driven selection of new indications in the gene therapy space
Presenter:
Pascal Joly, PhD
Principal
Catenion
Germany
Available On-Demand on May 26
Global Showcase Session by
CCRM
Description Forthcoming
Available On-Demand on May 26
Global Showcase Session by
Cellares
Description Forthcoming
Available On-Demand on May 26
Global Showcase Session by
Cell & Gene Catapult
Description Forthcoming
Available On-Demand on May 26
Global Showcase Session by
CellGenix GmbH
Description Forthcoming
Available On-Demand on May 26
Global Showcase Session by
Cell X Technologies
Description Forthcoming
Introducing the Most Advanced Ultra Cold Shipper, Cryoport Elite™
Available On-Demand on May 26
The Cryoport Elite™ multi-use shipper is aimed to sustain consistent temperatures during transit for longer than 4 days, prevents accidental openings during shock events, and provides real-time temperature monitoring on the outside of the shipper.
Presenter:
Lindsay Belcher, MBA
Vice President, Business Development, Americas
Cryoport Systems
USA
The Cymerus™ iPSC-derived MSC Platform
Available On-Demand on May 26
Cymerus™ is a clinical stage, iPSC-derived therapeutic stem cell platform technology.
Learning Objectives:
• Rationale and advantages of iPSC-derived therapies
• Details of first completed clinical trial worldwide with iPSC-derived cells in any disease
• Overview of broad ongoing clinical development pipeline
• Partnering opportunities
Presenter:
Kilian Kelly, MRPharmS, PhD
Chief Operating Officer
Cynata Therapeutics Limited
Australia
Available On-Demand on May 26
Global Showcase Session by
Eppendorf
Description Forthcoming
Next Gen Cell Therapy Manufacturing with ekko™ Acoustic Cell Processing System
Available On-Demand on May 26
This talk discusses industrialized cell therapy manufacturing and how the ekko™ Acoustic Cell Processing System addresses the entire manufacturing workflow.
Learning Objectives:
• The best practices for the industrialization of cell therapy manufacturing
• How acoustic cell processing technology addresses the needs of the entire manufacturing workflow
• How process optimization can be supported through use of the ekko™ Architect software, our protocol development tool for the ekko™ Cell Processing System
Presenters:
Samantha Sbardella
MilliporeSigma
USA
Robert Scott
MilliporeSigma
USA
Available On-Demand on May 26
Description Forthcoming
Available On-Demand on May 26
Global Showcase Session by
RoosterBio
Description Forthcoming
5 Things Biotechs Must Do to Effectively Scale Cell Collections
Available On-Demand on May 26
As cell collection demand increases, ensuring an increased quality of product is equally important. But how do you do this without creating burden on apheresis centers as they handle the demand? A reliable source of starting material starts with five cell collection essentials to improve efficiency between collection sites – and to effectively scale. Watch our video and learn what biotechs should do to effectively scale cell collections.
5 Must Do’s:
• Understand the collection site perspective.
• Collect cells at the right time – quality over quantity.
• Track available cell collection data – and know what available data exists!
• Standardize across multiple collection sites.
• Drive and maintain an effective feedback loop.
Biotechs and hospitals who watch this video will:
• Understand the collection site perspective.
• Understand collecting cells at the right time matters.
• Be equipped to know what available data exists and ways to track this data.
• Gain knowledge about standardization across multiple collection sites.
• Learn how data analysis can support feedback with stakeholders and optimize the cell collection process
150 Million-fold Cumulated Expansion of Encapsulated HIPS Cells in Bioreactor
Available On-Demand on May 26
We present the results of an extensive benchmark of cell culture technologies for hiPSC expansion. We compared standard 2D culture in flasks and spheroid culture in bioreactors with the C-Stem technology.
Learning Objectives:
• Comparing expansion factors & overall scalability of iPS cell culture systems
• Comparing the output of iPS technologies in terms of cell quality
Presenters:
Fabien Moncaubeig, PhD
Chief Development Officer
TreeFrog Therapeutics
France
Maxime Feyeux, PhD
Chief Scientific Officer and Co-Founder
TreeFrog Therapeutics
France
Kévin Alessandri, PhD
Chief Technical Officer and Co-Founder
Treefrog Therapeutics
France
Available On-Demand on May 26
Global Showcase Session by
VectorBuilder
Description Forthcoming
Available On-Demand on May 26
Global Showcase Session by
WellSky
Description Forthcoming
Available On-Demand on May 26
Global Showcase Session by
World Courier
Description Forthcoming
The Path to a Biologics License Application (BLA)
MAY 26 - 11:30 EDT
Cell and gene therapy treatments often serve rare disease populations. Clinical development includes clinical studies using fewer treated patients than would normally be used for traditional pharmaceutical Phase 1, 2 and 3 studies. These shortened development timelines mean needing to be ready for commercial approval can happen quickly. These series of topics reflect some common areas of risk that must be addressed prior to product approval.
Presenters:
Chair
Forthcoming
Pia Mountford, PhD
CRISPR Therapeutics
USA
Gary Rea
CRISPR Therapeutics
USA
Eduard Luss
Vertex Pharmaceuticals
USA
Luis Barrera, PhD
Beam Therapeutics
USA
Phishing for Cell Therapies - Therapeutic Deception
MAY 26 - 17:00 EDT
ISCT Presidential Task Force (PTF) on the use of Unproven/Unethical Cell & Gene Therapies
Direct-to-consumer (DTC) marketing of unproven and unlicensed cell-based interventions remains a borderless, serious challenge despite concerted efforts to regulate. DTC marketing frequently uses tokens of scientific and clinical legitimacy and includes extravagant claims about products to appeal to patients.
Such strategies may amount to therapeutic deception and are increasingly under scrutiny by regulatory agencies, such as the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) and the European Medicines Agency (EMA). In this session, we discuss multipronged efforts by different stakeholders, such as tech companies and legislators, to counteract misleading messaging and address the challenges posed by the global reach of the DTC industry.
Learning objectives:
• Understand deceptive practices in direct-to-consumer marketing that targets patients
• Review current efforts at the national and international level to delegitimize and contain such practices
Presenters:
Chair
Laertis Ikonomou, PhD
University of Buffalo
USA
Patricia Zettler, JD
The Ohio State University
USA
Virginia Lyons
Vermont State Senate
USA
Understanding the Necessary Conditions for First in Human Trials
MAY 28 - 15:30 EDT
Initiating FIH clinical studies for cell or gene therapy products create some unique challenges, despite being required to meet all regulatory requirements for filing and IND and securing Study May Proceed. These topics provide a comprehensive discussion of several current requirements.
Presenters:
Co-Chair
Karen Nichols, Esq.
Vertex Pharmaceuticals
USA
Co-Chair
Karen Major
Turnstone Biologics
Canada
Aisha Khan, MSc, MBA
University of Miami
USA
Patrick Au, PhD
Ensoma
USA
Fouad Atouf, PhD
US Pharmacopeia
USA
Global Regulatory Perspectives
MAY 29 - 17:00 EDT
Global Regulatory Perspectives Workshop
This flagship program represents the diverse activities and partnerships between international regulatory bodies, industry, clinicians and academia. This year’s topics include viral vector quality (translating from preclinical to First in Human, viral vectors compliance complexities), a discussion on gene editing components, as well as regulatory CMC issues affecting the clinical development of cell and gene therapies.
Presenters:
Co-Chair
Karen Nichols, Esq.
Vertex Pharmaceuticals
USA
Co-Chair
Dominic Wall, PhD, FFSc (RCPA)
Peter MacCallum Cancer Center
Australia
Scott Burger, PhD
Advanced Cell & Gene Therapy
USA
Richard Snyder, MD
Thermo Fisher Scientific
USA
ISCT-AABB Joint Working Group Project Updates
This session will provide an overview and updates on two current projects.
The Stability Project:
This project aims to educate the community regarding consideration for cellular therapy product stability programs. The deliverable will be to reference documents and/or other communication materials to help with the design of a stability program for HPC products specifically.
GTP Interpretative Tool Project:
This project aims to establish a GTP interpretative tool that can assist with clarification of HCT/P regulations under 21 CFR 1271 and Section 361 of the PHS Act and/or the FD&C Act
Presenters:
Chair
Michele Sugrue, MS, MT (ASCP) SBB
University of Florida
USA
Nadim Mahmud, MD, PhD
University of Illinois Cancer Centre
USA
Wade Atkins, MS, MT(ASCP)SBB, CQA (ASQ)
National Institutes of Health
USA
Impact of COVID-19 on the Practice of the CTL: Global Perspectives
Description Forthcoming
Presenters:
Chair
Joseph Schwartz, MD, MPH
New York Presbyterian Hospital
USA
Vicki Antonenas, BSc, MSc
Westmead Hospital
Australia
Yvette Tanhehco, MD, PhD, MS
Colombia University
USA
John Girdlestone, BSc, PhD
NHS Blood and Transplant
UK
Julie Smolich, MBA
NMDP / Be The Match
USA
Validation, Competency & Potency of Procedures - Case Studies
This session reviews three essential tools which are the pillars of comprehensive quality assessment of cellular therapy manufacturing:
- Risk assessment
- Define: Quality Risk Management
- Review the basic steps of risk assessment
- Provide examples of risk assessments in the cellular therapy processing laboratory
- Validation
- Define Qualification, Validation, and Verification
- When to use each type and what should be their critical components
- Provide examples of validations
- Audits
- Why are audits an essential tool for quality assessment and process improvement
- When should it be performed?
- Examples of process improvement audits in the cellular therapy processing laboratory
Presenters:
Chair
Lizette Caballero, BSc, MLS(ASCP)CM
The Janssen Pharmaceutical Companies of Johnson & Johnson
USA
Ronit Slotky, PhD, MSc
Vital
USA
Olive Sturtevant, MHP, MT(ASCP)SBB
Dana Farber Cancer Center
USA
Medhat Askar, MD, PhD, FRCPath
Baylor University Medical Center
USA
Lessons in MSC Applications from Pet Populations with Naturally Occurring Diseases
While cell-based therapy holds tremendous promise due to therapeutic efficacy evidenced in early stage clinical development, products reaching the market remains scarce, often due to failure of late-stage clinical trials. Strategies to optimize successful translation of cell-based therapies include collection of more predictive pre-clinical data through use of optimized pre-clinical models, defined mode(s) of action (MoA), and robust potency assays in each proposed indication. Humans and domestic animals are in close contact, share the same environments, and develop similar chronic inflammatory diseases. This session will discuss how data obtained from pre-clinical animal models or animal populations with naturally occurring disease can be valorized to improve research outcomes for both veterinary and human medicine.
Learning Objectives: Data obtained from regenerative medical research using strong pre-clinical animal models or animal populations with naturally occurring disease will highlight similarities and peculiarities of cell-based approaches in human and veterinary studies. Examples of both immune-mediated pathologies (i.e. atopic dermatitis, vasculitis, …) and inflammatory osteoarthritis will be covered. The information provided will assist researchers in determining additional ways to advance translational regenerative medicine through collaboration and use of strategic pre-clinical trials.
Presenters:
Chair
Tracy Webb, DVM, PhD
Colorado State University
USA
Antonio Villatoro, DVM, PhD, MBA
University of Malaga
Spain
Nathalie Saunier, PhD
Vetbiobank
France
COVID-19 Therapies and Complications of CAR T-cell therapy
This session will discuss non-pharmacologic and pharmacologic treatment for COVID-19 infection.
We will also discuss the management of neurotoxicity, as well as long-term complications and survivorship post CAR T-Cell therapy.
Presenters:
Chair
Nicholas Szewczyk, APRN, MSN, ANP-C
University of Texas MD Anderson Cancer Center
USA
Jeremy Randial, MD
MD Anderson Cancer Center
USA
Bianca Santomasso, MD, PhD
Memorial Sloan Kettering Cancer Center
USA
Sherry Adkins, RN, MSN, ANP-C
MD Anderson Cancer Center
USA
Modified T-Cells Therapies for Hematologic Malignancies and Solid Tumors
This session will discuss the current state-of-the-art CAR T-Cell therapy for hematologic malignancies and modified T-Cell therapy for treatment of solid tumors. Furthermore, we will discuss dual antigen targeting in lymphoma with CD19/CD20 CAR T-cell therapy.
Presenters:
Chair
Brian Primeaux, PharmD, BCOP
The University of Texas MD Anderson Cancer Center
USA
David Hong, MD
MD Anderson Cancer Center
USA
Partow Kebriaei
MD Anderson Cancer Center
USA
Parameswaran Hari, MD, MRCP
Medical College of Wisconsin
USA
Analytical Methods Development: Supporting Process Development and Manufacturing for Clinical Trials and Commercialization
In Cell and Gene Therapy, analytical assay development can focus on safety, stability and potency for example. These points will be addressed with current regulatory guidance and inclusion of steps for acceleration for product development.
Presenters:
Chair
Scott Burger, MD
Advanced Cell & Gene Therapy
USA
Paul Lehmann, MD, PhD
Cellular Technology Limited (CTL)
USA
William Janssen, PhD
WEJ Cell and Gene Therapy Consulting
USA
