[vc_row][vc_column][vc_message]The final ISCT 2019 program is now available! View the final program..

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Wednesday
2020-05-27
Thursday
2020-05-28
Plenary Hall
Offsite
Poster Hall
Exhibit Hall
ISCT Global Showcase Lounge
Friday
2020-05-29
Offsite
Exhibit Hall
ISCT Global Showcase Lounge
Saturday
2020-05-30
Plenary Hall
Plenary & Level 2 Foyers
Plenary Foyer
Plenary Hall
Offsite
Poster Hall
Exhibit Hall
ISCT Global Showcase Lounge
Offsite
Exhibit Hall
ISCT Global Showcase Lounge
Plenary Hall
Plenary & Level 2 Foyers
Plenary Foyer
08:30 - 10:00
Cell Processing Track Session 1 – Collection and starting materials
08:30 - 10:00
ISCT-Cord Blood Connect Session 1
08:30 - 10:00
GRP Workshop Session 1: Sterility Controls – Past, Present, Future
08:30 - 10:00
MSC Track Session 1 – MSC in normal and pathological tissue microenvironment
10:00 - 10:15
Coffee Break
10:14 - 11:45
Cell Processing Track Session 2 – Selection of cells and gene editing
10:15 - 11:45
ISCT-Cord Blood Connect Session 2
10:15 - 11:45
GRP Workshop Session 2: Post Processing Manufacturing
10:15 - 11:45
MSC Track Session 2 – MSC-derived Extracellular Vesicles: certainty and perspectives
11:45 - 13:00
Lunch
13:00 - 14:30
Cell Processing Track Session 3 – Cell Activation and Expansion
13:00 - 14:30
GRP Workshop Session 3: Combination Products (Biologics/Devices)
13:00 - 14:30
ISCT-Cord Blood Connect Session 3
13:00 - 14:30
MSC Track Session 3 – MSC Manufacturing for Clinical Use and Regulatory Issues
14:30 - 14:45
Coffee Break
14:45 - 16:15
MSC Track Session 4 – MSC-based Clinical Trials Worldwide
14:45 - 16:15
Cell Processing Track Session 4 – Product Characterization, just before product goes to patient
14:45 - 16:15
GRP Workshop Session 4: Topic TBD
14:45 - 16:15
ISCT-Cord Blood Connect Session 4
16:30 - 18:30
Technology Symposium Hosted by Miltenyi
16:30 - 18:30
Technology Symposium Hosted by Thermo Fisher
19:00 - 21:30
ISCT 2020 President’s Welcome Address and Exhibit Open House Reception
07:30 - 08:30
Hot Topic Session 2: Gene Edited and Engineered Cell Based Therapeutics for Cancer
07:30 - 08:30
Hot Topic Session 1: Liver Regenerative Medicine: State of the art, open needs, and next steps
08:30 - 10:30
Presidential Plenary: Mastering Pluripotent Cells With Therapeutic Intent

Full Session Details

Chair:
John Rasko, AO, BSc(Med), MBBS(Hons), PhD,
University of Sydney, AUS

Speakers:
Mario R. Capecchi, PhD, 2007 Nobel Laureate (Physiology or Medicine), University of Utah, USA
Keynote speaker sponsored by Cytotherapy, The official journal of the International Society for Cell & Gene Therapy

Marc Peschanski, MD, PhD, I-Stem, FRA

Rudolf Jaenisch, MD, Whitehead Institute and Massachusetts Institute of Technology, USA

08:30 - 09:00
Opening Remarks
10:30 - 10:45
Global Showcase Presentation by GenScript
10:30 - 11:00
Coffee Break
10:45 - 11:00
Global Showcase Presentation by Sartorius
11:00 - 12:15
Q&O Track Session 1: Qualification, Regulation of Gene Editing Tools in Cell & Gene Therapy

Full Session Details

Recent advances in genome editing technologies have substantially improved our ability to make changes in the genomes of eukaryotic cells. Viral vectors and programmable nucleases are already revolutionizing our ability to interrogate the function of the genome. This session provides an overview of current progress in qualifying and regulating targeted genome editing technologies as they are being used clinically to correct or introduce genetic mutations to treat diseases that are refractory to traditional therapies. Preclinical assessment and GMP manufacturing of these technologies as well as the regulatory requirements for FIH clinical trials utilizing these technologies will be discussed.

Chair:
Shirley Bartido, PhD, MBA, Cellectis, United States

Speakers:
Christopher Ballas, PhD, Rocket Pharma, United States

David Jones, FRSB, FBTS, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Stephan Reynier, MSc, Cellectis, France

11:00 - 12:15
SFC Track Session 1: Innovating Process Development for Sustainable Manufacturing

Full Session Details

Optimizing a product through process development is a natural step in translating the therapeutic to the clinic. While this is a critical milestone, many of the processes have not been optimized for larger-scale industrialization. This session will evaluate how industry innovators are implementing new processing platforms and strategies to position future products for sustainable industrialization

Chair:
Dominic Clarke, PhD, 
HemaCare Corporation, United States

Speakers:
Denis Bedoret, PhD, MaSTherCell Global, Belgium

Stuart Curbishley, PhD, University of Birmingham Medical School, United Kingdom

Ricardo Batista, PhD, Cellectis, France

11:00 - 12:15
Plenary Satellite 2a: MSC Mechanism of Action
11:30 - 01:30
Plenary Session 2: Mesenchymal Stromal Cells- Full Circle from Basic Research Insights to Clinical Trial Updates

Full Session Details

This session will bring together speakers who will provide a full spectrum overview of latest developments in the field of mesenchymal stromal cell research. This includes insights into newly hypothesized mechanisms of action and single cell characterization of mesenchymal stromal cells, clinical translation challenges using pooled bone marrow-derived mesenchymal stromal cells for treatment of refractory Graft-vs. Host Disease, and updates from a pioneering European trial on the use of mesenchymal stromal cells to treat refractory Sclerodoma.

Chair:
Sowmya Viswanathan, PhD, University Health Network Cell Therapy, CAN

Speakers:
Jacques Galipeau, MD
, University of Wisconsin-Madison, USA

Halvard Bönig, MD, PhD,  Johann-Wolfgang-Goethe University, GER

Dominique Farge-Bancel, MD, Paris Diderot University and Hôpital Saint-Louis, FRA

12:15 - 13:45
Lunch with Exhibits
12:30 - 13:30
Lunch & Learn by PBS Biotech
12:30 - 12:45
Global Showcase Presentation by Pall Biotech
12:30 - 13:30
Lunch & Learn by Terumo BCT
13:00 - 13:15
Global Showcase Presentation by AventaCell
15:15 - 15:45
Coffee Break
15:45 - 17:00
SFC Track Session 2: Can we industrialize CAR T therapies? The practical challenges in achieving wide-spread patient access

Full Session Details

Today the first two autologous CAR T therapies are commercialized in multiple developed countries, through dozens of health care facilities, and many hundreds of patients are benefiting from treatment! Now “industrializing” CAR T therapy to gain world-wide, broad patient access to this new standard of care, means not only extensive scale-up of manufacturing capacity but also transforming hundreds of health care centers into CAR T competent treatment sites using either autologous or “off-the-shelf” products in treating patients. What are some key considerations for how academia, industry and healthcare centers can meet this challenge? Today we’ll explore autologous, allogeneic, and stakeholder partnering perspectives from three experts active in pursuing this CAR T industrialization vision.

Chair:
Bill Milligan, Steminent Biotherapies, Canada/Taiwan

Speakers:
Gunther Busam, RPh, PhD, Celgene, Switzerland

Elizabeth Hexner, MD, Penn Medicine, United States

Wen Bo Wang, PhD, Fate Therapeutics, United States

15:45 - 17:00
Plenary Satellite Session 1b: iPSC Derived Organoids
15:45 - 17:00
Workshop: Success and Failure of Cell Therapy Clinical Trials for Acute and Chronic Lung Disease
15:45 - 17:00
Q&O Track Session 2: Manufacturing Process Validation – considerations for validation of autologous products

Full Session Details

Process Validation – it has to happen! Join us to hear regulatory perspectives and real-world examples of considerations specific to autologous products, including both cells and tissues. Are normal donor cells ok to use? What risks are associated with validating your process using cells or tissues from healthy donors?

Chair:
Emily Hopewell, PhD, Indiana University School of Medicine, United States

Speakers:
Antonio Ruiz-Garcia, MPharm, Hospital Universitario Virgen de las Nieves, Spain

Corey Smith, PhD, QIMR Berghofer, Australia

Aisha Khan, MSc, MBA, University of Miami, United States

17:00 - 19:00
Therapeutic Symposium Hosted by Novartis
17:30 - 18:30
Technology Spotlight Hosted by GE Healthcare
18:00 - 18:30
Elevator Pitch Abstract Presentations Session 1
18:00 - 19:30
Poster Session 1
19:00 - 21:00
ISCT Early Stage Professionals (ESP) Networking Reception (By invitation only)
19:30 - 21:30
ISCT Industry Networking Event (By invitation only)
06:30 - 07:30
ISCT 2020 5K Run
07:30 - 08:30
Hot Topic Session 4: Veterinary Medicine
07:30 - 08:30
Hot Topic Session 3: Long-Term Follow-up, Accreditation and Registries for CAR-T Therapy (Joint Session with EBMT)
08:45 - 10:15
Plenary Session 3: Advances and Emerging Technologies in Immune-Mediated Cancer Treatments

Full Session Details

CAR-T Cells represent the first example of a cellular therapy that has moved from immunological concepts developed in research laboratories to worldwide and large-scale industry-manufacturing of potent therapeutic agents. The bumpy road* for these developments exemplify the many scientific challenges that await developers of this class of therapeutics. While scientific developments continue to occur at a high pace for CAR-T and CAR NK therapies, the race to solve the logistical, medical, financial and societal issues is engaged, with the goal to bring this class of therapeutics to all patients in need of them. CAR-T and CAR NK Cells will likely pave the way for other forms of immune cellular therapies, but also for regenerative medicines.

Co-Chairs:
Bruce Levine, PhD, 
University of Pennsylvania, USA

Christian Chabannon, MD, PhD, Institut Paoli Calmettes, FRA

Speakers:
Marcela Maus, MD, PhD, Massachusetts General Hospital and Harvard Medical School, USA

Michael Hudecek, MD, University of Würzburg, GER

Katy Rezvani, MD, PhD, MD Anderson Cancer Center, USA

10:15 - 10:45
Coffee Break
10:30 - 10:45
Global Showcase Presentation by RoosterBio
10:45 - 12:15
Q&O Track Session 3: Regulatory CMC Considerations of ATMPs

Full Session Details

The Q&O track regulatory session will address the hot CMC topics of 2020. For many ATMP products identification of critical quality attributes (CQAs) that can predict clinical outcome is not easy, especially due to inherent variability of the starting materials. Product characterization and selection of most useful assays will be discussed in this session, as well as the GMP constraints across the US and the EU. In the panel discussion regulatory experts from US, EU and Japan will address the CMC readiness of companies and regulatory authorities in the context of the expedited regulatory programs of ATMPs.

Chair:
Paula Salmikangas, PhD, NDA Advisory Services Ltd., Finland

Speakers:
Christopher Bravery, PhD, Advbiols, United Kingdom

Shinichi NodaPhD, Pharmaceuticals and Medical Devices Agency(PMDA), Japan

Rocio Salvador-Roldan, European Commission, Belgium

10:45 - 12:15
Plenary Satellite 4a: Industrializing Clinical Delivery
10:45 - 12:15
OC Session: Imaging Cellular Therapeutics (Joint Session with HESI CT-TRACS)
10:45 - 12:15
SFC Session 3: Raising capital for CGT industrialization

Full Session Details

In this session we will discuss the current landscape of cell and gene therapies from the investor’s perspective. As these therapies reach more advanced stages of development and eventually commercialization the capital requirements will continue to increase – and along with this the need to expand the scope of the investor base.  We aim to address the following questions:

  • How do investors characterize opportunities for CGT companies relative to more traditional drug modalities?
  • What role does pharma need to play to support the CGT ecosystem?
  • Will investor appetite for CGT continue to increase, or have we hit a local maximum?
Chair:
Patrick Rivers, MBA, Aquilo Capital, United States

Speakers:
Jak Knowles, MD, Leaps by Bayer, United States

10:45 - 12:15
ISCT Presidential Task Force Session
10:45 - 12:15
Plenary Satellite Session 3a: Immunotherapy Oral Abstracts
12:15 - 13:45
Lunch with Exhibits
12:30 - 13:30
Lunch & Learn by GE Healthcare
12:30 - 12:45
Global Showcase Presentation by Pall Biotech
12:30 - 13:30
Lunch & Learn by MaxCyte
13:45 - 15:15
Plenary Session 4: Is Big Pharma ready for industrial scale Cell and Gene Therapy?

Full Session Details

Recent successes in the market authorization of cell and gene therapy products has generated tremendous excitement. However. to be successful, the industry now needs to move into a phase of industrialization, where like the car industry it needs the “eureka” moment of standardization that allows the efficient flow from product to patient. To realize this, we need to overcome the barriers between all the silos in the system (e.g. hospital, manufacture, testing, etc.) so that patients are efficiently treated.

Chair:
Anthony Ting, PhD, Athersys, United States

Speakers:
Angela Krackhardt, MD, Technical University of Munich, Germany

Alberto Santagostino, MBA, Lonza, Switzerland

Emanuele Ostuni, PhD, Novartis Oncology, Switzerland

15:15 - 15:45
Coffee Break
15:45 - 17:00
Plenary Satellite 4b: Industrializing the administration setting

Full Session Details

The supply chain is working now but how will it cope when there are tens of therapies and thousands of patients, globally? The “hidden challenge” is the last 100m within the clinical setting. Here, we will describe ways the infrastructure, equipment, staffing, training, and systems need to be designed to operate efficiently to treat the patients.

Chair:
Julie Murrell, PhD, 
MilliporeSigma, United States

Speakers:
Christopher Herbert, PhD, Leeds Teaching Hospitals NHS Trust, United Kingdom

Anne Black, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom

Christoph Demmerle, Novartis, Germany

15:45 - 17:00
SFC Track Session 4: Best practices for funding CGT startups from academia

Full Session Details

The path to taking a great platform or therapeutic program that has been incubated at an academic center and turning it into a biotech company is fraught with peril and cautionary tales. We want to explore the lessons learned by academic founders of successfully funded academic spin-outs and provide a better blueprint for others who are wondering how to pursue the creation of a company around their novel science.

Chair:
Patrick Rivers, MBA, Aquilo Capital, United States

Speakers:
Mike Milone, MD, PhD, Cabaletta Bio, United States

Colleen Delaney, MD, MSc, Nohla Therapeutics, United States

15:45 - 17:00
Q&O Track Session 4: Starting & Raw Material Selection for ATMP Manufacturing

Full Session Details

Starting and raw material selection is an essential aspect that need to be considered for ATMP manufacturing in order to guarantee quality of medicinal products to be used in patients. During this session the most important aspects regarding starting and raw material selection for ATMP manufacturing are going to be reviewed such as:

  • Differences in donor eligibility requirements, regulatory aspects to comply during donor selection and ethical considerations
  • Critical aspects to consider when using biological raw materials for ATMP manufacturing
  • Challenges to consider during vector production and control
  • Appropriate conditions to establish and test when using seed lots and cell banks
Chair:
Gloria Carmona, MPharm, Andalusian Network for Design and Translation of Advanced Therapies, Spain

Speakers:
Craig Spalding, MBA, Scottish National Blood Transfusion Service, United Kingdom

Rosaria Giordano, MD, Center of Cellular Therapy – Cell Factory Fondazione Ca’ Granda Ospedale Maggiore Policlinico, Italy

Daniela Bischof, PhD, Indiana University School of Medicine, United States

Gerhard Bauer, PhD, University of California Davis Institute for Regenerative Cures, United States

15:45 - 17:00
Plenary Satellite Session 3b: CAR-T for Solid Tumors
17:30 - 18:00
Elevator Pitch Abstract Presentations Session 2
17:30 - 19:00
Poster Session 2
19:00 - 23:00
ISCT 2020 Gala

Pavillons des Bercy

08:00 - 09:00
Q&O Track Session 5: Characterization of active substance and comparability

Full Session Details

Chair:
Rosemarie Bell, B.App.Sc Micro/Biochem MASM, Q-Gen Cell Therapeutics QIMR Berghofer Medical Research Institute, Australia

Speakers:
Mehrshid Alai-Safer, PhD, Kite Pharmaceuticals, United States

Mohamed Heidaran, PhD, Parexel International, United States

Krishnendu Roy, PhD, Georgia Institute of Technology, United States

08:00 - 09:00
Hot Topic Session 6: Safety Matters for Regenerated Tissues (Joint Session with TERMIS EU)
08:00 - 09:00
SFC Track Session 5: Providing effective cellular therapies in the face of commercialization – meeting patients’ needs and expectations

Full Session Details

Commercialization of cellular and gene therapies is irrelevant if the patients do not receive the therapy they require. As we industrialize the manufacturing of such products, assuming equivalent efficacy, the therapy that is the easiest to adopt, depending on process and cost, and is the least difficult for the patient to tolerate will be the most widely adopted. To arrive at this endpoint, we need to understand the patient’s needs and expectations when they consider cell and gene therapy options. In this context, it is important to discriminate between legitimate, safe and effective therapies versus alternative treatments that are offered to patients who are desperate. Cell and gene therapies, and particularly stem cell therapies need be placed into the category of highly advanced and often life saving therapies, if chosen and administered in a responsible and ethical way.

Chair:
Gerhard Bauer, PhD, 
University of California, Davis Institute for Regenerative Cures, United States

Speakers:
Kathie Rodden, NHS University Hospitals of Birmingham, United Kingdom

Mohamed Abou-El-Enein, MD, PhD, Charité – Universitätsmedizin Berlin, Germany

Mark Yarborough, PhD, University of California, Davis, United States

08:00 - 09:00
Hot Topic Session 5: The spleen plays a critical role in modulating therapeutic outcomes following administration of cellular therapies in acute treatment settings
09:15 - 10:45
Plenary Session 5: Gene Engineering: The Past, Present and the Future

Full Session Details

Gene-engineering is currently ‘in-vogue’ as a potential treatment for multiple monogenetic and rare diseases. This session will highlight the progress in the field of gene-insertion, vector biology and gene-editing for both the ex-vivo and in-vivo approaches of gene manipulation. The current challenges and safety issues will be discussed, with the spotlight on ongoing clinical trials as examples of potential curative therapies.

Chair:
Sandeep Soni, MD, Standford University, USA

Speakers:
Donald Kohn, MD, University of California Los Angeles, USA

Paula Rio, PhD, Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT), SPA

Carlos Fonck, PhD, DABT, BioMarin Pharmaceuticals Inc., USA

10:45 - 11:00
Coffee Break
11:00 - 12:00
SFC Track Session 6: Clinical experience in regenerative medicine and tissue engineering, the next wave of advanced therapies

Full Session Details

Chair:
Julie Allickson, PhD, Wake Forest Institute for Regenerative Medicine, United States

Speakers:
Petter Björquist, PhD, 
VERIGRAFT AB, Sweden

Martin Birchall, MD, University College London, United Kingdom

Heather Prichard, PhD, Humacyte, United States

11:00 - 12:00
Plenary Satellite Session 5a: Gene Therapy Clinical Trials
11:00 - 12:00
Plenary Satellite 6a: EV Technical Considerations
11:00 - 12:00
Q&O Track Session 6: Analytical Tools and Method Development

Full Session Details

Chair:
Gerry McKiernan, Cell Therapies Pty Ltd, Australia

Speaker:
Sophie Paczensy, MD, PhD, Indiana University School of Medicine, United States

Gerry McKiernan
Cell Therapies Pty Ltd, AUS
Sophie Paczensy, MD, PhD
Indiana University School of Medicine, USA
12:00 - 13:30
Lunch
12:15 - 12:35
ISCT Annual General Business Meeting
13:30 - 15:00
Plenary Session 6: Basics and translational potential of extracellular vesicles including exosomes

Full Session Details

Most cells release Extracellular Vesicles (EVs) into their environment. In particular, small EVs of 50-200 nm that include exosomes, have been shown to mediate intercellular communication in many physiological and pathophysiological processes. Small EVs from some cell sources, e.g. mesenchymal stromal cells (MSCs), can alleviate pathological processes and are considered as novel therapeutic agents. Within the session basic aspects of EV biology and their therapeutic potential will be discussed.

Chair:
Bernd Giebel, PhD, 
University Hospital Essen, Institute for Transfusion, GER

Speakers:
Clotilde Théry, PhD, Institut Curie, INSERM, FRA

Sai-Kiang Lim, PhD, Institute of Medical Biology, A*STAR, SGP

Rebecca Lim, PhD, Monash University, AUS

15:00 - 15:15
Coffee Break
15:15 - 16:30
Q&O Track Session 7: GMP Manufacturing Challenges

Full Session Details

Chair:
Shiraz Ziya, PhD, Sartorius Stedim UK Ltd, United Kingdom

Speaker:
Angela Osborne, PhD, eXmoor pharma concepts ltd, United Kingdom

Linda Kelley, PhD, Moffitt Cancer Center, United States

15:15 - 16:30
SFC Track Session 7: Fast Track Regulations

Full Session Details

Recent years have seen an increase in the number of fast track regulatory pathways available to developers, many of which are intended to accelerate commercialisation of promising cell and gene therapies. As these pathways begin to be tested and products are commercialised through them, this session will focus on both the opportunities and challenges that they present. Key differences between geographies will be discussed and how these novel pathways affect global product development plans.

Chair:
Siofradh McMahon, MSc, 
CCRM, Canada

Speaker:
Katy Spink, PhD, Dark Horse Consulting, United States

15:15 - 16:30
Plenary Satellite 5b: Ex-Vivo Stem Cell Based Clinical Trials
15:15 - 16:30
Plenary Satellite 6b: ISCT-ISEV Joint Session: MSC-EVs
15:15 - 16:30
Early Stage Professionals Session
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