Program

ISCT is pleased to present the Final Program to help you plan your ISCT 2017 London experience. View it Here.

What’s new for 2017?

  • 6 Hot Topic Roundtable sessions designed to cover the most cutting edge issues in the field
  • Oral Abstract Presentations held in Plenary Breakout Sessions alongside world renowned plenary speakers
  • Corporate Product Theatres – a chance to view new technologies, cutting edge product presentations, and corporate profiles

Click each session for confirmed speakers – updated March 28, 2017

Pre-Conference Day

Session Type
Cell Processing Track
Global Regulatory Perspectives (GRP)
Cord Blood Series
Cord Blood Quality Bootcamp
State of the Art in European MSC Clinical Trials
Corporate
07:00
07:30
08:00
08:30
09:00
09:30
10:00
10:30
11:00
11:30
12:00
12:30
13:00
13:30
14:00
14:30
15:00
15:30
16:00
16:30
17:00
17:30
18:00
18:30
19:00
19:30
20:00
20:30
21:00
21:30
Cell Processing Track Session 1 - ISCT-EBMT Joint Session: The Evolving Role of the Stem Cell Lab Part 1
Click to view confirmed speakers
Cell Processing Track Session 1 - ISCT-EBMT Joint Session: The Evolving Role of the Stem Cell Lab Part 1
08:00 - 10:30
Click to view confirmed speakers
Chair:
Mark Lowdell, PhD, FRCPath, FRSB, Royal Free Hopsital and University College London, United Kingdom
Speakers:
Boris Calmels, PharmD, PhD, Institut Paoli-Calmettes, France
Automation of HSCT processing

Christian Chabannon, MD, PhD, Institut Paoli Calmettes, France
High dose therapy and autologous HSCT for CaBr – time to revisit?

Ineke Slaper-Cortenbach, PhD, ZonMw, Netherlands
Challenges of accommodating GMP in hospital based labs supporting ATMP Trials

Paolo Muraro, MD, PhD, Imperial College London, United Kingdom
Current State of the Art in HSCT for MS

Welcome and Regulatory Roundup
Click to view confirmed speakers
Welcome and Regulatory Roundup
Speakers:
Karen Nichols, Esq.,VP, Regulatory and Quality, NantKwest Inc., United States
Dominic Wall, PhD, FFSc(RCPA), Operations Director, Peter MacCallum Cancer Centre, Australia
Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, United States

Global Regulatory Perspectives Workshop Session 1 - Genetic Modification
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Global Regulatory Perspectives Workshop Session 1 - Genetic Modification
08:30 - 10:00
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Moderator:
David DiGiusto, PhD, Executive Director, Stem Cells and Cellular Therapeutics Operations, Stanford Healthcare, United States
Speakers:
Matthias Renner, PhD, Deputy Head Non-Viral Gene Transfer Medicinal Products, Paul-Ehrlich-Institut, Germany
Michael Havert, PhD, Gene Therapy Reviewer, FDA, United States
Anne Dupraz Poiseau, PhD, Chief Regulatory Officer, Orchard Therapeutics, Ltd, United Kingdom

Case Study I
Case Study I

Cell Processing Track Session 2 - The Evolving Role of the Stem Cell Lab Part 2
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Cell Processing Track Session 2 - The Evolving Role of the Stem Cell Lab Part 2
10:45 - 12:45
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Chair:
Jaap Jan Boelens, MD, PhD, UMC Utrecht, Netherlands
Christian Chabannon, MD, PhD, Institut Paoli Calmettes, France
Speakers:
Ronjon Chakraverty, MBChB, PhD, University College London, United Kingdom
Novel strategies for Alloreactive ex-vivo T cell depletion

Martin Hildebrandt, MD, Technische Universität München, Germany
From Tissues and Cells to ATMPs – Definitions and Challenges

Mikkel Rosendahl, PhD, Copenhagen University Hospital, Denmark
Ovarian tissue cryopreservation for reconstitution of fertility post radiotherapy

Mark Lowdell, PhD, FRCPath, FRSB, Royal Free Hospital and University College London, United Kingdom
The role of the hospital Stem Cell Lab in delivery of ATMPs for clinical trials

Global Regulatory Perspectives Workshop Session 2 - Global Strategy for Development and Supply of Gene-Modified Cell Products
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Global Regulatory Perspectives Workshop Session 2 - Global Strategy for Development and Supply of Gene-Modified Cell Products
10:45 - 12:15
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Moderator:
Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd., United Kingdom
Speakers:
Martha French, BS, Vice President of Regulatory Affairs, Bellicum Pharmaceuticals, Inc.,United States

Case Study II
Case Study II

Lunch with Exhibits
Lunch with Exhibits
12:45 - 13:45

Cell Processing Track Session 3 - Product Characterization by Flow Cytometry Part 1
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Cell Processing Track Session 3 - Product Characterization by Flow Cytometry Part 1
13:45 - 14:45
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Speakers:
Ruud Hulpas, PhD, Cellular Technologies Bioconsulting, United States
Challenges in Flow Cytometry for Commercial Cell Therapy

John T. Elliott, PhD, NIST, United States
Using Artificial Reference Materials on a Flow Cytometer

Luisa de Jesus Saraiva, PhD, National Institute for Biological Standards and Control, United Kingdom
Biological Reference Material for Flow Cytometry

Global Regulatory Perspectives Workshop Session 3- Replication Competent Vector Testing of Gene-Modified Cell Therapy Products
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Global Regulatory Perspectives Workshop Session 3- Replication Competent Vector Testing of Gene-Modified Cell Therapy Products
13:45 - 14:45
Click to view confirmed speakers
Moderator:
Janet MacPherson, PhD, Development Manager, Royal Prince Alfred Hospital, Australia
Speakers:
Michael Havert, PhD, Gene Therapy Reviewer, FDA, United States
James Miskin, PhD, Chief Technical Officer, Oxford BioMedica, United Kingdom

Cell Processing Track Session 4 - Product Characterization by Flow Cytometry Part 2
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Cell Processing Track Session 4 - Product Characterization by Flow Cytometry Part 2
15:00 - 16:15
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Speakers:
Harry Dolstra, PhD, ‎Radboud University Nijmegen Medical Centre, Netherlands
Flow Cytometry-based QC Analysis of Cell Therapy Products

Renold Capocasale, BSc, FlowMetric Inc, United States
Validated Flow Cytometry: A Critical Check Point for Cellular Therapeutics

Tamara Laskowski, PhD, MD Anderson Cancer Center, United States
Harnessing the power of high-throughput multi-parameter flow cytometry to improve analysis of CAR T-cell cytotoxic function

Global Regulatory Perspectives Workshop Session 4 - Clinical Trials - Patient Populations in Developing Regulatory Regions
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Global Regulatory Perspectives Workshop Session 4 - Clinical Trials - Patient Populations in Developing Regulatory Regions
15:00 - 16:30
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Moderator:
Dominic Wall, PhD, FFSc(RCPA), Operations Director, Peter MacCallum Cancer Centre, Australia
Speakers:
Azizah Ab Ghani, PhD, Senior Principal Assistant Director, Head of Biologics Section, National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia, Malaysia
Peter Olagunju, MBA, ASQ-CQA, Senior Director, Commercial CMC Operations, bluebird bio, United States

Case Study III & Closing Remarks
Case Study III & Closing Remarks
16:30 - 17:15

ISCT 2017 President's Welcome
ISCT 2017 President's Welcome

Exhibit Open House and 25th Anniversary Silver Jubilee Celebration
Exhibit Open House and 25th Anniversary Silver Jubilee Celebration
19:30 - 21:30

ISCT-CBA Cord Blood Series Session 1 - CBT as a Platform for Cellular Therapy
Click to view confirmed speakers.
ISCT-CBA Cord Blood Series Session 1 - CBT as a Platform for Cellular Therapy
08:00 - 10:30
Click to view confirmed speakers.
Chair:
Juliet Barker, MBBS, Memorial Sloan Kettering Cancer Center, United States
Speakers:
Juliet Barker, MBBS, Memorial Sloan Kettering Cancer Center, United States
Elizabeth J. Shpall, MD, MD Anderson Cancer Center, United States
Jaap Jan Boelens, MD, PhD, UMC Utrecht, Netherlands

ISCT-FACT Cord Blood Quality Boot Camp Session 1
ISCT-FACT Cord Blood Quality Boot Camp Session 1
08:00 - 10:30

State of the Art in European MSC Clinical Trials Session 1
Organized by the ISCT MSC Committee in cooperation with the European Commission
State of the Art in European MSC Clinical Trials Session 1
08:00 - 10:30
Organized by the ISCT MSC Committee in cooperation with the European Commission
Chair:
Jacques Galipeau, MD FRCP(C), University of Wisconsin in Madison, United States
Speakers:
Frank Barry, PhD, REMEDI Regenerative Medicine Institute, Ireland
Eleuterio Lombardo,PhD, TiGenix SAU, Spain
Antonio Uccelli, MD, University of Genoa Department of Neurosciences, Italy
Charles Kessler, PhD, European Commission, Belgium
Willem Fibbe, MD, PhD, Leiden University Medical Center, Netherlands

- Introduction
- The EU Perspective on advanced MSC clinical trials
- MSC biology and manufacturing challenges
- MSC for GvHD
- MSC for multiple sclerosis

ISCT-CBA Cord Blood Series Session 2 - Immunotherapy
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ISCT-CBA Cord Blood Series Session 2 - Immunotherapy
10:45 - 12:45
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Chair:
Elizabeth J. Shpall, MD, MD Anderson Cancer Center, United States
Speakers:
Colleen Delaney, MD, MSc, Nohla Therapeutics, United States
Catherine Bollard, MBChB, MD, Children's National Medical Center and The George Washington University, United States
Katy Rezvani, MD, PhD, MD Anderson Cancer Center, United States

ISCT-FACT Cord Blood Quality Boot Camp Session 2
ISCT-FACT Cord Blood Quality Boot Camp Session 2
10:45 - 12:45

State of the Art in European MSC Clinical Trials Session 2
Organized by the ISCT MSC Committee in cooperation with the European Commission
State of the Art in European MSC Clinical Trials Session 2
10:45 - 12:45
Organized by the ISCT MSC Committee in cooperation with the European Commission
Chair:
Ivan Martin, PhD,University Hospital Basel, Switzerland
Speakers:
Enrique Gomez Barrena, MD, PhD, Hospital Universitario La Paz, Spain
Jens Kastrup, MD, DMSC, Rigshospitalet, Denmark
Christian Jorgensen, MD, PhD,Institute for Regenerative Medicine & Biotherapy (IRMB), France

- MSC for Osteoarthritis
- MSC for bone repair
- MSC for cartilage repair
- MSC for cardiac repair

ISCT-CBA Cord Blood Series Session 3 - Regenerative Medicine for Pediatric Diseases
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ISCT-CBA Cord Blood Series Session 3 - Regenerative Medicine for Pediatric Diseases
13:45 - 14:45
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Chair:
Joanne Kurtzberg, MD, Duke University Medical Center, United States
Speakers:
Joanne Kurtzberg, MD, Duke University Medical Center, United States

ISCT-FACT Cord Blood Quality Boot Camp Session 3
ISCT-FACT Cord Blood Quality Boot Camp Session 3
13:45 - 14:45

State of the Art in European Clinical Trials Session 3
Organized by the ISCT MSC Committee in cooperation with the European Commission
State of the Art in European Clinical Trials Session 3
13:45 - 14:45
Organized by the ISCT MSC Committee in cooperation with the European Commission
Chair:
Katarina LeBlanc, MD, PhD, Karolinska University Hospital Huddinge, Sweden
Speakers:
Francesco Dazzi, MD, PhD King's College London, United Kingdom

- MSC for sepsis - MSC for kidney transplantation

ISCT-CBA Cord Blood Series Session 4 - Autologous Regulation
ISCT-CBA Cord Blood Series Session 4 - Autologous Regulation
15:00 - 16:15
Speakers:
Jonathan Kimmelman, PhD, McGill University, Canada

ISCT-FACT Cord Blood Quality Boot Camp Session 4
ISCT-FACT Cord Blood Quality Boot Camp Session 4
15:00 - 16:15

Corporate Symposium - Miltenyi Biotec
Click to view speakers & description
Corporate Symposium - Miltenyi Biotec
16:30 - 18:30
Click to view speakers & description
Chair:
John Maher, PhD, FRCPath, FRSB, King’s College London, United Kingdom
Speakers:
Nina Kotsopoulou, PhD, Autolus Ltd., London, United Kingdom
Carolyn A. Keever-Taylor, PhD, Medical College of Wisconsin, United States
Alan Smith, PhD, Bellicum Pharmaceuticals, United States
Lawrence S. Lamb Jr., PhD, University of Alabama at Birmingham, United States

Essential Elements for Robust Cell Manufacturing

Join us for two hours of stimulating talks highlighting recent advances in automated manufacturing methods in a closed system for the production of T cells for clinical applications. A variety of perspectives and experiences will be represented, with speakers from academic medical centers to biopharmaceutical companies. Topics will include CAR T CMC strategies and manufacturing experiences with CAR T and γ/δ T cells.

Pre-Conference Day
Session Type
Hot Topics
Plenary Sessions
Plenary Breakout Sessions
Regulatory Track
Strategies for Commercialization Track
Quality and Operations Track
Corporate
07:00
07:30
08:00
08:30
09:00
09:30
10:00
10:30
11:00
11:30
12:00
12:30
13:00
13:30
14:00
14:30
15:00
15:30
16:00
16:30
17:00
17:30
18:00
18:30
19:00
19:30
Outer Column
Outer Column
Hot Topic Roundtable Session 1 - Potency Assays in ATMP Development and Delivery
Hot Topic Roundtable Session 1 - Potency Assays in ATMP Development and Delivery
07:30 - 08:30
Chair:
Mark Lowdell, PhD, FRCPath, FRSB, Royal Free Hospital and University College London, United Kingdom
Ruud Hulpas, PhD, Cellular Technologies Bioconsulting, United States
Speakers:
Ben Weil, MEng MRes AMIChemE EngD, University College London, United Kingdom
Wen Bo Wang, PhD, Cellular Dynamics International, a Fujifilm company, United States

Hot Topic Roundtable Session 2 - Advances in Stem Cell Based Therapeutics for Cancer
Click to view confirmed speakers
Hot Topic Roundtable Session 2 - Advances in Stem Cell Based Therapeutics for Cancer
07:30 - 08:30
Click to view confirmed speakers
Chair:
Massimo Dominici, MD University of Modena and Reggio Emilia, Italy
Khalid Shah, MS, PhD, MGH, Harvard Medical School, United States
Speakers:
Massimo Dominici, MD University of Modena and Reggio Emilia, Italy
Khalid Shah, MS, PhD, MGH, Harvard Medical School, United States
Samuel Janes, MBBS, PhD, University College London, United Kingdom

Successful treatment of both primary and metastatic tumors remains one of the greatest challenges in oncology. The recognition that different stem cell types can home to tumors following transplantation has unveiled new possibilities for their use in cancer therapy. Previously published studies have shown that different stem cell types home to tumors and thus can be armed with therapeutic transgenes, a strategy that can be used to inhibit tumor growth by targeting angiogenesis or selectively inducing apoptosis in proliferating tumor cells. Recently, studies have demonstrated the translational potential of stem cells engineered to release novel therapeutic proteins and oncolytic viruses by testing them in mouse models of primary and metastatic tumors that mimic clinical settings. This proposed session aims at bringing together investigators who have engineered different stem cell types to express tumor specific therapeutic proteins, microRNAs or release oncolytic viruses and demonstrated novel pre-clinical efficacy of engineered stem cells in mouse tumor models and in clinical studies.

Plenary Session 1 - Presidential Plenary on T-Cell Immunotherapy
Click to view confirmed speakers
Plenary Session 1 - Presidential Plenary on T-Cell Immunotherapy
09:00 - 10:30
Click to view confirmed speakers
Chair:
Catherine Bollard, MBChB, MD, Children's National Medical Center and The George Washington University, United States
Speakers:
Martin Pule, MB BCh, University College London, United Kingdom
Helen Heslop, MD, DSc (Hon), Baylor College of Medicine, United States
Chiara Bonini, MD, San Raffaele Scientific Institute, Italy

Coffee Break with Exhibits
Coffee Break with Exhibits

T-Cell Immunotherapy Plenary Breakout 1 - Virus Specific T Cells
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T-Cell Immunotherapy Plenary Breakout 1 - Virus Specific T Cells
11:00 - 12:15
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Chair:
Helen Heslop, MD, DSc (Hon), Baylor College of Medicine, United States
Speakers:
Karl Peggs, MD, MRCP, FRCPath, University College London, United Kingdom
Ann Leen, PhD, Baylor College of Medicine, United States

Oral Abstract Presentations:

Allistair Abraham

Children's National Medical Center, United States
SUCCESSFUL ENGRAFTMENT BUT HIGH VIRAL REACTIVATION AFTER REDUCED INTENSITY UNRELATED UMBILICAL CORD BLOOD TRANSPLANTATION FOR SICKLE CELL DISEASE

Michael Keller
Children's National Medical Center, United States
ADOPTIVE T CELL IMMUNOTHERAPY RESTORES TARGETED ANTIVIRAL IMMUNITY IN IMMUNODEFICIENT PATIENTS

T-Cell Immunotherapy Plenary Breakout 2 - Gene Engineered T Cells
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T-Cell Immunotherapy Plenary Breakout 2 - Gene Engineered T Cells
11:00 - 12:15
Click to view confirmed speakers
Chair:
Chiara Bonini, MD, San Raffaele Scientific Institute, Italy
Speakers:
Saar Gill, MD, PhD , University of Pennsylvania, United States

Oral Abstract Presentations:

Sarah Tettamanti

Clinica Pediatrica, Università Milano Bicocca, Osp. San Gerardo/Fondazione MBBM, Italy
Balance of anti-CD123 Chimeric Antigen Receptor (CAR) binding affinity and density for the targeting of Acute Myeloid Leukemia

Annu Luostarinen
Finnish Red Cross Blood Service, Finland
Low IL-2 concentration favors generation of early memory T cells over terminal effectors during CAR T-cell expansion

Josephine Dietrich
Cellex Patient Treatment GmbH, Germany
Targeting leukemia using an inducible universal chimeric antigen receptor (UniCAR) T cell technology

Non-Malignant Diseases Immunotherapy Plenary Breakout 1 - MSC in Autoimmune Disease
Non-Malignant Diseases Immunotherapy Plenary Breakout 1 - MSC in Autoimmune Disease
11:00 - 12:15
Chair:
Fernando Figueroa, MD, University of Los Andes, Chile
Speakers:
Fernando Figueroa, MD, University of Los Andes, Chile
Farida Djouad, PhD, French Institute of Health and Medical Research, France

Oral Abstract Presentations:

Hala Gabr

Cairo University, Egypt
Autologous Mesenchymal Stem Cell Therapy in Behcet Disease

Ana Cardesa Gil
Andalusian Initiative for Advanced Therapies, Spain
A multicenter randomized clinical trial evaluating the safety and feasibility of the treatment of GvHD with allogenic mesenchymal stem cells (MSC) from adipose tissue

Lunch with Exhibits
Exhibit Hall
Lunch with Exhibits
12:15 - 13:45
Exhibit Hall

Plenary Session 2 - Immunotherapy of Non-Malignant Diseases
Click to view confirmed speakers
Plenary Session 2 - Immunotherapy of Non-Malignant Diseases
13:45 - 15:15
Click to view confirmed speakers
Chair:
Giovanna Lombardi, PhD, King's College London, United Kingdom
Speakers:
Aimee Payne, MD, PhD, University of Pennsylvania, United States
Megan Levings, PhD, University of British Columbia, Canada
Fernando Figueroa, MD, University of Los Andes, Chile

T-Cell Immunotherapy Plenary Breakout 3 - CAR T Cells
Click to view confirmed speakers
T-Cell Immunotherapy Plenary Breakout 3 - CAR T Cells
15:30 - 17:00
Click to view confirmed speakers
Chair:
Martin Pule, MB BCh, University College London, United Kingdom
Speakers:
John Maher, MD, PhD King's College London, United Kingdom

Oral Abstract Presentations:

Carlos Ramos

Baylor College of Medicine, Houston Methodist Hospital and Texas Children's Hospital, United States
DIRECT COMPARISON OF IN VIVO FATE OF SECOND AND THIRD-GENERATION CD19-SPECIFIC CHIMERIC ANTIGEN RECEPTOR (CAR)-T CELLS IN PATIENTS WITH B CELL NON-HODGKIN LYMPHOMA (B-NHL): REVERSAL OF TOXICITY FROM TONIC SIGNALING

George Hucks
Children's Hospital of Philadelphia, United States
Humanized Chimeric Antigen Receptor (CAR)-modified T cells Targeting CD19 Induce Remissions in Children and Young Adults with Relapsed/Refractory Lymphoblastic Leukemia/Lymphoma

David Bishop
Westmead Institute for Medical Research; Westmead Hospital; The University of Sydney, Australia
DIFFERING CO-STIMULATORY, LINKER AND SPACER DOMAINS PRODUCE VARIATIONS IN CD4 AND CD8 CELL COMPOSITION AND CYTOTOXIC POTENTIAL IN CD19-SPECIFIC CHIMERIC ANTIGEN RECEPTOR (CAR19) T CELLS GENERATED WITH THE PIGGYBAC TRANSPOSASE.

Dror Mevorach
Hadassah-Hebrew University, Israel
Apoptotic Cells Therapy for the Prevention of Cytokine Release Syndrome (CRS) in CAR T-Cell Therapy

ISCT Chief Scientific Officer Abstract Showcase
Click to view confirmed presenters
ISCT Chief Scientific Officer Abstract Showcase
15:30 - 17:00
Click to view confirmed presenters
Chair:
Daniel J. Weiss, MD, PhD, University of Vermont College of Medicine, United States

Oral Abstract Presentations:

John Rasko

Royal Prince Alfred Hospital; University of Sydney; Centenary Institute, Australia
LentiGlobin Gene Therapy for Transfusion-Dependent β-Thalassemia: Update from the Northstar HGB-204 Phase 1/2 Clinical Study

Luca Urbani
UCL Great Ormond Street Institute of Child Health, United Kingdom
Development of a bioartificial oesophagus engineered with primary mesoangioblasts, neural and epithelial cells for preclinical studies

Kenneth Kotz
Draper Laboratory, United States
SEPARATION OF LYMPHOCYTES USING ACOUSTIC MICROFLUIDICS

Anthony Criquet
CellProthera, France
CHALLENGES BETWEEN CLINICAL SITES AND CELL THERAPY FACILITIES IN THE EXCELLENT TRIAL (EXPANDED CELL ENDOCARDIAC TRANSPLANTATION), A PHASE I/IIb CLINICAL TRIAL.

Michael Watts
University College London Hospitals, United Kingdom
VALIDATION OF AN ENFORCED CHANGE IN CRYOPRESERVATION METHOD AFTER HYDROXYETHYLSTARCH (HES) WITHDRAWAL: ENGRAFTMENT KINETICS OF 1007 AUTOGRAFT PROCEDURES

Yael Gothelf
BrainStorm Cell-Therapeutics, Israel
Safety and Efficacy of transplantation of NurOwn (Autologous Mesenchymal Stromal Cells Secreting Neurotrophic Factors) in Patients with ALS: a Phase 2 Randomized Double Blind Placebo Controlled Trial

Non-Malignant Diseases Immunotherapy Plenary Breakout Session 2 - Alloantigen Specific T Reg
Click to view confirmed speakers
Non-Malignant Diseases Immunotherapy Plenary Breakout Session 2 - Alloantigen Specific T Reg
15:30 - 17:00
Click to view confirmed speakers
Chair:
Megan Levings, PhD, University of British Columbia, Canada
Aimee Payne, MD, PhD, University of Pennsylvania, United States
Speakers:
Giovanna Lombardi, PhD, King's College London, United Kingdom

Oral Abstract Presentations:

Anke Fuchs (Theil)

Technische Universität Dresden, Medical Faculty; University Hospital Carl Gustav Carus, Germany
Regulatory T cell kinetics following adoptive transfer of expanded allogeneic regulatory T cells into patients with chronic graft-versus host disease

Krishna Komanduri
University of Miami, United States
Marked in vivo Donor Treg expansion via targeting of the IL-2/CD25 and TL1A/TNFRSF25 pathways ameliorates GVHD and preserves GVL

Halvard Boenig
Johann-Wolfgang-Goethe University, Frankfurt, Germany
Add back of selectively depleted alloreactive T-cells retaining the full immune repertoire of mature T-cells improves event-free survival (GRFS) and overall survival in a T-cell depleted haploidentical HSCT

Corporate Symposium - Terumo BCT
Click to view speakers & description
Corporate Symposium - Terumo BCT
17:30 - 19:30
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Chair:
Jim Beltzer, PhD, Terumo BCT, United States
Speakers:
Gerold Schuler, MD, University Hospital Erlangen, Germany
Annette Ekblond, MSc, PhD, University of Copenhagen, Denmark
Introna Martino, MD, PhD, ASST Papa Giovanni XXIII, Italy
Jim Beltzer, PhD, Terumo BCT, United States

Cell Manufacturing: Overcoming Challenges and Defining the Future

Agenda:

Introduction

Talk one: Cultivation of Dendritic Cells - From Beginning to the Future
Talk two: Leaving the Comfort Zone: Autologous to Allogeneic
Talk three: Addressing Practical Challenges in Cell Manufacture: Framing a Cost Analysis
Talk four: Case Studies for Scaling Cell Therapy Manufacture Next Generation Quantum System Protocols: Mesenchymal Stem Cells, T-cells and Viral Vector Production

Questions will be taken following the presentations.

Share Your Perspective Event
Drinks and Hors d'oeuvre will be served

Inner Column
Inner Column
Advanced Practice Professionals Track Session 1 - Predictors of Allogeneic Transplant Outcomes
Click to view confirmed speakers
Advanced Practice Professionals Track Session 1 - Predictors of Allogeneic Transplant Outcomes
07:30 - 08:30
Click to view confirmed speakers
Chair:
Valkal Bhatt, PharmD, BCOP, BCPS, Memorial Sloan Kettering Cancer Center, United States
Speakers:
Maria Gilleece, MD, FRCP, FRCPath, Leeds Teaching Hospitals Trust, United Kingdom
Tobi Fisher, PA-C, UT MD Anderson Cancer Center, United States

Corporate Breakfast Tutorial Hosted by GE Healthcare
Click to view speakers & description
Corporate Breakfast Tutorial Hosted by GE Healthcare
07:30 - 08:30
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Chair:
Philip Vanek, PhD, GE Healthcare, United States
Speakers:
Dolores Baksh, PhD, GE Healthcare, United States

Adopting Flexible and Versatile Manufacturing Equipment to Automate the Workflow of Cell Therapies

As patient specific, autologous cell therapies are advancing through clinical trials and are moving quickly toward commercialization, there continues to be a need for robust, closed, automated and scalable manufacturing solutions that can accommodate many patient samples, simultaneously. What will be required is a means to process patient material in a fashion which maximizes the efficiency of the processing workflow while meeting safety, quality and regulatory requirements. Any production approach should retain the fundamental principles of preventing contamination, patient sample mixing, loss of identity, and other events which may compromise the physical properties and integrity of the patient sample and/or final product. This talk will present details of what a manufacturing infrastructure needs to consider to address the above concerns and approaches one can take to design a smart, closed, and connected manufacturing footprint.

Corporate Breakfast Tutorial Hosted By MedCision and TrakCel
Click to view speakers & description
Corporate Breakfast Tutorial Hosted By MedCision and TrakCel
07:30 - 08:30
Click to view speakers & description
Speakers:
Samuel Kent, MedCision, United States
Matthew Lakelin, TrakCel, United Kingdom

Automating Downstream Processes In Cell Therapy: How Innovative Point-Of-Care Solutions Ensure Consistency And Traceability In A Complex Supply Chain

The translation of a live cell therapeutic from the clinic to commercial application is logistically complex, requiring robust SOPs, consistent results, and scalability to be successful. Automating downstream clinical processes provides these benefits, while avoiding human error and ensuring predictable patient outcomes. Cell thawing is the last step a cellular product undergoes before reaching the patient; automating this step is critical to successful commercialization. The ThawSTAR® automated cell thawing system de-risks cell thawing by eliminating water borne contamination and implementing thawing that is standardized, and customized to fit your cell product.

Mobile, automated cell therapy processing equipment like ThawSTAR widens the availability of cell therapies by expanding the number of centres capable of handling them. As the number of stakeholders in the supply chain grows, so too does the need for process consistency and consolidated reporting. TrakCel's cellular orchestration software platform helps drive consistency by introducing SOP-linked workflows at each step of the supply chain. By integrating data from multiple stakeholders, TrakCel gives cell therapy developers full needle-to-needle track and trace capabilities throughout the chain of custody.

MedCision and TrakCel are working together to create a standardization partnership that will integrate innovative downstream processing technology with connectivity solutions.

Corporate Product Theatre Hosted by Macopharma
Corporate Product Theatre Hosted by Macopharma

Regulatory Track Session 1 - Global Accelerated Access Landscape - North America
Click to view confirmed speakers
Regulatory Track Session 1 - Global Accelerated Access Landscape - North America
11:00 - 12:15
Click to view confirmed speakers
Chair:
Karen Nichols, Esq., NantKwest, United States
Speakers:
Sowmya Viswanathan, PhD, University Health Network, Canada
Kyle Norrie, BSc, Health Canada, Canada
Wilson Bryan, MD, FDA, United States

Strategies for Commercialization Track Session 1 - Cost, Price and Market Access: Putting the Pieces Together in an Industry Model
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Strategies for Commercialization Track Session 1 - Cost, Price and Market Access: Putting the Pieces Together in an Industry Model
11:00 - 12:15
Click to view confirmed speakers
Chair:
Dawn Driscoll, MBA, PhD ,DCi Biotech Inc/DCi Biotech Pty Ltd, Australia
Speakers:
Geoffrey MacKay, AVROBIO Inc, United States
Karen Hodgkin, MSc, Cell Medica Inc, United Kingdom
Eric Faulkner, MPH, Evidera, United States

This Strategies for Commercialization track session will look at the concepts of optimizing manufacturing costs, overall COGS and pricing, and the concepts of market access that pull it all together. The first speaker will address the concept of manufacturing costs, and how we as product manufacturers should think of the true cost of each product we deliver to a patient. The second speaker will address the ideas of overall development and operational costs. Then the last speaker will then pull together the unique ideas of costs vs price, and how to bridge the two for optimal market access. We will conclude our session with a lively Q&A panel.

Quality and Operations Track Session 1 - Risk Management
Click to view confirmed speakers
Quality and Operations Track Session 1 - Risk Management
11:00 - 12:15
Click to view confirmed speakers
Chair:
Vicki Antonenas, MSc , Westmead Hospital, Australia
Speakers:
Craig Wright, MSc, Royal Prince Alfred Hospital, Australia
Karen Burks, BSc, NHS Blood & Transplant, United Kingdom,
Olive Sturtevant, MT (ASCP), MHP, Dana Farber Cancer Institute, United States

Corporate Tutorial - Thermo Fisher Scientific
Plenary Hall
Corporate Tutorial - Thermo Fisher Scientific
12:30 - 13:30
Plenary Hall
Chair:
Eric Roos, Thermo Fisher Scientific, United States
Speakers:
Angel Varela-Rohena, Thermo Fisher Scientific, United States
Jim Riley, University of Pennsylvannia, United States
Xavier de Mollerat du Jeu, Director R&D, Thermo Fisher Scientific, United States

A Defined System for Commercial Scale CAR-T Production

Scalable Systems for efficient and cost-effective CAR T production:
This session will cover top considerations when selecting technology platforms to achieve scalable platforms to advance your CAR T cell therapy.

Although the cell and gene therapy industry is primed to produce viral vectors on a scale suitable for clinical supply of orphan indications, process development scientists are still working toward generating industrialized platform technologies that will enable efficient, simple, and inexpensive production of biologically active viral vectors for large-scale commercial manufacturing. New upstream based technologies, such as suspension production kits for high titer viral vector production, will be presented and discussed.

Explore how improvements in CART manufacturing can influence persistence in a clinically-relevant humanized mouse model. This session will discuss a defined T cell serum-free medium to address the challenges that sera use present for process development, biosafety and supply chain in commercial manufacturing processes. Compared CART grown in standard serum-containing medium, CAR T cells expanded in the defined T cell serum-free medium showed enhanced function and persistence, ultimately indicating long-term control of leukemia.

Corporate Product Theatre Hosted by Quality Assistance
Contact Brian Poole (brian@celltherapysociety.org) for more information.
Corporate Product Theatre Hosted by Quality Assistance

Corporate Product Theatre Hosted By Pall Life Sciences
Contact Brian Poole (brian@celltherapysociety.org) for more information.
Corporate Product Theatre Hosted By Pall Life Sciences

Regulatory Track Session 2 - Global Accelerated Access Landscape - Europe and Middle East
Regulatory Track Session 2 - Global Accelerated Access Landscape - Europe and Middle East
15:30 - 17:00
Chair:
Dominic Wall, PhD, FFSc(RCPA), Peter MacCallum Cancer Centre, Australia
Speakers:
Theofanis Chatzistamatiou, PhD, Dubai Cord Blood and Research Center, United Arab Emirates
Paula Salmikangas, PhD, Finnish Medicines Agency, Finland

Strategies for Commercialization Track Session 2 - Industrializing the Vein to Vein Supply Chain
Click to view confirmed speakers
Strategies for Commercialization Track Session 2 - Industrializing the Vein to Vein Supply Chain
15:30 - 17:00
Click to view confirmed speakers
Chair:
Jacqueline Barry, PhD, Cell and Gene Therapy Catapult, United Kingdom
Speakers:
Simon Ellison, MBA, Fisher BioServices UK, United Kingdom
Chris Creasey, PhD, Asymptote Ltd, United Kingdom
Peter Olagunju, MBA, bluebird bio, United States

Quality and Operations Track Session 2 - Quality Control Testing - Standardization
Click to view confirmed speakers.
Quality and Operations Track Session 2 - Quality Control Testing - Standardization
15:30 - 17:00
Click to view confirmed speakers.
Chair:
Diane Kadidlo, MT(ASCP), SBB, University of Minnesota, United States
Speakers:
Saskia Ihle, PhD, Lonza Biologics, Germany
Reginald Clayton, PhD, BioReliance, United Kingdom
Sowmya Viswanathan, PhD, University Health Network, Canada

Poster Session 1
Poster Session 1
17:00 - 18:30

Advanced Practice Professionals Track Session 2 - Novel Immunotherapies
Advanced Practice Professionals Track Session 2 - Novel Immunotherapies
17:00 - 18:30
Chair:
Alex Ganetsky, PharmD, Hospital of the University of Pennsylvania, United States
Speakers:
Saar Gill, MD, PhD, University of Pennyslvania, United States
Emma Morris, PhD, University College London, United Kingdom

Corporate Product Theatre Hosted By Akron Biotech
Corporate Product Theatre Hosted By Akron Biotech

Corporate Product Theatre Hosted By Marken
Corporate Product Theatre Hosted By Marken

Inner Column
Session Type
Hot Topics
Plenary Sessions
Plenary Breakout Sessions
Early Stage Professionals Sessions
Quality and Operations Track
Corporate
07:00
07:30
08:00
08:30
09:00
09:30
10:00
10:30
11:00
11:30
12:00
12:30
13:00
13:30
14:00
14:30
15:00
15:30
16:00
16:30
17:00
17:30
18:00
18:30
19:00
19:30
20:00
20:30
21:00
21:30
22:00
22:30
23:00
23:30
00:00
Hot Topic Roundtable Session 3 - Human Platelet Lysate
Click to view confirmed speakers
Hot Topic Roundtable Session 3 - Human Platelet Lysate
07:30 - 08:30
Click to view confirmed speakers
Chair:
Karen Bieback, PhD, Institute of Transfusion Medicine and Immunology , Germany
William Milligan, BSc, Steminent Biotherapeutics Inc., Canada
Speakers:
Katharina Schallmoser, MD, Paracelsus Medical University of Salzburg, Austria
Elena Jones, PhD, University of Leeds, United Kingdom
William Mirsch, MBA, Mill Creek Life Sciences, United States

Human platelet lysate (“hPL") supplements are becoming a more popular replacement for FBS in cell culture, but are also being investigated for direct clinical applications. However, there are still many questions about standardization for the use of hPL in clinical and commercial applications because of the multiple sources and approaches to production. This session will explore use of hPL for cell therapy clinical trials, GMP and QC standards to meet regulatory guidelines for ancillary materials, advantages over FBS, and some direct clinical applications of hPL in bone and cartilage regeneration.

Hot Topic Roundtable Session 4 - Biotech Financing in 2017: Challenges and Opportunities in Raising Funds
Click to view confirmed speakers
Hot Topic Roundtable Session 4 - Biotech Financing in 2017: Challenges and Opportunities in Raising Funds
07:30 - 08:30
Click to view confirmed speakers
Chair:
Miguel Forte, MD, PhD,mC4Tx, Bone Therapeutics, Belgium
Speakers:
Edward Hodgkin, PhD, Syncona Partners, United Kingdom
Patrick Rivers, BS, Aquilo Capital, United States
Alex Pasteur, PhD, F-Prime, United Kingdom

Cell and gene therapy represent the next wave of value adding propositions for the treatment of patients with unmet medical needs. This will happen through the industrialisation of multiple innovations and technical achievements in academia, start-ups and established biotech. The success depends, as always, on adequate financing, frequently accepting multiple degrees of risk. The discussion will focus on the broad aspects of the business models and financing for industrialisation of cell and gene therapy from target to patients via product development, manufacturing and market launch. Investors with extensive activity in this field will share their views, experience and wishes for the benefit of those that aim at providing innovative solutions to patients.

Plenary Session 3 - Cancer Immunotherapy
Click to view confirmed speakers
Plenary Session 3 - Cancer Immunotherapy
08:45 - 10:15
Click to view confirmed speakers
Chair:
Katy Rezvani, MD, PhD, MD Anderson Cancer Center, United States
Speakers:
Malcolm Brenner, MChB, PhD , Baylor College of Medicine, United States
Stephan Mielke, MD, PhD, University of Wuerzburg, Germany
John Barrett, MD, National Institute of Health , United States

The translation of major advances in the understanding of cancer immune surveillance into clinical practice has been challenged by the inherent complexities of the immune system, intense regulatory requirements and a commercial reluctance by the pharmaceutical industry to invest in this modality of therapy. More recently, however, immunotherapy has made great strides against many otherwise incurable cancers both as a bridge to transplant or as a stand alone therapeutic approach. This session will highlight the methodologies used to generate various types of T cells for adoptive immunotherapy of malignant diseases, the clinical utility of the CAR T-cell approach and how to move beyond CD19 as a target and the use of alloimmunotherapy as a platform to improve the outcome of cancer.

Coffee Break with Exhibits
Coffee Break with Exhibits

Coffee Break with Exhibits
Coffee Break with Exhibits

Cancer Immunotherapy Plenary Breakout 1
Click to view confirmed presenters
Cancer Immunotherapy Plenary Breakout 1
10:45 - 12:15
Click to view confirmed presenters
Chair:
Malcolm Brenner, MChB, PhD , Baylor College of Medicine, United States

Oral Abstract Presentations:

Premal Lulla

Baylor College of Medicine; Center for Cell and Gene Therapy, United States
Administration of T cells Targeting Tumor Associated Antigens to Patients with Myeloma

Mitchell Cairo
New York Medical College, United States
Enhancement of Anti-Tumor Activity of Expanded Natural Killer Cells against GD2+ Osteosarcoma (OS) in Combination with Romidepsin (HDAC inhibitor), ALT-803 (IL-15 Superagonist) and Dinutuximab

Heba Samaha
Baylor College of Medicine; Texas Childrens Hospital; Children's Cancer Hospital Egypt, United States
A cellular platform enables targeted brain delivery of T cells

Sylvie Shen
Sydney Children's Hospital; University of New South Wales; Children's Cancer Institute for Medical Research, Australia
MODULATION OF ANTI-TUMOUR ACTIVITY OF EX VIVO EXPANDED NK CELLS AGAINST NEUROBLASTOMA VIA HDACi AND PD1/PD-L1 BLOCKADE

Steven Highfill
National Institutes of Health, United States
CD4 AND CD8 T-CELL POSITIVE SELECTION INCREASES THE ROBUSTNESS OF THE CD22 CAR T-CELL MANUFACTURING PROCESS

Cancer Immunotherapy Plenary Breakout 2
Click to view confirmed presenters
Cancer Immunotherapy Plenary Breakout 2
10:45 - 12:15
Click to view confirmed presenters
Chair:
John Barrett, MD, National Institute of Health , United States

Oral Abstract Presentations:

Rachel Burga

Institute for Biomedical Sciences; Sheikh Zayed Institute for Pediatric Surgical Innovation; Program for Cell Enhancement and Technologies for Innovation, United States
Lymphocyte-nanoparticle biohybrids as a combined nanoimmunotherapy for cancer

Anne Merete Tryggestad
Oslo University Hospital, Norway
Results from a first in man Phase I/II adjuvant Dendritic Cell Vaccine study in high risk prostate cancer patients following radical surgery

Boris Calmels
Institut Paoli-Calmettes, France
FEASIBILITY AND SAFETY OF ALLOGENEIC EX VIVO ACTIVATED-NK CELL INFUSION AFTER MATCHED RELATED HEMATOPOIETIC STEM CELL TRANSPLANTATION: PRELIMINARY RESULTS OF A PROSPECTIVE PHASE I TRIAL

Iris Bigalke
Oslo University Hospital, Norway
WT1 and PRAME mRNA transfected TLR 7/8-polarized fast DC lead to specific immune responses in AML patients and have an impact on progression free survival

Kirsten Williams
Children's National Medical Center, United States
Complete remissions post Infusion of Multiple Tumor Antigen specific T cells for the Treatment of High Risk Leukemia and Lymphoma Patients after HCT

Lunch with Exhibits
Lunch with Exhibits
12:15 - 13:45

Lunch with Exhibits
Lunch with Exhibits
12:15 - 13:45

Plenary Session 4 - Industrialization with the Patient in Mind
Click to view confirmed speakers
Plenary Session 4 - Industrialization with the Patient in Mind
13:45 - 15:15
Click to view confirmed speakers
Chair:
Simon Ellison, MBA, Fisher BioServices UK, United Kingdom
Speakers:
Olav Hellebø, MBA, ReNeuron, United Kingdom
Marc Turner, MB, ChB, PhD, MBA, Scottish National Blood Transfusion Service, Scotland
Kurt Gunter, MD , Cell Medica Inc, United States
Sven Kili, MB, ChB, MRCS , GSK, United Kingdom

Cell and gene companies have moved through the research phase and evolved past development into viable, market ready organisations. This has been, and continues to be, a rocky road. However the evidence shows that success is reliant on creating a therapy that can treat patients beyond a clinical trial. This session will draw on learning experiences from other industries, combine them with examples from the cell and gene therapy industry to highlight the criticality of maintaining a patient focus throughout therapy development.

Cancer Immunotherapy Plenary Breakout 3
Click to view confirmed presenters
Cancer Immunotherapy Plenary Breakout 3
15:30 - 17:00
Click to view confirmed presenters
Chair:
Stephan Mielke, MD, PhD, University of Wuerzburg, Germany

Oral Abstract Presentations:

Shabnum Patel

The George Washington University; Children's National Health System, United States
HIV SPECIFIC T CELLS EXPRESSING AN X5–GPI ARTIFICIAL RECEPTOR CAN SUPPRESS HIV REPLICATION IN VITRO — IMPLICATIONS FOR A CURE STRATEGY FOR HIV+ INDIVIDUALS WITH HEMATOLOGIC MALIGNANCIES

Minoo Battiwalla
NHLBI, NIH, United States
SELECTIVE DEPLETION OF ALLOREACTIVE DONOR T CELLS WITH ADENOSINE – CLINICAL SCALE UP FOR ALLOGENEIC STEM CELL TRANSPLANTATION

Kyriakos Koukoulias
George Papanicolaou Hospital; Aristotle University, Greece
NON-TRANSPLANTABLE CORD BLOOD UNITS AS A NEW SOURCE FOR ADOPTIVE IMMUNOTHERAPY OF LEUKEMIA AND A PARADIGM OF CIRCULAR ECONOMY IN MEDICINE

Britta Eiz-Vesper
Hannover Medical School; Hannover Medical School, Germany
Modulation of heme oxygenase-1 activity to enhance WT1-specific T-cell responses for immunotherapeutic approaches

Chiara F Magnani
University of Milano-Bicocca, San Gerardo Hospital/Fondazione MBBM, Italy
PRECLINICAL EVALUATION OF DONOR-DERIVED SLEEPING BEAUTY MODIFIED CD19CAR+ LYMPHOCYTES FOR THE TREATMENT OF ACUTE LYMPHOBLASTIC LEUKEMIA

Industrial Translation Breakout Session - Industrializing: Case Studies
Click to view confirmed speakers
Industrial Translation Breakout Session - Industrializing: Case Studies
15:30 - 17:00
Click to view confirmed speakers
Chair:
Kurt Gunter, MD , Cell Medica Inc, United States
Speakers:
Patrick Rivers, BS, Aquilo Capital, United States
Eleuterio Lombardo, PhD, TiGenix SAU, Spain
Suzanne Farid, PhD, University College London, United Kingdom

Building on the plenary this session presents case studies from different viewpoints. The aim being to illustrate the fact that for a patient to be treated under a market authorised product there are multiple stakeholders that need to be satisfied, beyond clinicians, regulators, etc.

MSC Oral Abstract Presentations Session 1
Click to view confirmed presenters
MSC Oral Abstract Presentations Session 1
15:30 - 17:00
Click to view confirmed presenters
Chair:
Jacques Galipeau, MD FRCP(C), University of Wisconsin in Madison, United States
Donald G. Phinney, PhD, The Scripps Research Institute, United States

Oral Abstract Presentations:

Francisco Espinoza

Universidad de los Andes, Chile
Allogeneic Mesenchymal Stromal Cell (MSC) therapy for knee osteoarthritis (OA): a phase I/II randomized controlled trial

Lipi Singh
Advancells, India
Long Term Safety and Efficacy of Autologous Stem Cell Transplantation for the treatment of Type 2 Diabetes Mellitus

Hala Gabr
Cairo University, Egypt
Comparison Between Mesenchymal Stem Cells, Stem Cell Conditioned Media, and Mesenchymal Stem Cell Derived Microsvesicles in Regeneration in Murine Model of Acute Renal Injury

Veena Krishnappa
Scripps Florida, United States
Interruption of FGFR2 Signaling Licenses the Immuno-modulatory Activity of Human MSCs by Suppressing TWIST1 Expression.

Takeo Mukai
The Institute of Medical Science, The University of Tokyo, Japan
Neurotropism and Neuroprotective effect in Umbilical cord derived-Mesenchymal Stromal Cells

Poster Session 2
Poster Session 2
17:00 - 18:30

ISCT 2017 Gala
ISCT 2017 Gala
19:00 - 00:00

Advanced Practice Professionals Track Session 3 - Efficacy and Toxicities of Immunotherapy in Management of Hematologic
Click to view confirmed speakers
Advanced Practice Professionals Track Session 3 - Efficacy and Toxicities of Immunotherapy in Management of Hematologic
07:30 - 08:30
Click to view confirmed speakers
Chair:
Tobi Fisher, PA-C, UT MD Anderson Cancer Center, United States
Speakers:
Valkal Bhatt, PharmD, BCOP, Memorial Sloan Kettering Cancer Center, United States
Alex Ganetsky, PharmD, Hospital of the University of Pennsylvania, United States

Corporate Breakfast Tutorial - Irvine Scientific
Click to view speakers & description
Corporate Breakfast Tutorial - Irvine Scientific
07:30 - 08:30
Click to view speakers & description
Speakers:
Christopher Bravery, PhD, Consulting on Advanced Biologicals Ltd., United Kingdom
Jessie Ni, PhD, Irvine Scientific, United States

Scientific and Regulatory Considerations for Cell Therapy Culture Media and Supplements

Christopher Bravery, PhD, Consulting on Advanced Biologicals Ltd.
• Considerations when selecting culture media
o Quality and quality systems
o Chemically defined v animal-derived v recombinant
o Impact of early decisions on later development
Jessie Ni, PhD, Irvine Scientific
• Impacts of culture media selected on cell therapy technology
o Industrial definitions
o Impact of media composition on cell culture performance
o Impact of media composition on product development & support

Corporate Breakfast Tutorial Hosted by Lonza
Corporate Breakfast Tutorial Hosted by Lonza
07:30 - 08:30
Chair:
Nina Bauer, PhD, Lonza Ltd, Switzerland
Speakers:
Nina Bauer, PhD, Lonza Ltd, Switzerland
Andrea Toell, PhD, Lonza Cologne GmbH, Germany

Innovative Solutions for Manufacturing of Next Generation Cell Therapies

Lonza provides the cell therapy market with end-to-end solutions for successful commercialization. These solutions include tools that can be used to develop and test therapeutics, ranging from cell culture and discovery technologies to quality control tests and process optimization. As a world-leading contract manufacturing organization (CMO), Lonza’s manufacturing services can supply researchers with clinical-grade raw materials such as specialized media formulations and virus batches. Lonza’s cellular manufacturing platforms remove supply bottlenecks and enable the cell therapy industry to provide commercially viable therapies at a global scale.

In the tutorial, Lonza will present its capabilities in supporting the development of cell therapies using the example of viral and non-viral CAR-T products. Our experts will explore key topics such as
• overcoming manufacturing bottlenecks for CAR-T therapies
• ensuring product quality
• scaling robustness
• enabling commercially viable manufacturing through innovative platform technologies

More information on how Lonza helps support the development and manufacture of viral and non-viral CAR-T cell therapies is available www.lonza.com/Car-T.

Corporate Product Theatre Hosted by Miltenyi Biotec
Corporate Product Theatre Hosted by Miltenyi Biotec

Strategies for Commercialization Track Session 3 - Industrializing the CGT Business Model
Click to view confirmed speakers
Strategies for Commercialization Track Session 3 - Industrializing the CGT Business Model
10:45 - 12:15
Click to view confirmed speakers
Chair:
William Milligan, BSc, Steminent Biotherapeutics Inc., Canada
Speakers:
Matthew Durdy, MBA, Cell and Gene Therapy Catapult, United Kingdom
Dalia Mahmoud, PhD, Celgene, United States
Christopher Vann, BSc, Autolus Ltd, United Kingdom

Industrialising the CGT business model depends on market demand and adoption. However, with highly complex regulatory, manufacturing, quality control, cold chain distribution, and patient administration, COG and pricing are higher than typical drugs. This dynamic presents potential reimbursement and market entry challenges for commercializing cell and gene therapy products. Therefore, for industrializing CGT it is important to think about the commerical model early in development. Market access for patients must be a focus in the lab, through manufacturing process development, clinical development and at commercial launch, to ensure that these innovative products are reimbursed and adopted by physicians for their intended patients. What are the key considerations during development and key disciplines at launch for successful commercialization?

Quality and Operations Track Session 3 - Allogeneic Cell Therapy: From HSC Transplants to Targeted T cell Therapy
Click to view confirmed speakers
Quality and Operations Track Session 3 - Allogeneic Cell Therapy: From HSC Transplants to Targeted T cell Therapy
10:45 - 12:15
Click to view confirmed speakers
Chair:
Shirley Bartido, PhD, MBA, Cellectis Inc., United States
Speakers:
Stephan Reynier, MSc, Cellectis SA, France
Ekaterina Doubrovina, MD, PhD, Memorial Sloan Kettering Cancer Center, United States
Paul Veys, MBBS, FRCP, FRCPath, FRCPCH, Great Ormond Street Hospital for Children, United Kingdom

Allogeneic cell therapy has been used as an effective treatment against acute leukemia. This anti-leukemic effect, known as graft versus leukemia (GVL) is usually mediated by donor T cells. This GVL effect is often countered by the adverse effect against normal tissue known as graft versus host disease (GVHD). This workshop will describe different approaches that attempt to intensify the GVL effects provided by allogeneic cell therapy while minimizing the effects of GVHD so as to lower toxicity and provide an improved outcome.

ISCT Presidential Task Force Session
ISCT Presidential Task Force Session
10:45 - 12:15
Chair:
Massimo Dominici, MD, University of Modena and Reggio Emilia, Italy
Daniel J. Weiss, MD, PhD, University of Vermont College of Medicine, United States
Speakers:
Massimo Dominici, MD, University of Modena and Reggio Emilia, Italy
Gerhard Bauer, PhD, University of California Davis, United States
Aaron Levine, MPhil, PhD, Georgia Tech, United States
Karen Nichols, Esq., NantKwest, United States

Corporate Tutorial - BD Biosciences
Corporate Tutorial - BD Biosciences
12:30 - 13:30
Chair:
Scott Bornheimer, PhD, BD Life Sciences, United States
Speakers:
Scott Bornheimer, PhD, BD Life Sciences, United States
David DiGiusto, PhD, Stanford University, United States

FACS Technology in Cell Therapy Development and Production

Current and future innovations in fluorescence activated cell sorting (FACS) technology will enable the isolation of pure, well defined cells and the quantitative, standardized testing of final product in cell therapy production.

Corporate Product Theatre Hosted By Cryogatt Systems Ltd
Corporate Product Theatre Hosted By Cryogatt Systems Ltd

Corporate Product Theatre Hosted By BioSpherix
Corporate Product Theatre Hosted By BioSpherix

Strategies for Commercialization Track Session 4 - Industrializing the Hospital of the Future
Strategies for Commercialization Track Session 4 - Industrializing the Hospital of the Future
15:30 - 17:00
Chair:
Gerhard Bauer, University of California Davis, United States
Speakers:
Miguel Forte, MD, PhD, mC4Tx, Bone Therapeutics, Belgium
Shelly Heimfeld, PhD, Fred Hutchinson Cancer Research Center, United States
Ian Campbell, Innovate UK, United Kingdom

Over the recent years, cellular therapies have evolved from early phase clinical trials into safe and effective marketed therapeutics. Currently, only few medical centers can offer such therapies, therefore limiting the number of patients who can receive them. In order to make these therapeutic applications available to many more patients, it will be necessary to bring, to more hospitals, the equipment and also the skills to safely and effectively administer novel cellular therapies. This will possibly entail the development of new cellular therapy pharmacies with formulation labs, and a crew of trained personnel that will know how to apply "living medicines". These efforts will also require the rethinking and restructuring of current methods of cell manufacturing and formulation, in order to supply the anticipated large number of patients, world wide, with safe and effective cellular therapies.

Quality and Operations Track Session 4 - Cell Characterization and Potency
Click to view confirmed speakers.
Quality and Operations Track Session 4 - Cell Characterization and Potency
15:30 - 17:00
Click to view confirmed speakers.
Speakers:
Rosa Gonzalo, MSc, PhD,University Hospital Puerta de Hierro Majadahonda, Spain
Jorge Burns, PhD, University Hospital of Modena and Reggio Emilia, Italy
Aisha Khan, ABD, MSc, MBA, University of Miami, United States
Giuseppe Astori, PhD, San Bortolo Hospital, Italy

Early Stage Professionals (ESP) Session 1 - Advanced Strategic Innovations for Cell and Gene Therapies
Click to view confirmed speakers
Early Stage Professionals (ESP) Session 1 - Advanced Strategic Innovations for Cell and Gene Therapies
15:30 - 17:00
Click to view confirmed speakers
Chair:
Emily Culme-Seymour, PhD, GSK, United Kingdom
Patrick Hanley, PhD, Children's National Medical Center, United States
Speakers:
Ben Weil, MRes, EngD, University College London, United Kingdom
Avery Posey, PhD, University of Pennsylvania, United States
Thorsten Friedel, PhD, GSK, United Kingdom

The focus of this session will be scientific innovation, presented by early stage professionals. The session will be wide ranging, with topics about manufacturing the world's largest therapeutic cell bank to CAR-T cells and viral vector engineering for transgene delivery. At the end of this session, participants should be able to identify what a current advances being made with CAR T cells, What options are available to scale up UC-MSCs, and recent approaches to engineering vector-based transgene delivery.

Corporate Product Theatre Hosted by GE Healthcare
Contact Brian Poole (brian@celltherapysociety.org) for more information.
Corporate Product Theatre Hosted by GE Healthcare

Session Type
Hot Topics
Plenary Sessions
Plenary Breakout Sessions
Strategies for Commericalization Track
Quality and Operations Track
Corporate
07:00
07:30
08:00
08:30
09:00
09:30
10:00
10:30
11:00
11:30
12:00
12:30
13:00
13:30
14:00
14:30
15:00
15:30
16:00
16:30
Hot Topic Roundtable Session 5 - Novel Gene Editing Techniques
Click to view confirmed speakers
Hot Topic Roundtable Session 5 - Novel Gene Editing Techniques
07:30 - 08:30
Click to view confirmed speakers
Chair:
John Rasko, MBBS, PhD, FRCPA, FRCAP, Royal Prince Alfred Hospital, Australia
Speakers:
Madhusudan V. Peshwa, PhD, MaxCyte Inc., United States
Cliona Rooney, PhD, Baylor College of Medicine, United States

Hot Topic Roundtable Session 6 - Overcoming Analytical Challenges for Characterization of Advanced Therapies
Hot Topic Roundtable Session 6 - Overcoming Analytical Challenges for Characterization of Advanced Therapies
07:30 - 08:30
Chair:
Damian Marshall, PhD, Cell and Gene Therapy Catapult, United Kingdom
Speakers:
Ivan Wall, PhD, FRSB, CBiol, AMIChemE, AHEA, University College London, United Kingdom

This session will look at the range of analytical challenges faced by cell therapy developers, highlighting common problems, skills requirements and how new technologies can be used to characterise complex products.

Plenary Session 5 - Editing of the Species - from Genes to Organelles to Organs
Click to view confirmed speakers
Plenary Session 5 - Editing of the Species - from Genes to Organelles to Organs
08:45 - 10:15
Click to view confirmed speakers
Chair:
John Rasko, MBBS, PhD, FRCPA, FRCAP, Royal Prince Alfred Hospital, Australia
Speakers:
Douglas Turnbull, MBBS, PhD, Newcastle University, United Kingdom
Mitochondrial donation to prevent mitochondrial DNA disease
Adrian Thrasher, MBBS, PhD, University College London, United Kingdom
Gene therapy in severe immunodeficiency
Pablo Ross, PhD, UC Davis, United States
Next-Gen X – Xenogeneic generation of human organs

Increasingly, the cells, tissues and organs being deployed as advanced therapeutic products are being engineered prior to delivery to generate or enhance therapeutic efficacy. This session, which is designed to complement and expand upon the highly successful ‘Evolution of Species’ session at the 2016 Singapore Annual Meeting, will highlight key examples of this kind of cutting-edge biological engineering. Attendees will not only gain an understanding of what is happening in clinics right now, but will also glimpse the future as they are led on a fascinating journey - from genes, through organelles and finally to whole organs - with talks from the leaders in the field.

To read Individual Presentation Descriptions, visit the Plenary Session Spotlight Page: http://isct2017.com/plenary-session-spotlight/

Coffee Break with Exhibits
Coffee Break with Exhibits

MSC Oral Abstract Presentations Session 2
Click to view confirmed presenters
MSC Oral Abstract Presentations Session 2
10:45 - 11:45
Click to view confirmed presenters

Oral Abstract Presentations:

Paolo Madeddu

University of Bristol, United Kingdom
Transplantation of allogeneic adventitial progenitor cells improves vascularization and reduces myocardial fibrosis in a swine model of reperfused acute myocardial infarction

Carlijn Voermans
Sanquin Research, Netherlands
Interferon-gamma Impairs Expansion and Hematopoietic Support of Bone Marrow Mesenchymal Stromal Cells

Sabine Geiger
apceth Biopharma GmbH, Germany
AMELIORATION OF LUNG FUNCTION AND PULMONARY TISSUE REGENERATION AFTER TREATMENT WITH AAT-EXPRESSING HUMAN MSCS IN A MURINE MODEL OF ELASTASE-INDUCED EMPHYSEMA

Sowmya Viswanathan
University Health Network; University Health Network; University of Toronto, Canada
Human Autologous Mesenchymal Stromal Cells for the Treatment of Mid- to Late-Stage Knee Osteoarthritis – Preliminary Results from a First-in-North America Phase I/II Study

Late Breaking Abstracts Session
Click to view confirmed presenters
Late Breaking Abstracts Session
10:45 - 11:45
Click to view confirmed presenters

Oral Abstract Presentations:

Lauralyn McIntyre

Ottawa Hospital Research Institute; University of Ottawa, Canada
Cellular Immunotherapy for Septic Shock (CISS): A Phase I trial

JHANN ARTURO
INMUGEN CORPORATION, Colombia
ARTERIAL REGENERATION AND CLINICAL IMPROVEMENT OF SECONDARY AUTOIMMUNE RAYNAUD'S SYNDROME WITH AUTOLOGOUS BONE MARROW MONONUCLEAR CELLS (aBM-MNC). EARLY RESULTS OF PHASE II CLINICAL TRIAL.

JEONG HUN KIM
Seoul National University; Seoul National University; Seoul National University Hospital, South Korea
In vivo Genome Editing using Cas9 Ribonucleoproteins for Choroidal Neovascularization in Age-related Macular Degeneration Animal Model

Deepak Bhere
Brigham and Women's Hospital; Harvard Medical School, United States
Mesenchymal Stem Cells shuttle microRNAs via extracellular vesicles and prime resistant GBM to caspase mediated apoptosis

Lunch with Exhibits
Lunch with Exhibits
11:45 - 13:15

Plenary Session 6 - Stem Cells for Tissue Repair and Engineering
Click to view confirmed speakers
Plenary Session 6 - Stem Cells for Tissue Repair and Engineering
13:15 - 14:45
Click to view confirmed speakers
Chair:
Massimiliano Gnecchi, MD, PhD, FESC, University of Pavia & IRCCS Policlinico San Matteo, Italy 
Speakers:
Massimiliano Gnecchi, MD, PhD, FESC, University of Pavia & IRCCS Policlinico San Matteo, Italy 
Lola Reid, PhD, University of North Carolina at Chapel Hill, United States 
Ivan Martin, PhD, University Hospital Basel, Switzerland

In the last 20 years, a major effort has been made toward optimizing stem cell transplantation to regenerate damaged tissues and organs. The original rationale of this approach was based on the supposed ability of stem cells to repopulate the engrafted site by differentiation or trans-differentiation. Later, the pivotal importance of stem cell-mediated paracrine mechanisms was demonstrated and paved the way for a new field of research, which has the goal of harnessing the cell secretome as potential alternative to enhance tissue repair. At the same time, scientists in the field of tissue engineering are applying the principles of stem cell transplantation, material science, and bioengineering to construct biological substitutes that could potentially restore and maintain normal function in diseased and injured tissues. The gap between pre-clinical and clinical application is still a major impediment, but there are successful examples of how these approaches will hopefully change the way we treat our patients.

Tissue Repair and Engineering Plenary Breakout 1 - Vascular, Digestive and Respiratory Tissue Engineering
Click to view confirmed presenters
Tissue Repair and Engineering Plenary Breakout 1 - Vascular, Digestive and Respiratory Tissue Engineering
15:00 - 16:30
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Chair:
Massimiliano Gnecchi, MD, PhD, FESC, University of Pavia & IRCCS Policlinico San Matteo, Italy
Speakers:
Paolo Madeddu, MD, University of Bristol, United Kingdom

Oral Abstract Presentations:

Claire Crowley

UCL Great Ormond Street Institute of Child Health, United Kingdom
3D-culture of intestinal stem cells using an extracellular matrix hydrogel derived from decellularised intestinal tissue.

Maroun Khoury
Universidad de los Andes; Cells for Cells, Chile
Automated micro-fabrication of a vascular graft mimicking the structure of human coronary arteries based on layer deposition, nanofibers and dipping-spinning technologies

Hind Al belushi
Cancer Institute, United Kingdom
Evaluation of the chemical and biomechanical viscoelastic Properties of decellularised tracheal scaffolds

Toby Proctor
University College London; United Kingdom
PRODUCTION OF TISSUE ENGINEERED LARYNX AND EPITHELIUM IN A SINGLE GMP-COMPLIANT BIOREACTOR

Tissue Repair and Engineering Plenary Breakout 2 - Orthopedic Tissue Engineering
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Tissue Repair and Engineering Plenary Breakout 2 - Orthopedic Tissue Engineering
15:00 - 16:30
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Chair:
Lola Reid, PhD, University of North Carolina at Chapel Hill, United States

Oral Abstract Presentations:

Juliana Martinez-Atienza

Andalusian Initiative for Advanced Therapies, Spain
Preliminary results of a multicenter randomized clinical trial evaluating the safety and feasibility of an allogeneic nanostructured artificial anterior human cornea

Shiva Akbarzadeh
Alfred Hospital; Monash University, Australia
CEA AS AN ADJUNCT TREATMENT FOR MAJOR BURNS: A PHASE I STUDY

Ana Fernández-González
Unidad de Producción Celular e Ingeniería Tisular. Complejo Hospitalario Universitario de Granada; Instituto de Investigación Biosanitaria ibs.GRANADA; Andalusian Initiative for Advanced Therapies, Spain
Clinical, histological and homeostasis evaluation of tissue bio-engineered skin substitute: in vivo mouse model

Ora Burger
Bonus BioGroup Ltd., Israel
BonoFillTM – A Novel Treatment for Maxillofacial Bone Tissue Regeneration

Patricia Galvez
Advanced Therapies Area, Pharmascience Division, Bioibérica S.A, Spain
Design of 3D Bioprinted Articular Cartilage of MSCs-Loaded for Osteochondral Injuries

Identifying and Optimizing Emerging Technologies to Evaluate Cell Therapy Safety, MoA and Efficacy, HESI-CT TRACS Session
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Identifying and Optimizing Emerging Technologies to Evaluate Cell Therapy Safety, MoA and Efficacy, HESI-CT TRACS Session
15:00 - 16:30
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Chair:
William Shingleton, PhD, GE Healthcare, United Kingdom
Speakers:
Brooke Helfer, PhD, Celsense, United States
Nobuhiro Umeda, PhD, Astellas Pharma Inc., Japan
Jeff Bulte, PhD, The Johns Hopkins Institute for Cell Engineering, United States
Yoji Sato, PhD, NIHS Japan, Japan

Cell therapies show great therapeutic promise in the fields of regenerative medicine and immunotherapy. To realize their full clinical potential there is a need for greater understanding of their mode of action, how they migrate after administration to deliver their therapeutic benefits, their persistence at sites of action, and whether their properties, localization or distribution may cause safety issues. Currently, there are several existing and many emerging tools available to develop pharmacokinetic data on these cell-derived therapies to improve our understanding of the mechanism of action and demonstrate on target delivery, but adoption by clinical investigators has been limited.
The Health and Environmental Sciences Institute (HESI) Emerging Issues Committee launched a new multi-sector collaborative sub-committee to identify key needs for assessing the safety of cell therapies and identify opportunities to meet these needs. This program, the Cell Therapy - TRAcking, Circulation, & Safety (CT-TRACS) sub-committee, provides a neutral platform for cell therapy developers, researchers, regulators, imaging specialists and other stakeholders to interact, discuss current challenges and identify best practices to ensure that these therapies are safe and effective for use. In particular, the sub-committee aims to:
•Bring awareness on how the application of existing cell tracking technologies and methods can benefit the clinical translation of these new therapies; as well as seek input from therapy developers on how to best adapt these existing technologies for use with cell therapy products.
•Address concerns regarding the potential for tumorigenicity of pluripotent stem cell-derived products by assessing and/or developing methodologies and best practices that could support tumorigenicity evaluation.

In this session, CT-TRACS members and invited guest speakers will discuss these objectives and provide two case examples of applications. The ultimate goal is to promote the dialogue with the international community and initiate an interactive discussion about opportunities to address the challenges facing the translation of cell therapies into the clinic.
About the organization: HESI is a global non-profit institution whose mission is to collaboratively identify and help to resolve health and environment challenges through the engagement of scientists from academia, government, industry, NGOs, and other strategic partners. Learn more at: www.hesiglobal.org.

Strategies for Commercializaton Track Session 5 - Industrializing Talent Management
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Strategies for Commercializaton Track Session 5 - Industrializing Talent Management
07:30 - 08:30
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Chair:
Jim Faulkner, PhD, Autolus Ltd, United Kingdom
Speakers:
Jim Faulkner, PhD, Autolus Ltd, United Kingdom
Fungayi Chidothe, MBChB, MSc, Cell & Gene Therapy Catapult, United Kingdom
Nick Stephens, LLB, The RSA Group, United Kingdom

The ability to attract and retain talent is fundamental to the success of any business. The strategies employed to build a high-performing team in a cell therapy context – from Board level recruitment through to skilled technician – will be described. There will also be the opportunity to update on the findings of the Advanced Manufacturing Taskforce Skills sub-team.

Quality and Operations Track Session 5 - Quality Program Design and Operations
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Quality and Operations Track Session 5 - Quality Program Design and Operations
07:30 - 08:30
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Chair:
Annette Trickett, PhD , Prince of Wales Hospital, Australia
Speakers:
Gerry McKiernan , Cell Therapies PTY, Australia
Nicole Prokopishyn, PhD , Calgary Laboratory Services, Canada
Robyn Rodwell, PhD, Queensland Cord Blood Bank At The Mater, Australia

This session will cover some of the essential building blocks of quality management systems (QMS): Gerry McKiernan will present “Developing a QMS – where to start?.” This talk aims to assist in identifying where to start building a small or large QMS. Using a risk based, gradient approach of ‘What do I need now?’, a manageable and cost effective solution can be applied to the product lifecycle to determine what QMS elements are needed and when. Determining when to apply the appropriate controls will allow your project to progress without unnecessarily slowing down product development but still meet your regulatory and business objectives. Dr Robyn Rodwell will cover audits. The value of an effective formal audit program as a key management tool to monitor compliance with the principles of Good Manufacturing Practice and regulatory requirements, detect potential problems, ensure readiness for regulatory inspections and foster a culture of continuous improvement will be presented. The role of audits in a Quality Assurance Program, the different types of audit, the value of risk-based audits and the importance of focusing on critical processes and the prerequisites for auditors will be discussed. Methods to systematically manage, plan, prepare, conduct, report and follow-up audits and the benefits of an effective auditing system will be presented. Dr. Nicole Prokopishyn’s talk on Corrective and preventive action (CAPA) will focus on strategies for building a robust but manageable quality program that recognizes, assesses, and responds to ongoing & emerging issues. The key aspects of a CAPA plan will be discussed including how to make corrective and preventive actions successful and effective, how to develop focused, goal-oriented improvements, and appropriate reporting and follow-up in multi-disciplinary programs.

Strategies for Commercialization Track Session 6 - Industrializing Processes
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Strategies for Commercialization Track Session 6 - Industrializing Processes
10:45 - 11:45
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Chair:
Ohad Karnieli, MBA, PhD, ATVIO Biotechnology, Israel
Speakers:
Ohad Karnieli, MBA, PhD, ATVIO Biotechnology, Israel
Sarah Callens, BSc, Cell and Gene Therapy Catapult, United Kingdom
Rodney Rietze, PhD, Novartis, United States

Cost of Goods and manufacturability are critical elements in the success of the therapy. Achieving a reasonable CoGs for cell therapy is challenging and has to be integrated during the development stages to insure automation and process optimization. The session will focus on strategy to introduce and ensure manufacturability during development and will provide case studies and methodology examples. The session will end with a panel discussion with the PPD subcommittee experts.

Quality and Operations Track Session 6 - Upkeep and Maintenance of the Human Factor: Training, Education, and Competency
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Quality and Operations Track Session 6 - Upkeep and Maintenance of the Human Factor: Training, Education, and Competency
10:45 - 11:45
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Chair:
Lizette Caballero, MLS(ASCP)CM, UCSF BMT Laboratory, United States
Speakers:
Carlos Lee, BSc, Carolinas Healthcare System, United States
Jacqui Thompson, BSc, NHSBT Birmingham, United Kingdom
Rosemarie Bell, B.App.Sc Micro/Biochem MASM, QIMR Berghofer Medical Research Institute, Australia

Early Stage Professionals (ESP) Session 2 - What I Wish I Knew
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Early Stage Professionals (ESP) Session 2 - What I Wish I Knew
10:45 - 11:45
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Chair:
Emily Hopewell, PhD, Moffitt Cancer Center, United States
Speakers:
John Rasko, MBBS, PhD, FRCPA, FRCAP, Royal Prince Alfred Hospital, Australia
Cliona Rooney, PhD, Center for Cell and Gene Therapy/Baylor College of Medicine, United States
Michael Mendicino, PhD, Hybrid Concepts International, United States

The Early Stage Professionals committee strives to provide resources, career guidance and support to ESPs to help ensure their success in Cellular Therapy. The focus of this panel discussion session is to allow ESPs to gain from the experience of field leaders and learn things the leaders wish they would have known early in their careers. This session also provides ESPs an opportunity to ask these leaders relevant questions.

ISCT Annual General Meeting
ISCT Annual General Meeting
12:00 - 13:00

Strategies for Commercialization Track Session 7 - Ancillary Materials
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Strategies for Commercialization Track Session 7 - Ancillary Materials
15:00 - 16:30
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Chair:
Lynn Csontos,CQA, STEMCELL Technologies Inc., Canada
Speakers:
Lynn Csontos, CQA, STEMCELL Technologies Inc., Canada
Claudia Zylberberg, PhD, Akron Biotech, United States
Jiwen Zhang, PhD, GE Healthcare, United States
Brian Newsom, MBA, Thermo Fisher Scientific, United States

As the field of regenerative medicine surges forward with aggressive growth in clinical trials, the regulatory landscape for all aspects of the market continues to evolve. A critical consideration for the success of your translational path includes a risk based evaluation of all Ancillary Materials used in your process. In depth case studies will be discussed for specific Ancillary Materials used in clinical applications along with how to identify a good versus poor supplier of Ancillary Materials

Quality and Operations Track Session 7 - How To Write The CMC/Quality Section Of Your Regulatory Submission: The Common Technical Document (CTD) Module 3
Quality and Operations Track Session 7 - How To Write The CMC/Quality Section Of Your Regulatory Submission: The Common Technical Document (CTD) Module 3
15:00 - 16:30
Chair:
Christopher A. Bravery, PhD, Consulting on Advanced Biologicals Ltd, United Kingdom
Speakers:
Christopher A. Bravery, PhD, Consulting on Advanced Biologicals Ltd, United Kingdom
Karin Hoogendoorn, PharmD, Quality R.A., Netherlands
Jean-Hugues Trouvin, PhD, PharmD, Paris Descartes University , France

Most agencies now accept or require the common technical document (CTD) when submitting quality/CMC information for clinical trials and market approval. As the CTD is common to all medicinal products, be they small molecules or biological, it can appear confusing at first glance. This workshop aims to walk through the standardized document discuss how it should be used for cell-based products, and explain:
• What the purpose of each section is
• Whether the section is descriptive or data-driven
• What sorts of data are expected
• Considerations for style, use of figures and tables etc.