ISCT North America 2016 Regional Meeting Presentations

Program Book

Please note: Only those presentations where permission has been received for posting are available to meeting delegates. A large number of speakers are in the process of providing ISCT with revised slides and as a result, these presentations will be gradually uploaded to the website as they are received.

Reference to these materials will be useful but not comprehensive in developing appropriate standards of care. Their use does not confer any professional qualification or standard. Publication of these materials does not constitute an endorsement of ISCT. ISCT has not reviewed these materials to ensure consistency with acceptable practices. The views expressed in these materials represent the opinion of the authors. ISCT expressly disclaims any liability arising from any inaccuracy or misstatement. Each facility and/or individual referring to these materials should analyze the information, practices and procedures outlined therein to determine their acceptability for use in the context of their own obligations and within their own facility's standards and procedures.

Speakers for the following presentations have given authorization to post their materials.

Presentations are continually being added. Please check back regularly.

 

Friday, September 30 

Technical Science Session 1 - Recent Advances in Oncolytic Viruses for Cancer 
Chair: Khalid Shah (US)
Speakers:
Eric Bartee (US) - Integrating Checkpoint Blockade into Oncolytic Virotherapy
Manish Patel (US) - Virotherapy for Non-Small Cell Lung Cancer using Vesicular Stomatitis Virus Expressing Interferon-Beta
Khalid Shah (US) - Encapsulated Stem Cells Loaded with Oncolytic Viruses for Cancer Therapy

Technical Science Session 2 - CELL SEPARATION/PURIFICATION
Chair: Lizette Caballero
Speakers:
Dalip Sethi (US) - Adaptable Processing of Blood and Related Products
Alaina Schlinker (US) - LOVO Cell Processing System with Software 2.0: A Technology Overview and Data Review
Julien Camisani (CH) - Moving Towards a Versatile, Adaptive and Automated Process for Developing More than Minimally Manipulated Cell Therapies

 

Technical Science Session 3 - GENOME EDITING  
Chair: Matthew Porteus 
Speakers:
Matthew Porteus (US) - Genome Editing of Hematopoietic Stem and Progenitor Cells
Charles Gersbach (US) - Genome and Epigenome Editing for Gene Therapy and Cell Reprogramming
Quality and Operations Track Session 1 - ISCT–FACT JOINT SESSION: OUTCOME ANALYSIS FROM THE PROCESSING PERSPECTIVE
Chair: Deborah Griffin (US)
Speakers:
Paul Eldridge (US) - Ants on a Möbius Strip: Linking Outcomes between the Processing Lab and the Clinic
Athena Russell (US) - Outcomes in Mesenchymal Stem Cell Manufacturing

Plenary Session 1 -IMMUNOTHERAPY CLINICAL TRIALS AND STRATEGIES
Chair: Helen Heslop (US)
Speakers:
Barbara Savoldo (US) - Driving CARs and TCRs on Roads Less Travelled
Marco Ruella (US) - Chimeric Antigen Receptors for Hematological Malignancies: Building upon CART19
Aaron Foster (US) - Controlling Adoptive T Cell Therapy Efficacy and Safety using Molecular Switches

Workshop 1 - PRE–CLINICAL DEVELOPMENT
Chair: Sowmya Viswanathan (CA)
Speakers:
Sowmya Viswanathan (US) - Preclinical Development – an Iterative Process
Katy Spink (US) - Preclinical and Clinical Development of Pluripotent Stem Cell Derived Therapies: Lessons Learned from the AST–OPC1 Development Experience
Benjamin Fryer (US) - Developing a Clinical-Grade Cell Therapy From Published Research Methods

Workshop 2 - ISCT–FACT JOINT SESSION: ANATOMY OF AN AUDIT
Chair: Heather Conway (US)
Speakers:
Nicole L. Prokopishyn (CA) - Anatomy of an Audit
Martha Hackett (US) - Internal Audits: One Processing Facility’s Example

Oral Presentation Session 1 
Chair: Catherine Bollard (US)
Speakers:
Rayne Rouce (US) - Use of Highly Characterized EBV-specific T Cells for Treatment of EBV+ Lymphoma in an Immunocompetent Setting
Fenlu Zhu (US) - Manufacturing of Genetically-Engineered T Cells Expressing a Thymidylate Kinase (TMPK)-Based Suicide Transgene for the Treatment of Graft-Versus-Host Disease Follow Cellular Therapy
Kurt Gunter (US) - Manufacture of GMP-Compliant Functional Adenovirus-Specific T Cell Therapy for Treatment of Post-Transplant Infectious Complications
Yiewi Ma (US) - Generation of Monocyte Derived Dendritic Cells using Xeno-Free Clinical Grade Human Platelet Lysate

Quality and Operations Track Session 2 – FLOW CYTOMETRY TC
Chair: Lizette Caballero (US)
Speakers:
Carolyn Keever-Taylor (US) - Challenges for Product Evaluation by Flow Cytometry for Cellular Therapy Product Processing Laboratories
David Novo (US) - Quality Control and Standardization in Flow Cytometry Data Analysis
Scott Bornheimer (US) - FACS in Cell Therapy Development and Production

 

 Plenary Session 2 - GENE THERAPY CLINICAL TRIALS
Chair: Matthew Porteus (US)
Speakers:
Donald Kohn (US) - Gene Therapy for Sickle Cell Disease
Mark Walters (US) - Gene Therapy for  Hemoglobin Disorders

 

Saturday, October 1 
NORTH AMERICA REGULATORY TOWN HALL SESSION 
Co-Chairs: William Janssen (US) and Michael Mendicino (US)
Speakers:
Sowmya Viswanathan (CA) - Cell Therapy Stakeholder Group (CTSG) Interactions with Health Canada
Olive Sturtevant (US) - CTLM Cell Therapy Liaison Meetings 
Deborah Griffin (US) 
Massimo Dominici (US) - Dissecting Unproven Cellular Therapies: The International Society for Cellular Therapy (ISCT) Position

Technical Session 4 - FLOW CYTOMETRY
Chair: David DiGiusto (US)
Speakers:
Bryan Fox (US) - Flow Cytometric Preparation of CD34+ CD90+ HSC’s for Transplantation
 Amy Putnam (US) - Clinical Treg Flow Sorting: Challenges, Hurdles and Accomplishments
 

Advanced Practice Professionals Track Session 1 - CAR T CELLS
Chair: Tobi Fisher 
Speakers:
Valkal Bhatt (US) - Clinical Applications of Chimeric Antigen Receptor (CAR) – T Cell Therapy in Hematologic Malignancies
 

Quality and Operations Track Session 3 - Logistics of Product Transport
Chair: Raymond Hornung (US)
Speakers:
Raymond Hornung (US) - From A to B and Sometimes C: Transporting Stem Cells Around the World
Jessica Deveau (US) -  A Look Behind the Scenes From a Transport Perspective
 

Plenary Session 3 - CELL THERAPY AND TISSUE ENGINEERING I
Chair: Peter Coffey (US)
Presenters:
Peter Coffey (US) - Human Pluripotent Stem Cell Derived Disease Modelling for Drug Screening
Dennis Clegg (US) - Development of Cellular Therapies for Age–Related Macular Degeneration
Anthony Vugler (UK) - Translating a Cellular Therapy for Photoreceptor Degeneration
 

Workshop 3 - CHALLENGES FOR PHASE 3 & COMMERCIAL DEVELOPMENT OF CELL THERAPIES
Chair: Elizabeth J. Read (US)
Speakers:
Elizabeth J. Read (US) -  Is seamless product development possible?
Cliona Rooney (US) - The Ups and Downs of a Translational Researcher Working with Industry
Darin Weber (US) -  Common Regulatory Potholes on the Road to Phase 3 and Beyond
 
Oral Presentation Session 2 
Chair: Patrick Hanley (US)
Presenters:
Greg Butler (US) - Adipose-Derived Mesenchymal Stromal Cells (AdMSC); The First 100 Patients at Mayo Clinic
Greg Butler (US) -  Adipose-Derived Mesenchymal Stem Cell Coated Fistula Plugs for the Treatment Of Refractory Perianal Fistulizing Crohn’s Disease
Hongjun Wang (US) -  Autologous Islets and Mesenchymal Stem Cells Co-Transplantation in Patients with Chronic Pancreatitis After Total Pancreatectomy
Christopher Duma (US) - Injection of Autologous Adipose-Derived Stromal Vascular Fraction (ADSVF) into the Human Brain Ventricular System for Neurodegenerative Disorders: 2-Year Results of a Phase I Study in 20 Patients
 
Advanced Practice Professionals Track Session 2 - CORD BLOOD EXPANSION
Chair: Kimberly Woody (US)
Speakers:
Filippo Milano (US) - Umbilical Cord Blood Versus Unrelated Donor Transplants: Differential Effect of Pre-
Transplant Minimal Residual Disease on Outcomes
Colleen Delaney (US) - Overcoming the Cell Dose Barrier in Cord Blood Transplant Through the Use of Ex Vivo Expanded Cord Blood Progenitor Cells
 
Quality and Operations Track Session 4 - BOOTS ON THE GROUND I: BUILDING CELLULAR THERAPY FROM THE GROUND UP – PLANNING
Chair: Lynn O'Donnell (US)
Speakers:
Lynn O'Donnell (US), Diane Kadidlo (US) - Planning Tools and Techniques

 

ISCT Society Updates: Past, Present, and Future 
Speakers:
Massimo Dominici (IT) - ISCT 2017-2019 Strategic Plan
Catherine Bollard (US) - Update on Key ISCT Projects
William Milligan (CA) - ISCT-AABB Joint Working Group’s First Project on Human Platelet Lysate (HPL)

 

Workshop 4 - Transition from Experimental Therapy to Standard of Practice - What is Standard of Practice?
Chair: Bruce Levine (US)
Speakers:
Bruce Levine (US) - Leaving the Single Center Orbit: New Horizons in Clinical Cell Therapy
George Eastwood (US) - Collection and Donor Management: Important Considerations For Cell Therapy Commercialization
Charles Trammell (US) - Cryo Chain Strategies: From Clinical Research to Commercialization

 

Oral Presentation Session 3 
Chair: David DiGiusto (US)
Presenters:
Heather Daley (US) - Manufacture of First In-Human Implantable Polymer-Derived Tumor Vaccine Scaffolds (WDVAX) for Phase I Clinical Trial for Metastatic Melanoma
Patrick Hanley (US) - The Cost Effectiveness of Manufacturing Antigen-Specific T Cells in an Academic GMP Facility
Helen Negre (US) - Personnel Environmental Monitoring During Manufacturing of Mesenchymal Stromal Cells and CAR-T Cells
Nianzhen Li (US) - Robust Human Pluripotent Cell Reprogramming Using an Automated Cell Culture System
 
 Advanced Practice Professionals Track Session 3 - CTLS
Chair: Shannon Holloway (US)
Speakers:
Conrad Russell Cruz (US) - T Cell Therapies for Viral Infections
Carlos Ramos (US) - CAR-T Cells for Hematological Malignancies
 
Quality and Operations Track Session 5 - SUPPLY CHAIN DEVELOPMENT
Chair: Aby J. Mathew (US)
Speakers:
Aby J. Mathew (US) - How can Industry Suppliers Support Clinical Center Audit Programs and Mitigate Supply Chain Risks?
Darcie Radel (US) - Vendor and Supply Qualification
Olive Sturtevant (US) - Supplier Assessment for Qualifying Manufacturing and Laboratory Services
 
Workshop 5 - QUALITY SYSTEMS DEVELOPMENT: CREATING A PROGRAM THAT WORKS FOR YOU
Chair: J. Wade Atkins (US)
Speakers: 
J. Wade Atkins (US), Lizette Caballero (US), Olive Sturtevant (US) - A Quality System Covering Multiple cGMP Programs
 
Workshop 6 - ISCT EARLY STAGE PROFESSIONALS (ESP) SESSION: CELL THERAPY PROFESSIONAL DEVELOPMENT
Chair: Andrew Fesnak (US)
Speakers:
Don Siegel (US) - The Evolving Role of the Blood Bank/Transfusion Medicine Specialist in the Development and Administration of Novel Cell Therapies
Robert Margolin (US) - Cell Therapy Job Market – A CMO Perspective
Catherine Bollard (US) - How to Build a Successful Academic Career in Cell Therapy
 
ISCT–CBA JOINT SESSION: CORD BLOOD TRANSPLANT AND CORD Forest Room
BLOOD TISSUE ENGINEERING
Chair: Colleen Delaney (US)
Speakers:
Catherine Bollard (US) - Engineering Cord Blood Derived Virus Specific T Cells for Use After CBT
Filippo Milano (US) - Umbilical cord blood vs unrelated transplants: differential effect of pre-transplant minimal residual disease on outcomes
Shahin Rafii (US) - Vascular niche platform for clinical scale expansion of true hematopoietic stem and progenitor cells
 
Quality and Operations Track Session 6 - BOOTS ON THE GROUND II: BUILDING CELLULAR THERAPY FROM THE GROUND UP – IMPLEMENTATION
Chair: Diane Kadidlo (US)
Speakers:
Carlos Lee (US) - Establishing A New HCT/P Processing Facility
Darin Sumstad (US) - Product Development: Bringing a New Product to the Front Line
 

 

Sunday, October 2 

Technical Science Session 5 - LENTIVIRAL VECTOR HEMATOPOIETIC STEM CELL TRANSDUCTION OPTIMIZATION
Chair: Bruce Torbett (US)
Speakers:
Bruce Torbett (US) - The Ins and Outs of Lentiviral Vector Gene Delivery to HSCs
Byoung Ryu (US) - To Optimize Transduction of HSC with Lentiviral Vectors: Revisiting Multiplicity of Infection
Boro Dropulic (US) - Towards the Commercialization of Gene-Modified Cell Therapy Products

Technical Science Session 6 - VECTOR PRODUCTION
Chair: William Swaney (US)
Speakers:
William Swaney (US) - Development and Manufacture of a Lentiviral Vector for the Treatment of Hemophilia
Brian Sorrentino (US) -  Production of a Clinical Lentiviral Vector for XSCID
 

Industry Roundtable 1 - TRANSITION OF PRODUCTS FROM THE PAYER PERSPECTIVE
Chair: Nick Crabb (UK)
Speaker:
Nick Crabb (UK) - The Health Technology Assessment (HTA) of Cell Therapies
 

 

Quality and Operations TRack Session 7 -  IND CMC DEVELOPMENT
Chair: William Janssen (US)
Speakers:
William Janssen (US) - IND Construction and Organization: The Chemistry, Manufacturing and Control section
Cynthia Walker (US) - So...You were Granted an IND or IDE. Now What?
 

Plenary Session 4 - CELL THERAPY AND TISSUE ENGINEERING II
Chair: Amit Patel (US)
Presenters: 
Amit Patel (US) - Update in Cardiac Biological Therapies
Karen Christman (US) -  Injectable Extracellular Matrix Hydrogels for Regenerative Medicine
Tracy Criswell (US) -  Preclinical Testing of Cell Therapy for Skeletal Muscle Dysfunction
 
 

Industry Roundtable 2 - COMMERCIAL MODELS FOR CELL AND GENE THERAPY
Chair: David DiGiusto (US)
Speakers:
Daniel Kirby (US) - Commercial Models for Cell and Gene Therapy
Peter A. Altman (US) -  Commercial Models Cell and Gene Therapies 
Emily Culme-Seymour (UK) - Collaborative Approaches to Gene Therapy Development

Technical Science Session 7 - EXTRACELLULAR VESICLES: FROM BASIC SCIENCE TO THERAPEUTIC APPLICATIONS
Chair: Ahmed Ibrahim (US)
Speakers:
Oren Levy (US) - Assessing the immunomodulatory potential of extracellular vesicles
Ahmed Ibrahim (US) - Cardiosphere-derived Cell EVs in Tissue Healing and Regeneration
Kelvin Ng (US) - Towards manufacturing of extracellular vesicles
 
Oral Presentation Session 4
Chair: William Janssen (US)
Presenters:
Rachel Legmann (US) -  Industrialization of adenoviral vector production in an iCellis® 500 fixed bed bioreactor for the creation of autologous insulin producing liver cells for the treatment of diabetes: From bench to clinical scale
Mark McCall (UK) - Management of technical, manufacturing & commercial risks during the new product introduction process for pluripotent stem cell products
Nadine Mockel-Tenbrinck (DE) - Simple automated manufacturing of gene engineered T cells from lymphoma and melanoma blood samples
Jason Fiering (US) - Acoustic Separation for Purification of Lymphoctyes
 
Quality and Operations Track Session 8 -  BOOTS ON THE GROUND III: BUILDING CELLULAR THERAPY FROM THE GROUND UP – STANDARDIZATION & QUALITY OVERSIGHT
Chair: Lizette Caballero (US) 
Speakers: 
Sumona Sarkar (US) - Standardization and Measurement Assurance Efforts for Cell and Gene Therapy
Shadya George (US) - Quality Indicators by Design – Construction from the Ground Up

© 2017 International Society for Cellular Therapy. All rights reserved.
ISCT, International Society for Cellular Therapy, and the ISCT logo are registered service marks of The International Society for Cellular Therapy.
The BEACON and lighthouse logo is a service mark of The International Society for Cellular Therapy.