Download Discussion Day Tuesday 13th September 2016 - CAR

Discussion Day
Tuesday 13th September 2016
08.00 Registration & Coffee
Stream A: Autologous vs. Allogeneic: Which
Will Succeed in the Race to Market?
Leader: Sicco Popma Scientific Director, Gene
Modified Cell Therapy Leader, Johnson &
Johnson
9.00 Autologous vs. Allogeneic: Which
Will Succeed in the Race to Market?
10.30 Morning Refreshments & Networking
11.00 Summary & Discussion: Autologous vs.
Allogeneic: Which Will Succeed in the Race to
Market?
12.00 Networking Lunch
Stream C: Solid Tumor Target Identification and
Validation
Leader: Edmund Moon, Assistant Professor,
University of Pennsylvania
1.00 Solid Tumor Target Identification and
Validation
2.30 Afternoon Refreshments & Networking
3.00 Summary & Discussion: Solid Tumor Target
Identification and Validation
4.00 Post Discussion Day Debrief
5.00 Close of Discussion Day
Stream B: Overcoming the Inhibitory Tumor
Microenvironment
Leader:
9.00 Overcoming the Inhibitory Tumor
Microenvironment
11.00 Summary & Discussion: Overcoming the
Inhibitory Tumor Microenvironment
Stream D: The Transformative Power of
Correlative Sciences in Adoptive Immuno Gene
Therapies
Leader: Jos Melenhorst, Director, Product
Development & Correlative Sciences laboratory,
University of Pennsylvania
1.00 The Transformative Power of Correlative
Sciences in Adoptive Immuno Gene Therapies
3.00 Summary & Discussion: The Transformative
Power of Correlative Sciences in Adoptive
Immuno Gene Therapies
Conference Day 1
Wednesday September 14th, 2016
08.00 Registration & Breakfast
09.00 Chairman’s Opening Remarks
Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, Director,
Clinical Cell and Vaccine Production Facility, University of Pennsylvania
Updates from Leaders in the Field
09.10 The Race is On: CAR-Ts Where are We Now?
David Chang, CMO & EVP R&D, Kite Pharmaceuticals
09.40 Engineered T Cells for Hematologic Malignancies and Solid Tumors: The Juno Program
Mark Frohlich, EVP, Portfolio Strategy, Juno Therapeutics
10.10 Natural Killer Receptor T-Cells: A Different Approach to Target and Attack Cancer
Steve Buckanavage, VP, Marketing, Celyad
10.40 Novartis CTL019 Case Study
David Lebwohl, Senior Vice President & Global Program Head, CAR-T Program, Novartis
11.10 Speed Networking & Morning Refreshments
STREAM A
Discovery & Genetic T-Cell
Engineering
Chair: Dolores Schendel, CEO
& CSO, Medigene
Target Identification &
Validation
12.10 – 12.40
Understanding and
Improving the Activity of
CAR-T cells in Solid Tumors
Jennifer Brogdon, Director,
Exploratory ImmunoOncology, Novartis
12.42 – 1.12 Targeted
Insertion of an Anti-CD19
CAR into Primary Human T
cells Using ARCUS Gene
Editing Technology
Bruce McCreedy, SVP of Cell
Therapy, Precision
Biosciences
1.14 – 1.44 The ABC’s of
Adoptive T Cell Therapy
Using Optimal- Affinity
Natural TCRs Specific for
STREAM B
Translation & Clinical
Development
Chair: Michael Kalos, CSO, Cancer
Immunobiology, Eli Lilly
Robust Clinical Research
STREAM C
Manufacturing, Supply Chain
& Commercialization
Chair: Sadik Kassim, Associate
Director, Novartis
Manufacturing Strategies
12.10 – 12.40 Translation of
Preclinical
Research into the Clinic
Stephan Grupp, Director, Cancer
Immunotherapy Frontier
Program, Children’s Hospital of
Philadelphia
12.42 – 1.12 Improving Analysis
of CAR T-Cell Function through
High-Throughput MultiParameter Flow Cytometry
Tamara Laskowski, Post-Doctoral
Fellow, CAR T-Cell Therapy Lab,
MD Anderson Cancer Center
12.10 – 12.40 Automating CART cell
Manufacturing: Building a Solid
Foundation
Rodney Rietze, Lead, cGMP
Process Automation, Novartis
1.14 – 1.44 Single-Cell Metrics Of
The
Efficacy Of CAR+ T Cells
Navin Varadarajan, Assistant
12.42 – 1.12 Key Considerations
when
Evaluating CMOs for Late
Stage Clinical and Commercial
Production of Cell-Based
Immunotherapies
Claudia Zylberberg, CEO, Akron
Biotech
1.14 – 1.44 Large-Scale,
Reproducible
Biomanufacturing of HighQuality Cells: A Roadmap from
Hematological Malignancies
and Solid Tumors
Dolores Schendel, CEO &
CSO, Medigene
1.45 Networking Lunch
2.45 – 3.15 Gene Editing and
Vector Engineering to
Support Commercialization
of CAR-T Immunotherapies
Martha Rook, Head of Gene
Editing & Novel Modalities,
MilliporeSigma
3.17 – 3.47 Treatment of
Solid Cancers by Adoptive
Cell Transfer of Chimeric
Antigen Receptor
Transduced T Cells
Steven Feldman, Director,
Surgery Branch Vector
Production Facility, NCI
3.50 – 4.50 PANEL:
Innovations in Enhancing
Efficacy and Improving
Safety Profiles
Moderator: Dolores
Schendel, CEO/CSO,
Medigene
Tim Clay, Senior Director,
Research Projects Leader US,
Cell & Gene Therapy
Discovery Research, GSK
Klaus Kühlcke, CEO, EUFETS
Bruce Levine, Barbara and
Edward Netter Professor in
Cancer Gene Therapy,
Director, Clinical Cell and
Vaccine Production Facility,
University of Pennsylvania
Professor, University of Houston
the National Cell Manufacturing
Consortium
Krishnendu Roy, Director,
Center for Cell Manufacturing &
ImmunoEngineering, Georgia
Institute of Technology
2.45 – 3.15 Further Development
Of
CAR-T Cells for the Treatment
of Cancer
Rick Morgan, VP Immunotherapy,
bluebird bio
2.45 – 3.15 Innovative Solutions
for Manufacturing of Next
Generation Cell Therapies
Nina Bauer, Senior Manager,
Commercial Development,
Autologous Cell Therapy, Lonza
3.17 – 3.47 CAR T Cells Go Back
to School
Marcela Maus, Director, Cellular
Immunotherapy, MGH Cancer
Center
3.17 – 3.47 Challenges in CAR-T
Cell Manufacturing
Isabelle Rivière, Director,
Michael G. Harris Cell Therapy &
Cell Engineering Facility, Center
for Cell Engineering, Memorial
Sloan Kettering Cancer Center
3.50 – 4.50 PANEL: Developing
and Translating Clinical Trials
from Bench to Bedside
3.50 – 4.50 PANEL: From
Manufacturing to Market
Access: Getting Cellular
Therapies to Patients in Need
Moderator: Michael Kalos, CSO,
Cancer Immunobiology, Eli Lilly
Navin Varadarajan, Assistant
Professor, University of Houston
Sicco Popma, Scientific Director,
Gene Modified Cell Therapy
Leader, Johnson & Johnson
Stephan Grupp, Cancer
Immunotherapy Frontier
Program, Children’s Hospital of
Philadelphia
Louis Masi, Co-Founder & EVP,
FloDesign Sonics
Peter Hoang, SVP, Business
Development & Strategy,
Bellicum Pharmaceuticals
4.50 Afternoon Refreshments & Poster Session
Viral Vector Transfection &
Demonstrating Efficacy in Solid
Genetic Engineering
Tumor Indications
Moderator: Sadik Kassim,
Associate Director, Novartis
Steve Buckanavage, VP,
Marketing, Celyad
Steven Feldman, Director,
Surgery Branch Vector
Production Facility, NCI
Rodney Rietze, Lead cGMP
Process Automation, Novartis
Fred Koller, VP, Business
Development, Miltenyi Biotec
Transportation, Supply
Chain & Logistics
5.10 – 5.40 Reinventing the
Lentivirus System to Create
High Titer Packaging Cells
Ryan Cawood, CEO, Oxford
Genetics
5.10 – 5.40 Next-Generation
Investigative CAR-T Platforms
Towards the Goal of
Personalized Immunotherapy
Robert Berahovich, Director,
CAR-T Discovery, ProMab
Biotechnologies
5.42 – 6.12 TALEN® Based
Targeted
Genome Modifications for
Improved CAR-T Cell
Adoptive Immunotherapy
Laurent Poirot, Head, Early
Discovery, Cellectis
5.42 – 6.12 Development of
Cancer-Specific anti-EGFR CAR-T
cells for the Treatment of
Patients with Glioblastoma
Zonghai Li, President & CEO,
CARsgen
6.14 – 6.44 Novel Cellular
Engineering: Controlling
Specificity and Activity of
Adoptive Cellular Therapies
Peter Emtage, SVP Research
& Development, Cell Designs
Lab
6.14 – 6.44 TCR-Like CARs
Targeting Intracellular CancerSpecific Antigens for Treatment
of Solid Tumors
Cheng Liu, CEO, Eureka
Therapeutics
6.45
CAR-TCR Party Hosted by Juno Therapeutics
The Ritz-Carlton Boston
7.45
Close of Conference Day 1
5.10 – 5.40 Critical Assessment
of the
Impact of Packaging and
Logistics Decisions on the CAR-T
Clinical Pipeline
Mark Sawicki, CCO, Cryoport
Jim Reiner, Senior Product
Manager, UPS
5.42 – 6.12 Analytical
Challenges Around
Manufacturing
Christopher Wiwi, Director,
Analytical R&D, Celgene Cellular
Therapeutics
6.14 – 6.44 Characterization of
CAR-T Therapies: Advancing
Towards Precision
Sadik Kassim, Associate Director,
Novartis
Conference Day 2
Thursday September 15th, 2016
08.00 Breakfast Briefing by Draper Laboratory
Invite only
08.00 Coffee & Networking
09.00 Chairman’s Opening Remarks
Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, Director,
Clinical Cell and Vaccine Production Facility, University of Pennsylvania
Updates from Leaders in the Field
09.10 Near Term Targets and Next Generation TCR Engineered T Cell Therapy
Gwendolyn Binder- Scholl, CTO, Adaptimmune
09.40 Controlling Potency, Persistence, and Toxicity of T Cell Therapies Using Molecular Switches
David Spencer, CSO, Bellicum Pharmaceuticals
10.10 Tailored T Cell Therapies: The Autolus Approach
Christian Itin, CEO, Autolus
10.40 Building Automation, Reproducibility, and Transferability into CAR-T Cell Manufacturing
Fred Koller, Vice President, Business Development, Miltenyi Biotec
11.10 Speed Networking & Morning Refreshments
STREAM A
Discovery & Genetic T-Cell
Engineering
Chair: Tim Clay, Senior Director,
Research Projects Leader US,
Cell & Gene Therapy Discovery
Research, GSK
Innovative Methods to
Overcoming Safety & Toxicity
Challenges
12.10 – 12.40 Next-Generation
Bio-Engineering of Immune
Cells for Potency and
Persistence
Laurence Cooper, CEO,
ZIOPHARM Oncology
STREAM B
Translation & Clinical
Development
Chair: Michael Kalos, CSO,
Cancer Immunobiology, Eli Lilly
12.42 – 1.12 Pfizer Allogeneic
CAR-T Therapy
Barbra Sasu, Inter-rim CSO,
Rinat/Pfizer
12.42 – 1.12 PD1 Inhibition and
Autologous T cells Expressing
a GD2 Specific CAR with CD28
and OX40 Costimulatory
Combination Therapies &
Enhancing the Efficacy of
Frontline Cancer Therapies
12.10 – 12.40 The Horse Before
the CAR-T? Pretreatment With
Oncolytic Herpes Simplex I
Viroimmunotherapy Augment
CAR-T Cell Therapy
Kellie Haworth, Pediatric
Hematology, Oncology Fellow,
Nationwide Children’s Hospital
STREAM C
Manufacturing, Supply Chain
& Commercialization
Chair: Sadik Kassim, Associate
Director, Novartis
Regulatory Expectations
& Guidelines
12.10 – 12.40 Clinical
Considerations for CAR-T Cell
Therapy: A Regulatory
Perspective
Kristin Baird, Medical Officer,
Division of Clinical Evaluation,
Pharmacology & Toxicology,
Office of Cellular, Tissue &
Gene Therapies, CBER, FDA
12.42 – 1.12 EMA Regulatory
Perspective: Evolving the
Regulatory Conversation to
Match Scientific Innovation
1.14 – 1.44 Identifying the Best
Killers: Kinetic Assessment
of CAR-T Cell Potency Against
Liquid and Solid Tumors
Yama Abassi, VP, ACEA
Biosciences
1.44 Networking Lunch
The Future of CAR-T
Development: Emerging
Innovations & Technologies
2.45 – 3.15 New Models of
Engineered T Cells for Cancer
Bruce Levine, Barbara and
Edward Netter Professor in
Cancer Gene Therapy, Director,
Clinical Cell and Vaccine
Production Facility, University
of Pennsylvania
3.17 – 3.47 Potential of CAR T
Cells for Treating Infectious
Diseases
Thor Wagner, Assistant
Professor, Seattle Children’s
Hospital
Endodomains in Combination
for Children with
Neuroblastoma
Andras Heczy, Director, Liver
Tumor Program, Assistant
Professor, Baylor College of
Medicine
1.14 – 1.44 Cytokines as
Ancillary
Reagents: Ways to Reduce Risk
and Associated Costs
Timothy Manning, Product
Manager, Recombinant
Proteins R&D Systems, BioTechne
Unconventional CAR
Approaches:
Alternative CAR vehicles &
Looking Beyond Cancer
2.45 – 3.15 Novel CARs
Introduced into NK Cells
Facilitate Potent Tumor-Cell
Killing that Results in Tumor
Regression
Rohit Duggal, Director,
Experimental Therapy, Sorrento
Therapeutics
3.17 – 3.47 Target Engineered
Natural Killer Cells as “Off-theShelf” Cellular Therapeutics
Hans Klingemann, VP, R&D,
NantKwest
Paula Salmikangas, Chair,
Committee for Advanced
Therapies, EMA
1.14 – 1.44 Your CAR-T
Therapy has
the Green Light? How Strong is
Your Market Access Strategy?
Jan Nielsen, Vice President,
Sonexus™ Access & Patient
Support, Cardinal Health
Specialty Solutions
Pricing, Partnering & Novel
Business Models
2.45 – 3.15 How Will New
Cancer Cell Therapies be
Reimbursed?
Edmund Pezalla, VP, National
Medical Director,
Pharmaceutical Policy &
Strategy, Aetna
3.17 – 3.47 Delivering
Optimized Cell Therapies
Through Integrated
Technology Modules
Axel Hoos, Senior Vice
President, TA Head Oncology
R&D and Head, ImmunoOncology, GSK
3.47
Afternoon Refreshments & Networking
4.15
A Patient’s Experience with the Initial CART 19 Trial and Perspectives on Patient Access to
New Breakthroughs for Cancer Treatment
Doug Olson, Patient Advocate, The Leukemia and Lymphoma Society
4.45
Chairman’s Closing Remarks
Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, Director,
Clinical Cell and Vaccine Production Facility, University of Pennsylvania
5.00
Emily Whitehead Foundation Silent Auction
6.00
Close of Conference Day 2
Focus Day: Downstream Processing
Friday September 16th, 2016
08.00 Registration & Coffee
Stream E: CAR-T Cell Therapy: Regulatory
Challenges and Opportunities
Leaders: Paula Salmikangas, Chair, Committee
for Advanced Therapies, EMA
Kristin Baird, Medical Officer, Division of Clinical
Evaluation, Pharmacology and Toxicology, Office
of Cellular, Tissue and Gene Therapies CBER, FDA
9.00 CAR-T Cell Therapy: Regulatory
Challenges and Opportunities
10.30 Morning Refreshments & Networking
11.00 Summary & Discussion: CAR-T Cell
Therapy: Regulatory Challenges and
Opportunities
12.00 Networking Lunch
Stream G: Pricing and Reimbursement
Strategies for Engineered Cell Therapies
Leader: Edmund Pezalla, VP, National Medical
Director, Pharmaceutical Policy & Strategy,
Aetna
1.00 Pricing and Reimbursement
Strategies for Engineered Cell Therapies
2.30 Afternoon Refreshments & Networking
3.00 Summary & Discussion: Pricing and
Reimbursement Strategies for Engineered Cell
Therapies
4.00 Post Focus Day Debrief
5.00 Close of Focus Day
Stream F: Development Across the spectrum:
Pre-clinical and Trial Design, Academic
Involvement, Industry Scalability, and Clinical
Distribution
Sarah Nikiforow, Assistant Medical Director, Cell
Manipulation Core Facility, Dana Farber Cancer
Centre
Helen Negre, Technical Director, Novel Cell
Therapies, Dana Farber Cancer Centre
Marcela Maus, Director, Cellular
Immunotherapy, MGH Cancer Center
9.00 Automatizing Single Use Systems
and Novel Production Paradigms for Effective
Manufacturing
11.00 Summary & Discussion: Automatizing
Single Use Systems and Novel Production
Paradigms for Effective Manufacturing
Stream H: Current Trends and Best
Practices in Outsourcing for Long Term Cell
Immunotherapy Success
Leader: Peter Olagunju, Senior Director, Vendor
Management, bluebird bio
1.00 Current Trends and Best
Practices in Outsourcing for Long Term Cell
Immunotherapy Success
3.00 Summary & Discussion: Current Trends and
Best Practices in Outsourcing for Long Term Cell
Immunotherapy Success