Event Highlights
Hynes Convention Center,
Boston, MA
Preliminary Agenda Highlights
No other event can match the streamlined coverage of the latest innovations to overcome obstacles in development, scale up, and commercialization of cell and gene-based products through the latest research data and case studies.
Plenary Sessions
Tuesday-Thursday, September 26-28, 2017
PANEL DISCUSSIONS
T-Cell Based Immunotherapy Manufacturers: Fast Followers and Next Generation Innovators
Moderator: David DiGiusto, Ph.D., Executive Director, Stem Cells and Cellular Therapeutics Operations, Paediatric Transplantation and Regenerative Medicine, Stanford University
Panelists:
- Laurence Cooper, Ph.D, M.D., CEO, ZIOPHARM Oncology
- Geoffrey Hodge, Chief Technical Officer, UNUM
Alan Smith, Ph.D., Executive Vice President, Technical Operations, Bellicum Pharmaceuticals
Christian Homsy, M.D., CEO & Co-founder, Celyad (confirming)
Cell, Gene, and Tissue Therapies: Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies
Moderator: BPI Magazine
Panelists:
- David Brindley, DPhil, MEng, FRSA Managing Partner, Biolacuna & Senior Research Fellow, Nuffield Department of Paediatrics, University of Oxford, United Kingdom
- Jon Rowley, Ph.D., Founder & Chief Technology Officer, RoosterBio Inc.
Lynne Frick, Vice President, Business Development, IsoPlexis
Phil Vanek, General Manager, Cell Therapy Growth Strategy, GE Healthcare
James Miskin, Chief Technical Officer, Oxford BioMedica
Process Characterization and Comparability: Lessons for CAR T Cell Commercialization
Marc Better, Ph.D., Vice President, Product Sciences, Kite Pharma
Manufacturing and Commercialization Strategies for CAR-T Cell Therapies: Novartis
Brian Majors, Launch Director, Novartis
Achieving Large Scale, Cost-effective, Reproducible Manufacturing of High Quality Therapeutic Cells: A Roadmap to 2015
Krish Roy, Ph.D., Robert A. Milton Chaired Professor, Biomedical Engineering, Georgia Institute of Technology
Clinician’s Perspective on Cell and Gene Therapies
Emma Morris, Ph.D., M.D., Professor of Clinical Cell & Gene Therapy, Consultant Haematologist, UCL Institute of Immunity & Transplantation, University College London, United Kingdom
Advancements in Clinical Manufacturing for Cancer Vaccines & Anti-Aging Skin Care
Hans Keirstead, Ph.D., Chief Executive Officer, AIVITA Biomedical
Successfully Executing Autologous Scale-Up and Scale-Out Operations
Eytan Abraham, Ph.D., Head of Emerging Technologies R&T, Research and Technology, Lonza
Introduction to the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
Stacy Springs, Ph.D., Director, Center for Biomedical Innovation, Massachusetts Institute of Technology
An introduction to Advanced Regenerative Manufacturing Institute (ARMI)
Thomas Bollenbach, Ph.D., Chief Technology Officer, Advanced Regenerative Manufacturing Institute
Pluripotent Stem Cells: Making the Case for Commercialization
Robert Deans, CTO, BlueRock Therapeutics
Process Scale-up and Characterization Strategy for an Allogeneic Cell Therapy Product
Ravinder Bhatia, MSc., Scientific Director, PDMS, Janssen R&D
Successfully Executing Autologous Scale-Up and Scale-Out Operations
Alan Smith, Ph.D, Executive Vice President, Technical Operations, Bellicum Pharmaceuticals
Bioprocessing Track
Tuesday-Thursday, September 26-28, 2017
PANEL DISCUSSIONS
We Need to Talk about Particulates, Leachables and Extractables
Moderator: Ohad Karnieli, Ph.D., MBA, CEO, Atvio Biotech, Israel
Panelists:
- Jean Stanton, MSc, Director, Regulatory Compliance, Johnson & Johnson
- Carl Burke, Ph.D., New Platform Integration, Pharmaceutical Development & Manufacturing Sciences, Janssen
- Jean-Sébastien Parisse, MBA, Head of Sales, Aseptic Technologies
Adoption of an Automated Bioprocessing System
Shashi Murthy, Professor, Chemical Engineering, Northeastern University
US Approval of Three Rapid Microbiological Methods for MACI Product Release
John Duguid, Senior Director, Research & Development, Vericel Corporation
Process Development and Optimization in 3D Packed Bed Bioreactor Systems for Ensuring Successful Launch into Marketing Scale Manufacturing
Lior Raviv, MSc, Eng., Vice President of Development, Pluristem Therapeutics, Israel
Comparison of Adherent Cell Technologies for the Amplification of Virus Stocks and Viral Vectors
Steve Pincus, Ph.D., Associate Vice President, Virology and Analytical Methods Development, Fujifilm Diosynth Biotechnologies
Implementing Large Scale Data Processing and Analysis in Bioprocessing
Lisa Graham, Ph.D., CEO and Founder, Alkemy Innovation Inc.
Processing Non-Mobilized Leukapheresis Products for Upstream Cell Therapy Manufacturing
Alaina Schlinker, Ph.D., Manager, Cell Therapy Application Support, Fresenius Kabi
Exosomes in Cell Manufacturing: From by-Product to Product
Kelvin Ng, Ph.D., Scientist, Process & Product Development, RoosterBio, Inc
Advances in CAR-T Cell Manufacturing
Isabelle Riviere, Ph.D., Director, Michael G. Harris Cell Therapy and Cell Engineering Facility, Molecular Pharmacology, Memorial Sloan Kettering Cancer Center
Advanced Cellular Analytics of CD34 Drug Products
Ilya Shestopalov, Senior Scientist, Cell Analytics, bluebird bio, inc.
Application of ‘Omics Tools for Better Understanding and Characterizing Cell-Based Allogeneic Products for Cardiac Repair
Patrícia Gomes-Alves, Ph.D., Senior Scientist, Cell Bioprocesses Laboratory, Animal Cell Technology Unit, iBET, Portugal
Investing in Process Development for Increased MSC Production in Stirred Tank Bioreactors
Julie Murelle, Ph.D., Head of Cell Therapy Bioprocessing, MilliporeSigma
Commercialization and Clinical Development Tracks
Tuesday-Thursday, September 26-28, 2017
Commercialization Track
Enabling Greater Success of Cell Therapy Commercialization
Hari Kamaraju, MS, MBA, Senior Scientist, Janssen Research & Development
Converting a Research Paper / Process into a Clinical-Grade Cell Therapy
Benjamin Fryer, Ph.D., Team Leader / Cell Processing and Manufacturing, Heart Regeneration Program, University of Washington School of Medicine
Strategies for Leveraging the Japanese Cell Therapy Opportunity: A Foreign Cell Therapy Company Perspective
R. Lee Buckler, B.Ed, J.D., President & CEO, RepliCel Life Sciences Inc.
Navigating U.S. and EMA Regulatory Requirements for Autologous Cell Therapy Product
Kanti Thirumoorthy, Ph.D., Senior Director, Quality, Kite Pharma Inc
21st Century Cures Act and Regenerative Medicine Advanced Therapy (RMAT) Designation
Joyce Frey-Vasconcells, Ph.D., Regulatory Consultant, Frey-Vasconcells Consulting, LLC
Establishing and Managing an Allogeneic Therapy Supply Chain
Tom Bevington, MBA, Director of Clinical Supply, Manufacturing, Nohla Therapeutics, Inc.
Developments, Strategies and Experiences in Korea from the Development and Commercialization of an Allogeneic Cell Therapy for Osteoarthritis
Moon Jong Noh, Ph.D., Chief Technology Officer, TissueGene Inc.
Experiences of Navigating the RMAT Designation Pathway
Kevin Healy, Ph.D., Senior Director, Global Regulatory Affairs, Roivant Sciences Inc.
Clinical Development Track
Anticipating Clinical Success and Innovating Processes
Jane Lebkowski, President, Asterias Biotherapeutics
Development Of Multiplex Sensitive Anti-Drug-AntibodyAssays For CRISPR/Cas9 Genomic Medicines
Junxia Wang, Ph.D., Associate Director, Preclinical Sciences, Editas Medicine
Regulatory Update on Expectations Surrounding Potency Assays
Anna Gilbert, QA Director, Nohla Therapeutics
The Link Between Process Development and GMP Production
Shon Green, Preclinical Development, Eureka Therapeutics
Potency Testing for Expanded Stem/Progenitor Cell Product NLA101, Can Simpler Be Better?
Shelly Heimfield, Executive Vice President Manufacturing and Research, Nohla Therapeutics
A Cell Therapy for Parkinson’s Disease
Stefan Irion MD, Program Manager, NYSTEM Consortia, Memorial Sloan Kettering Cancer Center
For the first time, attend Cell & Gene Therapy Bioprocessing & Commercialization's Pre-Conference Workshops, held Monday, September 25!
Pre-Conference Workshops
Focus Day: Planning, Executing and ManagingManufacturing Process Change and Comparability Testing for Cell and Gene TherapiesWorkshop leaders:
Mahendra Rao, Vice President, Regenerative Medicine, Q Therapeutic, Strategic Advisor, The New York Stem Cell Foundation
Jason Carstens, Affiliate Assistant Professor, Chemical Engineering, University of Washington
Cell Based Immunotherapies: One Day Course
David Brindley, DPhil, MEng, FRSA Managing Partner, Biolacuna & Senior Research Fellow, Nuffield Department of Paediatrics, University of Oxford, United Kingdom
Technology Workshops
The Development of Animal-Component-Free, Chemically-Defined Culture Media for Immune Cells
Jessie Ni, Ph.D., Chief Scientific Officer, R&D, Irvine Scientific
Acoustic Cell Processing: A DisruptiveTechnology for Cell Clarification, Concentration, Washing and Perfusion In Therapeutic and Cell/Gene Therapy Application
John Rozembersky, VP, Marketing & Application Technologies, FloDesign Sonics
Chairpersons & Moderators (Bioprocessing)
Rod Rietz, Ph.D., Bioprocess Science and Innovation, Exploratory Immuno-Oncology, Novartis Institutes for Biomedical Research
Christopher Bravery, Ph.D., Director, Consulting on Advanced Biologicals Ltd, United Kingdom
Stephen Ward, COO, Cell Therapy Catapult, United Kingdom
Kim Warren, Head of Operations, AvroBio
Chris Gemmiti, Ph.D., Head of Operations, Sentien Biotechnologies Inc.
Alaina Schlinker, Ph.D., Manager, Cell Therapy Application Support, Fresenius Kabi