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Event Highlights

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.

Learn how to overcome bottlenecks and pain points through targeted sessions, panels, and dedicated networking sessions.

Plenary Sessions

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

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

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

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)