Cambridge Healthtech Institute ’s 2nd Annual

Cell Therapy CMC and Manufacturing

Characterizing and Commercializing Cell-Based Therapies

24-25 March 2020

 

Cambridge Healthtech Institute’s Cell Therapy CMC and Manufacturing conference takes an in-depth look at the practical challenges facing the manufacture and characterization of autologous and allogenic cell-based therapies, with dedicated sessions on emerging analytical methods, flexible CMC strategies, product release, cell processing, scalability, bioreactors, next-generation production technologies, automation, closed systems, supply chain and facility design.

Preliminary Agenda

COMPARABILITY AND PRODUCT VARIABILITY

CAR T Comparability Studies

Florence Salmon, PhD, Director Regulatory Affairs CMC, Novartis Pharma AG

Setting the Standards: Managing Product Variability over Time

Christiane Niederlaender, PhD, Director, AMBR Consulting, Former Senior Quality Assessor for Biologics, Medicines and Healthcare Products Regulatory Agency (MHRA); Former Member, Committee for Advanced Therapies (CAT), European Medicines Agency (EMA)

MACHINE LEARNING, METABOLOMICS AND PROCESS CONTROL

Metabolomics in Stem Cell Therapy Manufacturing

Athanasios (Sakis) Mantalaris, PhD, Professor, W.H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University

Applying Machine Learning in Bioprocess Development Strategies

Mark Tomishima, PhD, Executive Director, Genome Engineering, BlueRock

CELL THERAPY SCALE-UP AND MANUFACTURING

Product and Process Characterization of MSC-Based Cell Therapy Products

Maitane Ortiz Virumbrales, PhD, Senior Scientist, Cell Therapies, Takeda

Developing Manufacturing Processes for the Production of Gene-Edited Allogeneic CAR T Cells

Jean-Charles Epinat, PhD, Head of Process Development, Cellectis

Manufacturing Cell-Based Therapies

Anne-Sophie Lebrun, PhD, Head, Manufacturing, Bone Therapeutics

Efficient Processes for the Commercial Manufacture of Lentiviral Vectors

Carol Knevelman, PhD, Vice President, Head, Process Development, Oxford Biomedica

Process Validation for Cell-Based Therapies

Christopher Bravery, PhD, Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.




For more details on the conference, please contact:
Daniel Barry

Senior Conference Director

Cambridge Healthtech Institute

Phone: 781-247-6266

Email: dbarry@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: 781-972-1359

Email: sjohnson@healthtech.com

 

Companies L-Z

Carolyn Cooke

Business Development Manager

Cambridge Healthtech Institute

Phone: 781-972-5412

Email: ccooke@healthtech.com