Cambridge Healthtech Institute ’s Inaugural

Cell Therapy CMC and Manufacturing

19-20 March 2019


The success of cell-based therapies is underpinned by the ability to build scalable, robust, well controlled global manufacturing strategies in line with regulatory timelines, accelerated or otherwise.

Cambridge Healthtech Institute’s Cell Therapy CMC and Manufacturing conference takes an in-depth look at the practical challenges facing the manufacture of autologous and allogenic cell therapies at scale, with dedicated sessions on upcoming regulations, new and existing analytical methods, flexible CMC strategies, product release, cell processing, scalability, bioreactors, next-generation production technologies, automation, closed systems, supply chain and facility design. The meeting will feature extensive sessions on CAR-Ts.

Preliminary Agenda

Future of Cell Therapy Manufacturing

KEYNOTE PRESENTATION: Opportunities and Challenges in CAR T Manufacturing

Markwin Velders, PhD, Vice President, Operations, Managing Director, Kite Pharma EU B.V.

Next-Generation Bioprocess Development for Lineages Derived from Pluripotent Stem Cells

Robert Deans, PhD, CTO, Bluerock Therapeutics

Regulatory and CMC Strategies for Cell-Based Therapies

Regulatory Strategies for Cell and Gene Therapies

Vicky Coutinho, PhD, Senior Director, Regulatory Affairs, Autolus

Regulatory Aspects of Manufacturing and Control of Genetically Modified Cells

Matthias Renner, PhD, Scientist, Federal Institute for Vaccines and Biomedicines, Paul Ehrlich Institute

ATMPs: Are We There Yet?

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

GMP for ATMP Manufacturing: An Industry Experience with Kymriah

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

Product and Process Characterization for Release

Controlling Cell and Gene Therapy Manufacture through PAT

Damian Marshall, PhD, Head, Analytical Development, The Cell and Gene Therapy Catapult

Engineering Scalable Manufacturing of High-Quality Human Msc for Cell Therapy: From Up To Downstream Processing Integration To Cell Proteome Characterization

Margarida Serra, PhD, Senior Scientist, Stem Cell Bioengineering, IBET

Analysis of Purity and Packaging of Gene Therapy Vectors and VLPs to Support Process Development Decisions

Josefina Nilsson, Head, EM Services, Electron Microscopy Services, Vironova

Scale-Up and Manufacturing

Improving Functional Maturation of Human Pluripotent Stem Cells Derived Cardiomyocytes Through Metabolic Understanding

Paula M. Alves, PhD., CEO, IBET, Director Animal Cell Technology Unit, ITQB NOVA

Transforming Cell Therapy with Gene Editing: The Case of “Off-the-Shelf” Engineered CAR-T

Jean-Charles Epinat, PhD, CTO, Cellectis

Closed System Manufacturing for Adoptive T Cell Therapies

Ali Mohamed, PhD, Vice President, CMC, Immatics

Large Scale Production of LV and RV Vectors for T- and CD34+ Cells Transduction

Giuliana Vallanti, PhD, Director, Development & Quality Control Qualified Person, Molmed

CD362 to ORBCEL: The Rapid Development of a Novel Stromal Cell Therapy

Lisa O’Flynn, PhD, Head, Process Development, Orbsen Therapeutics

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

Senior Conference Director

Cambridge Healthtech Institute

Phone: (+1) 781-247-6266


For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson

Senior Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-1359


Companies L-Z

Carolyn Cooke

Business Development Manager

Cambridge Healthtech Institute

Phone: (+1) 781-972-5412