Cambridge Healthtech Institute’s 2nd Annual
Cell Therapy CMC, Quality and Analytics
Part of CHI's Ninth Annual The Bioprocessing Summit
August 21-22, 2017 | Westin Copley Place | Boston, MA

Cell-based therapies are extremely complex modalities and very difficult to characterize. Cambridge Healthtech Institute’s Cell Therapy CMC, Quality and Analytics meeting focuses on the technical and regulatory requirements needed to advance the development of cell therapies, including CAR-T and TCRs, with in-depth case studies and regulatory feedback on CMC development, potency assay development and validation, flow cytometry, critical quality attributes, critical process parameters, and product release.

Preliminary Agenda


Bernadette Keane, Ph.D., Consultant, Keane Consultancy

Challenges and Opportunities in Cell Therapy CMC: The Role of CQAs, In-Line Measurements, Flexible Automation, and Standards

Krishnendu Roy, Ph.D., The Robert A. Milton Chair and Professor, Biomedical Engineering; Director, Marcus Center for Cell Therapy Characterization Manufacturing (MC3M); Georgia Tech

Regulatory and CMC Strategies for Cell Therapies

Regulatory Aspects of Manufacturing and Control of Genetically Modified Cells

Matthias Renner, Ph.D., Paul Ehrlich Institute

EU Regulatory Pathways for Standard and Accelerated Approval Industry Perspective

Anthony Lodge, Ph.D., Manager, Regulatory Affairs, Chiesi

Key CMC Considerations for Cell Therapy Development and Approval

D. Allen Callaway II, MS, MBA, Associate Director, Global CMC Regulatory Affairs, Janssen (Pharmaceutical Companies of Johnson and Johnson)

Analytical Development and Product Characterization

Development of an Automated 28-Day Assay for T Cell Proliferation

Geoffrey Hodge, Ph.D., CTO, Unum

Potency Assay Development and Validation for Processed Human Nerve Allograft

Mark L. Friedman, Ph.D., Vice President, Regulatory Affairs and Quality Assurance, AxoGen Corporation

Allogeneic Cellular Cancer Vaccines: The Challenges of Characterization and Potency Assay Development

Sandra van Wetering, Ph.D., COO, DC Prime

Development and Implementation of a Cell-Based Potency Assay for a Dehydrated Human Tissue Product

Rebeccah Brown, Ph.D., Vice President, Global Regulatory Affairs, MiMedx Group, Inc.

Reliable Product Characterization by Flow Cytometry

Ruud Hulspas, Ph.D., Independent Consultant, Cellular Technologies Bioconsulting, LLC

Enumeration of CD34+ Cells by Flow Cytometry - USP’s Perspective

Huiping Tu, Ph.D., Scientist V, Biologics and Biotechnology Laboratory, USP

Advanced Techniques for Immunotherapy Product Characterization

Damian Marshall, Ph.D., Head, Analytical Development, Non-Clinical Operations, Cell & Gene Therapy Catapult UK

Autolus’ Approach for Early-Stage CAR-T Cell Production

Emma Chan, Ph.D., Senior Scientist, Process Development, Autolus Ltd.

Manufacturing Control Strategies for Cell Therapies

Christopher Bravery, Ph.D., Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.

Release and Quality Control

US Approval of Three Rapid Microbiological Methods for MACI Product Release

John Duguid, Ph.D., Senior Director, Research & Development, Vericel Corporation

Process Development from Academia to Industry

A Practical Guide to Process Development – An Academic Perspective

Patrick J. Hanley, Ph.D., Laboratory Facility Director, Cellular Therapy and Stem Cell Processing, Program for Cell Enhancement and Technologies for Immunotherapy, Division of Blood and Marrow Transplantation, Children’s National Health System

For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Phone: 781-247-6266

For media partnership opportunities, please contact:
Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419

For exhibit & sponsorship opportunities, please contact:

Companies A-K
Sherry Johnson
Business Development Manager
Phone: 781-972-1359

Companies L-Z
Carolyn Benton
Business Development Manager
Phone: 781-972-5412

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Event at a Glance
Event at a Glance

Celebrating 25 Years


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