Cambridge Healthtech Institute ’s 3rd Annual

Cell Therapy CMC and Analytics

August 13-14, 2018

To ensure the quality, safety and rapid production of cell therapies, companies must keep on top of their CMC and analytical strateigies. However, cell-based therapies are extremely complex to analysis with high variability.

Cambridge Healthtech Institute’s Cell Therapy CMC and Analytics meeting focuses on the technical and regulatory requirements needed to advance the analysis, quality and development of cell therapies with in-depth case studies and regulatory feedback on CMC development, product release, assay development and validation, flow cytometry, target product profiles, critical quality attributes, critical process parameters, and product release.

Preliminary Agenda


Regulatory Aspects of Manufacturing and Control of Genetically Modified Cells

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

Cell Therapy Product Manufacturing Considerations

Mohammad Heidaran, PhD, Biologist, Office of CTGT, CBER, US Food and Drug Administration, USA (invited)

Standards and Best Practices Applicable for Advanced Therapies

Fouad Atouf, PhD, Vice President, Global Biologics, USP


Tools and Strategies to Improve Confidence in Cell Counting Measurements

Laura Pierce, PhD, Biomedical Engineer, Biomedical Engineer, NIST

Potency Assays for Cell-Based Gene Therapies

Ilya Shestopalov, PhD, Senior Scientist, Cellular Process Characterization and Analytics, Bluebird Bio

Designing Strategies for Data-Driven Product Characterization

Marc-Olivier Baradez, PhD, Lead Analytical Development Scientist, Cell and Gene Therapy Catapult

CRISPR Gene Edited Cell Therapies: From the Research Bench to the Clinic

Sadik Kassim, PhD, Vice President, Process and Analytical Development, Mustang Bio, Inc.

Assessment of Comparability of a Gene Therapy Drug Product after Manufacturing Site and Process Changes

Stephen J. Duguay, PhD, Director, Cellular Process Characterization and Analytics, Bluebird Bio

How Much Data Do I Need to Provide on My Vector?

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

In vitro Product Characterization and Stability Studies of CAR T Cell Therapies

Carlotta Peticone, PhD, Senior Scientist I, Process Development, Autolus

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

For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359

Companies L-Z

Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412


Premier Sponsors:

Millipore Sigma

Unchained Labs