Cambridge Healthtech Institute’s 5th Annual

Cell Therapy CMC and Analytics

Improve Product and Process Analysis and Characterization

August 24-25, 2020

 

To ensure the safe and rapid production of cell-based therapies, companies must develop well-characterized processes and products in line with regulatory expectations. Cambridge Healthtech Institute’s Cell Therapy CMC and Analytics meeting focuses on the technical and regulatory requirements facing the analysis, quality control, and characterization of cell-based therapies with unpublished, in-depth case studies and regulatory feedback on the latest analytical methods, CMC development, assay development and validation, flow cytometry, target product profiles, critical quality attributes, critical process parameters, and product release.

Preliminary Agenda

COMPARABILITY

Establishing Comparability for Cell and Gene Therapy Products

Mo Heidaran, PhD, Vice President Technical, PAREXEL Consulting, PAREXEL International

Analytical Considerations for Developing a Comprehensive Comparability Strategy for Cell and Gene Therapies

Andrea Moore, PhD, Director, Analytical Development, Tmunity Therapeutics

ANALYTICS AND CHARACTERIZATION

Challenges and Opportunities in Cell Therapy CMC

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

CMC Regulatory Challenges for CAR T and AAV Modalities

Allen Callaway, PhD, Associate Director, Global CMC Regulatory Affairs, Janssen R&D

Guidelines for Cell Selection and Flow Cytometry in Large-Scale Processing of Therapeutic Cells

Ruud Hulspas, PhD, Independent Consultant, Cellular Technologies Bioconsulting, LLC

Data-Driven Cytometry: Automated Methods for Flow Cytometry Cell Population Identification and Biomarker Discovery

Ryan Brinkman, PhD, Professor, Department of Medical Genetics, University of British Columbia

Risk-Based Guidance for Critical Materials Management in Cell Therapies

Dominic Clarke, PhD, ISCT Process & Product Committee Co-Chair and Global Head, Cell Therapy, HemaCare

Starting and Raw Material Quality for Successful Scale-Up of Clinical and Commercial Manufacturing

Speaker to be Announced, ISCT

Characterizing Identity and Developing Identity Tests

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

Machine Learning as an Analytic Tool in Bioprocess Development

Mark Tomishima, Vice President of Platform Research, BlueRock Therapeutics




For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Cambridge Healthtech Institute

Phone: (+1) 781-247-6266
Email: dbarry@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Cooke
Manager, Business Development
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: ccooke@healthtech.com



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