Cambridge Healthtech Institute’s Inaugural
Cell and Gene Therapy Analytics
A Best Practices Exchange for Essential Assays and Product and Process Quality Strategies
May 7-8, 2020
A vast number of mainstream and emerging biotechs are now engaged in the discovery and development of cell and gene therapies, but significant advances in analytical and process technologies are required to support preclinical and clinical development, quality control strategies and progression through the regulatory steps needed to reach the market. The PEGS Cell and Gene Therapy Analytics conference offers an all case study format in which leading scientists will share their experiences with new tools, lessons and learnings – and what works and doesn’t work to move efficiently in this explosive new field of pharmaceutical science.
Preliminary Agenda
CHARACTERIZATION ASSAYS
Assay Development for Emerging Single-Cell Platforms
Eric S. Alonzo, PhD, Senior Scientist, bluebird bio
Characterization of Gene Therapies by Charge Detection Mass Spectrometry
Martin Jarrold, PhD, Professor, Chemistry, Indiana University
KEYNOTE PRESENTATION: T Cell-Intrinsic and -Extrinsic Mechanisms Response to CAR T Cell Therapy
Jan Joseph (Jos) Melenhorst, PhD, Adjunct Associate Professor, Pathology & Laboratory Medicine, University of Pennsylvania
INCREASING ANALYTICAL DEPTH AND THROUGHPUT
Deep Analysis to Support Early Stage Product and Process Characterization
Richard Rustandi, PhD, Research Fellow, Merck
Understanding the Effect of Post-Translational Modifications of AAV Capsid Proteins and Their Impact on AAV Infectivity
Lin Liu, PhD, Principal Scientist, Biologics Development, Sanofi
POTENCY ASSAYS
Overcoming the Limits and Variability of Cell and Gene Therapy Potency Assays
Zhenhong Li, PhD, Senior Director, Analytics, Analytics, Regenxbio, Inc.
High-Throughput Potency Methods Applied to Formulation Development of Live Viral Vaccines
Prashant Kumar, PhD, Senior Scientist, Vaccine Analytics, University of Kansas
PRODUCT QUALITY ATTRIBUTES
Analytical Methods for Quality Assessment of Cell-Based Medicinal Products
Wim Jiskoot, PhD, Professor, Drug Delivery Technology, Leiden University, The Netherlands
Challenges and Hope for the Chemical and Biological Characterization of AAV-Based Gene Therapy Products
Dong Xu, PhD, Senior Scientist, Biogen
REGULATORY UPDATES
Regulatory Update for Cell and Gene Therapy
Jean Stanton, Director, CAR-T Site Liaison, Janssen
International Regulatory Update
William C. Motel, PhD, Associate Director, Regulatory Affairs, IQVIA
ANALYTICAL CHALLENGES IN ADVANCING CELL AND GENE THERAPIES
Evaluating a Control Strategy for an Autologous Cell Therapy for Risk to Patients
Ken Riker, Director, Product Quality, Celgene
Machine Learning for the Rapid Classification of Flow Imaging to Characterize Cell Therapies
Amber Fradkin, PhD, Director, Particle Characterization Core Facility, KBI Biopharma
Development and Qualification of a Cell Counting Assay for Dose Determination
Michele Perry, Lead Microbiology Associate, Analytical Development, Synlogic
* The program is subject to change without notice, due to unforeseen reason.
Event Information updated
Sponsor updated
2020 PROGRAMS
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Emerging Indications for Therapeutic Antibodies
Immunogenicity Case Studies and Clinical Management
Improving Immunotherapy Efficacy and Safety
Engineering Antibody-Drug Conjugates
Gene Therapy: Advancing from Bench to Clinic
Immunogenicity Assessment and Regulatory Approval of Biologics
Advancing Bispecific Antibodies and Combination Therapy to the Clinic
Optimizing Bioassays for Biologics
Clinical Progress of Antibody-Drug Conjugates
Characterization for Novel Biotherapeutics
Cell and Gene Therapy Analytics
Engineering Bispecific Antibodies
Protein Expression System Engineering