Short Courses

Sunday, April 7
10:00 am – 1:00 pm

Preclinical and Clinical Assessment of Immunogenicity: Multidomain Therapeutics and New Modalities, Including Gene Therapy and CAR T

Darshana Jani, MSc, Associate Director, Global Lead Biologics, Clinical Assay Group, Global Product Development, Pfizer, Inc.

Translational Biotherapeutic Development Strategies Part 1: Discovery, Molecular Assessment and Early Stage Development

Zhiqiang An, PhD, Professor, Chemistry; Director, Texas Therapeutics Institute, University of Texas Health Science Center at Houston

Selection, Screening and Engineering for Affinity Reagents

Jonas V. Schaefer, PhD, Lab Head/Investigator II, Novartis Institutes for BioMedical Research (NIBR) Christian Kunz, PhD, Director, MorphoSys AG

2:00 – 5:00 pm

In silico Immunogenicity Predictions (Hands-on) Workshop

Vinodh B. Kurella, PhD, Principal Scientist, Protein Engineering, Merrimack Pharmaceuticals Additional Instructors to be Announced

Introduction to Host Cell Proteins: Analysis, Characterization, Risks, and Requirements

Denise Krawitz, PhD, Principal Consultant, CMC Paradigms LLC

Translational Biotherapeutic Development Strategies Part 2: Analytical and Clinical Considerations

Zhiqiang An, PhD, Professor, Chemistry; Director, Texas Therapeutics Institute, University of Texas Health Science Center at Houston
Liming Liu, PhD, Senior Principal Scientist, Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM), Merck Research Laboratories

Analytical Strategies for Gene Therapies

Francis Poulin, PhD, Director, Analytical Development, Sanofi
Claire Davies, PhD, Head, Bioanalytics, Sanofi

Tuesday, April 9
6:00 – 8:30 pm

Introduction to Biophysical Analysis for Biotherapeutics: Development Applications

Christine P. Chan, PhD, Principal Scientist, Global Manufacturing Science & Technology, Sanofi

CAR T-Cell Therapy for Solid Tumors

Soldano Ferrone, MD, PhD, Division of Surgical Oncology, Surgery, Massachusetts General Hospital, Harvard Medical School
Moonsoo M. Jin, PhD, Associate Professor, Molecular Imaging Innovations Institute, Radiology, Weill Cornell Medical College
Tara Arvedson, PhD, Director, Oncology Research, Amgen

Bispecific Antibodies: Formats, Developability and Applications

Nimish Gera, PhD, Director, Research and Development, Mythic Therapeutics

Thursday, April 11
5:45 – 8:15 pm

Design Strategies and Development of ADCs

Robert Lutz, PhD, Principal Consultant, Crescendo Biopharma Consulting

Bioassay Quality by Design

Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting

Subvisible Protein Particles in Immunogenicity: Measurement, Characterization and Impact

Björn Boll, PhD, Head, Particle Lab and Higher Order Structure Protein Analytics, Physical Chemical Analytics, Novartis Pharma AG

5:45 – 8:45 pm

Transient Protein Production in Mammalian Cells

Richard Altman, MS, Scientist, Protein Technologies, Amgen
Henry C. Chiou, PhD, Director, Cell Biology, Life Science Solutions, Thermo Fisher Scientific
Dominic Esposito, PhD, Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research

* The program is subject to change without notice, due to unforeseen reason.

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