Strategies and Technologies for Safe and Efficacious Therapeutics

This stream begins with an in-depth introductory training seminar providing a practical and comprehensive overview of immunogenicity. Leading into our Immunogenicity Assessment and Management conference delivering practical case studies on assay development and validation, clinical relevance, drug and target interference, regulatory perspectives, risk factors and management. New challenges posed by novel modalities including cell and gene therapies will be addressed. The conference is followed by an introduction to bioassay design and analysis training seminar including statistical concepts needed for bioassays. 

Conferences and Training Seminars Include:

May 15-16

Introduction to Immunogenicity

May 16-17

Immunogenicity Assessment and Management

May 18-19

Introduction to BioAssays

Keynote Presentation:

Innate Immune Response Modulating Impurities Testing for Generics and Biosimilars: Where We Are and What We Are Missing
Daniela Verthelyi, MD, PhD, Chief, Laboratory of Immunology, CDER, FDA

2024 PROGRAMS

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• Display of Biologics
• Engineering Antibodies
• Machine Learning for Protein Engineering

• Antibodies for Cancer Therapy
• Emerging Targets for Oncology
• Antibody Drug Conjugates

• TS: Intro to Bispecifics
• Advancing Bispecific Antibodies
• Engineering Bispecific Antibodies

• Advances in Immunotherapy
• Cell-Based Immunotherapy
• In vivo Cell and Gene Engineering

• Difficult-to-Express Proteins
• Optimizing Protein Expression
• Protein Production Workflows

• Digital Integration in Biotherapeutic Analytics
• Biophysical Methods
• Characterization for Novel Biotherapeutics

• TS: Intro to Immunogenicity
• Immunogenicity Assessment and Management
• TS: Intro to Bioassays

• Emerging Indications for Therapeutic Antibodies
• mRNA Therapeutics
• In vivo Cell and Gene Engineering