Mastering Immunogenicity

12-13 September 2011, Boston MA

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Program Day 1

Keynote Address

Valerie Quarmby

Principal Scientist and Director of the Department of BioAnalytical Sciences, Genentech, San Francisco CA, USA

Immunogenicity Risk Assessment: Opportunities and Gaps (download presentation)

Bonnie Rup

Immunogenicity Sciences, Pharmacokinetics Dynamics and Metabolism at Pfizer, Andover MA, USA

Biotherapeutic Immunogenicity Risk Factors – the science, reliability, and concepts for implementing predictive tools to improve their reliability (download presentation)

Vladimir Brusic

Director of Bioinformatics, Cancer Vaccine Center, Dana-Farber Cancer Institute, USA

Knowledge-based Systems for Assessing Immunogenicity (download presentation)

Scott McClain

Technical Scientist, Product Safety, Toxicology & Health Sciences at Syngenta Biotechnology, Inc, USA

The Current Allergy Safety Assessment Process for Novel Food Proteins in Relation to Genetically Modified Crops – including industry case studies that highlight existing challenges, regulatory safety guidance and industry practices (download presentation)

Anja Langenkamp

Scientist, Early & Investigative Safety, F. Hoffmann-La Roche Ltd, Roche Center for Medical Genomics, Basel, Switzerland

Pre-clinical Risk Assessment of First-infusion Reactions (presentation unavailable)

Birgit Reipert

Director R&D, Department of Immunology, TA BioTherapeutics, Baxter Innovations GmbH, Vienna, Austria

Case Study: Specification of CD4+ T Cell Epitopes of Human FVIII (download presentation)

Zuben Sauna

Principal Investigator, US Food and Drug Administration, Bethesda, MD, USA

The Immunogenicity of Protein Therapeutics: time to get personal? (download presentation)

Julio Delgado

Medical Director Immunology, Department of Pathology, University of Utah, USA.

Gaps in Translation of Immuno-Epitope Data into Clinical Laboratory Use (download presentation)

Daron Forman

Senior Scientist, Adnexus, A Bristol-Myers Squibb R&D Company, Waltham MA, USA

Deimmunization Strategy for Adnectins, Human Fibronectin Based Targeted Biologics (presentation unavailable)

David Ulaeto

Dept. Biomedical Sciences, Defence Science & Technology Laboratory (Dstl), Salisbury, UK

Therapeutic Potential of a Humanised Antibody for the Treatment of Venezuelan Equine Encephalitis Virus (download presentation)


Program Day 2

Jeremy Fry

Director of Sales, ProImmune

Comprehensive Immunogenicity Risk Assessment using ProImmune’s REVEAL™ System: an integrated suite of in vitro assays (download presentation)

Zuben Sauna

Principal Investigator, US Food and Drug Administration, Bethesda, MD, USA

The Assessment of Immune Responses Against Biological Drugs (download presentation)

Richard Goodman

Food Allergy Research & Resource Program, University of Nebraska, Lincoln NE, USA

Reconciling actual risks of food allergy with scientific risk assessment, regulatory and public demands (download presentation)

Birgit Schultes

Director of Disease Biology, Momenta Pharmaceuticals, Cambridge MA, USA

Case study: Identification of CD8 T cell epitopes on the 2,000 KDa MUC16 (CA125) and development of Pentamers for immune monitoring in ovarian cancer vaccine trials (download presentation)

Nik Schwabe

CEO, ProImmune

ProPresent™ Antigen Presentation Assay (download presentation)

Parallel Breakout Sessions

Technology Application and Strategy Forum

Moderator: Bonnie Rup

  • Limitations of currently available technologies and improvements necessary to accelerate their development; including
    • detection of anti-drug antibodies (ADA) in the presence of free drug,
    • characterization of ADA responses that cross-react with endogenous proteins
    • understanding sensitization potential
  • Development of appropriate strategies to manage the complexity of the immunogenicity risk assessment process
  • The use of in vitro assays to predict clinical immunogenicity risk


Immunogenicity Regulatory Guidance Forum

Moderator: Rick Goodman

  • How can research and development scientists interact with regulators to ensure that drugs based on the best new technologies can be developed efficiently and are fully qualified
  • How can industry, academia and regulators collaborate and share knowledge on common technologies applied across research areas


Breakout Session Feedback and Discussion
Summary and Conclusions