Immunogenicity Summit
Immunogenicity and Bioassay Summit

Combined Plenary Session: Parts One and Two

Part 1
| Part 2 | Download Brochure 

THURSDAY, October 11

1:30 Chairperson's Remarks

Valerie Quarmby, Ph.D., Director and Principal Scientist, BioAnalytical Sciences, Genentech, Inc.



1:35 Antibody/Antigen Complexes: Structure, Presentation & Immunogenicity

Roy JefferisRoy Jefferis, Ph.D., C.Chem., FRSC, MRCP, FRCPath, D.Sc., Professor Emeritus, School of Immunity & Infection, University of Birmingham UK - Biography 

It is accepted that aggregated forms of recombinant proteins can stimulate an immune response with the development of anti-drug antibodies (ADA). However, administered antibody, in the absence of aggregates, forms immune complexes that can be similarly processed. Complexes binding to Fc and complement receptors ((FcyR, FcRn, CR) can be directed to cellular compartments that process antigen for presentation and hence ADA generation. Protocols inducing tolerance may circumvent the development of ADA.

2:05 Interaction of Aggregrated Protein Therapeutics with Dendritic Cells and the Enhanced Activation of T Cells
Matthew Baker, Ph.D., CSO, Antitope Ltd
The importance of T cell help in the development of anti-drug antibodies has been widely accepted as a significant risk factor.  New data will be presented showing how protein aggregates can trigger innate responses leading to distinct dendritic cell phenotypes. Data from recent studies highlighting the impact of aggregates with specific properties on drug immunogenicity will also be discussed.




2:35 Update on US Regulatory Guidance

Susan KirshnerSusan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, CDER/FDA - Biography 

Treatment of patients with therapeutic proteins invariably results in the development of anti-drug antibodies in some of those patients. Anti-drug antibodies may negatively impact patients by inhibiting the activity of endogenous counterparts, reducing efficacy, altering pharmacokinetics and leading to hypersensitivity reactions. Anti-drug antibodies should be assessed during clinical studies and risk based mitigation strategies incorporated into clinical study designs. This talk will cover FDA guidance on these topics.

3:05 PANEL DISCUSSION: Regulatory Expectations Regarding Immunogenicity Assessment

Panelists include:
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic Proteins, Biotechnology, CDER/FDA

Paul Chamberlain, NDA Advisory Board

  • How and when to approach the regulators: Benefits of discussion with the regulators
  • How much characterization is necessary? How much is too much? What is the essential strategy?
  • Proper validation and characterization of assays
  • Neutralizing antibody assays: When should they be carried out and why?
  • Ligand binding assays. Can they be used instead of cell-based assays?
  • Pitfalls to avoid

3:35 End of Plenary Session and Part One

3:35 - 4:00 Refreshment Break in the Exhibit Hall with Poster Viewing, Followed by Part Two

Part 1 | Part 2 | Download Brochure 

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