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Speaker Interviews - Immunogenicity Summit 2011

Q1. Which talk(s) are you looking forward to the most? 

  • Melissa Cheu from Genentech is looking forward to the talks on  
  • Improved methods for more accurate detection of neutralizing antibodies from Michael Tovey (ENS Cachan)
  • Streamlining non-clinical immunogenicity assessments from Holly Smith (Lilly)
  •  Pre-existing ADAs in clinical studies from Stephen Keller (Abbott)
  • Tobias Manigold from Roche is looking forward to: 
  • The talks on immunogenicity and hypersensitivity reactions because he wants to learn how others deal with pre-clinical hypersensitivity findings
  • The talk by Ethan Shevach on Tregs, because it will shed some light into the controversial concept of Tregitopes.
  • Sandeep Kumar from Pfizer is interested in: 
  • Matt Baker’s talk on T epitope removal
  • Fiona Harding’s talk on identifying immunogenic regions of antibodies
  • Ethan Shevach’s talk on tregitopes
  • Fiona Harding from Abbott Biotherapeutics: 
  • Ethan Shevach’s discussion on harnessing T regulatory cells to ameliorate immune responses to allografts and exogenous therapeutics.
  • Kristina Howard’s FDA presentation on humanized mouse models.
  • Albert Torry from Regeneron Pharmaceutical says all the talks look excellent and is most interested in the following:  
  • Marie Rock from Midwest BioResearch on ligand binding assays because this is something they routinely perform at Regeneron
  • Holly Smith from Lilly on streamlining non-clinical assessments since it could potentially impact the entire field.
  • Melody Sauerborn from the University of Utrecht is looking forward to  
  • The FDA talk on Mice with a Human Immune System: Applicability and Use for Immunogenicity Studies as it is directly applicable to her work.
  • Matthias Hofmann from Novartis is looking forward to the following talks: 
  • Sam Song, Merrimack, on Overcoming High Levels of Drug Endogenous Counterpart in ADA Screening Assays
  • Holly Smith, Lilly, on Streamlining Non-clinical Immunogenicity
  • Stephen Keller, Abbott, on Dealing with Pre-Existing ADAs
  • Miranda van Beers, Utrecht, on The Impact of Aggregates on Immunogenicity in Immune Tolerant Mice
  • Sam Song from Merrimack is most interested in  
  • Talks about immunogenicity assay development, especially about drug tolerance; confirmatory CP assessment, and ligand-binding based Nab assay development
  • Reports about the value of immunogenicity assessment in pre-clinical drug studies and if immunogenicity assessment should be a routine assay for pre-clinical studies. He wants to find out when immunogenicity assessment should be included into the pre-clinical drug evaluation package and when it should not be.
  • Miranda van Beers, from A*Star is looking forward to 
  • Daniela Verthelyi’s FDA talk since she is going to address some of the more fundamental questions such as why certain molecular patterns are immunogenic.
  • Kristina Howard’s FDA talk to find out how her results from mice with a human immune system relate to the results from our studies in transgenic immune-tolerant mice.

Q2: What are your greatest challenges in Immunogenicity? 

  • Cheu: Pre-existing ADAs, drug tolerance, validating assays with surrogate samples that adequately represent the target population/disease state.
  • Manigold: Translation of incidence AND function from cynomolgus and other pre-clinical studies to human.
  • Kumar: Our ability to understand all the factors which can trigger an immune response and then use these to design safer biotherapeutics.
  • Harding: My greatest challenge is in developing predictive assays that correctly align with the information from clinical trials.
  • Hoffman:  Setting the cut point with samples with pre-existing immunogenicity and developing assays with high drug tolerance.
  • Sauerborn: Predicting immunogenicity.
  • Torri: The greatest challenge is trying to prepare in advance for what the agencies might request in the future.  The bar is constantly rising on what is expected by industry and we have to try to anticipate future requirements.
  • Song: Drug tolerance and sensitivity.
  • Van Beers: Gaining fundamental insights into the mechanism by which immune tolerance is overcome; working out which characteristics make an aggregate immunogenic, and which stresses and degradation pathways lead to the formation of such aggregates; determining the role protein oxidation plays in immunogenicity.

Q3: What do you regard as new and exciting in Immunogenicity?  

  • Cheu: Immunogenicity prediction and mitigation.  I've been hearing about some of these techniques for a few years, so it'll be interesting to see how it's being applied.
  • Manigold: Will be interesting to see whether transgenic mouse models are really likely to add value for prediction of the human situation.
  • Kumar: The ability to trace immunogenicity back to sequence/structural properties of biotherapeutics is very exciting. He is also excited about the link between aggregation and immunogenicity, and about improvements in our ability to predict immunogenicity by computational and experimental means at pre-clinical stages.
  • Harding: Humanized and/or transgenic animal models for assessing immunogenicity are new and exciting.
  • Hofmann: Integrating immunogenicity with PK and PD, and application of cell-based assays.
  • Sauerborn: The development of appropriate mouse models to predict immunogenicity.
  • Song: Neutralizing antibody assays and the pros and cons of cell-based vs. non-cell-based assays.
  • Van Beers: New results on the impact of subvisible particles on the immunogenicity of a protein, and the progress being made in the field of immunology in relation to immunogenicity.
  • Robert Hamilton: New guidelines for IgE antibody assays for new therapeutic drugs are of particular interest.

These challenges and many more will be presented and discussed thoroughly at the event, in both presentations and breakout discussions.

Recent publications by IMN 2011 speakers
M.M.C. van Beers, F. Gilli, H. Schellekens, T.W. Randolph, and W. Jiskoot. Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene. J Pharm Sci. DOI: 10.1002/jps.22744 (Epub ahead of print).

M.M.C. van Beers, M. Sauerborn, F. Gilli, V. Brinks, H. Schellekens, and W. Jiskoot. Oxidized and aggregated recombinant human interferon beta is immunogenic in human interferon beta transgenic mice. Pharm Res. 28:2393-2402 (2011).

Sandeep Kumar & Satish K. Singh & Xiaoling Wang & Bonita Rup & Davinder Gill. Coupling of Aggregation and Immunogenicity in Biotherapeutics: T- and B-Cell Immune Epitopes May Contain Aggregation-Prone Regions
Published online: 25 March 2011, # Springer Science+Business Media, LLC 2011

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