TUESDAY, OCTOBER 24 4:40 – 5:30 PM

Immunogenicity Assessment & Clinical Relevance

Meeting Regulatory Expectations Regarding Immunogenicity Assessment


Susan Kirshner, Ph.D., Associate Chief, Immunology Lab, Therapeutic Proteins, Biotechnology, FDA/CDER

Lauren Stevenson, Ph.D., Director, Development Biomarkers and Bioanalytical Sciences, Biogen, Inc

  • How and when to approach the regulators: Benefits of discussion with the regulators
  • How much assessment is necessary? How much is too much when no additional value is gained?
  • Neutralizing antibody assays: When should they be carried out and why?
  • Challenges often encountered in translating the current guidance’s on immunogenicity testing for individual drug candidates

Critical Issues in Cut Points and ADA Assay Validation

Moderator: Michael Partridge, Ph.D., Staff Scientist, Bioanalytical Sciences, Regeneron, Inc.

  • Experiences with cut point determination outlined in the April 2016 FDA draft guidance on assay
  • Complications experienced and means of overcoming the difficulties
  • Difficulties with analytical and biological variability
  • Cut point determination between positive and negative samples for assay validation
  • Interpretation of the validation data and relation to the clinical data

Strategies and Procedures to Reduce Interference in Immunogenicity Assays

Moderator: Jad Zoghbi, Ph.D., Senior Scientist, Biomarkers and Clinical Bioanalysis, Sanofi

  • Clinical relevance of ADAs and the issue of drug interference in patient management
  • Explore various methodologies for assessment of ADAs and the impact of drug interference on each
  • How selecting the appropriate approach depends on the nature of the target

Late Stage Clinical and Post-Marketing Strategies: Evolving ADA Assays Over Time

Moderator: Tressa Allington, Ph.D., Development Scientist, Bioanalytical Development, Alexion

  • Achieving highly sensitive assays while maintaining the link to clinical relevance
  • Changing the positive controls over time
  • Means of modifying cut points in new indications in a post-marketing setting
  • Maintaining continuity and comparability of immunogenicity data over many years of clinical development and multiple indications

Challenges in Developing Neutralizing Antibody (Nab) Assays

Moderator: Shan Chung, Ph.D., Senior Scientist and Group Leader, BioAnalytical Sciences, Genentech, Inc.

  • Factors for selection of cell-based Nab vs. non-cell-based Nab assays
  • Ligand binding assays and comparison with cell-based Nabs
  • How you deal with poor drug tolerance, lack of sensitivity and matrix interference
  • Interpretation of the results and implications for risk assessment

Dealing with Pre-Existing Positive ADA Activity in Study Patients

Moderator: Jim McNally, Ph.D., Head, Clinical Bioanalysis and QPD Program Rep, Quantitative Pharmacology and Drug Disposition, EMD Serono

  • Potential complications with pre-existing antibodies
  • How to distinguish between pre-existing antibodies and potential immune responses to the drug and to determine a meaningful drug-induced response
  • Examples seen in the clinic and their relevance
  • Implications for humanized antibodies and novel humanized antibody products
  • Implications regarding PK/PD safety and efficacy

THURSDAY, OCTOBER 26 9:30 – 10:30 AM

Immunogenicity Prediction & Control

Practical Application of Immunogenicity Preclinical Risk Assessment

Moderator: Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Biotechnology Products, CDER-FDA

  • Relevant risk factors
  • Potential of emerging antibody products for greater immunogenicity
  • Features of the risk analysis and risk mitigation plan
  • Risk assessment at different stages of development
  • How to translate the identified risk into a testing strategy
  • Management in the clinic of products with low and high risk of immunogenicity
  • Experiences with reporting findings to the regulatory authorities

Current and Emerging Predictive Tools: Selecting Candidates and Predicting Clinical Outcome

Moderator: Vibha Jawa, Ph.D., Director, Biologics and Vaccines Bioanalytics, Merck and Co. Inc.

  • Working in discovery – combining in silico and in vitro approaches
  • Applying tools in a matrix environment
  • Preparing for clinical success: Selecting the right tools for the question posed
  • Progress on the road to predicting clinical outcomes

Risk of Immunogenicity of Product-related Attributes, Process-related Impurities, and Leachables/Extractables

Moderator: Marisa K. Joubert, Ph.D., Principal Scientist, Process Development, Amgen, Inc.

  • Product-related attributes that cause the greatest concern for immunogenicity
  • Do level of attribute, dosing regimen, and patient population mitigate this risk?
  • Stringent requirements for process-related impurities and process reagents
  • Evidence that leachables/extractables (i.e. silicone oil) act as an adjuvant
  • Should product specifications be more biologically based?

Progress Towards Inducing Immunological Tolerance to Biotherapeutics

Moderator: Ronit Mazor, Ph.D., Post-Doctoral Fellow, Molecular Biology, National Cancer Institute

  • Tolerance mechanisms and different approaches for tolerance induction
  • Immunodominant T-cell epitopes and how these may be used as targets for tolerance induction
  • Methods for identification and removal of T cell epitopes and evidence for its impact on reducing immunogenicity
  • Tools to use with protein engineering to design non-immunogenic biotherapeutics
  • Applicability to enzyme-deficiency disorders, allergies, autoimmune disease and protein drugs in general

Understanding Monkey HLA and Peptide Presentation

Moderator: Priya Sriraman, Ph.D., Principal Investigator Non-Clinical Development, Celgene Corp

  • What is its similarity to humans?
  • To what extent can monkey immunogenicity results help understanding of immunogenicity in man?
  • To what extent could they guide deimmunization efforts?
  • Does characterization of a monkey immune response help us understand when it might (and might not) predict immunogenicity in man?
  • Can monkey be used as a model for tolerance induction studies?

Optimizing Bioassays for Biologics

Design of Experiments (DoE) for Development of Biological Assays


David Lansky, Ph.D., President, Precision Bioassay, Inc.

Martin Kane, MS, CRE, Managing Data Scientist, Statistical and Data Sciences Practice, Exponent

  • Why DoE?
  • What responses to focus on, and why, during early bioassay development
  • Design techniques and strategies for adapting bioassays to DoE
  • Simple graphical analysis methods for DoE on bioassays
  • Strategies for learning more about DoE

USP General Chapters for Bioassays

Moderator: Maura Kibbey, Ph.D., Director, Global Biologics, U.S. Pharmacopeia

  • Discussion of benefits and challenges for implementation of chapter guidance
  • Sharing ideas for future chapter revisions
  • Recommending new USP guidance that would be helpful


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