TUESDAY, OCTOBER 24 4:40 – 5:30 PM

Immunogenicity Assessment & Clinical Relevance

Meeting Regulatory Expectations Regarding Immunogenicity Assessment

Moderators:

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  • Experiences with cut point determination outlined in the April 2016 FDA draft guidance on assay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

Moderators:

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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