Immunogenicity Summit

Short Courses* 


Sunday, November 16

Speaker Bios 


1:30 – 4:30 pm SC1: Basics of Immunogenicity Testing

Instructors:
JimMcNallyJim McNally, Ph.D., Senior Principal Scientist, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.





Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.

This interactive session will enable attendees to work out a basic immunogenicity preclinical and clinical testing strategy for various molecules including bi-functional and other novel scaffolds. Areas of difficulty will be discussed with specific case studies. Attendees are encouraged to contribute with their own experiences and to bring questions for discussion or submit to the meeting organizers in advance.

The following topics will be covered:

  • Basic issues regarding screening, confirmatory and titer assays
  • Assay methodologies and various technologies
  • Current approaches to data analysis and cutpoints
  • Preclinical and clinical considerations
  • Common problems
 

5:30 – 8:30 pm Dinner SC2: Challenges of Immunogenicity Assessment

Instructors:
JimMcNallyJim McNally, Ph.D., Senior Principal Scientist, Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.





Francesca Civoli, Ph.D., Principal Scientist, Clinical Immunology, Amgen, Inc.

This interactive session of intermediate level will focus on the potential challenges of immunogenicity testing in preclinical and clinical development and present case studies demonstrating how they can be handled. Attendees are encouraged to contribute with their own experiences and to bring questions for discussion or submit to the meeting organizers in advance.

The following topics will be covered:

  • Challenges and approaches to resolve commonly encountered issues
  • Multi-domain binding proteins
  • Pre-existing ADAs
  • Emerging trends in the development of neutralizing antibody assays
  • Cross-reactivity to endogenous proteins
  • Clinical implications of ADAs
 

Tuesday, November 18


6:30 – 9:30 pm Dinner SC3: Immunogenicity Risk Assessment and Regulatory Strategy

Instructors:
LaurieGrahamLaurie Graham, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies FDA/CDER





BridgetHeelanBridget Heelan, MB, Ph.D., Vice President, Consulting, Parexel (ex-MHRA)

Priorities for the regulator: Hierarchy of concerns; Data requirements; Common gaps





Integrated approach: Risk identification; Aligning identified risks with CMC; Bioanalytical, non-clinical and clinical strategy; Ongoing risk management

Difficulties in comparative immunogenicity assessment: One versus two assay format for comparing biosimilars to innovators

Interactive case study: Illustration of preparation of an effective response to a regulatory scenario pertaining to immunogenicity-related risks for an investigational therapeutic protein

Questions and Answers
The following topics will be covered:

  • Benefits of timely discussion with the regulators
  • Neutralizing antibody assays (NAbs): When are they necessary?
  • The case for binding assays versus cell-based assays for NAbs
  • Novel products and biosimilars: What challenges are the regulatory authorities seeing and anticipating?
  • Pitfalls to avoid
 

6:30 – 9:30 pm Dinner SC4: Strategic Bioassay Design and Analysis

Instructors:
Liming ShiLiming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli Lilly and Company

This course will focus on the fundamentals of statistics and simple methodology that are routinely applied in the bioassay laboratory. Covered topics will include a review of statistical concepts and calculations, study design, assessing bioassay measurement quality and comparative studies.

The following topics will be covered:

  • Uniqueness of bioassay, especially cell-based potency assay
  • Considerations in bioassay development and validation
  • Bioassay measurements and calculations
  • Quality control of bioassay performance
  • Comparative studies for bioassay development and transfer
 


Speaker Bios 


*Separate registration is required.

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 Charles River(1) 



Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

2013 Speaker: Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefenseDivision, Emergent BioSolutions