Immunogenicity Summit

Pre-Conference Short Courses 


TUESDAY, October 9



SC1: Assays for Measuring Binding Antibodies*

8:00-9:00 am Short Course Registration

9:00-12:00 pm Short Course

Course Instructors:

Deborah Finco, Ph.D., Senior Principal Scientist, Immunotoxicology COE, Pfizer, Inc.

Stephen Keller, Ph.D., Associate Director II, Pre-Clinical & Clinical Development Sciences, GPRD Abbott Biotherapeutics Corp.

This interactive session will enable attendees to work out an immunogenicity pre-clinical and clinical testing strategy for various molecules including bi-functional and other novel scaffolds. Recent advances will be presented and areas of difficulty will be addressed 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. This course is of intermediate level.

The following topics will be covered:

  • Strategies for assay design
  • Assay methodologies and various technologies
  • Other considerations
  • Critical considerations in assay validation and areas of controversy
  • Common problems (matrix interferences, pre-existing antibodies)
  • Data


SC2: Neutralizing Antibody Assays*

12:30-1:30 pm Short Course Registration

1:30-4:30 pm Short Course

Course Instructors:

Deborah Finco, Ph.D., Senior Principal Scientist, Immunotoxicology COE, Pfizer, Inc.

Stephen Keller, Ph.D., Associate Director II, Pre-Clinical & Clinical Development Sciences, GPRD Abbott Biotherapeutics Corp.

Neutralizing antibodies not only affect efficacy of the therapeutic but also pose the danger of cross-reacting antibodies and ensuing adverse reactions. This interactive session is designed to enable attendees to understand how to design, develop and validate their assays for neutralizing antibodies with discussion on competitive ligand binding vs. bioassay formats. This discussion will include troubleshooting and case studies with actual compounds. Attendees are encouraged to contribute with their own experiences and to bring questions for discussion or submit to the meeting organizers in advance. This course is of intermediate level.

The following topics will be covered:

  • Strategy for design, development and validation of neutralizing antibody assays
  • Challenges and approaches to resolve commonly encountered issues
  • Interpretation and application of results
  • Emerging trends in the development of neutralizing antibody assays
  • Clinical implementation of established neutralizing antibody assays
  • Regulatory guidance and guidelines


Dinner SC3: Navigating the Regulatory Hierarchy of Concerns to Minimize the Impact of Immunogenicity-Related Risks on Product Registration*

4:30-5:30 pm Short Course Registration

5:30-8:30 pm Short Course

Course Instructors:

Paul Chamberlain, NDA Advisory Board

Amy Rosenberg, M.D., Director, Therapeutic Proteins, CDER/FDA


The following topics will be covered:

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

*Separate registration required.

 

2014 Brochure Cover

Download Brochure 

Premier Sponsor : 


 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