Tuesday, October 15
10:00 am – 1:00 pm

SC1: Mechanism of Action and Risk Based Approach for Developing Neutralizing Antibody Assays

Instructors: Jim McNally, PhD, Executive Director, Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics

Shan Chung, PhD, Associate Director and Principal Scientist, Genentech, Inc.

The development of neutralizing antibody assays is a daunting task that is complicated by the specific nature of each biotherapeutic. Many factors must be assessed to choose the proper assay format, to develop a robust assay, and choose when to invest in the development and implementation of these assays. This short course will focus on these topics and provide examples of current industry practices and publications. Specific focus will be given to a mechanism of action-based approach to selecting the assay format and relevant case studies will be provided.

Topics covered include:

  • Current Regulatory Guidance
  • NAb Assay Strategy – Immunogenicity Risk Assessment
  • Assay Format Selection – Mechanism of Action-based Approach
  • Validation and Implementation of NAb Assays
  • Case Studies

Tuesday, October 15
2:30 – 5:30 pm

SC2: Overcoming Drug and Target Interference in ADA Assays

Instructors: Jim McNally, PhD, Executive Director, Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics

Lilia Macovei, PhD, Bioanalytical Principal Investigator, Senior Scientist, Pfizer Inc.

Soluble drug or drug target can often interfere in the detection of anti-drug antibodies. Although not always straightforward, it can be addressed and mitigated in a properly designed immunoassay. This short course will give an overview of the different types of interferences and current methodologies and approaches being utilized to resolve or reduce them.

Topics covered include:

  • Types of Interferences
  • Immunogenicity Assay Designs and Susceptibility to Interference
  • Mitigation Strategies
  • Case Studies

Tuesday, October 15
6:30 – 9:30 pm

SC3: Validation of ADA Assays and Cut Point Calculations

Instructors: Jim McNally, PhD, Executive Director, Head of Research, Preclinical and Clinical Assays, CRISPR Therapeutics

Angela Yang, PhD, Scientist, Bioanalytical Sciences, Regeneron Pharmaceuticals, Inc.

This short course will focus on the validation of ADA Assays and Cut Point evaluations. We will provide an in-depth overview of the basic considerations around ADA assay validation, with significant focus on the process of evaluating different types of cut points, and the translation of the cut point established during validation to the real-world implementation during a pre-clinical or clinical study.

Topics covered include:

  • Tiered Testing Strategy – Basic issues regarding screening, confirmatory, and titer assays
  • ADA Assay Validation Strategies – Experimental design to execute a validation
  • Stepwise process for calculating different types of cut points
  • Practical challenges for the in-study implementation of cut points
  • Case studies related to the implementation of validation and study-specific cut points

Thursday, October 17
6:15 – 9:15 pm

SC4: Advice on Putting Together an Integrated Summary of Immunogenicity

Instructor: Bonita (Bonnie) Rup, PhD, Biopharmaceutical Consultant, Bonnie Rup Consulting, LLC

The purpose of this workshop is to share experience gained in preparing and reviewing the “Integrated Summary of Immunogenicity”, with case examples to illustrate the multi-disciplinary information that is most useful for the regulator assessing the scale of risk of undesirable immunogenicity for overall clinical benefit vs. risk. It will examine the sponsor team’s role and provide examples of how to address potential issues (and avoid introducing any new ones!) by generating a well-thought-out and constructed integrated summary.

Topics covered include:

  • Defining the Gap: priorities for the regulator; common gaps in dossiers; examples of Agency questions triggered by missing information; the regulator’s recommendations
  • Addressing the Gap: suggested structure; relationship to other parts of the dossier; what, where and how?; examples to illustrate how to present relevant information
  • The Role of the Sponsor Team
  • Interactive Discussion: Using the Integrated Summary of Immunogenicity to Minimize Regulatory Questions at the Marketing Authorization Stage

SC5: Bioassay Quality by Design

Instructor: Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting

The course will present and discuss the critical elements of designing a bioassay. The course will include the following. The course is essential for those individuals designing or validating a bioassay.

Topics covered include:

  • Range Finder Study Design for Dose Selection
  • Number of Doses in the Dose Response
  • Number of Plates and Plate Layout
  • PLA versus 4PL Fitting Methods
  • Outlier ID and Removal
  • Dose Masking for PLA
  • Robust Design and Optimization for a Bioassay
  • Standard Selection and Qualification
  • Validity and Systems Suitability Criteria Selection and Setting Limits

*Separate registration is required to attend short courses.

* The program is subject to change without notice, due to unforeseen reason.

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