WEDNESDAY, OCTOBER 25
DINNER | 6:00 – 9:00 PM

SC4: Advice on Putting Together an Integrated Summary of Immunogenicity

Instructors:

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

Bonnie Rup, Ph.D., Bonnie Rup Consulting LLC

The purpose of this workshop is for 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.

  • 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

Purpose

The purpose of this workshop is for 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.

Background

Information relevant for the assessment of the impact of undesirable immunogenicity of therapeutic proteins on overall clinical benefit vs. risk balance is distributed across many different sections of the regulatory dossier. This can make it difficult for regulatory reviewers to located the requisite data. Moreover, essential background information to describe the intrinsic immunogenic potential of the molecule, and how extrinsic factors (product quality, patient variables, dose regimen etc.) might interact to influence clinical manifestations, is often missing. Although there might be valid reasons for applying a particular strategy for evaluating immunogenicity, the Sponsor’s rationale is often not clearly explained. For this reason, the recent draft revision to the main EU immunogenicity guideline has formally endorsed the concept of including a summary document in the MAA dossier, with the objective of collating the essential information required by the regulatory assessor.

Who should attend?

This workshop is relevant to anyone who is involved in generating and compiling the input data for immunogenicity-­related sections of regulatory dossiers, including CMC, bioanalytical, non-clinical, clinical and regulatory specialists.

Part 1 – Defining the gap: João Pedras-­Vasconcelos

  • Priorities for the regulator
  • Common gaps in dossiers
  • Examples of Agency questions triggered by missing information
  • The regulator’s recommendations

Part 2 – Addressing the gap:

  • Suggested structure of the Integrated Summary of immunogenicity
  • Relationship to other parts of the dossier
  • What, where and how? Examples to illustrate how to present relevant information,

Including:

  • Intrinsic immunogenicity and systems biology
  • Linkage to product quality control strategy
  • Rationale for extent of evaluation
  • Correlation of bioanalytical and clinical signals

The Role of the Sponsor Team

  • Role of the Sponsor cross-functional project team from early Immunogenicity Risk Assessment through Integrated Summary of Immunogenicity
  • Identifying relevant information for your projects' Integrated Summary
  • Determining the Integrated Summary structure, level of detail and analysis, and links to other parts of the dossier
  • Using a well-constructed Integrated Summary to reduce potential concerns

Part 3 – Interactive discussion: Using the Integrated Summary of Immunogenicity to minimize regulatory questions at the Marketing Authorization stage

Discussion topics to be driven by participant’s questions and case examples

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

Dr. Pedras-Vasconcelos has been a biologics quality and immunogenicity reviewer with the Office of Biotechnology Products, Center for Drugs- FDA for 15 years, first as a researcher-reviewer (7 years) and then as a full time reviewer (8 years). He received his B. Sc. Honours in Microbiology in 1990, and an M. Sc. in Microbiology in 1993 from The University of Saskatchewan, Canada. He received his Ph. D. in Immunology in 1999 from Cornell University, Ithaca NY. Afterwards he completed a post-doctoral research fellowship at the Institute of Biological Sciences, National Research Council of Canada, and had a position as a term-Research Scientist at the Canadian Food Inspection Agency, both in Ottawa Canada. He joined the FDA in 2002, first with CBER and then CDER and has extensive regulatory experience in reviewing cytokines, fusion proteins, therapeutic toxins, hormones, immunomodulatory extracts, and enzyme replacement therapies. Joao is a standing member of the OBP immunogenicity working group and the coordinating committee for CDER Office of Pharmaceutical Quality Infectious Disease and Inflammation Center of Excellence. He was is also a member of the AAPS NAb assay working group.

Bonita (Bonnie) Rup, Ph.D., Biopharmaceutical Consultant, Bonnie Rup Consulting

Bonita Rup is a biopharmaceutical development consultant, providing expert advice on bioanalysis, immunogenicity risk assessment, and related regulatory strategy aspects of biopharmaceutical development. Previously she was Research Fellow at Pfizer, and lead the Immunogenicity Discipline, Assistant Vice President of Protein Bioanalytics in Wyeth, and held various positions directing development and application of immuno-ligand binding assay technologies for PK, immunogenicity and protein impurity analysis, and other aspects of biopharmaceutical development. During her career, she has been involved in multiple regulatory filings during preclinical, clinical development and marketing approval of biopharmaceutical products. She has been a member of AAPS, EIP, European IMI ABIRISK consortium, and Biosafe; with these organizations, she has been a co-author for multiple publications related to monitoring immunogenicity and bioanalysis of therapeutic proteins. Bonnie received her B.S. from University of Massachusetts, Amherst, Ph.D. from University of Texas, Austin, and conducted postdoctoral research at Duke University and University of Rochester, NY.

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