The challenges of assessing immunogenicity: an interview with Joao Pedras-Vasconcelos

We had the pleasure of interviewing Joao Pedras-Vasconcelos (Product Quality and Immunogenicity Reviewer, FDA; WA, USA). In this interview, Joao discusses the molecules and products he reviews and how important it is to understand how they affect efficacy and safety in patients. He continues to outline his responsibilities as an immunogenicity reviewer and the three board areas that are assessed: molecular characteristics, what the patient factors are, and what are the factors in the clinical trial that could lead to an immune response to the product. Joao also addresses:

  • The challenges of assessing immunogenicity
  • Where the field could be in 5–10 years’ time
  • Key advice to a new scientist

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