Immunogenicity is the ability of a foreign substance, such as a drug or vaccine, to provoke an immune response. While provoking immunogenicity is a desired outcome for vaccines, the development of anti-drug antibodies (ADAs) can inactivate a biologic drug’s therapeutic effects and potentially cause safety issues.
The issue of immunogenicity imposes both scientific and regulatory challenges on biologic drug development programs. In this webinar, Certara’s Morena Shaw and Piet van der Graaf provided practical insights on how to address these issues.
Ms. Shaw explained best practices for developing an Integrated Summary of Immunogenicity (ISI), a document required by regulatory agencies that includes the immunogenicity risk assessment, assay strategy, clinical trial design, immunogenicity results and risk mitigation strategies (REMS). She also discussed how to anticipate the needs and considerations for characterizing ADAs at the various stages of drug development (IND, BLA, Post-Marketing) and the importance of selecting the ideal format for your ADA assay to enable interpreting the results.
Certara’s Immunogenicity (IG) Simulator is a Quantitative Systems Pharmacology (QSP) platform based on an extensive model of the human immune system to predict immunogenic response to therapeutic proteins, combined with a biologic physiologically-based pharmacokinetic (PBPK) model. Dr. van der Graaf discussed how the IG Simulator uses first-in-human (FIH) data to design Phase II/III trials, predict impact of disease and co-medications, extrapolate to new populations, and predict if IG can be managed by dosing adjustments.