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Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

Live webinar

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 such as:

  • How does the risk of immunogenicity impact compound prioritization and clinical trial design?
  • How do intrinsic/extrinsic factors impact the patients’ risk of immunogenicity and is this risk manageable via dose adjustments?
  • How will you assess the risk of ADAs for emerging therapeutic modalities including cell and gene therapies?
  • How will you address regulatory requirements to identify the impact of immunogenicity on drug safety and efficacy as well as its incidence in non-clinical and clinical studies?

Thus, building a sound strategy for predicting and characterizing the immunogenicity of a biologic drug is crucial during every stage of development. In this webinar, Certara’s Morena Shaw and Piet van der Graaf will provide practical insights on how to address these issues.

Ms. Shaw will explain 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’ll also discuss 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 will discuss 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. 

By attending this webinar, you’ll learn:

  • Why creating an ISI early in drug development leads to better ADA assessments
  • How the IG Simulator supports decision-making from discovery through clinical
  • Why using this groundbreaking model will facilitate compound prioritization and inform go/no decisions for biologics developers

By working with partners that have pioneered strategies for predicting and assessing immunogenicity and anticipating what the supportive data will be required, drug developers can maximize the likelihood that their biologic achieves clinical and regulatory success.

Our Speakers
Bio Pic PietGraaf
Piet van der Graaf, PharmD, PhD
Senior Vice President, Quantitative Systems Pharmacology
With over 20 years of experience working in the pharmaceutical industry at Sanofi and Pfizer, Piet brings considerable skill and experience to QSP projects and contributes to the strategic development of Certara.  He is also Editor-in-Chief of CPT.
Morena Shaw
Morena Shaw
Associate Director Clinical Pharmacology

Morena Shaw has nearly 20 years of experience supporting both large and small molecule drug development. Specialties include Translational and Nonclinical Pharmacology, MABEL dosing strategies, Bioanalytics and IND GAP analysis. She has years of experience developing immunomodulatory monoclonal antibody therapies to support innovative clinical trial design and analysis as well as regulatory filings. Before transitioning to large molecule pharmacology, Morena contributed to RTK, GPCR, transporter, and enzyme target small molecule therapeutic programs at Pfizer Global Research and Development and Janssen Pharmaceuticals. Morena is a native San Diegan who did her graduate and undergraduate studies at UCSD.

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