Certara Webinars Presents: Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

Dec 15, 2021

Posted by Certara

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Add to Calendar + 2021-12-15 11:00 2021-12-15 12:00 America/New_York Certara Webinars Presents: Predicting and Taming Immunogenicity: Strategies for your Biologic Drug

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.

BY:

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, 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. 

Certara
accelerates medicines to patients using proprietary biosimulation software and
technology to transform traditional drug discovery and development. Its clients
include 1,600 global biopharmaceutical companies, leading academic
institutions, and key regulatory agencies across 60 countries.

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.

BY:

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, 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. 

Certara
accelerates medicines to patients using proprietary biosimulation software and
technology to transform traditional drug discovery and development. Its clients
include 1,600 global biopharmaceutical companies, leading academic
institutions, and key regulatory agencies across 60 countries.

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