Predictive Immunogenicity for Better Clinical Outcomes

Collaborative Workshop hosted by: Centers of Excellence in Regulatory Science and Innovation (CERSIs) and FDA
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Quanterix VP of Accelerator Services, Dan Sikkema, PhD joins the Expert Panel on Day 1, Session 5 of the FDA-CERSI Collaborative Workshop.

This event is free of charge and open to the public. Attend in-person or via webcast. Pre-registration is required.

Register Here

Workshop Goals and Objectives:

Protein therapeutics have continued to gain an increasing share of the pharmaceutical market and now provide medical interventions for some of the most complex and intractable diseases. Immunogenicity, the propensity of a therapeutic protein to induce immune responses, principally by development of antibodies, may affect safety and/or efficacy, and is thus an important concern in the development and regulation of protein therapeutics. Patients, regulators and the biopharmaceutical industry are all affected by immunogenicity. Recently, both the US Food and Drug Administration and the European Medicines Agency have released Guidance Documents for industry focusing on immunogenicity.

This timely public workshop will present advances in the development of technological tools for predictions of immunogenicity and discussions on how to engage relevant stakeholders in application of these tools during drug development.

The specific objectives of this workshop are to:

  • Communicate to stakeholders the “state of the science” regarding technological approaches for prediction of immunogenicity including non-clinical (in silico) studies for detection of neo-antigens, the use of novel animal models, and strategies to de-immunize protein molecules.
  • Explore strategies for choosing appropriate tools and interpreting the results since the novel tools and information available in this field are complex and not amenable to simple prescriptive approaches during drug development.

Session Themes:

  • Advances in understanding the biology of T- & B-cell responses as it applies to the immunogenicity of therapeutic proteins
  • New analytical techniques and improvements in existing technologies to predict immune response to therapeutic proteins
  • Mathematical models that can integrate seemingly disparate measurements related to immunogenicity
  • Big data and immunogenicity: How “omics” workflows can be used to generate and analyze large data sets as they relate to immunogenicity
  • Identification and application of biomarkers for predicting immunogenicity
  • The Holy Grail: Deimmunizing protein therapeutics
  • The human cost and the economic burden: How immunogenicity affects patients and the economic burden on the healthcare system

Who Should Attend?

This workshop is open to the public. The intended audience includes those with an interest in immunogenicity of therapeutic proteins and related assessments including the biopharmaceutical industry and related companies, regulators, patient advocacy groups, academic researchers, clinicians involved in patient care and clinical research, government agencies, payors such as insurance companies, medical product policy makers, and the public.

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