Mitigating Immunogenicity Risk

    Mitigating Immunogenicity Risk

    Applying Knowledge-Based Strategies from Early Assay Development/Validation to Clinical Monitoring

    10 – 12 October 2023, live online training


    Large molecule therapeutics have the added complexity of formation of anti-drug antibody (ADA). Consistently confirming the presence of ADA requires a reliable and robust method with decreased impact of drug, soluble drug target, co-drugs, or other interference. In addition, the data from the ADA method should have clinical relevance for treatment of subjects. This course will examine current and evolving methodology to overcome challenges in ADA methods. Issues that will be discussed are developing positive control antibodies for drugs engineered to decrease potential ADA, ADA to drug modifiers, drug and soluble drug target interference, ADA methods for cell and gene therapy drugs, bispecific antibody therapeutics, oligonucleotides, and pre-existing antibodies. This webinar will discuss data analysis using artificial intelligence to reliably calculate cut points. Case studies will be used to highlight challenges and resolutions.

    Learning Objectives

    • Understanding current regulatory expectations (FDA and EMA Regulatory Expectations)
    • Identify potential challenges to ADA methods
    • Practical consideration for development of positive controls
    • Understanding the complexity of potential interference
    • Gain knowledge of new technologies to overcome assay interference
    • Implementing a strategy to overcome challenging methods
    • Designing ADA methods for modified drugs
    • Understanding and targeting domain specificity
    • Working with cut point challenges
    • Value of in study cut points
    • Using AI for robust calculation of cut point
    • Practical guides from selected case studies

    Key Topics

    • Developing appropriate positive controls (pAb vs. mAb)
    • Imprecision in ADA methods
    • Overcoming drug tolerance
    • Matrix interference
    • Soluble drug target interference
    • Subject co-drug or dietary interference
    • ADA to molecule modifiers (PEG)
    • Modifying assays for rare disease population cut point
    • Clinical relevance of ADA results
    • Relevance of pre-existing antibodies
    • ADA to cell and gene therapy drug products
    • Regulatory perspectives
    • Artificial intelligence: tools for cut point calculations

    Who should attend?

    Laboratory Managers, Lead Scientists, Development Scientists, Validation Scientists, Regulatory Affairs, Clinical Scientists, Quality Assurance, Data Scientists

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 7 days
    • Training in digital format
    • Digital and LinkedIn certificates


    Stephanie Pasas-Farmer
    Stephanie Pasas-Farmer is a recognized bioanalytical expert in the areas of discovery and regulated bioanalysis for pharmaceutical, biologics and hybrid technologies, including antibody-drug conjugate technology.
    Dr. Gwen Wise-Blackman
    Dr. Wise-Blackman is a consultant and project lead at BioData Solutions, with over 24 years of experience. Her attention is devoted to providing guidance to small and large biotechnology and pharmaceutical companies in support of drug development. Her work includes supporting regulatory approval of large molecule therapeutics.
    Mitigating Immunogenicity Risk

    Mitigating Immunogenicity Risk

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 1 997 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Online workbook & materials


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori
    +421 222 200 543

    Training Details
    • Start Date
      10. October 2023
      02:00 PM Vienna time
      01:00 PM London time
      08:00 AM New York time
      05:00 AM Los Angeles time
    • End Date
      12. October 2023
    What participants said about this course

    "It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."
    Tech Transfer Lead, Novartis

    "Practical examples were extremely useful and well presented."
    Senior Development Specialist, Bioton

    "Diving into the case studies and the ensuing discussion and learnings were great."
    Regulatory Affairs Specialist, Csl Behring

    "Excellent work of the lecturer, good materials, clear explanations."
    Clinical Pharmacologist, Boehringer Ingelheim

    "You succeed only when you are trained enough! Trust Symmetric's Training Team to achieve your goals."
    Analytical Developer, Gedeon Richter

    "Thank you for sharing all the links and informative material. Very professional organization and execution."
    Manufacturing Manager, Thermo Fisher Scientific

    "Very well organized event. Thanks and hope to work-learn from you again soon."
    Deputy Manager of Solid Dosage Forms Plant, Gedeon Richter

    "Many thanks for the invitation, organization of the training and the atmosphere. I found the course very well organised and presented."
    Formulation Manager, Curia