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Mitigating Immunogenicity Risk
Mitigating Immunogenicity Risk

Course Description

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.
  • 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
  • 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

Mitigating Immunogenicity Risk

New Dates TBA, Live Online Training
Regular price €1.850,00
Unit price
per 
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.

Dr. 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.

Training dates will be announced soon. In meantime, feel free to request an agenda.

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Course Description

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.
  • 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
  • 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

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"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

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

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.

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