Virtual Training: Mitigating Immunogenicity Risk
We are all geared up for NBC 2023. Join us for a co-sponsored discussion with KCAS “Panel Discussion: Common Challenges in Bioanalytical Assay Validation/Development in CGTP,” a demonstration of the beta version of an automated software tool for determining cut point using Random Effects Model for your CGTP datasets, and some Ariadne and BioData swag at booth #213!
October 10-12, 2023
Summary
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
Trainers
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.
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.