Mitigating Immunogenicity Risk

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

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

TRAINER

Dr. Gwen Wise-Blackman

BioData Solutions, USA, Senior Consultant

Dr. Wise-Blackman is a consultant and project lead at BioData Solutions. 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. She has over 24 years of experience in both mid-size pharma companies and contract research organizations. She has led detail-oriented teams to successful completion of client projects. Her focus is on pharmacokinetic (PK), pharmacodynamic (PD) biomarker, immunogenicity, neutralizing antibody, and cell-based assays. Dr. Wise-Blackman earned her Doctor of Philosophy degree in pharmacology from the University of Virginia. She received her Bachelor of Science in Biology from the Massachusetts Institute of Technology. She is a sought-after trainer for bioanalytical method development and validation, technology transfer, and implementing process controls for challenging cell-based assays.

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