Sr. Scientist Genentech South San Francisco, California
Presentation Description: The characterization of target binding interactions is critical at each stage of therapeutics development. During early development, it is important to design fit-for-purpose in vitro Molecular Interaction Characterization (MIC) assays that accurately determine the binding affinity of therapeutic antibodies for their targets. Such information enables PK/PD modeling, estimation of dosing regimens, and assessment of potency. While binding affinities seem to be readily obtained, there is little discussion in the literature on how the information should be generated and used to enable key decision-making in drug development. The introduction of new antibody modalities poses additional challenges to the development of MIC assays and increases the needs to discuss the impact of developing context-appropriate MIC assays. In this presentation, we will discuss MIC strategies to overcome these challenges to enable IND filings for several representative new antibody modalities.
Upon complete, participate will be able to better understand gaps that exist in characterizing molecular interactions to support drug development.
Upon complete, participate will be able to better understand challenges associated with molecular interaction characterizations to support the development of new therapeutic modalities
Upon complete, participate will be able to increase the awareness of the importance of MIC studies in support of therapeutic development thereby helping to shape best practices within the community