This presentation focuses on case studies through the eyes of a biomarker scientist working before and after being transported from ‘planet Biomarkertopia’ to ‘planet Earth’ to demonstrate the processes, challenges and some of the limitations of validating biomarker assays using single and multiplexing approach. You will also learn about the latest trends in single and multiplex biomarker assay validation.
The assessment of immunogenicity of biological protein drugs is a key component in drug development. A basic knowledge in immunology is a prerequisite for understanding the principles of adverse, unwanted immune responses. In addition, emerging technologies are making analytical and clinical data interpretation more challenging. Likewise, the comparative immunogenicity analysis of an innovative therapeutic and biosimilar needs to be addressed closely.
The goal of this webinar, presented by Dr. Afshin Safavi, Co-Founder and CSO of BioAgilytix, is to review the concept of parallelism and relative accuracy for biomarker studies, using various case studies to increase awareness of the bioanalytical challenges and considerations as they pertain to these, as well as to reagent lot-to-lot variability.
In this webinar, BioAgilytix’s Dr. Dominique Gouty and Dr. Arno Kromminga summarize the recommendations from the AAPS Ligand Binding Assay Biosimilar subcommittee and Biosimilars Action Program Committee on the Development and Validation of PK, Anti-Drug Antibody (ADA), and Neutralization Antibody Assays (NAB) for Biosimilar Drug Development, and describe how this information can be used to reduce the risks present in biosimilar drug development.
Abstract: Biomarker analysis has become a common practice by many pharmaceutical companies to help PK/PD modeling. The reliability of outcomes is heavily influenced by the quality of the reagents. One of the challenges that bioanalytical labs face when running biomarker studies is the control of lot-to-lot variability of critical reagents and commercial immunoassay kits. Case studies will be presented to highlight the key bioanalytical considerations involved in running successful biomarker analyses in support of clinical studies.
Afshin Safavi, Ph.D., Founder & Chief Scientific Officer, is a veteran biochemist with extensive experience in establishing and leading bioanalytical teams in support of the development of biological products in preclinical and clinical-trial laboratories. Prior to founding BioAgilytix, he was the Director of Ligand Binding and Immunoassay, operating under GLP at AAIPharma. At Talecris BioTherapeutics, he led the Preclinical and Clinical Assay Development team, building on his experience as a senior scientist at Nobex Corporation, GlaxoSmithKline and IGEN International. Dr. Safavi is considered an expert in the area of immunoassay with a wide working knowledge of various platforms. He obtained his B.S. in Biochemistry from UCLA, his Ph.D. in Biochemistry from University of Kentucky Medical School, and completed a two-year postdoctoral assignment at the Emory University, Department of Pathology.
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