Due to their complex nature, multidomain biologics present unique bioanalytical challenges. This class of biotherapeutics is broadly defined as therapies composed of two or more distinct domains, each with a specific mechanism of action. This structural complexity offers the potential for increased efficacy compared to traditional monoclonal antibody therapies, which typically function through a single mechanism. However, the presence of multiple domains adds complexity to bioanalytical assays used to assess the safety and efficacy of these therapies. The multimodal nature of multidomain biologics necessitates specialized strategies for assay design and validation to ensure that all components of the biologic are captured in the final analytical output.
In this webinar, the featured speakers will share key insights into the development and validation of pharmacokinetic and immunogenicity assays tailored for multidomain biologics. Attendees will learn how to employ a single assay to characterize the therapeutic profile and determine when additional molecular characterization should be incorporated throughout the clinical development timeline.
Register now to discover best practices for developing and validating bioanalytical assays that support the successful advancement of multidomain biologics.
Speakers
Lynn Kamen, Scientific Officer, Executive Director, BioAgilytix
Lynn Kamen is a Scientific Officer at BioAgilytix. She earned her PhD in Immunology at the University of Michigan and completed a postdoctoral fellowship in Immunology at the University of California San Francisco. Dr. Kamen has over a decade of experience working in drug development, from early target discovery through clinical development for both large and small molecules at several companies, including Portola Pharmaceuticals and Alector.
More recently, she was a Principal Scientist at Genentech, where she supported the in vitro biological characterization of large molecules and led the development of immunogenicity assays including ADA, NAb and immunogenicity risk ranking assays. Dr. Kamen is also the Co-Lead of the AAPS NAb working group.
Message Presenter
Christopher Tiedje, Associate Director and Principal Investigator, BioAgilytix Europe GmbH
Dr. Christopher Tiedje is an Associate Director and Principal Investigator at BioAgilytix Europe GmbH, Hamburg, where he oversees the conduct of pharmacokinetic, immunogenicity and biomarker bioanalytical assay establishment, validation and sample analysis in support of sponsors’ drug development programs.
Chris obtained his Diploma degree in Biochemistry from the Leibniz Universität, Hannover, and then earned his PhD in Biochemistry and Molecular Biology at Kiel University (CAU). Before joining BioAgilytix in early 2020, Chris had a distinguished academic career, including postdoctoral positions at Hannover Medical School and the Babraham Institute, Cambridge and an Associate Professorship at Københavns Universitet in Copenhagen.
Message Presenter
Joshua Cubbison, Manager II of Bioanalytical Operations, BioAgilytix
Josh Cubbison serves as a Manager II of Bioanalytical Operations at BioAgilytix, where he oversees the development, qualification and validation of bioanalytical methods in support of large molecule drugs. He has worked in the regulated CRO space for over 12 years, including the last seven-plus years at BioAgilytix. While possessing experience across several platforms, Josh’s specialty lies in cell-based immunogenicity assays, such as neutralizing antibody (NAb) and enzyme-linked immunosorbent spot (ELISpot) assays.
Message Presenter
Liz Nolff, MS, Manager II of Bioanalytical Operations, BioAgilytix
Liz Nolff has over 20 years of assay development and validation experience with various modalities and therapies (cell and gene therapy, enzyme replacement, monoclonal antibodies and lipid and hormone small molecule ligand binding assays). Nolff serves as Manager II, BPM at BioAgilytix, servicing a strong client portfolio specializing in Immunogenicity, PK, Oligo Hybridization LBA and Biomarker studies. She previously worked for Enzo Life Sciences (NY, USA) and Cayman Chemical (MI, USA), identifying emerging areas of research, diagnostics and drug discovery, and implementing products of interest to various disciplines into these pipelines. She earned her BSc from Michigan State University (MI, USA) and her MSc from Johns Hopkins University (MD, USA)
Message PresenterWho Should Attend?
This webinar will appeal to professionals across the following roles and fields:
- Pharma/biopharma professionals
- Clinical Pharmacologists
- Bioanalytical Scientists
- Translational Biologists
- Clinical Development
- Clinical Operations
- Clinical Project Managers
- Clinical research staff
- Executives, Directors
What You Will Learn
Attendees will learn:
- Strategies for developing PK assays for multidomain biologics
- Insights into the immunogenicity analysis of multidomain biologics
- About case studies showing the different approaches for bioanalysis of multidomain therapeutics
Xtalks Partner
BioAgilytix
BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalytical laboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in a GxP environment. BioAgilytix maintains state-of-the-art laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany.
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