ON-DEMAND Webinar
Potency Assays For Gene & Cell Therapy Products
Now Streaming On-Demand
In association with Oxford Global, this webinar features an expert panel to discuss our work with potency assays for gene and cell therapy products. As the number of gene and cell therapy products in development continues to increase, so has BioAgilytix's focus on their importance.
Hear from our team of experts that are helping our customers pursue the opportunities of this compelling therapeutic strategy by leveraging our deep NAb assay capabilities and vast experience with a variety of viral vectors.
Our experts will discuss lessons learned from their experiences and offer insight into the multiple stages of specific assays including critical reagents, regulatory standards, assay formats and timelines.
Jim McNally, Ph.D. (Moderator) is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue. A key part of his role at BioAgilytix is advising on emerging scientific developments and providing scientific and regulatory guidance.
Jay Stringer, Ph.D. has more than 10 years’ combined experience working with numerous immunoassay formats in academic, clinical, and BioAgilytix labs. At BioAgilytix, Jay currently manages a team of scientists and analysts developing, qualifying, and validating assays to support sample testing for clients. He has supported multiple clients in different species for AAV ADA testing utilizing a simple bridging approach on the MSD platform.
Luke Armstrong, Ph.D. has over a decade of experience in reagent product development and contract research in cell-based assays, pharmacology, molecular cloning, protein expression, and immunoassays. In his role at BioAgilytix, Luke manages a research and development and operations team providing quality services in cell-based assays for detection of neutralizing antibodies to large molecule biologic drugs. Luke earned his Ph.D. in Biochemistry and Molecular Biology from the University of California, Davis, and was a postdoctoral fellow in the Department of Biochemistry at the University of Washington.
Todd Lester is a seasoned biotechnology and pharmaceutical project management professional. In his role at BioAgilytix, he oversees and leads all technical aspects of complex bioanalytical studies, including design, interpretation, analysis, documentation, and reporting of results, investigations, and deviations.
Xiaoxi Yang, Ph.D. has 10+ years of experience in assay/device development research in the Pharmaceutical/Diagnostics fields. In her role at BioAgilytix, Xiaoxi manages an operations team to develop and validate ligand binding assays to support the trials for large molecule biologic drugs. She led and executed several anti-drug antibody (ADA) assays to support adeno-associated virus (AAV)-based gene therapy programs with varying formats.
Marianne Scheel Fjording, MsC, PhD. has an extensive background in large molecule bioanalytical assay set-up and assay validation with 25+ years of experience working in the pharmaceutical and biotechnology industry. In her role as Scientific Officer, Executive Director, she provides scientific and regulatory support to clients and the operational teams at BioAgilytix as well as bioanalytical strategies to clients.
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