ON-DEMAND Webinar
Platform Usage to Support Advanced Drug Modalities
Now Streaming On-Demand
Technology platforms not typically used for regulated bioanalysis are now utilized more frequently to support cell and gene therapy programs. Flow cytometry, ELISpot and quantitative PCR are all tools now leveraged to assess exposure, durability, immunogenicity and function of novel modalities. In this webinar, we’ll discuss their utilization and current thoughts around expectations for performance characteristics in the regulated space.
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., Chief Scientific Officer, offers 20 years of experience in bioanalytical assay development and program leadership in pharmaceuticals and biotechnology. At BioAgilytix, he advises on emerging scientific developments and provides scientific and regulatory guidance. Prior to BioAgilytix, Dr. McNally was Executive Director at CRISPR Therapeutics (MA, USA), with previous roles at Genzyme (MA, USA), Pfizer (MA, USA), EMD Serono (MA, USA) and Shire (MA, USA).
Dr. McNally is a recognized thought leader in the development and application of bioanalytical methods used in regulatory submissions and progression of biotherapeutics from research through clinical development. He has special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue.
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