Platform usage to support advanced drug modalities
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.
What will you learn?
- An overview of flow cytometry, ELISpot and quantitative PCR as it relates to clinical analysis
- Discuss multi-parameter analysis using flow cytometry to assess both drug and patient responses
- Discuss recent white papers and guidance for the use of these platforms
Who may this interest?
- Bioanalytical scientists
- Clinical pharmacologists
- Clinical operations
Speaker
Dr. Jim McNally, PhD
Chief Scientific Officer
BioAgilytix (MA, USA)
Dr. Jim McNally 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.
In association with
