ON-DEMAND Webinar

Interactive Panel Webinar: Bioanalytical Testing for Gene Therapy

Novel Approach to ADA Assay Development to Overcome Target Interference Issues from Dimerization
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Now Streaming On-Demand

MassBio and BioAgilytix would like to welcome you to our February webinar. This interactive discussion will feature a live Q&A session and include insight from experts in the fields of bioanalytical testings and gene therapy studies.

During this informative webinar...

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.

Topics will include:
  • Immunogenicity for complex therapeutics
  • CLIA or not CLIA
  • Regulatory considerations for PCR assays
  • ELISpot Assay Considerations
About the Presenters

Dr. Jim McNally has an extensive background in bioanalytical assay development and program leadership spanning 20+ years working in the pharmaceutical and biotechnology industry. Prior to joining BioAgilytix, Dr McNally was Executive Director at CRISPR Therapeutics (MA, USA), where he led a team of scientists to develop assays to support development of gene-edited therapeutic candidates.

He has also previously held roles at Genzyme (MA, USA), Pfizer (MA, USA), EMD Serono (MA, USA) and Shire (MA, USA), which have given him broad experience in the development of large molecule, gene therapy and cell therapy biotherapeutics. He has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group on this topic.

Interactive Panel Webinar Bioanalytical Testing for Gene Therapy

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