ON-DEMAND Webinar
Interactive Panel Webinar: Bioanalytical Testing for Gene Therapy
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.
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.
- Immunogenicity for complex therapeutics
- CLIA or not CLIA
- Regulatory considerations for PCR assays
- ELISpot Assay Considerations
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.