Gyrolab®: Case Studies in Assay Development & Validation

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.

Carla Mejia has over 13 years of experience in the pharmaceutical industry, including over 8 years at BioAgilytix. Before joining the BAL team, Carla worked for GSK (NC, USA) and Grifols (NC, USA). She has over a decade of experience working on development, validation and sample analysis of immunogenicity ELISA and PK assays. She has extensive experience developing assays for a variety of matrices for both animal and human studies.

At BioAgilytix, Carla currently manages an FTE model team that develops, validates and executes sample analysis for PK, ADA and biomarker assays on multiple platforms including MSD, ELISA and Gyros platforms. She earned her Bachelor of Science in Biochemistry from North Carolina State University (NC, USA).