APRIL 29, 2020—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced the addition of Jim McNally, Ph.D. to its leadership team as Chief Scientific Officer.
Dr. McNally brings with him an extensive background in bioanalytical assay development and program leadership working for almost 20 years in the pharmaceutical and biotechnology industry. His prior roles at Genzyme, Pfizer, EMD Serono, Shire and CRISPR Therapeutics have given him broad experience in the development of large molecule, gene therapy and cell therapy biotherapeutics. He is a thought leader in the development and application of bioanalytical methods used in regulatory submissions and is specifically skilled in progression of biotherapeutics from research through clinical development. Dr. McNally has a special interest in the immunogenicity of biotherapeutics and leads an industry-wide working group to address this issue.
Dr. McNally’s role at BioAgilytix will be to advise on emerging scientific developments and provide scientific and regulatory guidance. He will continue to work across the industry to drive the development of regulations and guidance for bioanalytical testing representing BioAgilytix’s experience and expertise in these areas. “I am so excited to have the opportunity to join the amazing BioAgilytix team and to collaborate with so many scientists both internally and externally,” said Dr. McNally. “I look forward to continuing to drive exceptional science and compliance for all of our clients across the industry.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With US headquarters in North Carolina’s Research Triangle area, a laboratory in Boston, Massachusetts, and European headquarters in Hamburg, Germany, BioAgilytix provides global services for biomarkers, immunogenicity, PK, and cell-based assays supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e. product release testing, stability testing, etc.). We also offer diagnostic testing services through our Boston laboratory.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to many of the top global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.