Let’s talk bioanalytical assay development and regulatory compliance.
In this episode, host Adam Stasio interviews Jim McNally, a leading expert in bioanalytical assay development and program leadership. With almost 20 years of experience in the pharmaceutical and biotechnology industry, Dr. McNally has worked on the development of large molecule, gene therapy, and cell therapy biotherapeutics. He is a thought leader in the application of bioanalytical methods used in regulatory submissions and has a special interest in the immunogenicity of biotherapeutics. Dr. McNally's role at BioAgilytix is to advise on emerging scientific developments and provide scientific and regulatory guidance to drive exceptional science and compliance for clients across the industry. In this insightful podcast, Dr. McNally shares his knowledge on the development of regulations and guidance for bioanalytical testing.