Interview with Kaitlyn Barago
In this short interview, Nancy reviews her education and experience in the development of cell and gene therapy products. She provides insights into how the complexity of biologics make bioassay design, development, and validation of assays challenging. She also empathizes with scientists who have limited training in biostatistics and advocates for educating bench scientists, statisticians and others involved in generating and reviewing data to elevate the conversation on approaches to generate high quality regulatory submissions.