Mark Reid
Clinical Network Services (CNS) Pty Ltd, Australia
Title: Key steps in moving a vaccine from proof of concept in mice to human clinical trials
Biography
Biography: Mark Reid
Abstract
Key practical steps for moving a vaccine candidate from laboratory grade research material and animal proof of concept data to human clinical trials is discussed. Key considerations include manufacturing considerations (to Good Manufacturing Practice, GMP) and the capacity to make the vaccine at industrial scale with long stability periods; Good Laboratory Practice (GLP) toxicology studies, species selection and study types will be discussed in addition to the design of First in Human studies to demonstrate safety, tolerability and immunogenicity of early vaccine candidates. Key business considerations for the investigator “pitch deck” are also reviewed as the first question asked by large, vaccine companies when considering a new vaccine is: “can this vaccine be sold”.