Dr. Richard Dennett is responsible for the management of projects involving
the development of Chemistry Manufacturing and Control (CMC). He
provides scientific, technical, and regulatory expertise for a broad range of
activities, including, but not limited to, Quality by Design (QbD), Technology
Transfer/Comparability, and cGMP compliance/validation. He has 17 years of
biopharmaceutical industry experience, including 8 years in construction and
operational roles at a UK CMO. Dr. Dennett has actively advised on 2 successful
FDA and EMA NDA/MAA submissions, each with QbD content, for a small
molecule and a biologic, respectively. Dr. Dennett has first-hand experience
of process/product development from concept through to regulatory market
authorization as well as being a leading, recognized regulatory consultant in the
field of Quality by Design. Dr. Dennett earned his PhD in applied biochemistry at
Liverpool John Moores University in the UK.