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 the following activities:
- Quality by Design (QbD), Technology Transfer, Comparability, cGMP compliance, Process Validation, Technical due diligence and gap analysis, identification and project management of outsource cGMP contract manufacture
- Preparation and review of regulatory documentation (CMC sections of IND and IMPD for clinical trials applications and MAA, BLA/IND Module 3 and 2.3 submissions).
Richard brings 17 years applied industrial and commercial biopharmaceutical experience to his role, with a previous 8 years in cGMP Biopharmaceutical Contract Development and Manufacture; acquiring in depth knowledge across a broad range of biopharmaceutical technologies and product types including recombinant vaccines, gene therapies, (stem) cell- based therapies, monoclonal antibodies and biosimilars.
Richard has worked on a number international projects involving successful ‘start to finish’ recombinant drug product development, cGMP manufacture and market approval. Richard has significant experience with cGMP facility design and realization; including interfacing company project management for the construction and validation of a €30M, UK Government funded ‘National Biomanufacturing Centre’, Liverpool, UK (now a biologics subsidiary of Actavis Plc.). He has additional expertise in technology transfer of intellectual property and the commercialization of new start-up companies and therefore readily understands the challenges for emerging biotech and early stage biopharmaceutical development.
Richard has held key role positions at companies which include Eden Biodesign (Actavis), Celltech Medeva, Automation Partnership, Sheffield University, AstraZeneca.
With a Ph.D. research grounding in applied biochemistry, obtained at Liverpool John Moores University (UK), matched with his industrial technical background, Richard is able to provide cross matched technical and regulatory expertise; being able to readily understand and translate the needs of the client to deliver focused and successful projects.