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Richard Dennett, Ph.D.

Director at Voisin Consulting Life Sciences

Profile

Dr. Richard Dennettis responsible for the management of projects involving the development ofChemistry Manufacturing and Control (CMC) and Quality. He provides scientific,technical and regulatory expertise for the following activities:

  • Qualityby Design (QbD); including successful EMA/FDA filings, TechnologyTransfer/Comparability, cGMP compliance, Process Validation, Technical duediligence and gap analysis, identification and project management of outsourcecGMP contract manufacture
  • Preparationand review of regulatory documentation (CMC sections of IND and IMPD forclinical trials applications and MAA, BLA/IND Module 3 and 2.3 submissions).
  • Technicaland Regulatory Strategies

Richard brings over 20 years applied industrial and commercial biopharmaceutical experience to his role, including 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. Additionally, small molecules.

Richard has worked on a number international projects involving successful ‘start to finish’ recombinant drug product development, cGMP manufacture and BLA/MAA market approval. Richard has significant experience with cGMP facility design and realization; including being the interfacing Project Manager for the construction and validation of a €30M, UK Government funded ‘National Biomanufacturing Centre’, Liverpool, UK (now a biologics subsidiary of Actavis/Allergan). He has additional strong 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 (Allergan), Celltech Medeva (Novartis), Automation Partnership (Sartorius), 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.

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