Importance of Innovation and Design in the Scalability of Cell & Gene Therapies

In by

Spotlight Article

Podcast Interview


STRATEGIES FOR SCALE-UP & SCALE-OUT


Dr Stephen Ward, Dr Julie Kerby & Dr Damian Marshall

Stephen Ward, Chief Operating Officer, Cell and Gene Therapy Catapult. Stephen brings over 17 years of biological medicine research, development, and manufacturing experience to the organisation. Stephen enjoys converting early research ideas into regulatory compliant products for patients and has developed and validated scaleable, commercial manufacturing processes for cell based medicinal products, vaccines, and recombinant biologicals using Quality by Design principles. In addition, his recent interests have been in the use of multi-disciplinary commercial/academic programmes (early in the product lifecycle) to predict the effects of manufacturing stress upon cell-based therapies.
Julie Kerby, Head of Manufacturing Development, Cell and Gene Therapy Catapult. Working closely with our collaborators she is responsible for the development and technical transfer of cell and gene therapy manufacturing processes ensuring they meet quality and regulatory requirements. Julie has more than 20 years’ experience across large pharma, biotech and academic laboratories, including 7 years at Pfizer Ltd as Biology Lead for a cell replacement therapy for Age Related Macular Degeneration which achieved First-in-Human in 2015. Julie holds a BSc. Hons degree in Biology from the University of Southampton.
Damian Marshall, Head of Analytical Development, Cell and Gene Therapy Catapult. Joining the Cell and Gene Therapy Catapult in August 2013, Damian leads the assay development and validation team which underpins a diverse portfolio of cell therapy products at various stages of clinical maturity from pre-FiM to phase III. Damian has over 15 years of assay development experience in the cell therapy and life sciences fields having previously managed the R&D portfolios for both SMEs and LGC Ltd and has successfully managed a European life sciences business with an annual turnover in excess of £15 million. Damian graduated with a degree in biological sciences and a PhD in developmental biology from Manchester University.