Innovation and Technology development strategies for successful implementation

• Considerations to bring in innovative ideas that provide solutions to existing development and manufacturing challenges
• Strategies to enable continuum development across scales with novel technologies that promise next generation manufacturing features
• Integration of technology roadmaps with portfolio timelines for an optimum benefit during testing and implementation

Presented by Irina Ramos, PhD, Senior Distinguished Scientist, CMC and Innovation Lead at J&J Innovative Medicine

Irina is currently a CMC project lead and an innovation lead at Johnson and Johnson Innovative Medicine organization. She works across functions and sites to facilitate the intersection between technology development and innovation applications into portfolio programs. Irina Ramos has been a key driver of the technology development and implementation strategy for continuous biomanufacturing. At AstraZeneca, with her team, she has worked to increase fundamental understanding of the various downstream unit operations of drug substance manufacturing, managing the design, testing and qualification of process equipment and automation on the systems to integrate them. Irina holds a BS/MS in Chemical Engineering from University of Porto (Portugal) and a PhD in Chemical & Biochemical Engineering from University of Maryland, Baltimore County (UMBC). For the past 15+ years, Irina’s work in the pharmaceutical industry has spanned from early to late-stage process development and validation, process scalability, CMC and technology transfer to both clinical and commercial manufacturing. With that experience, Irina lead process transfer efforts of the AZ COVID-19 vaccine. She has been involved with NIIMBL consortium since 2020, in particular with the Process Intensification program by leading the Control Strategy workstream). Irina has been teaching a graduate level class on Biotechnology Master program since 2015 about bioprocess and CMC regulatory considerations. She is passionate about mentorship and developing resources to improve the communication of science.