FIH TO CLINICAL ACCELERATION CONCURRENT Implementing the first mile of big data early to deliver smarter, scalable manufacturing
Friday, June 2, 2023 08:00 AM - 09:00 AM
Room 252AB
FROM FIH TO CLINICAL ACCELERATION
Concurrent
Session Poll
Chair
Dominic Clarke, PhD, Partner, Orange County Bio, USA
Speakers
Kevin Gordon, MSIS, Chief Digital Officer, Ori Biotech, USA
Mark Lowdell, PhD, FRCPath, FRSB, Professor of Cell and Tissue Therapy, University College London, UK
Najib Rehman, Digital Automation Lead, ATMPS, UK
Session Description
The adoption and growth of cell & gene therapies is fueled by fostering clinical acceleration. The complexity of these therapies combined with increased production results in large amounts of data. As more of these complex therapies advance to the clinic and reach greater patient populations, how the industry captures and manages this data will be fundamental to success. Data comes in many forms and is generated at each step within a process and captured early in the product lifecycle this data helps to establish the critical quality attributes. Unfortunately, no matter how much data is generated, having limited visibility or transparency directly impacts overall consistency through predictability and adaptability. This session intends to openly discuss as an industry, strategies to properly capture and manage data early to reduce the common fragmented information architecture and establish a platform for accelerated clinical, scalable success. Looking ahead, the session’s panelists discuss whether novel digital technology provides an opportunity to develop a future healthcare ecosystem predicated upon connected data, collaboration and cooperation across the industry, and debate whether this paradigm shift represents an achievable future or stands merely as unattainable utopia.
- Pre-session poll - click here to answer the poll before the session starts
- Post-session poll - click here to answer the poll at the end of the session
Chair
Dominic Clarke, PhD, Partner, Orange County Bio, USA
Speakers
Kevin Gordon, MSIS, Chief Digital Officer, Ori Biotech, USA
Mark Lowdell, PhD, FRCPath, FRSB, Professor of Cell and Tissue Therapy, University College London, UK
Najib Rehman, Digital Automation Lead, ATMPS, UK
Session Description
The adoption and growth of cell & gene therapies is fueled by fostering clinical acceleration. The complexity of these therapies combined with increased production results in large amounts of data. As more of these complex therapies advance to the clinic and reach greater patient populations, how the industry captures and manages this data will be fundamental to success. Data comes in many forms and is generated at each step within a process and captured early in the product lifecycle this data helps to establish the critical quality attributes. Unfortunately, no matter how much data is generated, having limited visibility or transparency directly impacts overall consistency through predictability and adaptability. This session intends to openly discuss as an industry, strategies to properly capture and manage data early to reduce the common fragmented information architecture and establish a platform for accelerated clinical, scalable success. Looking ahead, the session’s panelists discuss whether novel digital technology provides an opportunity to develop a future healthcare ecosystem predicated upon connected data, collaboration and cooperation across the industry, and debate whether this paradigm shift represents an achievable future or stands merely as unattainable utopia.
