Risk Assessment of IM Tools and Digital Infrastructures for Advanced Therapies Manufacturing

Risk Assessment of Information Management Tools and Digital Infrastructures for Advanced Therapies Manufacturing

About the project

The project investigates the critical risks associated with the increased reliance on data collection and processing, information management, and broader digital infrastructures and systems needed for the manufacture, administration, and monitoring of personalised medicines.

Information management tools and digital infrastructures are an increasingly critical component in the manufacture, monitoring, and adoption of Advanced Therapies such as cell and gene therapies. Recent trends show a growing number of advanced therapies authorised on the market, manufacturing becoming available at the bedside and in more decentralised settings, and a gradual adoption and reimbursement of these therapies through national healthcare systems such as the NHS.

These trends also point to an increased requirement to establish more sophisticated, reliable, and resilient data collection, information management tools, and digital infrastructures at several stages in the manufacture, quality control and assurance, transportation, storage, infusion, post-treatment monitoring, reimbursement, and regulatory compliance management of advanced therapies. The use of sensors and actuators for data collection, of algorithmic decisional tools, and (quasi-)automated processes at several stages listed above, provide undoubtable benefits such as increased cost optimisation, more reliable quality controls, and a more meaningful understanding of patient outcomes. However, this increased reliance on more sophisticated digital infrastructures and processes raises new risks pertaining to data security, data integrity, reliability, and accuracy of algorithmic decisional tools, and, importantly, patient data protection and privacy.

This Future Targeted Healthcare Manufacturing Hub study aims to investigate the current state of play and critical risks associated with the increasing use of information management tools and digital infrastructures for the manufacturing, monitoring and adoption of Advanced Therapies.

The study will answer three critical questions:

What data and information management tools, algorithmic tools, and digital processes are currently used throughout the vein-to-vein and post-treatment monitoring process for both product and patient?
What are the key benefits and limitations of these current tools and processes?
What are the risks associated with the increased deployment and reliance on these tools and infrastructures, taking into consideration that they affect key stakeholders (patients, healthcare providers, clinicians, manufacturers, etc) differently?

Media coverage

Personalised medicine made in hospitals can revolutionise the way diseases are treated – the challenge now will be implementing it. Read: The Conversation