CERSI for the Digital Transformation of Medicines Development and Manufacturing
Lead Research Organisation:
University of Strathclyde
Department Name: UNLISTED
Abstract
The COVID-19 pandemic demonstrated vividly that regulatory innovation can accelerate the speed of access to new medicines for patients. Continuing to ensure reliable access to affordable, safe, effective and environmentally sustainable medicines requires rapid medical, scientific, engineering and digital innovation across industry, academia, government and regulators. This innovation is underpinned and enabled by digital technologies such as Al/ML, blockchain, increased simulation power and increasingly complex mechanistic and hybrid models. These technologies develop at an ever-increasing rate, and it is essential that regulatory processes can keep pace to benefit from the greater efficiency and speed digital transformation brings whilst assuring patient safety remains paramount. This UK Centre for Excellence in Regulatory Science and Innovation for digital tools in medicine's chemistry, manufacturing and control will deliver the 21st-century regulatory science and innovation needed to unlock the benefits of the digital transformation of medicines development and manufacturing for the pharmaceutical industry, regulators, and society. Collaboration through this network will build clear regulatory frameworks to address sector-specific challenges, including harmonisation of guidance across different digital tools, the complexity and black-box nature of some models, data quality and security concerns, regulatory expertise shortages, and trust issues among patients and the public
Technical Summary
"Traditional medicines regulatory practice has relied on empirical slow development approaches with inefficient data usage. To unlock the transformative potential of digital technologies, a fundamental shift in approach is urgently needed. The development of digital tools often proceeds with minimal regard for regulatory requirements. If this approach continues, industry, regulators and academia will not realise the full impact of emerging digital technologies, such as Artificial Intelligence (Al)/Machine Learning (ML), hybrid and physics-based models. It is vital to consider regulatory aspects from the outset of digital tool development, particularly during the conceptualisation phase, to assure compliance. Decisions in data provenance, digital technology development and application in early development can have significant regulatory implications later on.
While Health Authorities support the use of these digital technologies, effective implementation demands specialised skills for their development and review, and the increasing pace of digital tool development exacerbates this challenge. There is a pressing need for unified standards to guide these tools to maturity and immediate solutions are required to support and promote best practices.
This Centre for Excellence in Regulatory Science and Innovation (CERSI) aims to fill this gap by focusing on the regulatory science needed to enable digital Chemistry, Manufacturing, and Control (CMC) procedures in the pharmaceutical industry. The CERSI unites expertise in advanced manufacturing, digital and CMC research, regulatory affairs, and industrial practice, to tackle sector-specific challenges identified by the CERSI community, such as interpretation of regulations, lack of standardised mature solutions, bias and lack of explainability of Al and other digital solutions, data quality issues and insufficient domain expertise.
CERSl's strategic initiative focuses on developing a regulatory readiness framework for Quality by Digital Design, delivering consensus on and evidence for the standardisation of data, models, and software systems. The framework will be developed collaboratively with initial UK focus before expanding to an international workshop with white paper outputs, case studies on the development and evaluation of digital tools and a comprehensive training programme for regulators, industry, regulatory affairs professionals and researchers. This effort will help transform emerging digital technologies into trusted components for the regulation of medicines development and manufacturing. By collaborating closely with regulators, industrial scientists, academics, regulatory affairs teams, and digital solution providers, the CERSI will position the UK at the forefront of modernising medicines regulation, paving the way for a global model for digitally enabled CMC regulatory submissions. "
While Health Authorities support the use of these digital technologies, effective implementation demands specialised skills for their development and review, and the increasing pace of digital tool development exacerbates this challenge. There is a pressing need for unified standards to guide these tools to maturity and immediate solutions are required to support and promote best practices.
This Centre for Excellence in Regulatory Science and Innovation (CERSI) aims to fill this gap by focusing on the regulatory science needed to enable digital Chemistry, Manufacturing, and Control (CMC) procedures in the pharmaceutical industry. The CERSI unites expertise in advanced manufacturing, digital and CMC research, regulatory affairs, and industrial practice, to tackle sector-specific challenges identified by the CERSI community, such as interpretation of regulations, lack of standardised mature solutions, bias and lack of explainability of Al and other digital solutions, data quality issues and insufficient domain expertise.
CERSl's strategic initiative focuses on developing a regulatory readiness framework for Quality by Digital Design, delivering consensus on and evidence for the standardisation of data, models, and software systems. The framework will be developed collaboratively with initial UK focus before expanding to an international workshop with white paper outputs, case studies on the development and evaluation of digital tools and a comprehensive training programme for regulators, industry, regulatory affairs professionals and researchers. This effort will help transform emerging digital technologies into trusted components for the regulation of medicines development and manufacturing. By collaborating closely with regulators, industrial scientists, academics, regulatory affairs teams, and digital solution providers, the CERSI will position the UK at the forefront of modernising medicines regulation, paving the way for a global model for digitally enabled CMC regulatory submissions. "
