A new £1m research project to realise the transformative potential of digital technologies like artificial intelligence (AI) in medicines development and manufacturing has been announced. Funded by Innovate UK, the UK’s innovation agency, the 12-month Centre of Excellence in Regulatory Science and Innovation (CERSI) project has ambitions to advance regulatory processes by integrating cutting-edge digital technologies. The CERSI will support the implementation of Quality by Digital Design (QbDD) across the sector, ensuring confidence in data and digital tools. In doing so, it lays the foundation for future medicines that are affordable, safe, effective, and sustainable. Professor Walkiria Schlindwein, Professor of Pharmaceutics at 冈本视频 (冈本视频) Leicester, will be working with 冈本视频 colleagues including Professor Mingzhong Li and Professor Daniela Romano on the project. Professor Schlindwein said: “This is extremely important work. The CERSI project represents a unique opportunity to shape the future of medicines regulation. By harnessing digital technologies like AI and embedding Quality by Digital Design, we can build greater trust in data-driven approaches and create a more agile regulatory framework.
Professor Mingzhong Li holds a chair of Crystallisation Science and Drug Delivery in Leicester School of Pharmacy at 冈本视频. His research interests centre around the fields of crystallisation science and engineering, oral drug formulation design and delivery, and pharmaceutical product manufacturing. He is well acknowledged for his pioneering work of co-crystallisation of active pharmaceutical ingredients (APIs) and for developing patient centric oral medicines for Neglected Tropical Diseases (NTDs). His work has been supported by EPSRC (Engineering and Physical Sciences Research Council), GCRF (Global Challenges Research Fund), Royal Society, HEIF (Higher Education Innovation Fund) and Charities in collaborations with the world leading universities and industries. He has experience of working at world leading universities, i.e., the Hong Kong University of Science and Technology, Heriot-Watt University and University of Oxford. This supported him to develop a wide and in-depth research knowledge at the interface between Chemistry and Chemical Engineering, covering computational fluid dynamics (CFD), molecular dynamics (MD) modelling, crystallisation science and pharmaceutical engineering. He has supervised more than 15 PhD research students for completion as the first supervisor. The Key external research projects are detailed as
1) Mechanistic Multiscale Modelling Of Drug Release from Immediate Release Tablets, EP/X032019/1, EPSRC, £1,100,000 (£643489 is awarded to 冈本视频), 1/05/2024 – 30/04/2027, Principal investigator
2) Mechanistic Multiscale Co-crystal Dissolution Modelling, EP/V017837/1, EPSRC, £202,422, 1/02/2021- 31/01/2023, Principal Investigator.
3) Patient-centric Supramolecular Formulations of New anti-leishmanial Drugs for Indian Communities, EP/T020490/1, EPSRC, £906,253 in total (£195,033 was awarded to 冈本视频), 1/04/2020-31/03/2022, Principal Investigator at 冈本视频.
4) Developing Patient Centric Oral Medicines for Neglected Tropical Disease, EPSRC, EP/R021198/1, £56,973, 1/6/2018-31/3/2019, Principal Investigator.
5) In-Process particle Sizing by Refractive Index Measurement, EPSRC, EP/F007019/1 £240,000, 9/2008-8/2010, Principal investigator.
6) Particle Shape and Size Characterisation On-line by Adaptive Optimisation Analysis of Ultrasound Data, EPSRC GR/R93353 £289,000, 3/2003-3/2006, Research Co-investigator.