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MEng Materials Science and Engineering / Course details
Year of entry: 2023
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Course unit details:
Lab to Clinic
|Unit level||Level 7|
|Teaching period(s)||Semester 2|
|Offered by||Department of Materials|
|Available as a free choice unit?||No|
Taking research ideas from the laboratory to the clinic for patients is complex but very aspect important in biomedical materials research.
The unit aims to:
- provide an insight into taking research ideas into the clinic, focussed on biomedical products (class I- III devices) and tissue engineering/regenerative scaffolds (including acellular, cell-containing and decellularised matrices).
- describe how in vitro tests, bioreactors, in vivo tests, as well as clinical trials can be applied appropriately (and where necessary) in the lab-to-clinic journey.
A greater depth of the learning outcomes will be covered in the following sections:
- Knowledge and understanding
- Intellectual skills
- Transferable skills and personal qualities
Teaching and learning methods
Lectures (live and pre-recorded), including from invited external experts from selected regulatory consultants, biomedical device start-ups/spin-outs, SMEs/cell therapy businesses/catapults; coursework, recommended textbooks, web resources, and electronic supporting information (Blackboard).
Knowledge and understanding
- ILO 1: To classify biomedical devices (e.g. Class I, II/IIa/IIb/III)
- ILO 2: To describe the important stages involved in translating a biomedical device idea into the clinic, and the regulatory process (focussed on the UK/EU (CE marking) and USA markets), including post-market surveillance
- ILO 3: To apply intellectual property and regulatory aspects in lab- to-clinic translation strategy
- ILO 4: To select appropriate experimental and test methods that are product specific to meet regulatory requirements
- ILO 5: To build a lab-to-clinic road-map for an innovative biomedical device or combined advanced therapy medicinal product (cATMP)
Transferable skills and personal qualities
- ILO 6: Develop skills to work as part of a team to analyze and solve problems in research and business across cultures
- ILO 7: Communicate and present orally and in writing
|Written assignment (inc essay)||100%|
Feedback given (Written and verbal)
- Bioreactors for tissue engineering: Principles, design and operation, J. Chaudhuri and M. Al-Rubeai, eds., Springer, 2010.
- The business plan workbook: The definitive guide to researching writing up and presenting a winning plan, 7th edition, C. Barrow, P. Barrow and R. Brown, Kogan Page, 2012.
- Futurewise: The six faces of global change, 4th edition, P. Dixon, Profile Books, London, 2007.
- The tipping point: How little things can make a big difference, M. Gladwell, Abacus, 2002.
- When cultures collide: Leading across cultures, 3rd edition, R. D. Lewis, Nicholas Brealey Publishing, 2006.
|Scheduled activity hours|
|Independent study hours|
|Jonny Blaker||Unit coordinator|