MEng Materials Science and Engineering with Biomaterials

Year of entry: 2022

Course unit details:
Lab to Clinic

Course unit fact file
Unit code MATS42502
Credit rating 15
Unit level Level 7
Teaching period(s) Semester 2
Offered by Department of Materials
Available as a free choice unit? No

Overview

Taking research ideas from the laboratory to the clinic for patients is complex but very aspect important in biomedical materials research. 

Aims

The unit aims to:

  1. 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).
     
  2. 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.

Learning outcomes

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
     

Intellectual skills

  • 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
     

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback given (Written and verbal)

Recommended reading

  • 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.

Study hours

Scheduled activity hours
Lectures 15
Independent study hours
Independent study 135

Teaching staff

Staff member Role
Jonny Blaker Unit coordinator

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