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Module

PED3007 : Drug Discovery and Development

  • Offered for Year: 2022/23
  • Module Leader(s): Dr Lindsey Ferrie
  • Lecturer: Dr Matthew Leach, Dr Sasha Gartside, Dr Ruben Thanacoody, Dr Jason Gill, Dr Simon Wilkinson
  • Owning School: Biomedical, Nutritional and Sports Scien
  • Teaching Location: Newcastle City Campus
Semesters
Semester 1 Credit Value: 20
ECTS Credits: 10.0

Aims

The module will cover the preclinical and clinical ethics, techniques and data analysis used in drug development in the UK. Students will gain an insight into the workings of the pharmaceutical industry learning about current and future trends in analytical techniques, the use of laboratory animals and the regulatory aspects of the sector. The module will also provide students with the practical and ethical skills necessary for the humane use of animals and humans in biomedical research.

Outline Of Syllabus

The module comprises of lectures by leading experts from the pharmaceutical industry and academics with experience of drug development/ translational pharmacology.

Topics covered will include:
-       Separation techniques (Chromatographic and non-chromatographic).
-       Basic animal (rodent) handling, anaesthesia and surgical techniques.
-       Animal models and in vivo techniques used in pre-clinical development.
-       Ethical considerations in both pre-clinical and clinical drug development.
-       Regulatory toxicology.
-       Clinical trial methodologies.
-       Critical evaluation of pre-clinical/clinical trial data.
-       Pharmaco-vigilance and risk management.
-       Role of regulatory bodies in clinical pharmacology and drug development.

Teaching Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Guided Independent StudyAssessment preparation and completion140:0040:00Drug evaluation- 2500 words
Guided Independent StudyAssessment preparation and completion115:0015:00Online MCQ test (1 hour) for PIL Certificate award, 14 hours prep time (optional)
Scheduled Learning And Teaching ActivitiesLecture171:0017:00PiP including module talk
Guided Independent StudyDirected research and reading150:0050:00N/A
Scheduled Learning And Teaching ActivitiesSmall group teaching41:004:00PIP Seminars
Structured Guided LearningStructured research and reading activities16:006:00Online self-paced learning for GCP training. 3-weekly programmes of ~2 hours reading time
Scheduled Learning And Teaching ActivitiesSmall group teaching31:003:00Weekly Q&A webinar to support PIL AB online training - Synchronous online
Structured Guided LearningStructured research and reading activities35:0015:00Online self-paced learning for PIL AB Certificate. 3-weekly programmes of ~5 hours reading time
Scheduled Learning And Teaching ActivitiesDrop-in/surgery31:003:00Drug Evaluation support session - PIP
Guided Independent StudyIndependent study147:0047:00Writing up lecture notes, revision and general reading
Total200:00
Teaching Rationale And Relationship

The lectures provide the students with the basic theoretical knowledge and information to support the learning outcomes of the modules.

The PIL Q&A webinars will provide students with the opportunity to check their understanding of the self-paced learning with experts and will support students who wish to complete the Home Office PIL Certificate.

The seminars will allow the students to apply their theoretical knowledge focusing specifically on the four elements of the module; ethics, techniques, regulations and data analysis. This will provide an opportunity to complete some case study based problem solving activities. Seminars will also provide the opportunity for students to work in teams to interpret data and literature which will support the individual drug evaluation report at the end of the module (summative assessment).

Assessment Methods

The format of resits will be determined by the Board of Examiners

Other Assessment
Description Semester When Set Percentage Comment
Essay1M70Drug evaluation (2,500 words)
Prof skill assessmnt1M30Case study response (500 words).
Formative Assessments
Description Semester When Set Comment
Computer assessment1MOnline MCQ assessment for Home Office PIL Certificate
Assessment Rationale And Relationship

The drug evaluation will be used to assess independent learning, information retrieval and critical analysis skills as well as computer literacy and the ability to appropriately justify drug development recommendations.

The case study response will provide evidence of knowledge acquisition, problem solving and evidence-formed reasoning.

In order to demonstrate the required competence levels and provide evidence of professional and practical skills development to be awarded the Home Office PIL certificate students will complete a formative MCQ assessment.


FMS Schools offering Semester One modules available as ‘Study Abroad’ will, where required, provide an alternative assessment time for examinations that take place after the Christmas vacation. Coursework with submissions dates after the Christmas vacation will either be submitted at an earlier date or at the same time remotely.

Reading Lists

Timetable