PF6612: Research Methods in BioPharma Processes and in the Development of Novel BioTherapeutics

Credit Weighting: 10
No. of Students: Min 10, Max 50.
Pre-requisite(s): None
Co-requisite(s): None
Teaching Period(s): Semester 3.
Teaching Methods: 12 x 4hr(s) Workshops (lectures, practicals, case studies and presentations); 90hr(s) Directed Study; 62hr(s) Other (self-directed study)
Module Co-ordinator: Dr John V (Eoin) Fleming, School of Biochemistry and Cell Biology.
Lecturer(s): Staff, School of Pharmacy.
Module Objective: Enhance the ability of students to plan, perform and critically evaluate research and optimization studies, highlighting the key role that they play in process design and in the development of therapeutic approaches that employ advanced cellular and biomolecular approaches to treat human disease.
Module Content: An introduction to the scientific logic that underpins research and optimisation studies. Refining research questions, research planning, searching for evidence (key words and electronic databases), collecting and presenting research data. Writing a literature review. Critically evaluating research quality, and its application to BioProcess and Novel Drug design. Review the recent advances in the field through the critical appraisal of study design in the areas of pharmacogenetics, 'Omic' technologies, personalised approaches to vaccination/advanced antibody derivatives/cell based therapies and gene therapy (including CRISPR gene editing, cloning, transgenics and BioPharming). Ethical implications of genomics and personal biological information.
Learning Outcome: On successful completion of this module, students should be able to:
  • Demonstrate an ability to formulate research questions and to design qualitative and quantitative research projects.
  • Demonstrate an ability to write a research report by completing at least a hypothesis, an abstract and a preliminary literature review.
  • Demonstrate an ability to use technology to facilitate research and teamwork.
  • Outline the features and limitation of the technologies used to assess the cellular basis for the detection and treatment of disease.
  • Describe current examples of personalised medicines and present a vision for the future of personalized medicines.
  • Outline the ethical implication of generating personal biological datasets.
Assessment: Total Marks 200: Continuous Assessment 200 marks (1 x 3,000 word written assignment, 80 marks; 1 x 3,000 word literature review, 120 marks.).
Compulsory Elements: Continuous Assessment. Oral if required.
Penalties (for late submission of course/project work etc.): Where work is submitted up to and including 7 days late, 5% of the total marks available shall be deducted from the mark achieved. Where work is submitted up to and including 14 days late, 10% of the total marks available shall be deducted from the mark achieved. Work submitted 15 days late or more shall be assigned a mark of zero.
Pass Standard and any Special Requirements for Passing Module: 50%.
End of Year Written Examination Profile: No Formal Written Examination.
Requirements for Supplemental Examination: Marks in passed element(s) of Continuous Assessment are carried forward, Failed element(s) of Continuous Assessment must be repeated (as prescribed by the School of Pharmacy).

University College Cork

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