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Curricular information is subject to change
On successful completion of this module students should be able to:
-Describe the development process from discovery of a molecule to administration as a medicine to patients
-Be able to discuss rational drug design and high throughput screening
-What are the safety requirements needed before a drug can be approved?
-Understand the role of post-marketing surveillance
-Cite clinical trial case studies of recent drugs that have been approved for major diseases
-Cite examples of drug delivery technologies for non-injected delivery of biotech molecules
-Know the requirements and outputs examined for clinical trials in Phases 1-4
-Be able to write an essay on attrition causes in clinical development and possible remedies
-Understand what happens at a FDA advisory committee from the case study example presented
- Assess the role of new imaging modalities and alternative animal models in development
This module covers all the elements that go into a discovery programme for a new chemical entity along with its development in going from a lead to a hit. From preclinical studies in animals and cells covering toxicology and the processes of pharmacokinetics and pharmacodynamics, we then move into the clinical development phases, right through to FDA approval. We see that in 2020 the clinical development process is flexible and can expedited by parallel rather than linear movement between clinical phases where the next stage can start without full reporting of the current phase. This can be accompanied by review at breakneck speed by the Regulators in an emergency pandemic.
| Student Effort Type | Hours |
|---|---|
| Lectures | 12 |
| Autonomous Student Learning | 90 |
| Total | 102 |
Ideally, students should be familiar with basic pharmacokinetics and pharmacodynamics to get the most from the module. However, we will do some recapping in the event that there are attendees from non-pharmacology backgrounds.
Learning Recommendations:Biomedical undergraduate modules in pharmacology, biochemistry and physiology taught in science, medicine or veterinary to 3rd year level. Undergraduate chemists with an interest in the drug development process would be welcome. MSc students in Biotechnology are welcome to attend. Undergrad medicinal chemists are especially welcome and usually achieve good outcomes.
| Description | Timing | Component Scale | % of Final Grade | ||
|---|---|---|---|---|---|
| Examination: End of Semester Written Examination | 2 hour End of Trimester Exam | Yes | Standard conversion grade scale 40% | No | 100 |
| Resit In | Terminal Exam |
|---|---|
| Autumn | Yes - 2 Hour |
• Feedback individually to students, post-assessment
Exam writing guide to be presented to students ahead of exam. Going over scripts post-exam with individual students. Availability to meet students ahead of exam.
| Name | Role |
|---|---|
| Professor Orina Belton | Lecturer / Co-Lecturer |
| Dr Colm Collins | Lecturer / Co-Lecturer |
| Dr Ena Prosser | Lecturer / Co-Lecturer |