PHAR40050 Drug Discovery and Development I

Academic Year 2024/2025

The module is an introduction to the processes of discovery and development in Pharma and Biotech from a pharmacological perspective. Contributors have backgrounds in industry and academia. This is an essential course for those considering a role in the pharmaceutical industry.

- High throughput screening and Hit-to-Lead in Discovery.
- Pharmacokinetics in discovery and development: ADME
- Pro-drugs- Challenges in drug development
- Biomarkers: a diabetes case study
- The rise of biopharmaceuticals
- How to develop a blockbuster peptide product
- Delivery of biotech molecules by non-injected routes
- Clinical development from Phase 1-Phase 3 with case studies
- Assessing drug safety using modern toxicology methods in early Discovery
- Investment in biotechnology by venture capital companies

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Curricular information is subject to change

Learning Outcomes:

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 in Discovery
-Assess pharmacokinetic studies in working out doses and tissue target concentrations
-What are the safety requirements needed before a drug can be approved?
-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 how biomarkers can be used in Development
-How prodrugs of small molecules can be used to improve pharmacokinetic profiles

Indicative Module Content:

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 saw that in 2022 the clinical development process is flexible and can be 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 - this can allow emergency use of essential drugs and vaccines.

Student Effort Hours: 
Student Effort Type Hours


Autonomous Student Learning




Approaches to Teaching and Learning:
In-person lectures (subject to Covid advice at the time), private reading of an assigned text and up-to-date research article pdfs. 
Requirements, Exclusions and Recommendations
Learning Requirements:

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.

Module Requisites and Incompatibles
PHAR40150 - Drug Delivery & Clinical Trial

Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Exam (In-person): End-of-trimester written in-person exam. n/a Graded No


Carry forward of passed components
Resit In Terminal Exam
Summer Yes - 2 Hour
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

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.

Rang, HR. Drug Discovery and Development, 2nd Ed. Elsevier. This is a background text, but all essential materials will be provided as Open Acess pdfs of articles.
Name Role
Professor Orina Belton Lecturer / Co-Lecturer
Professor David Brayden Lecturer / Co-Lecturer
Dr Colm Collins Lecturer / Co-Lecturer
Dr Fiona McCartney Lecturer / Co-Lecturer
Dr Ena Prosser Lecturer / Co-Lecturer