2022/23 Taught Postgraduate Module Catalogue

BIOL5123M Drug Discovery and Development Pathways

5 creditsClass Size: 100

Module manager: Professor Alexander Breeze
Email: a.l.breeze@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2022/23

Pre-requisite qualifications

Sufficient entry qualifications for one of the named MSc programmes.

Module replaces

BIOL5164M Biopharmaceutical Development Pathway

This module is not approved as an Elective

Module summary

This module will set the scene for the full programme by providing an overview of the drug development pathway from research and development to marketed product. The focus will be on small molecule drugs, peptide drugs and biologics (antibodies, vaccines, gene therapy, ADCs) with special reference to illustrate how their development differs. This module will also introduce the medical, scientific and economics drivers - costs, number of leads, attrition rate - associated with drug discovery and development. It will introduce the regulatory environment within which drug development is practiced covering GLP, GCP, GMP, and provide a context for these through reference to landmark cases.

Objectives

The objectives of the module are to:
1. Introduce the concept of pharmaceuticals with emphasis on the difference between small molecule drugs, peptide drugs and biopharmaceuticals, with attendant consequences for development, manufacture, testing, routes of administration and patent protection;
2. Introduce the concept of drug development as a pathway or pipeline with distinct phases;
3. Provide a context for regulations (GLP/GCP/GMP) in phases of drug development;
4. Introduce the methodologies associated with the drug development pathway;
5. Provide an overview of economic and other drivers (medical and scientific) on pharmaceutical development.

Learning outcomes
On completion of the module, students should be able to:
1. Evaluate the advantages/disadvantages of small molecule drugs, peptide drugs and biopharmaceuticals;
2. Describe individual phases of drug development and which regulations and methodologies are most appropriate at each phase;
3. Discuss the historical context for introducing GLP/GCP/GMP with respect to landmark cases;
4. Identify the critical aspects that contribute to attrition rates in drug discovery and development;
5. Show a broad understanding of the economic and other drivers of drug discovery and development.

Skills outcomes
Team working.

Syllabus

The module will cover the following:
- The overall drug development pathway from research and development to marketed product, including the ways in which the discovery and development of small molecule drugs, peptide drugs and biopharmaceuticals differ;
- An introduction to drivers and economics - costs, number of leads, attrition rate, intellectual property and patent review and the emergence of personalised medicine;
- An introduction to the Target Product Profile in defining the development process;
- An introduction to and the historical background to the regulations for GMP, GLP and GCP;
- How do pharmaceutical developers satisfy the regulatory authorities at each stage of the process? - How are drugs launched onto the market and how are authorities assured of continued drug quality?
- Introduction to Pharmacovigilance and consequences of Product Re-call.

Teaching methods

Delivery type	Number	Length hours	Student hours
Lectures	6	1.00	6.00
Class tests, exams and assessment	1	2.00	2.00
Tutorial	1	1.00	1.00
Private study hours			41.00
Total Contact hours			9.00
Total hours (100hr per 10 credits)			50.00

Private study

Essay on a comparison of traditional small molecule medicines and biopharmaceuticals: analysis of medical, scientific and economic drivers, including future global healthcare trends and challenges.

Opportunities for Formative Feedback

Student progress will be monitored through the discussions that will take place during the taught sessions, the oral presentation session and the tutorial.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Essay	2000 words	90.00
Oral Presentation	Flash presentation	10.00
Total percentage (Assessment Coursework)		100.00

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated

Reading list

The reading list is available from the Library website

Last updated: 13/12/2022

Disclaimer

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