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2021/22 Taught Postgraduate Module Catalogue

BIOL5164M Biopharmaceutical Development Pathway

5 creditsClass Size: 33

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

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2021/22

Pre-requisite qualifications

A first degree (BSc hons) in a Biological Sciences subject, Bioprocessing or Biochemical Engineering: class 2(i) or above.

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 biologics (antibodies, vaccines, gene therapy, ADCs) although small molecule drugs will be referenced to illustrate how their development differs from biologics. This module will also introduce the medical, scientific and economics drivers - costs, number of leads, attrition rate - associated with drug development. It will introduce the regulatory environment within which biologic drug development is practiced covering GLP, GCP, GMP, and provide a context for these through reference to landmark cases.

Objectives

The objectives are to:
- Introduce the concept of biopharmaceuticals with emphasis on them being distinct from small molecule drugs, with attendant consequences for development, manufacture, testing, routes of administration and patent protection.
- Introduce the concept of drug development as a pathway or pipeline with distinct phases.
- Provide a context for regulations (GLP/GCP/GMP) in phases of drug development.
- Introduce the methodologies associated with the drug development pathway.
- Provide an overview of economic and other drivers (medical and scientific) on biopharmaceutical development.

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

Syllabus

The module will cover the following:
- The overall drug development pathway from research and development to marketed product, including the ways in which biologics development differs from small molecule development.
- 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 Biologics 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
Fieldwork	1	4.00	4.00
Lecture	6	1.00	6.00
Tutorial	1	1.00	1.00
Private study hours			39.00
Total Contact hours			11.00
Total hours (100hr per 10 credits)			50.00

Private study

Essay on the emergence of biopharmaceuticals as alternative modalities to traditional small molecule medicines: 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 (including the tutorial) and during the site visit.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Essay	2000 word essay	90.00
Oral Presentation	Team-based 4-minute flash presentation on assigned sub-topic of the essay question	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

There is no reading list for this module

Last updated: 15/07/2021

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