2024/25 Taught Postgraduate Module Catalogue

BIOL5124M Introduction to Pharmaceutical Science and Commerce

15 creditsClass Size: 100

Module manager: Prof Alex Breeze
Email: A.L.Breeze@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2024/25

Pre-requisite qualifications

Sufficient entry qualifications for one of the named MSc programmes.

Module replaces

BIOL5123M - Drug Discovery and Development PathwaysBIOL5134M - Commercialising pharmaceutical products

This module is not approved as an Elective

Module summary

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. - Forms of intellectual property (IP), protection of IP rights and mechanisms of exploitation of IP rights - The factors and strategies affecting commercial value: a) Nurturing creativity and innovation: b) Commercial, economic, societal, legal & technological drivers: c) Opportunity dimensions; proposition, people, place, process, profit: d) Open innovation – concept & implementation.

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.
6. provide students with an understanding of the economic drivers across the pharmaceutical industry;
7. explore the role of intellectual property rights in the creation of economic value;
8. examine the exploitation models that can be used to take pharmaceutical products to market;
9. develop students’ understanding of leadership and team roles within a commercial setting.

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. Show a broad understanding of the economic and other drivers of drug discovery and development and identify the critical aspects that contribute to attrition rates in drug discovery and development.
4. Identify appropriate IPR, and how to protect these rights, to add value to applied R&D programmes
5. Understand how to identify, contextualise and communicate opportunities for pharmaceutical products
6. Articulate their preferred roles within a team & leadership style and understand the range of skills needed to develop successful working relationships in a commercial setting

Skills outcomes
Team working, presentation skill, essay writing, understanding concepts associated with pharmaceutical development and the drug development pathway

Syllabus

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. It aims to explore how intellectual property rights are used to maximise economic value, and how business strategies align with external drivers to bring economic (and healthcare) benefits from proprietary products.

Teaching methods

Delivery type	Number	Length hours	Student hours
Class tests, exams and assessment	2	2.00	4.00
Lecture	17	1.00	17.00
Tutorial	4	1.00	4.00
Private study hours			125.00
Total Contact hours			25.00
Total hours (100hr per 10 credits)			150.00

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. Progress will be measured through reflective logs and formative assessments (such as pitching the OBM) during the module.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Literature Review	1000 words short review of an aspect of drug discovery	0.00
Oral Presentation	Flash presentation	0.00
Essay	Patent claim report. Freedom to operate 1500 words	30.00
Report	Teamwork & leadership – self-assessment and reflection 2500 words	70.00
Total percentage (Assessment Coursework)		100.00

Resit of the assessed pieces of work - essay (patent claim, freedom to operate) and report/reflective log when failed.

Reading list

The reading list is available from the Library website

Last updated: 31/07/2024

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