Module and Programme Catalogue

Search site

Find information on

2022/23 Taught Postgraduate Module Catalogue

BIOL5180M Biopharmaceutical Drug Discovery and Non-clinical testing

20 creditsClass Size: 30

Module manager: Dr David Brockwell
Email: D.J.Brockwell@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2022/23

Pre-requisite qualifications

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

Pre-requisites

BIOL5164MBiopharmaceutical Development Pathway

Module replaces

BIOL5162M Biopharmaceutical Drug DiscoveryBIOL5168M Biopharmaceutical Development: Pre-Clinical

This module is not approved as an Elective

Objectives

The module objectives are to:
- Provide an overview of the industrial drug discovery process.
- Provide an introduction to the aspects of a target that are important in the assessment of its link to a disease and its mechanism of action, including developing an understanding of the role of the target in biological processes associated with health and disease and the tractability of targeting it.
- Provide an overview of the biologics drug discovery pipeline, covering the common set of biologics (antibodies and their alternatives, vaccines, peptides and gene therapies).
- Provide an introduction to the preclinical testing requirements for biologics and how this enables clinical development and ultimately marketing application.
- Provide an understanding of the different testing requirements for different biological products (e.g. monoclonal antibodies, recombinant proteins, gene therapy products and vaccines).
- Gain an understanding of analytical techniques to examine pharmacokinetics, toxicokinetics and anti-product antibodies.
- Understand how the non-clinical data translates to starting dose for human trials.
- Understand the need to bring together a cross functional team to build a complete understanding of the risk/benefit for a particular project, in doing this it will introduce some of the key roles within the biopharmaceutical industry that make up project teams and how they interact.
- Appreciate the need for team and individual working to research and make recommendations about biologics drug discovery programmes and to develop plans for the experimental delivery of such a programme.

Learning outcomes
On completion of the module students should be able to:
- Explain, with examples, the core elements of the biopharmaceutical drug discovery process
- Critically appraise a target and explain the rationale for progressing the preclinical development.
- Provide an initial view as to the disease setting in which a particular target fits and how to prosecute the discovery of a biologic drug.
- Explain the risks associated with a particular approach to a target and what can be done to de-risk the approach.
- Critically appraise the preclinical development strategies for a range of candidate molecules.
- Identify go/no go points and develop an understanding of the decision making process to continue or stop a project.
- Evaluate the approaches employed to assess the properties of lead molecules and how these may be optimised.


Syllabus

In particular the module will introduce fundamental concepts of what makes a good target for a drug discovery project including:
- Strength of hypothesis – This is related to the biology of the target and requires a critical answer to the question, “What information supports the hypothesis that this molecule is a target?”
- Disease association – Developing an understanding of what role the target plays in human disease.
- Feasibility - “Can a potential biologic drug be developed against the target and how could this be achieved?” This will follow the drug development pipeline addressing the areas of biologic drug formats, biological libraries and screening for target hits, assay development, lead identification to hit-to-lead optimisation.
- The module will also deal with the integration of basic pharmacological understanding of the interaction of the biologic and the target and how that impacts on the relevance of the molecules being developed
- Safety – Understand the risks of targeting a particular molecule and what data can be utilised to build this understanding.
- Toxicology (selection of relevant species, study design considerations, duration, endpoints).
- Reproductive toxicology, genotoxicology/carcinogenicity.
- Safety pharmacology.
- ADME (absorption, biodistribution, metabolism and excretion), PK/PD.
- Tissue cross reactivity.
- Estimation of starting dose for first in human trial.

Teaching methods

Delivery typeNumberLength hoursStudent hours
Workshop16.006.00
Workshop17.007.00
Workshop18.008.00
Lecture12.002.00
Lecture21.503.00
Lecture51.005.00
Tutorial12.002.00
Tutorial21.002.00
Private study hours165.00
Total Contact hours35.00
Total hours (100hr per 10 credits)200.00

Private study

Private study will involve students undertaking background reading to support and widen understanding of the lecture material and prepare for the assessments. The latter involves groups working in teams to develop a group presentation and an individual written interim report.

Opportunities for Formative Feedback

This will be done through tutorials held throughout the term.

Methods of assessment


Coursework
Assessment typeNotes% of formal assessment
ReportIndividual completion of structured report form60.00
PresentationProject portfolio review – group presentation and Q&A session40.00
Total percentage (Assessment Coursework)100.00

Normally resits will be assessed by the same methodology as the first attempt or an alternative assignment of equivalent scope.

Reading list

There is no reading list for this module

Last updated: 16/08/2022

Disclaimer

Browse Other Catalogues

Errors, omissions, failed links etc should be notified to the Catalogue Team.PROD

© Copyright Leeds 2019