2023/24 Taught Postgraduate Module Catalogue

BIOL5384M Biopharmaceutical drug discovery and non-clinical testing

30 creditsClass Size: 33

Module manager: Professor David Brockwell
Email: D.J.Brockwell@leeds.ac.u

Taught: Semesters 1 & 2 (Sep to Jun) View Timetable

Year running 2023/24

Pre-requisite qualifications

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

Module replaces

BIOL5180M - Biopharmaceutical Drug Discovery and Non-clinical testing

This module is not approved as an Elective

Module summary

The aim of the module is to provide an integrated overview of the development and non-clinical testing pathway of a mAb-based therapeutic. The module will explain how and why a multitude of the therapeutic candidate’s in vitro and in vivo properties are necessary to be obtained and assessed in addition to its affinity for a validated target to de-risk the translation from promising candidate to a licensed therapeutic produced at scale.

Objectives

The module objectives are to:
- Provide an overview of the industrial biopharmaceutical discovery process.
- Introduce the aspects of a target that are important in the assessment of its link to a disease and its mechanism of action and its tractability as a target
- 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 a variety of biopharmaceuticals and how this enables clinical development and ultimately marketing application.
- Gain an understanding of analytical techniques to examine pharmacokinetics, toxicokinetics and anti-product antibodies and how 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:
1. Explain, with examples, the core elements of the biopharmaceutical drug discovery process
2. Evaluate the risks associated with a particular approach to a target and what can be done to de-risk the approach.
3. Identify go/no go points and develop an understanding of the decision-making process to continue or stop a project.
4. Evaluate the risks of targeting a particular molecule and how toxicological data can be utilised to build this understanding.
5. Describe the basis of choice of species for toxicological studies and the experimental design and duration of these studies
6. Recognise that absorption, biodistribution, metabolism, excretion) and pharmacokinetics/dynamics are vital both for candidate development and for translation to clinical testing.

Syllabus

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.
- 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 type	Number	Length hours	Student hours
Workshop	1	6.00	6.00
Workshop	1	8.00	8.00
Lecture	1	2.00	2.00
Lecture	5	1.50	7.50
Lecture	6	1.00	6.00
Tutorial	1	2.00	2.00
Tutorial	2	1.00	2.00
Private study hours			266.50
Total Contact hours			33.50
Total hours (100hr per 10 credits)			300.00

Opportunities for Formative Feedback

This will be done through the three tutorials held throughout the term and in mid-term review of the planned assessed presentation.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Report	Historical development of Hercerptin from a non-clinical perspecctive. Individual completion of structured report form (1500 words)	15.00
Report	Structured report for biobetter development. Individual completion of structured report form (3400 words)	45.00
Presentation	Project portfolio review (bio-better development)– group 30 min presentation and Q&A session	40.00
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: 15/03/2023

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