2016/17 Taught Postgraduate Module Catalogue

BIOL5168M Biopharmaceutical Development: Pre-Clinical

10 creditsClass Size: 30

Module manager: Professor Nicola Stonehouse
Email: n.j.stonehouse@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2016/17

Pre-requisite qualifications

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

Pre-requisites

BIOL5164M

Biopharmaceutical Development Pathway

This module is not approved as an Elective

Module summary

In this module the student will get a detailed understanding of preclinical requirements to enable an asset to proceed into first in human trials and further clinical development and ultimately marketing application. The module will cover selection of relevant animal species, detailed toxicology study designs incorporating essential endpoints including biomarkers. The student will understand the differing testing requirements for different biological modalities e.g. monoclonal antibodies, recombinant proteins and gene therapy products. This module will link preclinical development with modules describing the process from early discovery, biologics manufacturing and clinical design required to bring ideas through to clinical trials and into the commercial space.

Objectives

The objectives are to:
- 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

Learning outcomes
On completion of the module, students should be able to:
- 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

The module will cover the following:
- 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
Lecture	1	2.00	2.00
Lecture	2	1.50	3.00
Lecture	5	1.00	5.00
Seminar	1	3.00	3.00
Tutorial	1	2.00	2.00
Private study hours			85.00
Total Contact hours			15.00
Total hours (100hr per 10 credits)			100.00

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 individual written reports.

Opportunities for Formative Feedback

This will be undertaken via the tutorial and the first piece of written work.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Report	Plan of how the pathway could be altered.	20.00
Oral Presentation	Group presentation	30.00
Report	Individual brief review of historical development pathway for a named molecule.	25.00
Tutorial Performance	Discussion of written work during tutorial	25.00
Total percentage (Assessment Coursework)		100.00

Oral presentation could be replaced by an appropriate piece of written work.

Reading list

There is no reading list for this module

Last updated: 11/08/2016

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