2016/17 Taught Postgraduate Module Catalogue

BIOL5162M Biopharmaceutical Drug Discovery

10 creditsClass Size: 30

Module manager: Professor Michael McPherson
Email: m.j.mcpherson@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.

Module replaces

BIOL5158M

This module is not approved as an Elective

Module summary

The module will provide an outline to the principles of drug discovery of biological molecules (as distinct from small chemical molecules) providing a grounding in the knowledge and skills required by those working in the biopharmaceutical industry.The module will provide a basis for considering the drug development pipeline at the preclinical stage from: - druggable target identification, - target validation, - biologic drug formats, - biological libraries and screening for target hits, - assay development, - lead identification to- hit-to-lead optimisation. - preclinical disease modellingThe module may draw comparisons with small molecule drugs but WILL NOT deal with small molecule drug discovery. Neither will it deal with clinical development, drug manufacture, delivery or formulation. The module will introduce students to the analytical process used by industry to generate a strong rationale to commence a project. This includes, target identification and justification, a basic understanding of the path forward, the best mode of action (e.g. format of the biologic; naked antibody, immunoconjugate, peptide, ADC etc). The module will introduce the concepts of critical decision-making based on incomplete data and give an understanding of the challenges faced by the biopharmaceutical industry of biologic drug discovery in bringing new treatments to market.The module will be linked with the Biomanufacturing and Preclinical development modules and the Practical Skills module, and these may use of the same set of targets for training purposes.

Objectives

On completion of this module, students should be able
- 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 biologic drug discovery pipeline, covering the common set of biologics (antibodies and their alternatives, vaccines, peptides and gene therapies).
- Emphasise 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.
- Provide opportunities for team and individual working to research and make recommendations about 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.
- Explain the risks associated with a particular approach to a target and what can be done to de-risk the approach.

Skills outcomes
Commercial awareness, creative problem solving, flexibility, independent working, initiative, leadership, research skills and time management are equally important skills in this module.

Syllabus

In particular the module will introduce fundamental concepts of what makes a good target for a drug discovery project including;

a) 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?”. This information is initially developed from an understanding of the relevant scientific literature and bioanalytical tools available including findings from peer reviewed papers and utilising ‘big data’ with bioinformatics.

b) Disease association – Developing an understanding of what role the target plays in human disease. Utilisation of literature and public sources including the use of bioinformatic databases to answer the question, “Does the target show a correlation with the disease and what would be the mode of action of a biologic drug?”. This includes biological findings including those from transgenic animals (using traditional and more experimental techniques such as CRISPR/Cas9), the generation and availability of tool reagents.

c) 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. This may for example relate to target modulation by monoclonal antibodies, non-antibody scaffold proteins, peptides, nucleic acid aptamers, gene therapy, vaccines and viral products or other recombinant proteins. It would include progression from screens for binding to inhibition/activation or other modulatory assays, testing in primary cell assays, then secondary disease related assays and considering the issues associated with in vivo testing. It will also deal with the iterative nature of such processes including affinity maturation or other optimisation and re-selection and testing to identify hits as lead clinical candidates. 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

d) Safety – Understand the risks of targeting a particular molecule and what data can be utilised to build this understanding. “Are there any safety issues that need to be considered?”

e) The course will provide links to other modules being taught in this MSc course including, Non-clinical development, clinical development and biologics manufacture

Examples of potential targets for study include:
Rituximab, Herceptin, Yervoy (Ipilimumab), Erythropoietin.

Teaching methods

Delivery type	Number	Length hours	Student hours
Class tests, exams and assessment	1	6.00	6.00
Group learning	2	1.00	2.00
Seminar	2	3.00	6.00
Tutorial	2	1.00	2.00
Private study hours			84.00
Total Contact hours			16.00
Total hours (100hr per 10 credits)			100.00

Private study

Students will be allocated to groups and will be provided with a target from one of the following classes; (a) a first in class biologic to address an unmet clinical need for which there is no clinical solution or (b) a best in class biosimilar biologic for which there exists a clinical competitor. For their target they will develop a hypothesis and will then follow the process of biologic drug discovery to answer the questions relevant to industry:
- What information supports the hypothesis that this molecule is a target?
- Does the target show a correlation with the disease and what would be the mode of action of a biologic drug?
- Can a potential biologic drug be developed against the target and how could this be achieved?
- Are there any safety issues that need to be considered?

The assessments associated with this module will involve
(a) AS A GROUP work together effectively and make substantial contributions to the final outcomes of the group. Assessed by tutors and peer assessment.
(b) AS A GROUP at an industry style Portfolio Review Panel process each team will present their findings and recommendations (to include the background data, highlighted risks, challenges, potential rewards) to a target review team of peers, staff and industry representatives who will question the group and evaluate their outcomes. ALL Students will be expected to actively participate both in presenting and answering questions. Students will also be expected to contribute to questioning other groups. All students will contribute to PEER ASSESSMENT using structured feedback sheets.
(c) INDIVIDUALLY students will also be required to complete a structured report form to ensure that they address the necessary questions.
There will also be the expectation that students will use physical as well as virtual meetings to maintain momentum and progress.

Opportunities for Formative Feedback

There will be an interim workshop to monitor team and individual student progress, and two group working sessions. Students will also be expected to use a virtual meeting environment.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Report	Project report using structured proforma	60.00
Group Project	On-going contributions assessed at contact sessions (includes peer assessment)	10.00
Oral Presentation	Group presentations at Portfolio Review Panel style session (includes peer assessment).	30.00
Total percentage (Assessment Coursework)		100.00

Resit candidates must complete an individual presentation and an individual report.

Reading list

There is no reading list for this module

Last updated: 04/08/2016

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