2024/25 Taught Postgraduate Module Catalogue

BIOL5208M Integrated Drug Development Plan

15 creditsClass Size: 33

Module manager: Dr Christian Bassi
Email: C.Bassi@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) View Timetable

Year running 2024/25

Pre-requisite qualifications

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

Module replaces

BIOL5280M Integrated Drug Development Plan, 20c

This module is not approved as an Elective

Module summary

This module integrates the pre-clinical aspects of biopharmaceutical product development. Students will create a development plan for a biological medicine to enable its progression to first time in human clinical trials. This will include writing a target product profile, manufacturing, non-clinical and clinical plans; with consideration of the regulatory aspects.

Objectives

The objectives are to:

- Enable the students to develop a deeper understanding of the relationship between, and interdependence, of drug discovery, CMC, non-clinical, clinical and regulatory elements of biologics development.

- Develop an understanding of how to put a biologics medicine development strategy and plan together.

- Develop an appreciation of how to interact with regulatory authorities.

- Provide awareness of the business aspects of biologics development and the relationship with the science.

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

1. Describe the broad range of activities involved in progression of a biological medicine from research to the clinic.

2. Design a biologics development plan to enable a first time in human study.

3. Recognise the importance of the business aspects of biologics development in the context of the development plan.

4. Demonstrate project management, teamwork and communication skills essential for integrated biologics medicines development.

5. Ability to discuss and defend proposal with regulators.

Syllabus

With students working in teams (Drug Development Teams), the module will cover the following:

- Creating a target product profile for a defined biological molecule.

- Designing the manufacturing plan for the molecule.

- Designing the non-clinical plan for the molecule.

- Designing the clinical plan for the molecule.

- How to review relevant regulatory guidelines and seek regulatory authority advice.

- Understanding the basics of project management including timelines, cost and risk considerations.

Teaching methods

Delivery type	Number	Length hours	Student hours
Small Group Learning	4	2.00	8.00
Lecture	5	2.00	10.00
Seminar	3	1.00	3.00
Private study hours			129.00
Total Contact hours			21.00
Total hours (100hr per 10 credits)			150.00

Opportunities for Formative Feedback

Students will meet with an allocated tutor on a regular basis to update on progress made against project timeline and discuss next stages of the project. Progress will be monitored through these sessions.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Group Project	CSWK1: Written documentation for regulatory panel (4 sides A4, 11pt font) (group) Group presentation (4 slides, 15 minute presentation). Q&A on presentation . Minutes of meeting (2 slides A4 limit) (group)	40.00
Report	CSWK2: Integrated drug development plan report (5000 words)	60.00
Total percentage (Assessment Coursework)		100.00

Assessment in the form of group work will be an individual resit

Reading list

The reading list is available from the Library website

Last updated: 31/07/2024

Disclaimer

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