2022/23 Taught Postgraduate Module Catalogue
BIOL5280M Integrated Drug Development Plan
20 creditsClass Size: 33
Module manager: Professor Eric Blair
Email: G.E.Blair@leeds.ac.uk
Taught: Semester 2 (Jan to Jun) 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
BIOL5164M | Biopharmaceutical Development Pathway |
Module replaces
BIOL5265M - Integrated Drug Development PlanThis 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:
- Describe the broad range of activities involved in progression of a biological medicine from research to the clinic.
- Design a biologics development plan to enable a first time in human study.
- Understand the importance of the business aspects of biologics development in the context of the development plan.
- Understand the importance of teamwork and communication skills essential for integrated biologics medicines development.
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 |
Seminar | 1 | 3.00 | 3.00 |
Seminar | 3 | 2.00 | 6.00 |
Tutorial | 4 | 1.00 | 4.00 |
Private study hours | 187.00 | ||
Total Contact hours | 13.00 | ||
Total hours (100hr per 10 credits) | 200.00 |
Private study
The students will need to work as teams and provide independent input which needs to be integrated into the team output.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) | 20.00 |
Oral Presentation | CSWK2: Group presentation (4 slides 15 minute presentation). Q&A on presentation & CSWK1. Minutes of meeting (2 slides A4 limit) (group) | 20.00 |
Report | CSWK3: Integrated drug development plan report (5000 words) | 60.00 |
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 moduleLast updated: 27/09/2022
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- Undergraduate module catalogue
- Taught Postgraduate module catalogue
- Undergraduate programme catalogue
- Taught Postgraduate programme catalogue
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