2016/17 Taught Postgraduate Module Catalogue

BIOL5265M Integrated Drug Development Plan

10 creditsClass Size: 30

Module manager: Professor John Colyer
Email: j.colyer@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) 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

This module integrates the pre-clinical aspects of biopharmaceutical product development. Students will gain an understanding of the scientific and regulatory requirements to enable a biological medicine to progress from research to a phase I clinical trial. They will create a development plan for a biological medicine to support progression to the first time in human clinical trial. This will include writing a target product profile, developing 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 with consideration of the regulatory requirements.
- 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 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
Class tests, exams and assessment	1	3.00	3.00
Seminar	4	2.00	8.00
Tutorial	4	1.00	4.00
Private study hours			85.00
Total Contact hours			15.00
Total hours (100hr per 10 credits)			100.00

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	Report (with individual elements)	50.00
Oral Presentation	Group presentation including individual elements. Infividual presentation.	40.00
Tutorial Performance	Individual contribution	10.00
Total percentage (Assessment Coursework)		100.00

Group report: 50% of formal assessment (40% group: 10% individual) Oral presentation: 40% of formal assessment (20% group; 20% individual)

Reading list

There is no reading list for this module

Last updated: 05/08/2016

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