BIMCB22: Commercial Biotechnology 2 $£ Taking Drugs to Market

Module code: BIMCB22

Module provider: School of Biological Sciences

Credits: 20

Level: Postgraduate Masters

When you'll be taught: Semester 2

Module convenor: Dr Chris Jones, email: c.i.jones@reading.ac.uk

Pre-requisite module(s):

Co-requisite module(s):

Pre-requisite or Co-requisite module(s):

Module(s) excluded:

Placement information: NA

Academic year: 2024/5

Available to visiting students: No

Talis reading list: No

Last updated: 23 May 2024

Overview

Module aims and purpose

This module will introduce students to the operational processes used in the biopharma sector to bring new drugs to the market. Students will be introduced to the regulatory processes required to bring new drugs to market and will go through some of the key steps in this process such as running clinical trials, data management, pharmacovigilance, ethics and the clinical and pre-clinical research pipeline.  This module will give students an understanding the drug development process from drug discovery and candidate selection though to pre-clinical testing and toxicology, the principles of Good Laboratory/Manufacturing Practice, clinical trials and regulatory approval.  

Module learning outcomes

By the end of the module, it is expected that students will be able to: 

1. Apply critical thinking and problem-solving skills to identify and address key challenges and risks in the drug development process. 
2. Demonstrate knowledge of the regulatory considerations involved in developing biotechnology products. 
3. Demonstrate knowledge of the different phases of clinical trials and the key considerations in designing and conducting successful trials. 
4. Critically evaluate the organisational structure of a range of biotechnology companies in the context of successfully bringing drugs to market. 

Module content

• Regulatory requirements for drug approval. 
• The research pipeline in biotechnology. 
• GLP and GMP principles. 
• Principles of clinical trial design. 

Structure

Teaching and learning methods

Teaching will be delivered through formal lectures and seminars in which students will discuss key concepts in the drug development process with the aid of case studies provided by industry. Students will also be expected to learn through self-directed study and through group working. Learning will be assessed by an oral exam in which students will be given data and evidence from a hypothetical drug development scenario and asked to evaluate the potential future steps in the drug development and approval process. 

Study hours

At least 34 hours of scheduled teaching and learning activities will be delivered in person, with the remaining hours for scheduled and self-scheduled teaching and learning activities delivered either in person or online. You will receive further details about how these hours will be delivered before the start of the module.

Please note the independent study hours above are notional numbers of hours; each student will approach studying in different ways. We would advise you to reflect on your learning and the number of hours you are allocating to these tasks.

Semester 1 The hours in this column may include hours during the Christmas holiday period.

Semester 2 The hours in this column may include hours during the Easter holiday period.

Summer The hours in this column will take place during the summer holidays and may be at the start and/or end of the module.

Assessment

Requirements for a pass

Students need to achieve an overall module mark of 50% to pass this module.

Summative assessment

Penalties for late submission of summative assessment

The Support Centres will apply the following penalties for work submitted late:

Assessments with numerical marks

• where the piece of work is submitted after the original deadline (or any formally agreed extension to the deadline): 10% of the total marks available for that piece of work will be deducted from the mark for each working day (or part thereof) following the deadline up to a total of three working days;
• the mark awarded due to the imposition of the penalty shall not fall below the threshold pass mark, namely 40% in the case of modules at Levels 4-6 (i.e. undergraduate modules for Parts 1-3) and 50% in the case of Level 7 modules offered as part of an Integrated Masters or taught postgraduate degree programme;
• where the piece of work is awarded a mark below the threshold pass mark prior to any penalty being imposed, and is submitted up to three working days after the original deadline (or any formally agreed extension to the deadline), no penalty shall be imposed;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension to the deadline): a mark of zero will be recorded.

Assessments marked Pass/Fail

• where the piece of work is submitted within three working days of the deadline (or any formally agreed extension of the deadline): no penalty will be applied;
• where the piece of work is submitted more than three working days after the original deadline (or any formally agreed extension of the deadline): a grade of Fail will be awarded.

The University policy statement on penalties for late submission can be found at: /cqsd/-/media/project/functions/cqsd/documents/qap/penaltiesforlatesubmission.pdf

You are strongly advised to ensure that coursework is submitted by the relevant deadline. You should note that it is advisable to submit work in an unfinished state rather than to fail to submit any work.

Formative assessment

Formative assessment is any task or activity which creates feedback (or feedforward) for you about your learning, but which does not contribute towards your overall module mark.

Seminars will provide students with an opportunity to gain feedback on their understanding of the topics covered in the module. 

Reassessment

Additional costs