MSc Advanced Therapy Medicinal Products / Course details

Year of entry: 2020

Course unit details:
Introduction to Advanced Therapy Medicinal (ATMP) products: from the lab to the clinic

Unit code MEDN69740
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Full year
Offered by School of Medical Sciences
Available as a free choice unit? No

Overview

Advanced Therapy Medicinal Products (ATMPS) offer promise as treatments for previously untreatable and high-burden diseases and significant investment has been made globally in order to continue to drive forward the fast paced development of these exciting new treatments. Unlike traditional medicines, ATMP development has unique considerations and complexities at every stage in the development process from pre-clinical, through trial development to clinical delivery. This module with give you the insight and understanding across all of these complexities and current developments in the field allowing you to become familiar with the key requirements of ATMP development from bench to bedside.

Aims

 

This module will provide a comprehensive and broad overview of the development of advance therapy medicinal products from bench to bedside. You will begin by gaining an understanding of the molecular biology and broad science that underpins ATMP development and treatment. You will develop an understanding of the preclinical requirements of ATMP development to translate from bench to clinic including an overview of animal models commonly used to mimic human disease. You will understand the complexities involved in the manufacturing process of ATMPs including an understanding of commonly used viral and non-viral vectors and vector production. Additionally you explore the breadth of ATMP products currently under development and commercially available and how these can be used to modify disease states. You will explore and understand the range of pathological conditions which commonly utilise ATMPs for disease modification or control such as genetic disorders, cancer, rare and long term diseases. Additionally you will gain an understanding of the complexities and challenges of clinical delivery and management of an ATMP. This will include an overview of the associated toxicities of commonly used ATMP products and consideration of issues relating to long term follow up. Finally you will develop an understanding of the unique requirements required for the operational delivery of ATMPs including the need for specialist governance arrangements; this will include an overview of the various ATMP governing bodies and an understanding of the complexities of the ATMP regulatory landscape.

Learning outcomes

 

1. Demonstrate a critical and in depth understanding of the principles of ATMP development and clinical delivery and their application to disease.  

2. Critically evaluate and interpret the evidence presented in pivotal studies and seminal literature to identify current challenges related to ATMP clinical development. 

3. Communicate scientific information convincingly with a focus on ATMP development by developing a scientific abstract and presenting finding in a poster or oral presentation format.

4. Apply understanding of the indications and clinical management of an ATMP for a specified disease to identify significant and relevant clinical issues and generate a novel ideas for their management, demonstrating consideration of the use of an interdisciplinary approach.

5. Work in a group to assign a common solution to a complex problem relating to an unmet clinical need.              

6. Synthesise and develop rational arguments to contribute to key areas of controversy and discussion in the ATMP regulatory landscape.    

7. Provide and receive constructive feedback to and from peers and respond appropriately

Assessment methods

Method Weight
Written assignment (inc essay) 30%
Report 20%
Oral assessment/presentation 50%

Feedback methods

Feedback to students will be made through Turnitin.

 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Michelle Davies Unit coordinator

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