The module provides advanced knowledge in the modern cell and gene therapy area, its development, advances and challenges and how cell and gene therapy aims to use the power of cell-based medicines, including regenerative medicine, to deliver new treatments. It also looks at some specific examples from the following areas: Immune Cell therapies (CAR-T immunotherapies), Gene-modified Therapies (GTMPs), iPCSs therapies (stem-cell therapies); AVV and lentiviral-based therapy, CRISPR-Cas9 gene editing therapy. Furthermore, it discusses the clinical relevance of cell and gene therapies, delivery methods, and manufacturing aspects. It will assess their scale and costs, commercial opportunities, good manufacturing practice (GMP) and good clinical practice (GCP) basics and apply relevant regulation and legislation.
Total Hours: 150 including: "off the job" learning (approximately 39 hours) and on the job learning.
Assignment 1 (Essay, 1200 words) - 60%
Assignment 2 (Essay, 750 words) - 40%
All assessments must be passed in order to pass the module.
Reassessment: Like-for-like
The intended subject specific learning outcomes.
On successfully completing the module students will be able to:
Demonstrate comprehensive knowledge of the underlying concepts and principles associated with cell therapy: Cell-based Immunotherapies (including CART-T, CAR-NK and CAR macrophages and derivatives), Gene-modified Therapies (GTMPs), iPCSs therapies (stem-cell therapies);
Demonstrate comprehensive knowledge of the underlying concepts and principles associated with gene therapy (GTMPs): viral vector platforms, CRISPR-Cas9 gene editing therapy.
Consider and explain the impact of cell and gene therapy, the issues and challenges faced in transplantation and integration, and ethical concerns and regulations.
Discuss detailed examples of gene and cell therapies that are currently available and demonstrate their mechanism to cure diseases.
Understand and discuss key concepts and challenges associated with manufacturing scale-up (the role of automation) and clinical aspects of advanced cell and gene therapy.
The intended generic learning outcomes.
On successfully completing the module students will be able to:
Develop and demonstrate an ability to work and communicate effectively with others.
Analyse, evaluate and correctly interpret data.
Present and communicate data effectively.
Demonstrate the ability to obtain and use information from a variety of sources as part of self-directed learning.
Demonstrate time-management and organisational skills within the context of self-directed learning.
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