Biological and Advanced Therapies

*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:

Pharmaceutical Medicine Non-Award (Part-time)

Module Code 7BBP0014 

This module provides advanced training in the area of medicines produced by biotechnology. Students will study the new therapeutic technologies that are in development, as well as the ethical and regulatory frameworks that apply to these products. The differences between the clinical development programmes required by these different technologies will also be explored. The areas covered include monoclonal antibodies, bi-specific antibodies, antibody-drug conjugates, vaccines (both prophylactic and therapeutic), therapeutic proteins, gene therapy and cell therapy.

• To provide advanced training in the area of medicines produced by biotechnology.
• To provide an in depth understanding on how to develop prophylactic vaccines and the differences between these and therapeutic vaccines.
• To give students an understanding of the new therapeutic technologies that are in development.
• To give students an understanding of the ethical and regulatory frameworks that apply to these products.
• To give students an in-depth knowledge of the differences in the clinical development programmes required by these different technologies.

By the end of this module students will be able to:

• Describe the new technologies that are now available and those in development.
• Describe the range of products available with recombinant DNA technology.
• Discuss the different needs between the pre-clinical and clinical trial needs of natural proteins and modified proteins.
• Describe the range of monoclonal antibodies available and those in development and discuss the potential long-term safety issues with monoclonal antibodies.
• Describe the global need for new and improved vaccines and the barriers to their development.
• How to carry out a clinical trial programme and how to measure outcomes.
• Define what is a therapeutic vaccine and describe how a therapeutic vaccine could influence therapy in a common disease area.
• Describe what is a therapeutic peptide product and the regulatory and development challenges involved.
• Describe the breadth of advanced therapies that are available and in development, including gene therapy, stem cell therapy, CAR T cells and other cell therapies.
• Describe in detail the ethical and regulatory frameworks that apply to these products.

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject.