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Description
This module will expose students to a broad set of concepts associated with the commercialisation of a highly regulated therapeutic product and the foundation and growth of a business including the requirement to raise significant funding. It will also address in detail the regulatory environment for advanced therapeutic medicinal products (ATMPs) and provide an understanding of the ethical issues associated with advanced therapy development. Students will develop and implement entrepreneurial, managerial and communication skills through the commercialisation and biotechnology business plan activities with the goal of devising a realistic commercial proposition for the advanced therapy sector.
On completion of this module, students will be able to:
- Understand the commercial and business processes for ATMP development, including the key cost drivers and quality requirements
- Evaluate the business plans of others and formulate their own for the development of an ATMP and articulate this to experts within the field
- Conceptualise and communicate the positive and negative attributes associated with an ATMP in order to secure investment for commercialisation
- Specify the business context of scientific work and understand the commercial skills required for clinical and commercial development. Appreciation that successful commercial and business development is equally as challenging as scientific development.
- Understand and communicate the ethical issues associated with stem cell and gene therapies.
- Evaluate and identify the complex regulatory processes that control ATMP development, including understanding of the key aspects to regulatory affairs and the differences between the major regulatory bodies (such as the European, U.S. and Japanese regulators).
Module deliveries for 2024/25 academic year
Last updated
This module description was last updated on 8th April 2024.
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