Course overview
The aim of this course is to further extend prior knowledge of drug discovery in the critical evaluation of the major phases of the drug development process and apply this knowledge to the commercialisation aspects of a new drug program. Intellectual property and patenting in the pharmaceutical industry; ownership of knowledge, ownership of information, IP protection. Clinical trials insight into industry. Diagnostics and Personalised medicine. Regulatory affairs; filing a New Drug Application (NDA); the evaluation of an NDA by the Food and Drug Administration and the Therapeutics Goods Administration. The use of data in drug development. Pharmaceutical commercialisation: how companies are funded; private and public funding of the pharmaceutical industry; spin-off and start-up companies; Ethical behaviour in pharmaceutical commercialisation; Role of pharmacoeconomics in strategic drug development.
Course learning outcomes
- Apply knowledge of drug discovery and development to evaluate the key data and contributors towards the successful commercialisation of a pharmaceutical product.
- Demonstrate an awareness of the different types of funding available to commercialise pharmaceutical products and the costs and timelines of the process.
- Describe the relationship between regulatory requirements, industry needs, and drug efficacy and safety.
- Understand the importance of patents for the protection of intellectual property, be able to run a patent search, and subsequently interpret the major sections and their significance.
- Demonstrate the ethical and cultural issues surrounding bio-prospecting and the rights of Indigenous peoples.
- Apply the methods used to assign a commercial value to a pharmaceutical project and to a pharmaceutical company.