Drug Development 2

Course aim

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.

Course content

Intellectual property and patenting in the pharmaceutical industry; ownership of knowledge, ownership of information, IP protection. Clinical trials insight into industry. Diagnostics & 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.

Textbook(s)

Raymond G. Hill and Duncan B. Richards 2020, Drug Discovery and Development: Technology in Transition, Current, Churchill Livingstone (Elsevier)

Prerequisite(s)

Corequisite(s)

Nil

Teaching method

Note: These components may or may not be scheduled in every study period. Please refer to the timetable for further details.

Assessment

Presentation, Report, Test/Quiz

Fees

EFTSL*: 0.125
Commonwealth Supported program (Band 4C)
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Fee-paying program for domestic and international students
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Non-award enrolment
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* Equivalent Full Time Study Load. Please note: all EFTSL values are published and calculated at ten decimal places. Values are displayed to three decimal places for ease of interpretation.