This course builds on the framework provided in BIOT3071, Commercial Biotechnology, in providing material necessary for the commercialisation of biotechnology products and training students in professional issues important for their careers. The grounding in IP provided in BIOT3071 will be augmented with material and case studies which cover the developments in IP relevant to the biotech industry. Planning and control of R&D projects, project management. Review of the Australian biotech industry including analysis of sources of capital and comparisons with the situation existing in the USA. Specific treatment of the regulatory approval process for biopharmaceuticals, with specific material on GMP and process validation for r-DNA derived therapeutics and gene therapy products. The practical/tutorial component in the course will involve the students in small group as well as individual assignments, where presentations will be made to the class. Assignments will cover such areas as drafting of provisional and PCT patent applications; business plans for biotech companies; case studies analysing specific companies and products; requirements for regulatory approval. The course will be carried out in association with staff and conjoint appointments in the School as well as visiting lecturers.