Reforming the regulatory environment for innovative health technologies. This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and ....Reforming the regulatory environment for innovative health technologies. This project aims to comprehensively map the regulatory pathways that innovative health technologies must navigate from the laboratory to the clinic, and to identify areas of over and under regulation. Pathways for innovative procedures, medicines and devices will be analysed in three cutting edge case studies - genome editing, biologic medicines and bio-printing - with particular focus on therapeutic goods registration and patents. Doctrinal, qualitative and iterative research methods will be used. The primary intended outcome is a set of recommendations to assist policy makers in ensuring consistency of regulatory policy and practice, thereby supporting innovation and safe clinical translation, for the benefit of all Australians.Read moreRead less
Material Transfer Agreements and Open Science in the Genome Era. Research paradigms are changing rapidly in the Genome Era. Open access databases are increasingly popular and are required by public funding agencies. The role of material transfer agreements (MTAs) in this open access era is not clear. This project aims to assess the extent to which MTAs facilitate exchanges of biological materials between organisation in Australia and internationally. The project will assess whether MTAs are refl ....Material Transfer Agreements and Open Science in the Genome Era. Research paradigms are changing rapidly in the Genome Era. Open access databases are increasingly popular and are required by public funding agencies. The role of material transfer agreements (MTAs) in this open access era is not clear. This project aims to assess the extent to which MTAs facilitate exchanges of biological materials between organisation in Australia and internationally. The project will assess whether MTAs are reflecting the open data access movement or maintaining traditional closed proprietary practices. The project will make policy, ethical and legal recommendations for the development of MTAs to promote exchange of materials nationally and internationally and to facilitate the developing collaborative research culture. Read moreRead less