Simultaneous gene silencing and supressing gene silencing in the same cell

The present invention relates to genetically modified cells that are capable of optimal transgene expression by co-expressing a silencing suppressor whilst at the same time are also capable of silencing a gene, such as a naturally occurring gene of the cell. The present invention also relates to methods of producing the modified cells, as well as relates to processes for obtaining a genetically modified cell with a desired property.

A QUM partnership approach to regulating biosimilars in Australia

Despite the realisation of the potential implications from biosimilars is relatively recent, much has already been written about raising the awareness of differences between biosimilars and originating/ reference listed (innovator) pharmaceuticals. The European Medicines Agency has led the global charge in regulating biosimilars. Regardless of sufficient similarities across international regulations, differences do exist across jurisdictions. The consideration of regulating biosimilars demands a congruent approach across all stages: pre-registration (Australian copyright protection, patent, international obligations), registration (confidential information, international regulators, safety and efficacy), post-registration (Pharmaceutical Benefit Scheme, prescriber and dispenser awareness). Our National Medicines Policy could provide the necessary congruent framework and function for national and international regulation of biosimilars. The Policy concedes that pharmaceuticals will be affected by financial policies and trade considerations, international treaty obligations, industrial policies, education policies and the need for public-private partnerships.

Is Australia ready for biosimilars?

The biosimilars market is potentially the single fastest growing pharmaceutical sector with an estimated worth of US$67bn in global sales by 2020. This market generally refers to larger molecule, biological, protein-based pharmaceuticals which have lost its patent. This has stimulated the emergence of non-conventional pharmaceutical investors such as Fujifilm and Samsung as well as host countries such as Brazil, Mexico, China, India, South Korea, Turkey and Russia, which view biosimilars as a key macroeconomic driver of growth. Internationally, the European Medicines Agency has led the regulation of the quality, safety and efficacy of biosimilars; however, many countries have developed their own biosimilar regulatory frameworks. Despite the similarity of these with European guidelines, differences do exist across jurisdictions and have implications for cross-jurisdictional registration and regulation. The consideration of biosimilar regulation, however, demands attention beyond quality, safety and efficacy. The potential implications of extended patent protection, international trade and globalisation require a congruent policy approach to their regulation. Notwithstanding the fact that Australia is a relatively small pharmaceutical market and that there are only 14 biosimilar products currently approved for use, Australia’s geographical proximity to pharm-emerging countries and its trade relation with the major pharmaceutical markets have positioned Australia in a unique position to influence international development and regulation of biosimilars. Australia’s National Medicines Policy (2000) potentially provides the foundation for a partnership approach to biosimilar regulation, minimise duplication of regulatory efforts while at the same time fostering a viable pharmaceutical industry.

Interrupting malaria transmission: quantifying the impact of interventions in regions of low to moderate transmission

Malaria has been eliminated from over 40 countries with an additional 39 currently planning for, or committed to, elimination. Information on the likely impact of available interventions, and the required time, is urgently needed to help plan resource allocation. Mathematical modelling has been used to investigate the impact of various interventions; the strength of the conclusions is boosted when several models with differing formulation produce similar data. Here we predict by using an individual-based stochastic simulation model of seasonal Plasmodium falciparum transmission that transmission can be interrupted and parasite reintroductions controlled in villages of 1,000 individuals where the entomological inoculation rate is <7 infectious bites per person per year using chemotherapy and bed net strategies. Above this transmission intensity bed nets and symptomatic treatment alone were not sufficient to interrupt transmission and control the importation of malaria for at least 150 days. Our model results suggest that 1) stochastic events impact the likelihood of successfully interrupting transmission with large variability in the times required, 2) the relative reduction in morbidity caused by the interventions were age-group specific, changing over time, and 3) the post-intervention changes in morbidity were larger than the corresponding impact on transmission. These results generally agree with the conclusions from previously published models. However the model also predicted changes in parasite population structure as a result of improved treatment of symptomatic individuals; the survival probability of introduced parasites reduced leading to an increase in the prevalence of sub-patent infections in semi-immune individuals. This novel finding requires further investigation in the field because, if confirmed, such a change would have a negative impact on attempts to eliminate the disease from areas of moderate transmission.

Intellectual Property – What Went Wrong!

In its simplest form the patent system is designed to encourage the disclosure of innovative thought in exchange for a period of exclusivity in which the grantee of the rights may profit from such knowledge. I will attempt in this paper to show that patentees seeking to enforce their patents in Australia will face great difficulty through a number of potentially fatal pitfalls. I also submit that as a result of the decisions in Australia in reported patent cases in the last ten years, legal advisers should place their clients on notice that if they are trying to enforce their patents they are unlikely to succeed...

Intellectual Property Laws Amendment Bill 2013

This submission relates to the proposed amendment of the Crown Use provisions in the Patents Act 1990 (Cth) (“the Patents Act”),which are contained in Intellectual Property Laws Amendment Bill 2013 (“The Bill”). Specifically, the submission relates to the method of calculation of the remuneration payable to the patent applicant/owner in circumstances where the Crown exercises its rights under Chapter 17 of the Patents Act.

Submission: Towards a Stronger and More Efficient IP Rights System : Getting the Balance Right

1. In March 2009, the Australian Government, through IP Australia its administrator of Intellectual Property Rights (IPR) acquired by registration or grant, issued two consultation papers for comment by interested stakeholders. 2. The Consultation Papers have invited written submissions directed towards the object of the paper, namely encouraging discussion on certain proposed changes and their impact on business and innovation. 3. I understand the invitation to make written submissions is predominantly in the areas raised by the Consultation Papers and the questions posed. However, I have made a brief reference to several other areas of concern with the current Australian patent law, which in my opinion inhibit innovation and therefore come under the wider agenda of the government to work toward a stronger and more efficient IP rights system. 4. In this regard, the Consultation Papers indicate that if the IPR are less likely to be invalidated and more likely to be enforced, this confidence will reflect in a greater investment in research leading to innovation. 5. This submission relates to the Balance Paper.

Community pharmacy dispensing of prescription medicine sample packs: Changing the business of medicine initiation?

Prescription medicine samples (or starter packs) are provided by pharmaceutical manufacturers to prescribing doctors as one component in the suite of marketing products used to convince them to prescribe a particular medicine [1,2]. Samples are generally newer, more expensive treatment options still covered by patent [3,4]. Safe, effective, judicious and appropriate medicine use (quality use of medicines) [5] could be enhanced by involving community pharmacists in the dispensing of starter packs. Doctors who use samples show a trend towards prescribing more expensive medicines overall [6] and also prescribe more medicines [7]. Cardiovascular health and mental health are Australian National Health Priority Areas [8] and account for approximately 30% and 17%, respectively, of annual government Pharmaceutical Benefits System (PBS) in 2006 [9]. The PBS is Australia's universal prescription subsidy scheme [9]. Antihypertensives were a major contributor to the estimated 80 000 medicine-related hospital admissions in Australia in 1999 [10] and also internationally [11,12]. The aim of this study was to pilot an alternative model for supply of free sample or starter packs of prescription medicines and ascertain if it is a viable model in daily practice.

Is Australia positioned to take advantage of biosimilars?

Australia currently has a small generic and biosimilar industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small volume biological pharmaceuticals. In recent times, Australia has made incremental changes to its regulation of biosimilars – in patent registration, in the use of commercial confidential information, and in remuneration. These improvements, together with Australia’s geographical proximity and strong trade relationship with the Asian biocluster have positioned Australia to take advantage of potential public cost savings from the increased use of biosimilars.

Breaking the DNA-vaccine bottleneck

Monash University in Australia has developed a new approach towards DNA vaccine development that has the potential to cut the time it takes to produce a vaccine from up to nine months to four weeks or less. The university has designed and filed a patent on a commercially viable, single-stage technology for manufacturing DNA molecules. The technology was used to produce malaria and measles DNA vaccines, which were tested to be homogeneous supercoiled DNA, free from RNA and protein contaminations and meeting FDA regulatory standards for DNA vaccines. The technique is based on customized, smart, polymeric, monolithic adsorbents that can purify DNA very rapidly. The design criteria of solid-phase adsorbent include rapid adsorption and desorption kinetics, physical composition, and adequate selectivity , capacity and recovery. The new show technology significantly improved binding capacities, higher recovery, drastically reduced use of buffers and processing time, less clogging, and higher yields of DNA.

Materials, methods and systems for purification and/or seperation

Materials, methods and systems are provided for the purifn., filtration and​/or sepn. of certain mols. such as certain size biomols. Certain embodiments relate to supports contg. at least one polymethacrylate polymer engineered to have certain pore diams. and other properties, and which can be functionally adapted to for certain purifications, filtrations and​/or sepns. Biomols. are selected from a group consisting of: polynucleotide mols., oligonucleotide mols. including antisense oligonucleotide mols. such as antisense RNA and other oligonucleotide mols. that are inhibitory of gene function such as small interfering RNA (siRNA)​, polypeptides including proteinaceous infective agents such as prions, for example, the infectious agent for CJD, and infectious agents such as viruses and phage.

Method for planning and executing obstacle-free paths for rotating excavation machinery

This invention concerns the control of rotating excavation machinery, for instance to avoid collisions with obstacles. In a first aspect the invention is a control system for autonomous path planning in excavation machinery, comprising: A map generation subsystem to receive data from an array of disparate and complementary sensors to generate a 3-Dimensional digital terrain and obstacle map referenced to a coordinate frame related to the machine's geometry, during normal operation of the machine. An obstacle detection subsystem to find and identify obstacles in the digital terrain and obstacle map, and then to refine the map by identifying exclusion zones that are within reach of the machine during operation. A collision detection subsystem that uses knowledge of the machine's position and movements, as well as the digital terrain and obstacle map, to identify and predict possible collisions with itself or other obstacles, and then uses a forward motion planner to predict collisions in a planned path. And, a path planning subsystem that uses information from the other subsystems to vary planned paths to avoid obstacles and collisions. In other aspects the invention is excavation machinery including the control system; a method for control of excavation machinery; and firmware and software versions of the control system.

Remote monitoring of underwater objects

A system for monitoring conditions in a remote environment. The system comprising a data transmission network including a plurality of data sensing nodes. Each data sensing node includes an environment sensing means for periodically sensing the environment around node, a transmission means for periodic wireless transmission of sensed data to adjacent data sensing nodes. These adjacent data sensing nodes combining their sensed data with the received data from other data sensing nodes and on transmit the combined data.

The pragmatic approach : the myriad gene patents before the Australian courts

The Full Court of the Federal Court of Australia in D'Arcy v Myriad Genetics [2014] FCAFC 115 recently upheld the validity of Myriad Genetics' Australian BRCA1 gene patent over isolated DNA sequences.

Moderation in higher education: Four discourses

Across the globe, higher education institutions are working in environments of increasing accountability with little sign of this trend abating. This heightened focus on accountability has placed greater demands on institutions to provide evidence of quality and the achievement of standards that assure that quality. Moderation is one quality assurance process that plays a central role in the teaching, learning and assessment cycle in higher education institutions. While there is a growing body of research globally on teaching, learning and , to a lesser degree, assessment in higher education, the process of moderation has received even less attention (Watty, Freeman, Howieson, Hancock, O'Connell, et al. 2013). Until recently, moderation processes in Australian universities have been typically located within individual institutions, with universities given the responsibility for developing their own specific policies and practices. However, in 2009 the Australian Government announced that an independent national quality and regulatory body for higher education institutions would be established. With the introduction of the Tertiary Education Quality Standards Authority (TEQSA), more formalised requirements for moderation of assessment are being mandated. In light of these reforms, the purpose of this qualitative study was to identify and investigate current moderation practices operating within one faculty, the Faculty of Education, in a large urban university in eastern Australia. The findings of this study revealed four discourses of moderation: equity, justification, community building and accountability. These discourses provide a starting point for academics to engage in substantive conversations around assessment and to further critique the processes of moderation.