Major pharmaceutical and biotechnology companies are based in the US, Europe and some parts of Asia. With the absence of a strong local pharmaceutical industry presence here, many Australian researchers are at a disadvantage. Diffusion of industry know-how and potential for financial support are limited.
Through our Virtual Pharma Committee, our network of capabilities and our linkages to government and industry Therapeutic Innovation Australia has the capacity to assist local researchers in translating their projects from the academic environment into clinical trials.
The Virtual Pharma Committee is a national resource of leading academics and industry professionals. Its objective is to harness its undoubted expertise in drug development, Australia requires a coordinating entity to ensure efficiency in translation of advances relating to small molecule pharmaceuticals. This entity will mimic the role of the major pharmaceutical companies in the modern network model of drug development.
According to the McKinnon Investment Plan (Prof Ross McKinnon, 2011) that underpins TIA's approach, "Drug therapy underpins the treatment of most human diseases and there is unmet demand for novel and improved therapeutic agents, including both small molecules and biologics. The sustainability of the predominant pharmaceutical development model, namely the fully integrated pharmaceutical company model, is currently under increasing pressure from myriad challenges including an onslaught of patent expirations, increasing pressure from payers and more stringent regulatory environments. As a result, major drug developers are critically examining current R&D practices and, in some cases, considering a radical overhaul of their R&D models. Emerging from this is a new model of drug development, commonly termed a fully integrated pharmaceutical network (FIPNet). This network model enables more efficient utilisation of existing resources across the academic, biotechnology, contract research organisation (CRO) and pharma sectors. Under this model, each stakeholder plays a complementary and integrated role in the R&D process. Particularly important in the FIPNet model is the formation of closer alliances between drug developers (pharma) and contract research organisations (CROs) in order to reduce overhead costs, increase efficiency, and bolster output.
Consideration of these changes in the model of pharmaceutical development is critical for achieving successful translation of Australia’s discoveries in the pharmaceutical area. However, the FIPNet model poses significant challenges locally. Australia has established through several academic institutions and commercial operations, an excellent range of service providers in both the preclinical and clinical areas (including RDDT, ICP Firefly, Vivopharm, Tetra Q, Q Pharm, Cmax, CPR Pharma Services and Nucleus Network). Significantly however, Australia lacks ‘big pharma’ research capability and as a result, lacks infrastructure and critical mass in several areas fundamental to the successful implementation of the FIPNet model. Notable among these are translational chemistry capability and access to drug screening programs that provide deeper insight into potential development pathways.
The proposed ‘Therapeutic Innovation Australia’ model provides a mechanism to address the current challenges to drug development in Australia. The development of an expert panel in the pharmaceutical area will mimic the pharma capability in FIPNet models, providing a coordinating focus for FIPNet style development programs and an aggregation of existing drug development expertise and capability. This panel will focus expertise to identify key infrastructure gaps, guide researchers on drug development with a greater emphasis on translational outcomes and will also provide a vehicle for closer alliances between researchers and other sectors in the FIPNet. Critically, such a panel will also provide a focus for engagement of the Australian translational research community with critical overseas stakeholders. It is anticipated that similar expert panels will also facilitate translational outcomes in other key areas including clinical trials, cell therapies and biopharmaceuticals.
The establishment of the PDN aims to achieve the following:
- To integrate Australia’s existing drug development capability, currently focused primarily in a small number of research intensive pharmacy schools, isolated university pharmacology departments and among preclinical service providers, many of which have spun out of the academic departments.
- To provide researchers and industry with advice concerning facilitated pathways for drug development in order to lower attrition rates and ensure efficiency in developmental planning.
- To ensure significantly improved infrastructure linkages across Australia for drug development with clearly defined access and optimised utilisation."