The Advantage of Team Australia: Speed, Accuracy, and Reduced Cost
In today’s highly competitive pharmaceutical and biotech industries, choosing the right partner is paramount to success.
As geographical boundaries become increasingly less of an obstacle, Australian-based Contract Research Organizations (CROs) such as Accelagen offer many advantages that significantly enhance drug development. However, when meeting with prospective Accelagen clients across the U.S. and other locations, they frequently reveal misgivings about working with a CRO “on the other side of the planet.”
We get it. However, the Australian regulatory system offers many advantages for pharmaceutical companies aiming to expedite the development process of new drugs, particularly in clinical trials. Before entrusting your project to any CRO, here are some thoughts that merit serious consideration.
Speed: Efficient Regulatory Processes
One of the under utilized benefits of working in Australia with an experienced CRO, is the faster turnaround time facilitated by the streamlined regulatory procedures. Compared to many other countries, the regulatory approval process in Australia is known for its efficiency and responsiveness.
Regulatory agility means companies can navigate the necessary regulatory steps more swiftly, enabling them to progress from preclinical research to clinical trials in a shorter timeframe. Regulatory approvals for new programs can be obtained within 30 to 45 calendar days, a remarkable contrast to the lengthy timelines encountered in other jurisdictions. Nimbleness expedites the transition from discovery to development, allowing companies to enter the clinic earlier and bolster asset valuation.
Moreover, Australian CROs play a pivotal role in enhancing the efficiency of drug development. These organizations specialize in providing comprehensive services for drug development, including formulation development, analytical testing, and manufacturing. By partnering with an Australian CRO, pharmaceutical and biotech companies can benefit from the expertise and resources of these organizations, which can significantly expedite the development process.
Quality: Internationally Recognized Data
As an International Council for Harmonisation (ICH) member, Australia adheres to globally recognized guidelines. Strict adherence underpins the production of high-quality clinical trial data. Data generated in Australia is routinely accepted by regulatory authorities worldwide, including the FDA and EMA, underscoring its reliability and integrity.
The Australian clinical trial infrastructure also maintains high data integrity standards and compliance with Good Clinical Practice (GCP) guidelines, ensuring that clinical trial data is robust and reliable. This commitment to data quality enhances the credibility of clinical trial results and facilitates their acceptance by regulatory authorities. Pharmaceutical companies can leverage the integrity of Australian clinical trial data to expedite the regulatory approval process for their drugs in multiple jurisdictions.
Cost Effectiveness: Maximizing Returns
Previous reports[1] have shown Australian-based clinical trials are notably more cost-effective than those conducted in Europe or the U.S. The Australian government’s streamlined regulatory processes and generous research and development tax incentives enable companies to achieve substantial cost savings without compromising quality.
By optimizing resources and minimizing regulatory hurdles, companies can allocate their budget more efficiently, thereby reducing the cost of bringing new drugs to market.
The Australian Research and Development Tax Credit System
The Australian Research and Development Tax Credit System is a government initiative to incentivize and support innovation in various industries, including pharmaceuticals, biotechnology, technology, and manufacturing. The R&D tax credit program encourages companies to invest in research and development activities by providing financial incentives through tax offsets or cash rebates.
The opportunity to claim tax rebates of up to 43.50 cents per dollar of research conducted further amplifies the financial benefits of working with an Australian CRO.
Under the Australian R&D tax credit system, eligible companies can claim tax offsets for qualified R&D expenditures incurred during the financial year. The Australian Taxation Office (ATO) administers the program and is available to companies of all sizes, including startups, small and medium-sized enterprises (SMEs), and large corporations.
How Australia’s Tax Credit System Works
The R&D tax credit is calculated based on the eligible R&D expenditure incurred by the company during the financial year. Eligible R&D expenditure may include expenses related to conducting R&D activities such as salaries, wages, materials, contractors, and overhead costs directly attributable to R&D projects.
Companies with an annual revenue turnover of less than AU$20 million can claim a refundable tax offset of 43.5% for eligible R&D expenditure. In other words, qualified companies can receive a cash refund of up to 43.5 cents for every dollar of R&D expenditure incurred, even if they are in a tax loss position.
Companies with an annual turnover of AU$20 million or more can claim a non-refundable tax offset of 38.5% for eligible R&D expenditure. This offset refund is not available as cash. However, companies can use the income tax liability for the current or future financial years.
To be eligible for the R&D tax credit, companies must demonstrate that their R&D activities meet specific criteria defined by the ATO. These criteria include systematic, investigative, and experimental activities to generate new knowledge or improve existing products, processes, or services. Overall, the Australian R&D tax credit system is a valuable incentive for companies to invest in innovation and R&D activities, driving economic growth, fostering competitiveness, and encouraging technological advancements across various industries.
Additional Advantages of Considering an Australian CRO
In case improved speed, reliable data, and reduced cost were insufficient reasons to consider working with an Australian CRO, such as the team at Accelagen, here are a few more items to throw into the mix.
- World-Class Infrastructure: Australia boasts a leading healthcare system and robust data management practices underpinned by world-class medical research infrastructure, particularly in early clinical trial development.
- Ethnically Diverse Population: With a multicultural population, Australia provides a unique opportunity to expose new therapies to a diverse range of ethnic groups, enhancing the quality and relevance of clinical trial data.
- Data Exclusivity: Australia’s intellectual property system offers secure data exclusivity for new pharmaceutical products, further safeguarding the interests of innovators.
Partnering with an Australian CRO presents an unparalleled opportunity to accelerate drug development initiatives while maximizing efficiency and minimizing costs. The advantages extend beyond regulatory expediency to encompass a holistic ecosystem conducive to innovation and success.
Embrace the Australian advantage with Accelagen today and unlock the full potential of your pharmaceutical endeavors. Contact us today to begin your journey to faster turnaround time, improved regulatory acceptance, and reduced costs. We might be on the other side of the planet, but we’re as close as you need us to be.
[1] As per https://www.frost.com/files/6514/7374/3781/Novotech_WP_20160701_v2.1.pdf, accessed 29 February 2024