October 18, 2023
The development of new drugs and vaccines has traditionally been a lengthy process, typically requiring nearly a decade to advance from phase I clinical testing to approval.1 However, the very rapid success of the mRNA vaccines developed to combat the COVID-19 pandemic, which received regulatory approval in just 11 months, has shifted the paradigm and perception of drug development. That unprecedented speed was made possible by intensified collaboration among competing drug makers, substantial government funding, and an extensive array of regulatory adjustments that achieved critical goals without compromising safety.
While those compressed timelines reflect unique conditions at play during the pandemic, many companies developing novel drugs have sought to leverage the strategies applied to COVID-19 vaccine development in their current and future drug development efforts. Developers are exploring a range of tactics, including greater investment in expedited approval pathways, rolling regulatory review, wider use of validated manufacturing platforms, new communication pathways, novel clinical trial designs, and more extensive collaborative networks.1
Even before the pandemic, drug development timelines were accelerating, driven by expedited approval programs. Over 350 such designations were awarded by the U.S. FDA in the last three years, largely benefiting smaller pharma and biotech companies.2 Drug candidates with expedited approvals typically receive their first approval 15 months faster than the industry benchmark.3
Clinical trials have been a key target of efforts to compress timelines without compromising quality. The adoption of a host of innovative approaches and new technologies that were already being explored — particularly decentralized and virtual trials leveraging digital technologies like telehealth, eConsent, and wearables — was accelerated by the pandemic. It has been estimated that further utilization of artificial intelligence and machine learning may further reduce clinical trial times by up to 300%.4
With the high cost pressures associated with drug development compounded by financial incentives to be first to the clinic and the market, drug developers are racing to take advantage of every opportunity to move more nimbly. While the approaches mentioned above are widely recognized and pursued, others, including the benefits associated with conducting clinical studies in Australia, have received far less attention and may provide a real competitive advantage to those who access them.
Clinical trials conducted in Australia are often less expensive and can be more efficiently implemented owing to Australia’s favorable regulatory and business environment. The Australian Government is also committed to the clinical trials sector, providing significant incentives to encourage companies to conduct early-phase studies in the country.
Clinical trial fast track advantages and favorable regulatory pathways feature no requirement for filing of an investigational new drug (IND) application for streamlined approval to conduct clinical trials, shortened timelines for study setup and first patient enrollment (completion of the site initiation visit and start of a study within six weeks), and permission to use non-GMP material for phase I trials. In addition, clinical data can be assessed more quickly than in other markets, further reducing development timelines. Costs of clinical trials also tend to be lower in Australia. For instance, early-phase clinical trials are 28% cheaper than U.S. trials before tax incentives and 60% cheaper after those incentives are taken into consideration.5
Drug developers are taking advantage of the benefits Australia has to offer. According to the South Australian government, in 2022 two-thirds of drugs approved by the U.S. FDA were supported by data generated in Australia.6 At the end of 2022, meanwhile, Australia was ranked third behind the United States and China with respect to the overall number of planned clinical trials, while the United States, Australia, and Thailand accounted for 75% of phase I and II trials planned at that time.7 Notably, phase I activity in Australia grew 17.2% from 2012 to 2015 compared with the global rate of 1.8%, and each year approximately 1,000 new clinical trials are initated.5 Furthermore, two-thirds of Australian trials were conducted by international pharmaceutical companies, with half of those U.S.-based companies.8
To encourage more companies to engage in R&D in Australia, Innovation Australia, assisted by AusIndustry and the Australian Taxation Office (ATO), offers targeted tax offsets that include a 43.5% refundable tax offset for eligible entities with an aggregated annual turnover of less than $20 million and a 38.5% non-refundable tax offset for all other eligible entities. The patent box program established by the Australian federal government, meanwhile, encourages innovation and investment in the country‘s biotech and medical sectors by reducing taxes on income from Australian medical and biotech patents.9 Furthermore, medical products are one of six designated priority areas within the Modern Manufacturing Strategy, which helps manufacturers scale up, compete internationally, and create jobs.
The favorable business environment in Australia not only makes collaborating with Australian contract research organizations (CROs) attractive — the supportive ecosystem also ensures that partnering with contract development and manufacturing organizations (CDMOs) can lead to cost savings and increased efficiency as well. The benefits can be truly maximized by partnering with Australian CDMOs that provide end-to-end services from early-stage development to commercial manufacturing. In addition to tax incentives, investment support, and patent protections, sponsors benefit from streamlined development with reduced timelines, costs, and risks when a program can stay with the same partner at the same site throughout the development cycle. Australian CROs and CDMOs also provide U.S. companies access to Asian markets without language barriers.
As a global CDMO based in Australia, Mayne Pharma partners with clients to develop and deliver small molecule pharmaceutical oral solid, liquid, cream, ointment, and nasal spray dosage forms, including packaging and serialization from concept to commercialization, to change the lives of patients around the world. We leverage our 40+ years of experience and expertise in development, manufacturing, and analytical capabilities to provide end-to-end services tailored to each individual client and project.
Based in Adelaide, South Australia, Mayne Pharma’s purpose-built facility was established by Faulding in 1984 but has benefited from several rounds of investment since then. Over the past five years alone, Mayne has invested more than $40 million (AUS) in capacity and capability expansions, the most recent being a $12 million investment in partnership with the government of South Australia (a $4.8 million MMI grant) to increase encapsulation and blister and bottling packing capabilities. Currently, the plant has a footprint of 12,000 m2, but there is ample space for further expansion on the company’s 81,000-m2 campus.
A crucial feature of Mayne Pharma that enables us to provide a world-class, customer-oriented outsourcing experience is our approach to project and quality management. We are committed to delivering on Mayne’s promise with respect to security of supply, quality, service, and price. Our quality system has been successfully inspected by various regulatory authorities, including the FDA, Australia’s Therapeutic Goods Agency (TGA), and the EMA, and our facility has been audited by numerous customers. In fact, our more than 200 employees work with pharmaceutical companies of all sizes, from Big Pharma to mid-size, specialty, and emerging pharma companies, as well as generics firms. Mayne’s truly global nature can be seen with its export experience — over 67% of products made by Mayne are shipped outside of Australia.
Mayne provides non-GMP production of preclinical studies and GMP clinical and commercial manufacture for phase I through phase III clinical trials and marketed products. Our team of experts can provide assistance with the documentation for customer regulatory submissions and bidirectional tech transfer of products and processes. Notably, we can handle both potent substances up to OEB-3 and controlled drug products, including cannabinoids. Mayne supports its development and manufacturing activities with an extensive range of in-house analytical method capabilities and development techniques.
Some of the specialized development capabilities at Mayne Pharma include immediate- and modified-release oral formulations, taste-masking and bioavailability enhancement solutions, using spray drying, spray coating, and fluid-bed processing technologies. Innovation is a top priority at Mayne, a strategy that is reflected by our 60+ Australian patents applications (25+ granted) and 340+ patent applications in other countries around the world.
Beyond our experience and wide range of technical capabilities, as an Australian CDMO, Mayne is positioned to help clients benefit from the programs offered by the Australian government to encourage pharmaceutical R&D and manufacturing in the country. For instance, working with Mayne Pharma Services in Australia can provide customers with access to the benefits of the patent box, which, in combination with Mayne’s proven experience in generating intellectual property, can accelerate their patent protection goals. Clients may also be eligible to take advantage of R&D tax incentives, and Mayne Pharma can facilitate introductions to local CROs.
Focus on Spray Drying and Spray Coating Expertise
Spray drying and spray coating are related technologies widely employed in pharmaceutical formulation to entrap different substances and to protect particles. Spray drying is commonly used to transform liquid drug formulations into dry, easily storable powders or particles, particularly to improve the solubility and bioavailability of poorly water-soluble drugs by converting them into amorphous or finely dispersed forms. Formulation of drugs based on poorly soluble active pharmaceutical ingredients (APIs) continue to present challenges, comprising up to 40% of commercialized products and 70–90% of drug candidates in development.10 Spray coating, which involves applying a thin, uniform layer of a coating material onto drug particles or dosage forms, like tablets or capsules, is leveraged to aid in enteric coatings, sustained-release formulations, and multiparticulate drug delivery systems, as well as for taste masking and cosmetic improvements to tablets.
Demand for spray drying and spray coating continue to grow, with the market expected to expand from U.S. $1.97 billion in 2023 to $2.78 billion by 2028.11 This growth can be attributed to several factors: the precise control enabled over particle size, which is critical for enhancing dissolution rates and optimizing drug delivery; the ability to encapsulate sensitive compounds, protecting them from degradation and ensuring stability; the suitability of the processes for continuous manufacturing, which aligns with the pharmaceutical industry's growing interest in efficient, cost-effective production methods; and the adaptability of spray drying and coating to a wide range of drug types, including multi-drug combination products.
Despite the heightened demand for these capabilities, capacity — not to mention the nuanced expertise needed to achieve the best results for a given project — remains limited globally. The extensive experience in spray drying and coating held at Mayne Pharma’s Adelaide site — which actually predates Mayne’s acquisition of the facility — is a strong differentiator for the company, particularly within the Australian market.
Reduction of development timelines has become essential in the post-COVID-19 pharmaceutical market. Given the supportive ecosystem and commitment by the Australian government to expand the pharma and biotech sectors, partnering with Australian CROs and CDMOs is an effective approach to accelerating development programs while simultaneously reducing costs. The number of early-phase clinical trials taking place in Australia is growing rapidly, and increasing benefits can be realized by engaging an Australian CDMO that can support those local clinical studies.
Collaboration with Mayne Pharma can help maximize those benefits for clients with small molecule candidates. Our decades of experience and proven success supporting projects from concept to commercialization, including tailored solutions across all stages of development, our long history of innovation and connections with Australian government programs, and a local network of CROs ensures that customers achieve their milestones as rapidly and cost-effectively as possible.
In summary, sponsors looking to establish a true competitive advantage should consider Australian companies as valuable partners for achieving innovation, efficiency, and success in their drug development endeavors. With more and more global pharmaceutical companies taking advantage of the benefits of Australia’s ecosystem, those that are not risk missing out on one of the industry’s best kept secrets.
Grant Swart is the General Manager at Mayne Pharma Services. Grant has held several senior management positions, including Head of Operations at Aspen Pharma and Reckitt. In his various roles, he has successfully built high-performing teams, supporting them in delivering exceptional business results in both supply and commercial. He has spent much of his career focused on change and business transformation driving sustainable profitable revenue. He has a strong background in Lean methodologies which he has applied across many organzations.