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AusBiotech on Funding, Regulatory Navigation, International Expansion, and Clinical Trial Development in Australia’s Biotech Industry
Australia's biotech industry is poised for significant growth as it enhances clinical trial capabilities, expands into advanced manufacturing, and fosters innovation across therapeutic areas.
Australia’s biotech industry is rapidly growing and advancing, but several issues persist, including securing funding, navigating complex regulatory environments, expanding into international markets, and transitioning from early-phase to later-stage clinical trials. Currently, AusBiotech is working toward improving the industry by actively advocating for its members, facilitating strategic partnerships, and engaging in international collaborations. In an interview with AusBiotech CEO Rebekah Cassidy, she discussed the organization’s current movements and strategic focus. Cassidy highlighted how AusBiotech’s efforts to streamline regulatory processes, promote innovation, and expand clinical trial and manufacturing capabilities contribute to overcoming these challenges and driving growth in Australia’s biotech sector.
Umbrella Organization AusBiotech in Therapeutics, Medical Technology, Diagnostics, Digital Health, and Agri-Biotech
AusBiotech plays a fundamental role in Australia’s biotechnology landscape, representing a diverse membership that spans from startups to large multinational corporations. The organization’s influence extends across various sectors within biotech, with a focus on 4 main areas including therapeutics, medical technology, devices and diagnostics, as well as digital health and agri-biotech.
AusBiotech CEO and Managing Director, Rebekah Cassidy, detailed the organization’s broad representation within Australia’s biotech industry: “We represent the total ecosystem in many ways. Our members come from all parts of the biotech sector, from startups and SMEs to research institutes and large multinationals.” This inclusivity allows AusBiotech to advocate effectively for its members’ interests and promote collaboration across the sector.
She further highlighted AusBiotech’s role in fostering collaboration and partnerships: “Australia’s biotech sector is energized, with strong growth and new investments across all states and territories. We facilitate new connections and partnerships, which are essential for our members’ success in a competitive global market.”
The Latest Industry Movements in Australia: Regenerative Medicine, AI and Genetics A Current Focus
Showcasing the latest developments, AusBiotech reported significant industry movements with Orthocell, an Australian headquartered company developing regenerative medicine products. Here, the locally based business reported achieving record quarterly and yearly revenue, primarily driven by sales of its medical devices, Striate+ for dental bone regeneration and Remplir for peripheral nerve repair. Under the umbrella of Ausbiotech, the strong performance of the biotech industry is showcased through various strategic partnerships, such as that with BioHorizons Implant Systems, one of the largest global dental implant players, among numerous others for global distribution.
In the field of genetics, Australia is emerging as a prominent player with the latest expansion of locally based Genetic Technologies’ geneType genetic risk assessment tests into Canada and New Zealand. Following their successful entry into the US market through a partnership with Stayhealthy, this move highlights Australia’s proactive efforts to penetrate global markets. Developed since 2022, the geneType tests, rooted in Australia’s contributions to the Human Genome Project, underscore the nation’s advancing role in international biotech endeavors.
Australia’s One Stop Shop for Clinical Trials: Moving Toward Later-Stage Developments and Manufacturing
Australia is positioning itself at a critical juncture in biotech development, focusing on key areas. Historically excelling in early-phase clinical trials, the country now seeks to expand its capabilities to later-stage trials. National initiatives like the “one-stop shop” for clinical trials streamline processes, further enhancing Australia’s appeal as a prime clinical trial destination.
The biotech sector prioritizes growth and innovation by advancing clinical trial capabilities for later-stage developments and supporting high-tech and advanced therapy manufacturing. These efforts aim to achieve critical mass in the biotech industry, attract substantial investments, and strengthen Australia’s position in the global market. While Australia has earned a strong reputation for its Contract Research Organization (CRO) sector, it is diversifying by expanding into data management and advanced manufacturing services to attract investments and expand the nation’s biotech capabilities. Aligning with global trends, “the Australian Government’s sovereign manufacturing strategy includes a significant emphasis on medical science, aiming to attract advanced manufacturing investments, particularly in advanced therapies.”
AusBiotech, an umbrella organization in therapeutics, medical technology, diagnostics, digital health, and agri-biotech. AusBiotech COO/Deputy CEO Rosanne Hyland (left) and CEO Rebekah Cassidy (right) at the Australian Pavilion, BIO 2024, San Diego. Photo: GeneOnline.
Navigating Regulatory Challenges and Fostering International Collaboration
Navigating regulatory frameworks and fostering international collaboration remains essential for Australia’s biotech sector to thrive globally. AusBiotech works closely with government bodies and industry associations to advocate for favorable regulatory policies and facilitate partnerships that enhance Australia’s biotech capabilities worldwide. Australia’s regulatory system, well-regarded for its market access pathways, continues to evolve through ongoing reviews like the recent Health Technology Assessment (HTA) review, influencing policy discussions.
AusBiotech collaborates with peer organizations like Medicines Australia and the Medical Technology Association of Australia (MTAA) to ensure member support during regulatory transitions. Cassidy highlights the organization’s role in international collaboration, stating that engagements with organizations like the International Council of Biotechnology Organizations allow Australia to align with global standards and promote its biotech capabilities globally.
AusBiotech’s proactive stance on regulatory advocacy and international collaboration leverages synergistic efforts to navigate regulatory landscapes and foster impactful international engagements. This approach not only ensures regulatory compliance but also drives innovation and growth within Australia’s biotech industry. By enhancing clinical trial capabilities, expanding into advanced manufacturing, and fostering innovation, Australia strengthens its global position and attracts significant investments, with a collaborative mindset that aligns it with international peers.
Annual Events, AusMedtech and AusBiotech, Drive Industry Growth
Australia hosts two major biotech events annually: AusMedtech and AusBiotech. AusMedtech, focused on the medtech sector, convened in Adelaide earlier this year, drawing approximately 500 delegates. Organized by AusBiotech, this event energized discussions and showcased innovative companies emerging in the Australian Medtech landscape.
In contrast, AusBiotech, scheduled for late October to early November in Melbourne of this year, is one of Australia’s largest biotech conferences. It serves as a platform for the entire Australian biotech ecosystem, attracting both local stakeholders and international delegations seeking to forge connections and collaborations.
“We’re very excited about future developments and are absolutely open to having conversations with any countries that want to talk to us about their delegations. Locally and globally, we’re entering into all discussions with a truly collaborative mindset, knowing that we’re not separate and distinct, but rather joined in many ways.”
AusBiotech showcases its commitment to global biotech innovation at BIO 2024 in San Diego. AusBiotech COO Rosanne Hyland (left) and CEO Rebekah Cassidy (center) meet with GeneOnline CEO Thomas Huang (right) at the Australian Pavilion. Photo: GeneOnline.
