Australia, home to a world-class early phase clinical trial ecosystem
About Avance Clinical – the Australian CRO for Biotechs and 2020 winner of the Frost & Sullivan “Asia-Pacific CRO Market Leadership Award”
Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 20 years. Avance specialises in supporting biotech companies with their early phase clinical trials leveraging the world-class early phase clinical trials ecosystem in Australia.
Avance Clinical is able to deliver great value to biotech clients through deep experience with the ethics and regulatory process, established relationships with all of the early phase trial sites and adoption of technologies such as Medrio’s integrated eClinical solutions.
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Under six-week approval times. No IND required. Dedicated early phase site network.
Australia is a well-established and increasingly preferred global destination for early phase clinical trials. With more than two decades delivering early phase trials, Australia’s proven specialist ecosystem attracts biotechs wanting rapid drug development solutions with attractive rebates that bring down already competitive clinical trial costs. Australia’s effective management of the COVID-19 pandemic makes it even more attractive for sponsors wanting to mitigate against costly delays in their drug development programs.
The pillars of this world class early phase clinical trial ecosystem are the streamlined ethics and regulatory process and access to high quality private facilities that specialize in the conduct of both Phase 1 and Phase 2 trials in healthy and patient populations. Importantly during the COVID-19 crisis that has closed facilities around the globe, 100% of Australia’s Phase 1 Units have remained open allowing for trial continuity and ongoing drug development activities. This world-class early phase clinical trial ecosystem is underpinned by the financial attractiveness of the Australian Government’s R&D rebate which offers a rebate of up to 43.5% on clinical trial spend in Australia.
Streamlined Ethics and Regulatory Process
The Australian ethical and regulatory review process is the fastest in the world for undertaking early phase clinical trials. The Australian regulatory body for clinical trials, the Therapeutic Goods Administration (‘TGA’), offers two schemes for conducting clinical trials in Australia, namely the Clinical Trial Notification (CTN) Scheme and Clinical Trial Exemption (CTX) Scheme. Most clinical trials initiated in Australia are done so under the CTN Scheme. The CTN Scheme involves a simple notification process following ethics approval for the study. It is important to note that an active IND is not required to initiate trials in Australia under the CTN or CTX Scheme. Avance Clinical CEO, Yvonne Lungershausen says “that the majority of Avance Clinical’s clients are overseas biotechs looking to develop their products for international markets and while we recommend to our clients that they are in active discussions with the regulators it is not required for an active IND to be in place with the FDA prior to initiating trials in Australia.”
The scientific and ethical review for clinical trials in Australia is managed by the Human Research Ethics Committee (HREC). Study documentation is submitted electronically via eProtocol prior to an HREC meeting. Due to the streamlined regulatory and ethical review process Avance Clinical can achieve a Site Initiation Visit (SIV) and commence a study within 5 – 6 weeks of submission to the HREC.
Leading the way with high-quality ethical review in strict compliance with both international and local Australian clinical trial guidelines, Bellberry Limited is a national, private not-for-profit organisation providing streamlined scientific and ethical review of human research projects across Australia. Bellberry is Australia’s largest independent reviewer of human research studies providing services to almost a third of clinical trials conducted in Australia. Along with the quality of scientific and ethical review, timeliness is integral in supporting research, particularly in early phase studies. With twelve committees, Bellberry has an average turnaround time of about 20 working days from submission of application to review decision.
“Conducting research on humans carries risk. We have a public responsibility to ensure that all interactions undertaken during research are scientifically and ethically acceptable. The provision of review by a Human Research Ethics Committee is a vital part of ensuring the appropriateness of any research. As a country where world class research takes place, Australia recognises the value and importance of this review,” explained Kylie Sproston, Bellberry Limited CEO.
This year, Bellberry gained international recognition for the quality of its work by becoming the first Australian organisation to achieve accreditation for excellence and ethically sound processes in running HRECs from the US-based Association for the Accreditation of Human Research Protection Programs (AAHRPP), re-enforcing Australia’s position as the high quality early phase clinical destination.
“High research and quality standards (especially early phase capability), comparable costs, timely trial approval and reliable patient recruitment make Australia an attractive destination to conduct clinical trials.” Novartis – Clinical trial Capability Report
“In early phase clinical trials Australia is 28 per cent cheaper than the US before tax incentives, and 60 per cent cheaper after tax incentives.” Australia: Preferred Destination for Early Phase Clinical Trials. Frost & Sullivan
Medrio’s eClinical Solutions Facilitates Rapid Start-up
Avance Clinical is able to deliver significant value to biotech clients and capitalize on the streamlined ethics and regulatory process through partnering with progressive technology companies like Medrio. Medrio is a trusted eClinical provider offering an Electronic Data Capture (EDC) platform with integrated ePRO, eConsent, and Direct Capture.
Medrio CEO, Mike Novotny, commented that “Medrio has supported numerous study starts in Australia, over 150 with Avance Clinical alone, and we’re always impressed with the speed of their timelines.”
The team of in-house Clinical Programmers at Avance Clinical work directly in the Medrio eClinical platform to deliver a study ready, integrated EDC platform in parallel to the ethics review process. The outcome is that study start-up from final protocol to first patient enrolled can be achieved within 6 weeks. Australia’s streamlined ethics and regulatory process and Medrio’s eClinical platform is a perfect combination for accelerating study start-up, a critical component to early phase trials.
Listen to Avance Clinical CEO Yvonne Lungershausen and Sandrien Louwaars, Director of Business Development Operations, on Medrio’s new podcast series Trial Talks.
Australia’s over two decades of early phase research expertise was kick-started by Avance Clinical CEO Yvonne Lungershausen.
In 1999 Yvonne along with colleague Jane Kelly, CMAX Clinical Research CEO, conducted the first Phase 1 first-in-human study of a new chemical entity in Australia. Their knowledge and processes went in to setting-up what are now the leading Phase I facilities in Australia.
The top reasons for selecting Australia are:
- The Government R&D grant means up to 43.5% rebate on clinical trial spend
- Telehealth pivot during COVID-19 pandemic – speed and continuity
- Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
- No IND required for clinical trials
- Full GMP material is not mandated for Phase I clinical trials
- Established clinical trial environment with world-class Investigators and sites
- Established healthy subject databases and specialised patient populations
- Five independent Phase 1 facilities across Australia including hospital-based units for critical care
- Major hospitals with world class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
- Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia’s counter-flu and allergy seasons
“Australia is home to some of the world’s leading scientists, physicians and healthcare professionals. It boasts world-class medical research and healthcare infrastructure, a stable socioeconomic environment, an ethnically diverse population and a strong intellectual property regime.
An efficient regulatory system, including a rapid clinical trial approval system, well-established clinical trial infrastructure, experienced and well-qualified personnel and globally competitive tax incentives for research and development (R&D) investment, all help make Australia a leading destination …” Clinical trial Capability Report
Spotlight on Australia’s World Class Early Phase Trial Sites (alphabetical order)
The network of private clinical trial sites are the lifeblood of Australia’s world-class early phase ecosystem. With the ability to conduct trials from small first in human, healthy volunteer trials to conducting complex multi-centre phase 1 and phase 2 patient trials involving both small molecules and biologicals these specialist Australian sites cater for the full spectrum of early phase trials. Importantly during the COVID-19 crisis all of these sites have remained open to ensure clinical trial continuity.
Avance Clinical has great relationships with all of these high-quality early phase sites conducting studies across the spectrum of healthy volunteer and patient-based Phase 1 and Phase 2 trials. In combination with the streamlined regulatory review process provided by the Bellberry HREC, the CTN Scheme administered by the TGA and the Australian Government’s R & D rebate of up to 43.5% on clinical trial spend, Australia remains the premier destination globally for early phase clinical trials.
CMAX is Australia’s longest established facility for clinical trials, delivering high quality clinical trials for their international sponsors. Centrally positioned in the heart of Adelaide, CMAX is located opposite the Royal Adelaide Hospital and adjacent to the innovative BioMed City precinct. For the past 26 years CMAX has been conducting world-leading research for local and international clients, specialising in a range of early-phase trials and first-time-in-human studies. Their robust quality management systems provide sponsors with reassurance that trial data will be acceptable to the FDA and other regulatory agencies and have a long history of supporting international sponsors through this phase. CMAX CEO, Jane Kelly advised that “We’ve never seen more demand for our early phase trials, so it would seem that there is good recognition of the benefits of completing this work down under! In fact, a good portion of our work comes via word-of-mouth referrals, particularly from within the dynamic US biotech sector, which we see as evidence that our early phase advantage is real.”
Linear is a tech-centric, solutions focused clinical research group, specialising in first-in-human and other clinical pharmacology trials, first-in-human oncology trials, and first-in-patient trials, enabled by their strategic location within the QEII Medical Centre in Perth, Western Australia. It is co-located with a 600-bed tertiary adult hospital, 738-bed private hospital, state cancer centre, 400-bed paediatric hospital, numerous therapeutic specific research institutes, and the University of Western Australia Medical School. Dougal Thring, Head of Clinical Solutions at Linear commented that “with extensive expertise across the country, Australia is able to execute all aspects of early phase trials, low sample transport risks, and ensuring the highest quality output of data, accepted by global regulators.”
With 150 phase I beds co-located within major Hospitals in Melbourne and Brisbane, Nucleus Network is Australia’s largest Phase 1 clinical trials specialist. Nucleus Network’s clinics are located within two of Australia’s most prestigious teaching hospitals – the Alfred Hospital in Melbourne, and the Brisbane Hospital in Brisbane. These major city locations also provide Nucleus Network with access to over 7.5 million people for healthy volunteer and patient clinical trials. Nucleus Network has specialized physical infrastructure and specialized recruitment strategies to deliver complex first in human clinical trials to large volume scale biosimilar and through to the management of severely impaired renal patients across their different facilities. These are some of the reasons Nucleus Network was entrusted with the first COVID-19 vaccine trial in the southern hemisphere. Jeffery Wong, Director of Business Development for Nucleus Network stated that “with over 15 years’ experience in conducting early phase clinical trials for US, Asian and European Biotechnology and Pharmaceutical companies, Nucleus Network understand the evolving landscape of drug development. Access to patients, shortened recruitment timelines and the evolution of pharmacodynamic biomarkers are key fundamentals underpinning Nucleus Networks multi-site to approach to phase I clinical trials.”
Paratus Clinical operates three private clinics in the high population areas of the east coast of Australia with a fourth clinic to open in Q3, 2020. Paratus Clinical has been established to meet an increasing demand for clinical research sites in Australia with an emphasis on supporting both healthy volunteer and patient based studies. In particular they have conducted 17 early (Phase I-II) studies in both patients and healthy subjects for new medicines and vaccines. “We have built our success on our unique patient recruitment capability and large patient database which allows us to rapidly recruit and deliver large scale trials in competitive timeframes” said Matt Clacy, Chief Commercial Officer for Paratus Clinical.
PARC Clinical Research is a 12-bed clinical trials unit located within a major tertiary hospital, the Royal Adelaide Hospital, with an extensive track record in conducting Phase 1-3 high quality clinical trials across most medical and surgical specialities. It has staff and Intensive Care-level facilities able to manage a range of clinical trials, from low acuity trials through to those requiring invasive complex monitoring and high-acuity care. Professor Guy Ludbrook, Director of PARC Clinical Research stated that “PARC recognises the importance of having a strategic development plan in place, from the time of first-in-human trials, which aligns with current and future clinical need for a therapeutic product. To that end, it has extensive links to researchers, clinicians, health and academic centres, and health jurisdictions, across a broad range of medical disciplines. This ensures that every trial is designed to maximise the opportunities to obtain the knowledge essential to determine the optimal way forward for product development.”
Scientia Clinical Research has world-class clinical trial expertise and state of the art facilities enabling them to conduct a wide range of clinical trials, with a focus on early stage clinical research. Located in the Bright Alliance Building with the Nelune Comprehensive Cancer Centre and services of the Sydney Children’s Hospital. The facility is also co-located in a major research precinct with Prince of Wales Hospital, Royal Hospital for Women, UNSW Sydney and the Lowy Cancer Research Centre. “Utilising the capabilities of our state of the art facilities, our mission is to support the continuous development of new medicines to help to improve health and find better treatment options for patients,” said Scientia Clinical Research CEO, Lisa Nelson.
USC Clinical Trials Australia was established in 2015 with a goal to bridge the gap between innovative medicines and community.
The centre performs clinical trials in chronic diseases, vaccines, cancer, healthy volunteers, and medical devices across all phases of development.
Lucas Litewka, Director, USC Clinical Trials states, “Our network of sites work alongside primary and specialist care investigators to access a new population of over 850,000 patients. Community engagement forms the backbone of our recruitment strategies, a critical success factor in ensuring we can meet rapid enrolment goals in healthy volunteer and chronic disease studies.”