Article by Teresa C. Gallagher, Ph.D., M.S.
On November 13, 2018, BIOCOM’s San Diego office offered a panel presentation to its members on “Clinical Trials in the Asia Pacific Region: The Competitive Edge.” BIOCOM is a trade association and advocate for California’s life science sector, with offices in San Diego, Los Angeles, the San Francisco Bay Area, Washington DC, and Tokyo. Panel members were Cameron Johnson, CEO Nucleus Network, Australian Phase 1; Aditya Kotta, Business Development, Novotech; and Stewart Walker, Vice President, CoSec Consulting.
According to Aditya Kotta of Novotech, 4.56 billion people, 60 percent of the world’s population, lives in Asia, making it an attractive region for conducting clinical trials.
Nucleus Network is an Australian Phase 1 site specializing in the conduct of First-in-Human, Phase 1 clinical trials. Novotech, headquartered in Australia since 1996 and operating in the Asia Pacific region, is internationally recognized as a regional full-service CRO. CoSec Consulting is an Australian boutique firm of experienced governance professionals, offering a suite of end-to-end corporate, compliance and statutory secretarial services. To participate in Australia’s R&D incentive program, you need to have a subsidiary in Australia. CoSec acts as a subsidiary, and Walker represents CoSec in the U.S. and Australia.
Cameron Johnson, Nucleus Network’s CEO, presented on the advantages of conducting clinical trials in Australia. Nucleus Network is an Australian dedicated phase 1 clinical trials organization specializing in the conduct of First-in-Human (FIH) clinical trials, with extensive experience in the conduct of all of the early phase study designs in Healthy Volunteers and Patient Populations, including FIH, single ascending dose (SAD), and multiple ascending dose (MAD). Nucleus Network has conducted well over 500 early phase studies over the last 10 years, with the majority of these being sponsored by overseas companies who saw the benefits of working in Australia. Ninety percent of their revenue comes from the U.S., with 80% from biotech companies and 20% Big Pharma.
Australia has become a destination for both small and large pharmaceutical and biotech companies looking to conduct early stage clinical trials. The country has a well-established ecosystem for early phase trials, and is internationally recognized for its world-class research capabilities and highly skilled researchers, all critical prerequisites for early phase trials. The Australian government has adopted policies and practices to attract more global drug developers to the country to conduct early stage clinical trials. According to a Frost and Sullivan report, more than 1,000 research projects covering medical device, pharma and biotech have been conducted in Australia in recent years, amounting to more than $1 billion being spent on clinical trials.
According to Johnson, what’s driving the U.S. market to come to Australia is really three key aspects: the speed, the quality, and the cost of conducting early phase trials.
Speed. The Australian government has shortened the time required to start early-phase clinical trials by simplifying regulations. U.S. companies conducting early stage trials in Australia do not need to file a detailed IND before starting a Phase 1 trial that is reviewed by the FDA. Clinical trials in Australia operate under a notification program that significantly reduces the regulatory burden on clinical trial sponsors, enabling sponsors to save both time and money. Under the Clinical Trial Notification (CTN) scheme, clinical trial materials are submitted to an institutional ethics committee that reviews the scientific validity, design, safety and ethical aspects of the proposed research, and notifies the Therapeutic Goods Association (TGA) of the trial following the site approval. Although the TGA does not review trial plans in advance, the agency can audit and investigate the management of a clinical trial.
According to Josh Vosovic, Nucleus Network’s Director of Business Development, their strong overseas client base is largely due to Australia’s regulatory framework.
This pathway has proven to be an attractive and effective model for clients who have been able to rapidly enter the clinic and generate quality data that is acceptable to the overseas regulatory authorities. Some of their clients have solely relied upon the Phase 1 data generated in Australia to then successfully open their IND with the FDA and move straight into Phase II clinical trials. Typical times from submission of Protocol and Investigator’s Brochure to the ethics committee through to clinical trial approval and commencement are 4-5 weeks. Limited CMC materials are required.
From a clinical trial supplies perspective, Australia follows the 2009 U.S. Guidance on manufacture for Phase 1 materials, where the manufacture does not have to be completed in a GMP licensed facility, but does need to be done within the principles of GMP. Nucleus Network is supported by clinical trial pharmacists that can formulate active pharmaceutical ingredients (APIs) into clinical doses for just-in-time compounding, saving on time and costs associated with shipping to Australia.
Quality. Data output from studies carried out in Australia meet global standards and are accepted by both the FDA and the EMA, and can be used to support international regulatory applications, including the U.S. FDA IND submission. Nucleus Network has been audited by the U.S. FDA, has been inspected by the EMA, and has received ANVISA certification. They are regularly audited by Sponsors, averaging an audit every 3-4 weeks.
Cost. Another major incentive for attracting trials to Australia is the cost-effectiveness. Australia’s government offers tax incentives to attract more global drug developers to the country to conduct early stage clinical trials. Government incentives directed at research development, including clinical trials, include a 43.5% R&D tax benefit for eligible organizations with annual revenues of less than $20 million in Australian dollars, and a 38.5% non-refundable R&D tax offset for eligible companies with total annual revenue of more than $20 million.
According to CoSec’s Walker, this is the “cherry” on top of the other benefits of conducting early stage clinical trials in Australia.
According to Nucleus Network’s Johnson, it is 20-25% cheaper to do early stage clinical trials in Australia compared to the U.S., due to favorable exchange rates, and for companies that are eligible for Australia’s R&D program, Australia can be up to 60% cheaper compared to the U.S. However, getting into the clinic faster is where the real financial aspect comes into play.
Finally, Australia provides an outstanding entry point to conducting later stage clinical trials in the Asia Pacific region.
Biocom. “Clinical trials in the Asia Pacific region: The competitive edge.” Live program, November 13, 2018, San Diego, CA.
Novotech Update: 8 reasons why Australia should be your next clinical trial destination. https://bit.ly/2La6Fom
Australia the not-so-secret destination for pharma and biotech clinical trials.