05 Apr 2024 | Nate DiTommaso, Rachel Capone, Renee Boerner
Have you ever wondered why some companies choose to do their first in human clinical trials in Australia? Are there any real advantages or are people just looking for an excuse to go to the ‘Land Down Under,’ cuddle with koalas, or visit the Sydney Opera house? There are plenty of good reasons to start your clinical development in Australia that have nothing to do with the beautiful landscape or Aussie culture.
In Australia, the Therapeutic Goods Administration (TGA) regulates the use of unapproved drugs in clinical trials under the therapeutic goods legislation (https://www.tga.gov.au/clinical-trials). There are two different regulatory pathways for conducting clinical trials, either through the Clinical Trial Notification (CTN) or Clinical Trial Approval (CTA) schemes. While both schemes require approval by Human Research Ethics Committees (HREC), only the CTA scheme requires TGA review prior to the start of the clinical trial. Fortunately, many products, including small molecules, viral vaccines, and recombinant proteins, can proceed via the CTN scheme. The CTN scheme only requires submission of an online form and fee, approval by the HREC and institutional authorizations, with a focus on trial design, the potential risks and ethical acceptability. For first in human trials, the only Chemistry, Manufacturing and Controls (CMC) information required is found within the Investigator’s Brochure (IB) in contrast to the US, Europe and Canada which require a complete Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) submission. This significantly reduces the Sponsor’s up-front burden on documentation required for the clinical trial application. Australia’s streamlined process and clinical trial infrastructure allows for trials to start within approximately 6-12 weeks from the time of the CTN application, which can reduce the overall drug development time and cost for Sponsors. Due to its fast and pragmatic regulatory framework, Australia has become a preferred destination for conducting clinical trials with over 1800 new trials initiated per year, which has increased by more than 22% since 2015 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9876817/).
Other reasons to conduct clinical trials in Australia include:
- Adherence to Good Clinical Practice (GCP) standards and International Counsel for Harmonization (ICH) E6 guidance.
- Access to world-class scientific and medical research infrastructure.
- High quality of data and results.
- Portability of the data including but not limited to the Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada.
- English is the native language.
- Australia’s population diversity is representative of the United States, Europe, and Canada; and
- Potential government supported financial benefits (https://www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-in-australia).
The government supported benefits include up to a 43.5% cash back incentive for research and eligible clinical expenses for small companies (with revenue <$20 million) or a 38.5% tax offset for large companies. The only catch is that you need to be a registered entity in Australia, however there is no brick and mortar required. Those savings should justify and more than cover your next vacation, I mean a business trip, to Australia!
Keep in mind that Australia may not be the optimum choice for everyone. For instance, applications for conducting clinical trials involving genetically modified organisms are much more complex and require a longer timeline. Therefore, it is important to consider multiple options when deciding where to begin clinical development. Syner-G BioPharma Group offers a team of experienced regulatory affairs professionals that can provide you with expert consultation and strategic planning around those decisions. If you need assistance with defining your regulatory strategy or writing your clinical protocol and IB to get you into the clinic in Australia or elsewhere, Syner-G can help. If your strategy takes you to other countries requiring full dossiers with CMC information, Syner-G’s specialized CMC services (both Regulatory CMC and CMC Technical) are also available. Wherever you are in your product lifecycle, Syner-G is here to assist.
G’day mate!
Nate DiTommaso, MS
Nate DiTommaso, MS is a Regulatory Affairs Manager and a member of the Syner-G team since the acquisition of Impact Pharmaceutical Services in January 2022. He has over 5 years of Regulatory Affairs experience in the pharmaceutical industry and is well versed in GxP, as well as in the Clinical and Quality operational aspects of drug development.
Nate assists internal and external stakeholders with the preparation, submission, and maintenance of investigational new drug (IND) applications, as well as new drug applications (NDAs) and biologic license applications (BLAs). He provides strategic guidance and regulatory information to product development teams, assist in the authoring and review of regulatory documents to ensure compliance with applicable regulations and guidelines, leads and/or coordinates FDA interactions and communications, and serves as the US Authorized Representative (primary FDA contact) for INDs and NDAs.
Nate has successfully managed large scale documents and submissions for multiple different products in oncology, dermatology, neurology and psychiatry. Nate has experience preparing and reviewing many types of regulatory documents including, IB’s, protocols, CSR’s, orphan drug requests, fast track/breakthrough requests and DSURs/annual reports. He also has experience with preparing strategies and meeting materials (requests and briefing packages) for facilitating discussions with FDA at all phases of development (pre-IND to NDA).
Prior to joining Syner-G, Nate received a bachelor’s degree in Pharmaceutical Sciences at MCPHS University in 2015, master’s degree in Regulatory Affairs and Health Policy at MCPHS University in 2017 and has spent most of his career on the Sponsor side of drug development with focus on R&D, nonclinical studies and early phase clinical development (phase 1 and 2 trials).
Rachel Capone, MSHS
Regulatory Affairs Manager
Rachel Capone, Regulatory Affairs Manager at Syner-G BioPharma Group since October2021 comes with 9+ years’ experience in the pharmaceutical industry. Rachel is an experienced Regulatory Affairs professional in the pharmaceutical industry, skilled in global regulatory strategy, document drafting and strong program and project management.
Rachel spent most of her career on the Sponsor side of drug development with a focus on global regulatory strategy, R&D, early phase development and post approval projects. Rachel has been involved in receiving FDA approval for 2 major NDA submissions for products focused to treat substance use disorders and serious mental illnesses. Rachel also has experience preparing and reviewing regulatory documents including INDs, NDAs, annual reports, DSURs, PSMFs, orphan drug designation, fast track/breakthrough designations, protocols, and labeling.
Rachel also has experience with preparing strategies and meeting materials to facilitate discussions with FDA and has attended multiple FDA meetings including Type B, Type C and Advisory Committee Meetings.
Rachel’s work experience includes Impact Pharmaceutical Services, Indivior and PPD.
Rachel received a Master of Science in Health Sciences (MSHS) focused on Regulatory Affairs from The George Washington University School of Medicine and Health Sciences in 2019.
Renee J. Boerner, PhD
VP, Regulatory Affairs
Renee has over 25 years of experience in the pharmaceutical and biotechnology industries. She is a highly regarded Regulatory Affairs, CMC, and Quality professional with proven success in investigational and marketing regulatory applications for small and mid-sized companies across multiple therapeutic areas, including oncology, CNS, and infectious diseases.
Renee has served as a regulatory lead or significant contributor for the approval of four US commercial products, including the primary FDA contact for 1 NDA and 1 BLA and collaborating with commercial partners for approvals in Europe, Taiwan, and South Korea.
At Syner-G, Renee is responsible for establishing standards and strategies for worldwide regulatory submissions supporting multiple therapeutic areas across all stages of development (IND, CTA/IMPD, BLA, NDA, MAA). She also provides strategic regulatory support, specializing in biologics and advanced therapies (vaccines, cellular-derived products including extracellular vesicles, and gene therapies).
Before joining Syner-G, she utilized her regulatory expertise at several organizations, including Bavarian Nordic, Argos Therapeutics, and BioDelivery Sciences International, where her responsibilities included establishing and leading regulatory teams, creating and implementing regulatory strategies, and contributing to Modules 1-5. Prior to Regulatory Affairs, Renee was responsible for the Analytical and Formulation development group supporting the clinical development of numerous biopharmaceuticals at Diosynth Biotechnology.
Renee earned her PhD in Biochemistry from the University of Minnesota, Twin Cities, MN, and a BS in Biochemistry from the University of Wisconsin, Madison, WI.