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Australia's New Approach Methodologies Advantage

 

HM.BioConsulting Spotlight Series ISSUE 10-1  ·  MAY 2026


A Strategic Intelligence Report by

Henning Mann, HM.BioConsulting, Emma Aitken, Australian Trade & Investment Commission, Michael Phelan, InnovApproach Consulting


Prepared by Henning Mann, PhD  |  Founder & Principal, HM.BioConsulting

May 2026 


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EXECUTIVE SUMMARY

  

Australia has quietly become a powerful launchpad for early-phase clinical development, and a rising hub for New Approach Methodologies (NAMs), including organ-on-chip, organoids, and in silico platforms. However, for many US and EU biotech and drug development innovators, this opportunity remains largely undiscovered.


This whitepaper argues that Australia's unique regulatory architecture, centered on the Clinical Trial Notification (CTN) pathway, the Therapeutic Goods Administration (TGA), and an internationally progressive Human Research Ethics Committee (HREC) system, delivers a measurable competitive advantage for drug developers seeking to move faster and cheaper from preclinical to first-in-human. When combined with Australia's emerging NAMs ecosystem, government-backed infrastructure, and a 43.5% R&D tax rebate, that proposition is quite compelling.


We identify three strategic dimensions of the Australian advantage: speed and cost in early-phase trials; regulatory openness to NAMs data as supporting evidence for first-in-human applications; and a nationally coordinated NAMs research infrastructure that is actively seeking international partnership and technology transfer.


For HM.BioConsulting clients, whether drug sponsors with NAMs data seeking an efficient pathway to early-stage clinical trials or organ-on-chip developers seeking clinical validation partners, this landscape represents a genuine bilateral opportunity that HMBC is uniquely positioned to navigate.


01  The Australian Early-Phase Clinical Trial Advantage


For international biotechs, Australia offers one of the clearest risk-reduction plays available in early drug development. The combination of regulatory speed, cost efficiency, and globally accepted data quality is well-documented and increasingly attractive given regulatory headwinds in the United States.


1.1  The Regulatory Architecture: TGA and the Dual-Pathway System

Australia's clinical trial framework is administered by the Therapeutic Goods Administration (TGA), the Australian equivalent of the US FDA. Unlike the FDA's Investigational New Drug (IND) application system, which requires pre-trial review and approval by the regulator before studies can begin, Australia operates two parallel pathways:

•        Clinical Trial Notification (CTN) Scheme: The primary and fastest route. Under CTN, the TGA is notified of the trial rather than asked to approve it in advance. Ethics review and institutional sign-off (through an accredited HREC) carry the regulatory burden. Crucially, an IND equivalent is not required before patient recruitment can begin.

•        Clinical Trial Approval (CTA) Scheme: Used for higher-risk trials. More comparable to an IND process, but still generally faster than US timelines.

The CTN pathway is the workhorse of early-phase research in Australia. Because HREC review occurs concurrently with (or even before) TGA notification, the entire study start-up process, from sponsor engagement to first patient recruitment, can be completed in as little as 5–6 weeks. In the US, an equivalent Phase I IND review alone can consume three to six months.

 

 

1.2  The HREC System: Ethics as Enabler

Human Research Ethics Committees (HRECs) are the guardians of clinical trial ethics in Australia. Accredited HRECs operate in both the public and private sectors. The most prominent private sector HREC, Bellberry Limited, reviews approximately 40% of all clinical trials conducted in Australia through the CTN pathway.

Critically, Bellberry is actively engaged in shaping how NAMs data is understood and evaluated within the ethical review process. As detailed in Bellberry's 2024 NAMs Workshop Report (conducted jointly with the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, ASCEPT), Bellberry is working with the TGA, academia, and industry to develop HREC expertise in evaluating organ-on-chip and other NAM-derived preclinical evidence for first-in-human trial applications.

This means Australia's ethics system is proactively building the competency to accept NAMs data. Not necessarily as a replacement for all traditional preclinical evidence, but as a complement that can strengthen the safety case for early human trials. For NAM technology developers, this creates a genuine pathway to clinical utility that does not yet exist in most other jurisdictions.


KEY INSIGHT: Why Australia Allows Faster First-in-Human Entry

Under the CTN pathway, Australian HRECs focus on the scientific and ethical merit of the trial design, risk-benefit analysis for participants, and the quality of supporting evidence. They are not constrained to require the same preclinical data package as a US IND. This creates regulatory flexibility (with appropriate scientific justification) to incorporate novel evidence sources, including NAMs, into the preclinical dossier.


The TGA, whose Director of Toxicology (Dr. Chris Schyvens) actively participates in the Bellberry/ASCEPT NAMs Working Group, has confirmed that nothing in the Therapeutic Goods Act explicitly prohibits the use of alternative models, provided adequate scientific justification is presented.

 

Source: Bellberry/ASCEPT NAMs Workshop Summary Report, November 2024


1.3  Data Quality, Global Acceptance and Cost Efficiency

Data generated under Australian GCP-compliant trials is accepted by all major regulatory agencies including the FDA and EMA. A company can complete Phase I (and often Phase II) in Australia and then transition directly to a US or EU Phase II or III program without repeating trials.


Furthermore, the combination of the AUD/USD exchange rate and the Australian Government's Research and Development Tax Incentive (R&DTI), effectively reduces trial costs by nearly half. The R&DTI provides a refundable tax offset of up to 43.5% on eligible R&D expenditure for most early-stage biotechs. This rebate applies across all eligible R&D activities in Australia, including preclinical work and Phase I and Phase II clinical trial costs. Compared with the US R&D tax credit (standard rate up to 20%, but with an effective rate of approximately 6-8% net benefit), the differential is stark.

Global biotech companies, particularly US ones, have already voted with their programs. Australia is a first-choice Phase I destination for many US biotechs; what is missing is awareness of how NAMs fit into this picture.


 

02  Leveraging Australia's Regulatory Framework for NAMs in Drug Development

The intersection of Australia's fast-track clinical trial system with the global shift toward New Approach Methodologies (NAMs) creates a unique strategic opening. For biotech companies developing or using organ-on-chip systems, organoids, in silico models, or other NAMs in their preclinical pipeline, Australia offers a regulatory environment that is actively engaging with this paradigm shift.


2.1  What Are NAMs and Why Do They Matter?

New Approach Methodologies (NAMs) is the internationally accepted term (aligned with US FDA and EU EMA nomenclature) for human-relevant alternatives to traditional animal testing in medical product development. NAMs encompass three broad categories:


•        In Vitro: Microphysiological systems (organ-on-chip), organoids, 3D bioprinted constructs, spheroids, iPSC-derived tissues

•        In Silico: Computational modelling, AI/ML-based prediction, digital twins, virtual human simulations

•        In Chemico: Cell-free methods, biochemical pathway assays, chemical genetics approaches


The global pivot toward NAMs is driven by legislative tailwinds (the US FDA Modernization Act 2.0, and the proposed Act 3.0 before Senate, persistent failure of animal models to predict human responses adequately, the rising complexity of biologics and cell/gene therapies, and the high cost and ethical burden of traditional animal studies. As noted by Dr. Danilo Tagle of NIH's NCATS when participating at the Bellberry/ASCEPT NAMs Workshop in Melbourne in November 2024, the NIH now operates under a Congressional mandate to develop a strategic plan for transitioning research toward NAMs.


2.2  The TGA's Position on NAMs

Australia's Therapeutic Goods Administration has engaged directly and constructively with the NAMs question. The Therapeutic Good Act contains no absolute mandate for animal testing, and no prohibition on alternative models. What the TGA requires is adequate scientific justification when deviating from conventional preclinical approaches.


This is a critically different stance from the US FDA's historical posture, which has, until the FDA Modernization Act 2.0, effectively required animal studies as a precondition for IND approval. The TGA's approach, aligned with ICH guidelines and the European EFSA's 3Rs framework (Replacement, Reduction, Refinement), gives sponsors meaningful flexibility to construct a NAM-supported preclinical package.

The TGA's current engagement with international bodies, including ICCVAM (USA), JaCVAM (Japan), and the EU Joint Research Centre for Alternatives to Animal Testing, further signals that it is preparing for a future where NAMs data is increasingly integrated into regulatory submissions.


2.3  Practical Pathways: NAMs Data Supporting First-in-Human Applications

For international biotechs using organ-on-chip or other NAMs in their preclinical programs, the Australian CTN pathway creates several practical opportunities:


•        Strengthening Phase I Applications with NAMs Evidence: HREC review under CTN focuses on risk-benefit analysis and ethical acceptability. A well-constructed submission incorporating multi-organ chip safety data (e.g., for hepatotoxicity, cardiotoxicity), organoid efficacy data, or in silico PK/PD modelling can complement (or in some cases partially replace) animal studies, provided the scientific justification is robust and the HREC has appropriate expertise.


•        "Second-in-Class" vs Novel Molecule Pathways: As the Bellberry/ASCEPT workshop noted, ethical considerations differ significantly between novel first-in-class molecules and those with structural analogs already in clinical use. For the latter, existing clinical data from related compounds can support a lighter NAMs-forward preclinical package.


•        Regulatory Sandboxing Opportunity: Bellberry and ASCEPT have explicitly called for the development of "regulatory sandboxes" where NAM technology developers, sponsors, and regulators can stress-test emerging models against the Australian legal framework. This creates a structured pathway for NAM companies to validate their tools in a real regulatory context.


•        HREC Education as a Strategic Asset: Bellberry's active investment in training its HRECs to understand NAM data, including in silico methodologies that may require data scientists and computational modelers on ethics panels, means Australian ethics committees are among the most NAMs-literate in the world. This is not yet the case in most US IRBs.

 

 

2.4  The Bellberry/ASCEPT NAMs Workshop Series

In November 2024, Bellberry Limited and the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) convened the first in a planned three-meeting NAMs Workshop Series in Melbourne. This initiative brought together an extraordinarily high-level group: the TGA's Director of Toxicology, the NIH's NCATS representative (Dr. Danilo Tagle), Therapeutic Innovation Australia's leadership, CSIRO researchers, and academics from Monash, Melbourne, Sydney, and Flinders universities.


The workshop produced a set of action items that function as a de facto NAMs roadmap for Australia: developing a consensus statement on NAMs implementation, building HREC capacity, establishing regulatory sandboxes, creating connection mechanisms between NAM technology developers and pharma end-users, and developing a communication strategy for NAMs policy. A second workshop was planned for September 2025, with a third in 2026, culminating in formal policy recommendations.


For international companies, this workshop series signals that Australia's NAMs conversation is happening at the highest levels of its regulatory and scientific community and that the doors are open for international participation and partnership.


STRATEGIC IMPLICATION FOR US/EU BIOTECHS

A US drug sponsor that has generated human-relevant organ-on-chip preclinical data faces a challenging path through the traditional FDA IND process, where animal study requirements are still firmly embedded. The Australian CTN pathway offers an alternative: conduct a first-in-human Phase I study in Australia, supported in part by NAM-derived evidence (with appropriate scientific justification), generate FDA-accepted safety data in humans, and use that clinical data as the foundation for a subsequent US IND. This will dramatically compress the traditional preclinical-to-clinical timeline and reduce animal study burden.

 

This summary reflects the explicit direction of the Bellberry/ASCEPT NAMs Roadmap and the TGA's stated willingness to engage with the scientific community on NAM integration.

 

03  Australia's NAMs Excellence: Research Infrastructure and Partnership Opportunities

Australia's NAM capabilities extend well beyond regulatory openness. In 2023, the Commonwealth Scientific and Industrial Research Organisation (CSIRO), Australia's national science agency, published a landmark national strategy assessing the potential of emerging non-animal models for medical product development. The country has developed a nationally coordinated research infrastructure in organoids, microphysiological systems, and computational biology. And while a NAMs-forward CTN submission doesn’t require NAMs generated in Australia, the country’s research excellence and integrated community offers a compelling opportunity for international collaboration.


3.1  Government-Backed Research Infrastructure

Australia has built a cluster of world-class organoid and NAM research facilities, most with explicit mandates to serve academic, government, and commercial partners, including:


Australian Organoid Facility (AOF) — University of Queensland

Located at the Australian Institute for Bioengineering and Nanotechnology (AIBN), the AOF is a not-for-profit automation facility producing quality-assured organoids for basic, translational, and contract research. Using state-of-the-art robotic platforms (AOF Explorer G3 Workstation), the facility offers high-throughput organoid production, drug screening, high-content imaging, and model development services across brain, kidney, blood vessel, and cancer organoid systems. The AOF is explicitly structured as a partner for CROs and pharma companies.


NSW Organoid Innovation Centre (NSWOIC)

Funded by the NSW Government and launched in early 2025, the NSWOIC is a multi-institutional initiative combining UNSW Sydney, the University of Sydney, and the Children's Medical Research Institute. It integrates robotics, AI, and advanced stem cell technologies to provide accessible, reproducible organoid production for drug discovery, disease modelling, and personalized medicine applications. Notably, the Centre highlights that the FDA has authorized organoids and organ-on-chip models as alternatives to animal testing, a direct validation signal for US partners.


Victorian Centre for Functional Genomics — Peter MacCallum Cancer Centre

The VCFG at Peter Mac provides genomic screening capabilities that complement organoid and NAM drug discovery pipelines, offering a critical link between target identification and disease model validation, particularly relevant for oncology-focused organ-on-chip developers.

Stem Cell Disease Modelling Laboratory — University of Melbourne

The Pébay Lab at Melbourne specializes in iPSC-derived disease models, with particular expertise in neurodegeneration and retinal disease, application areas where organ-on-chip technologies are making significant inroads.


3.2  Commercial NAMs Companies: An Emerging Australian Ecosystem

Australia is producing commercially sophisticated NAM companies with technologies that complement or compete with leading US and EU players. Several are already attracting international attention:


Inventia Life Science

Inventia is Australia's most internationally visible organoid company, recently recognised by Genetic Engineering & Biotechnology News (GEN) in its Top 10 Organoid Companies list. The company's RASTRUM™ platform enables rapid, automated and reproducible 3D cell culture, with applications across oncology drug screening and personalized medicine.


Tessara Therapeutics

Tessara Therapeutics develops iPSC-derived 3D brain micro-tissue models through its proprietary RealBrain® platform. Its ArtiBrain™ (healthy brain) and ADBrain™ (Alzheimer's disease model) products serve CNS drug discovery, one of the highest-attrition areas of pharmaceutical development where human-relevant models are most urgently needed. Tessara's Scientific Officer, Professor Paul Adlard, is a member of the Bellberry/ASCEPT NAMs Scientific Advisory Committee.


Gelomics

Gelomics has developed LunaX™, a photocrosslinking technology for rapid, reproducible 3D tissue model construction. Positioned for CRO, pharma, and academic markets, Gelomics enables tunable extracellular matrix stiffness to mimic healthy and diseased tissue conditions, a critical capability for drug response modelling. The company has a growing international distributor network.


3.3  Therapeutic Innovation Australia (TIA): The Translation Infrastructure

Therapeutic Innovation Australia (TIA) provides the critical infrastructure bridge between academic NAMs research and commercial application. Its pipeline voucher system connects researchers and SMEs with world-class research facilities at Technology Readiness Levels 3–6 (TRL 3–6) and is specifically designed to generate the regulatory-grade preclinical data needed to support First-in-Human trial applications. TIA data shows a rising share of projects involving sophisticated models, with approximately 10% now incorporating NAMs.


 

04  Strategic Implications

The convergence of Australia's early-phase clinical trial advantage with its rapidly maturing NAMs ecosystem creates a set of concrete, actionable opportunities for emerging biotech companies – and HM.BioConsulting clients.


For US or EU Biotech Companies Using NAMs in Preclinical Development


•        Consider Australia as a Phase I launch jurisdiction: The CTN pathway's speed (5–6 weeks to study start), 43.5% R&D rebate, and absence of an IND requirement make it financially and operationally compelling for most early-phase programs.


•        Build a NAMs-inclusive preclinical dossier: Work with Australian CROs and the HREC system to structure a submission that incorporates organ-on-chip or organoid data as supporting evidence. HMBC can connect you with the right CRO partners and regulatory advisors who understand how to present NAM-derived evidence effectively. These comprehensive dossiers can include QSAR, PBPK, cell-based specificity, organoid safety pharmacology, organ-on-a-chip DILI prediction, etc., and can be coordinated with Australian clinical CROs.


•        Generate FDA-accepted human data faster: Australian Phase I data is accepted by the FDA. Use it to anchor your US IND application with actual human safety data, not just preclinical projections.


•        Access Australian NAMs research partners: The AOF, NSWOIC, VCFG and others offer contract research and collaboration pathways. For US sponsors and NAMs developers seeking validation data in additional model systems, Australian facilities offer cost-effective, high-quality options.


HOW HM.BIOCONSULTING CAN HELP 

 HM.BioConsulting operates at the intersection of science, strategy, and commercial execution. For companies seeking to leverage the Australian advantage, HMBC offers:

 

• Strategic assessment of the Australian regulatory pathway for your specific program and product profile


• Identification and introduction to Australian CRO, HREC, and research facility partners


• NAM commercialisation strategy: positioning, partnership development, and market entry planning for US/EU/AU markets


• Business development support for bilateral partnerships between US NAM developers and Australian clinical research organisations


• Fractional BD and commercialization leadership for companies that need senior expertise without full-time overhead

 

 

 

05  Outlook and Conclusions

The convergence of forces shaping this landscape will only accelerate. The FDA Modernization Act 3.0, if enacted, will further reduce animal study requirements in US drug development, increasing the urgency for validated NAM solutions. Australia's regulatory framework is already ahead of this curve. The Bellberry/ASCEPT NAMs Workshop Series will produce formal policy recommendations by 2026, potentially creating the world's first formal regulatory guidance on NAM data integration for First-in-Human trials.


At the same time, the structural advantages of Australia's clinical trial system, speed, cost, and data quality, are not diminishing. If anything, they are gaining relevance as US regulatory uncertainty, capital efficiency pressures, and the rising complexity of novel therapeutics push biotechs to seek more agile development pathways.

The bilateral opportunity between the US and Australia in the NAM and organ-on-chip space is significant, and the infrastructure to capture it exists today. Together will adequately deployed business development, strategic advisory, and commercialization partnerships this opportunity can be translated into executed agreements.


Inquire with HM.BioConsulting how we can provide the support you need.

 

ABOUT THE CO-AUTHORS

Emma Aitken is a Director with the Australian Trade and Investment Commission, the Australian Government’s official agency responsible for international trade promotion and investment attraction. Emma has over eight years’ experience working with US life sciences and healthcare companies, providing market information, advice and connections to Australian partners.

 

Dr. Michael Phelan is Founder and Principal Consultant at InnovApproach Consulting. Dr. Phelan has unparalleled expertise in NAMs FDA regulatory strategy and led the first and most advanced ISTAND program submission to date. Now based in Melbourne, Australia, Dr. Phelan is at the forefront of Australia’s accelerating NAMs research and industry ecosystem.

 

 

To discuss how HM.BioConsulting can support your Australia strategy,

contact Henning Mann at


06  Resources

Key Sources & Further Reading

•        Tessara Therapeutics

•        Gelomics

 

 

© 2025 HM.BioConsulting. All rights reserved. This document is prepared for informational purposes only and does not constitute regulatory, legal, or financial advice. All links and sources verified at time of publication.

 
 
 
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