Australia, AI, and Autolomous

In 2025, data and AI moved from a biotech buzzword to a necessity. Indeed, biotechs are under increasing pressure to adopt AI solutions to accelerate development timelines, improve manufacturing efficiency, and unlock value from vast amounts of scientific and operational data. And, while adoption remains a challenge due to regulatory hurdles, Australia is well positioned to do just this, with AI policies already in place to strengthen the country’s role as a gateway to the Oceanic and APAC markets.

To discuss this in depth, pharmaphorum spoke with Alexander Seyf, CEO of Autolomous, about the future of AI in Australian biotech, the role of data infrastructure in commercial success, and how Australia's life sciences sector is becoming a global leader.

Q. Describe the Australian biotech landscape. What was it like and what has it become today?

Alexander Seyf: We have an outsider view on this: Autolomous is a UK-based company pioneering cloud-native and AI-enhanced digitisation of life sciences manufacturing and supply chains from R&D through to commercialisation.

Today, we see a coordinated life sciences environment with a national strategy, sovereign manufacturing intent, and the readiness to invest the capital required for success. To us, Australia has world-class science, global leadership in running quality clinical studies, and real strength in applied domains such as medical devices, diagnostics, vaccines, genomics, and precision medicine.

But, like Europe, Australia has lacked support for building commercial companies on home-grown intellectual property; the best ideas have scaled elsewhere, typically the US, because that’s where the capital and customers are.

This is changing, and quickly — and we want to accelerate it further. Take SMART CRC, an AUS$238 million programme supporting sixty-odd partners across academia and industry working to make sure next-generation Australian biotech products can be scaled for commercialisation. This and other efforts make Australia more attractive for global expansion beyond Europe and the US. 

Rapid and reliable scaling requires integrated systems and processes end to end. Often, unfortunately, start-ups and even more mature companies invest in end-to-end integration too late, and it slows them down, which is dangerous in a highly competitive global market. Australia isn't alone in this. We see the same issue in the US and Europe.

Q. AI solutions are a must, but regulatory hurdles often get in the way. How is Australia uniquely positioned with regard to AI policy?

I think Australia's decision to regulate AI through existing sector frameworks is the right call. It means regulation that adapts to the product, rather than to the technology it happens to use.

Like the US and China, and unlike the EU, Australia hasn't gone down the single AI Act route. The National AI Plan from December 2025 and the AI Safety Institute established in January 2026 created a technology-neutral framework built on existing laws. In February 2026, the TGA restated its position in guidance on software as a medical device: what triggers therapeutic goods regulation is the manufacturer's intended purpose, not whether the product happens to use AI. The EU AI Act, by contrast, sits on top of the existing device rules and pushes a lot of AI products into the high-risk bracket.

The Australian bet is that risk-proportionate, sector-led oversight lets good products move faster without giving up on safety. That should turn into a real competitive advantage for Australian companies, provided it’s executed well. We want to help Australian companies do exactly that. And it will certainly help if the TGA keeps playing a leading role in shaping governance inside the international frameworks.

Q. What role does data infrastructure play in commercial success today?

Data infrastructure still gets treated as a support function, when it's actually the foundation for seamless, reliable scaling and, ultimately, commercial success.

If you're making a medicine — investigational or commercial — you need end-to-end control over product identity, deviations, corrective and preventive actions (CAPAs), and traceability, and you need it documented. In cell and gene therapy, personalised vaccines, and radiopharmaceuticals, that goes all the way down to a single patient or a single batch. That's a data integration problem dressed up as a manufacturing problem.

The companies that struggle with seamless scaling for swift clinical development and commercialisation — and I've watched a few — are the ones that treat their data infrastructure as a downstream concern, tomorrow’s problem. That can mean paper batch records, disconnected LIMS, Excel deviation logs, and then a scramble at IND or MAA stage. It's not that they can't get through. It's that the cost and time involved generate delays for patients and healthcare systems, create audit risk, and expose inconsistencies and human error. That kills margins.

The Australian Digital Health Agency’s 2025–26 Corporate Plan prioritises interoperability, ‘share by default’ data access and AI governance – important for any life-sciences operator that must connect with hospitals, biobanks, regulators, and regional partners.

Manufacturers that already have their data in order will plug into that environment seamlessly. Those still working off paper and disconnected systems will find the gap widening and stay exposed to the errors they never caught.

Q. Where does Autolomous sit in all this?

Data infrastructure is the foundation everything else stands on. It enables the effective and reliable scaling of innovation that is vital for commercial success. Without data integration, AI solutions simply cannot gain access to the data or provide the benefits everyone is expecting from it.

Our autoloMATE platform was designed from the workflow up for life sciences operations and has been proven, with numerous academic and corporate customers and partners, to achieve substantial gains in reliability, productivity, scalability, and cost-effectiveness. Highly secure, cloud-native, and AI-enhanced, autoloMATE is a modular GxP platform that creates a digital backbone across manufacturing and supply chain operations in life sciences.

We're ISO 9001- and ISO 27001-certified and working towards ISO 13485 certification. We bring operating experience in the UK, EU, and US, and we're looking forward to working with Australian companies and learning from them in return.

We deliberately joined AusBiotech and became a SMART CRC associate. Australia's national strategy is credible, the sovereign manufacturing intent is real, and there is an appetite for data infrastructure partners who've already done the compliance work in other jurisdictions.

Q. How can AI strengthen the Australian biotech industry to access Oceanic and APAC markets?

AI is where governance and productivity meet. Applied properly and built on end-to-end digitisation, it enables export readiness from day one, backed by a governance story that travels.

AI can be the productivity multiplier that makes export readiness achievable from the day of approval. Not the "AI-powered" marketing gloss. Real, boring, operational AI: batch record intelligence, deviation triage, CAPA prioritisation, release testing analytics, and workforce augmentation for a sector that doesn't have enough experienced GMP staff to go around. That's how a small manufacturer can run at global-competitor tempo without a global-competitor headcount.

Governance is the other half. Australia's Voluntary AI Safety Standard, the AI Safety Institute, and the TGA's sector-led approach together give Australian companies a credible governance story to take into Singapore, Japan, Korea, and the Pacific region. If you meet the Australian bar, you're most of the way there for the rest of APAC. That's the compounding advantage nobody's talking about.

Q. What closing thoughts would you like readers to take away from our discussion?

Three things: execute on strategy, ensure the right mix of your own governance and the standards you operate within, and build secure sovereign infrastructure.

1. Australia has done the groundwork: national strategy, joint advisory group, SMART CRC, and early capital commitments. Execution is what determines whether the next decade delivers.
2. Make the existing framework work for you while helping it evolve. Ensure your governance is defensible and stay in the rooms where the national, regional, and global standards get written.
3. Sovereign capability requires sovereign infrastructure. Physical manufacturing plants matter. So does the digital layer that makes them efficient, interoperable, secure, and auditable — and their output exportable.

About the interviewee

Alexander Seyf is the co-founder and chief executive officer at Autolomous. He is a seasoned entrepreneur, business leader, and management consultant, with strong business acumen and strategic thinking, combined with an innovative mind to challenge existing thinking. He has over 30 years of consistent progression, building and reinventing businesses and working with market-leading firms and clients. A leader and a people person, Seyf is client-focused, with an influential and enthusiastic view and strong management style to identify and realise new business opportunities and create and lead cross-functional teams to exceed expectations.