This article is adapted from Burnet's 2023 Annual Report. Read the report here.
From the outset, the aim of the Burnet Diagnostic Initiative (BDI) has been to capitalise on Burnet’s expertise in diagnostics research and accelerate translation into market-ready products to improve access to high quality diagnostics.
Point of care diagnostics play a critical role in improving timely access to quality care, particularly in rural, remote, and under-resourced communities.
There is an urgent need for the development of simple, low-cost tests that can be operated in the field without sophisticated health infrastructure.
During the past 15 years, Burnet has built a successful track record in the development of new diagnostics in the fields of HIV (human immunodeficiency virus), hepatitis E, COVID-19, and other infectious diseases.
For those discoveries to have impact, they must be effectively translated into products that can be manufactured and distributed—reliably, cost-effectively, and in large numbers—to populations around the world.
"In diagnostics research, if you can’t translate the innovation, the idea, the concept into a tangible product that can be used in health screening around the world, then you won’t have the impact.” —Jennifer Barnes, Director, Office for Research Translation
The work of producing, distributing, and marketing those innovative products, not always but often, requires collaboration with commercial partners.
For that reason, the focus in recent years has been on ensuring that BDI has the systems in place to demonstrate the quality and rigour of its research, and share that research with potential commercial partners in such a way that they can quickly and confidently enter into partnerships and licensing agreements that will deliver those innovations to the market at pace.
In July 2023, after many months of work led by Director Jennifer Barnes, and Scientific Director Professor Heidi Drummer, BDI was awarded ISO 9001 certification, a globally recognised standard for quality management administered by the independent International Organization for Standardization (ISO).
ISO 9001 certification confirms that an organisation has developed and embedded processes that enable its workforce to consistently deliver high quality products and services.
In the case of BDI, this meant developing a highly detailed, online documentation system to record each step of the research process.
As a result, all decisions and outcomes can be traced, confirmed and, if necessary, replicated.
It guarantees a level of transparency and accountability that builds trust with partners and potential partners, and provides them with industry-aligned, collaboration-ready data.
“The easiest and most effective way to build trust is to produce well-documented, high quality, reproducible science,” Ms Barnes said.
“It is also about sound strategy and transparency in product development. It is about being able to trace back to why a decision was made, evaluate the evidence that was discussed, in what meeting, what conclusion was reached, and who approved it.”
Already, the quality management system implemented by the BDI team has improved their capacity to work effectively with external partners.
For example, while undertaking a fee-for-service clinical study in 2023, the team was able to provide the commissioning biotech company with restricted online access to results, streamlining an auditing process that previously would have required an onsite visit and days of trawling through researchers’ laboratory notebooks.
In a recent exploratory meeting with a potential commercial partner, the team was able to respond to a question instantly and comprehensively, simply by sharing a link to the relevant documentation.
“It’s that professionalism, that ability to respond quickly and confidently that makes the difference,” explained Ms Barnes.
“The team and I aren’t second guessing ourselves because we know the relevant information has already been recorded to a standard we’re happy with.”
The system was developed in such a way that the requirement for documentation remains relatively light in the early stages of research, and becomes increasingly detailed as the work progresses towards translation.
Twelve months down the track, the team is now looking to refine the system to ensure that it is as efficient and user-friendly as possible, while still supporting a high standard of accountability.
For now, the ISO 9001 applies only to BDI, but the systems and processes developed for the certification are being shared across Burnet.
The standardisation and documentation of research work has flow on benefits, including creating a repository of text-based information that can be called upon for grant applications, proposal documents, clinical case studies and ethics enquiries.
“It saves us reinventing the wheel every time we produce one of these documents and it just lifts everyone’s work,” Ms Barnes said.
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