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Bridging the valley of death
John Brumby
John Brumby discusses BioCurate and the challenge of commercialisationThe Hon. John Brumby AO
The following essay is an excerpt from our upcoming book: Australia’s Nobel Laureates Vol. III: State of Our Innovation Nation 2020 and Beyond, taking a whole of economy health check of Australia’s innovation ecosystem.
When I was a young backbencher in the Hawke Government, one of the people I admired and learned from was the Minister for Science, Barry Jones. Barry had written the globally influential book Sleepers, Wake! in which he warned that ‘technologically based transitions create revolutionary economic and social changes.’ He called on governments to shape the future for the better through smart responses to technological change. To his credit, Barry Jones pushed the Hawke Government to invest a lot more in science, R&D and technology. He secured some wins, including a $1m National Biotechnology Program. Barry once told me, however, that he had a recurring nightmare. He worried that after all our efforts and all our investments, we would look back in years to come and find that Australian scientific research had not moved far along the path from the laboratory to the market. If this happened then our research would have failed to make its maximum possible impact in the world.
I’m afraid to say these fears came true. Australia can be proud of our scientific achievements, especially in medical research. But an ongoing frustration is that too little of it makes the long journey to market. Too much is lost in the ‘valley of death’ before it can even reach the clinical trial stage. And if it doesn’t reach clinical trial, it can’t reach patients. BioCurate was set up to address this problem, and has already become an important part of Australia’s innovation ecosystem.
BioCurate came about thanks to an unprecedented partnership between the Vice Chancellors of Victoria’s two biggest universities: Monash University and the University of Melbourne. It was the first time two universities of this size, in such close proximity to one another (making them competitors) had come together in this way. Both Vice Chancellors recognised that their universities were sitting on a gold mine. Melbourne and Monash receive about $100m per annum each in government funding for medical research, and both are in the top 100 universities in the world for research output. But the Vice Chancellors also realised that the right settings were not in place to make good on the promise of this research—to get it to the bedsides of the patients that need it. They decided to put their money where their mouths were. Each university invested $25m, and the Victorian Government invested another $10m. BioCurate was launched in 2016, and I was proud to come on board as Chair. In 2017 we were delighted to appoint distinguished haematologist and oncologist Dr Glenn Begley as BioCurate’s inaugural CEO.
The Biotech Century
I have long been passionate about medical research. To my mind there are two reasons why Australia should aim to be a world leader in this area. One is the potential benefit to patients. Science has made great strides in the battle against disease and disability, but there is still a long way to go. Australia faces increasing challenges with the rising incidence of cancer, heart disease, diabetes and more. The financial and emotional costs of these diseases to individuals, families and communities is immense. If Australia can be at the forefront of medical research, then our patients will be among the first to benefit—if we can meet the challenge of commercialisation.
The second reason Australia should aim to be a world leader in medical research is the potential economic benefit. Every time there has been a global economic revolution—whether the agricultural or industrial revolutions, or the information revolution we are still living through today—those societies prospered which got out in front and led the way. I have long believed that the next big revolution will be in biotechnology.
That’s why the government in which I served as a Minister, Treasurer and then Premier invested so heavily in the scientific institutes and infrastructure necessary to position Victoria at the forefront of the biotech revolution. In the year 2000, Premier Steve Bracks announced that we would aim for our state to be recognised as one of the top five biotechnology locations in the world by 2010. We invested in the Bio21 Institute at the University of Melbourne, and the Florey Institute of Neuroscience and Mental Health, which is now the largest brain research group in the Southern Hemisphere. We helped double the size of the Walter and Eliza Hall Institute and funded the Australian Regenerative Medicine Institute at Monash University. We secured the tools scientists told us they needed: the $100 million IBM Blue Gene supercomputer for the University of Melbourne, for example, as well as the Australian Synchrotron at Monash.
We also fixed the legislative roadblocks that meant it was easier to set up a new gold mine in Kalgoorlie than it was to obtain approvals for a small biotech start-up in Victoria. We amended the partnerships legislation in an effort to make Victoria the easiest place in Australia to attract venture capital and commercialise research.
Today Melbourne is known as a top city for research and innovation in the medical space. But the missing piece of the puzzle is still commercialisation. It’s a formidable obstacle: a recent study by Tufts University estimated that the cost of bringing a new drug to market in the USA is around $US1.4bn—plus another $1.2bn in returns foregone by investors during the eight to 12 years the development process can take. It’s no wonder that in Australia, many new discoveries fail to get the investment support necessary to bring them into that process in the first place. This failure is one of the key reasons the Federal Government established the Medical Research Future Fund (MRFF)—not just to support more medical research, but to help it move along through translation and commercialisation.
The challenge of commercialisation
The QS World University Rankings ranks 1000 universities on factors ranging from research performance to academic reputation, graduate employability, and staff to student ratio. Australia currently has seven universities in the top 100. This is a very good result. But there is another global ranking we should also be paying attention to: Reuters’ list of the World’s Most Innovative Universities. This list identifies the institutions doing the most to invent new technologies and contribute to new markets and industries. It is based on analysis of patent filings as well as research paper citations. On this list, South Korea has six universities in the top 100. Singapore has two, as does Israel. (It’s worth noting that these two countries each have economies approximately the size of Victoria’s.)
At present, the number of Australian universities appearing on Reuters’ list of innovative universities is zero. This needs to change, which means we need to understand why so many of our discoveries falter in the ‘valley of death’ between discovery and development. There are multiple reasons:
Funding: Australia’s peak funding body for medical research, the National Health and Medical Research Council (NHMRC), spends its $900 million annual budget on research, not commercialisation. For this reason, scientists looking to secure a portion of that funding will understandably focus their efforts on the research side. Like everyone else, scientists go where the incentives lead them.
Intellectual Property: A related issue is the difficulty of securing Intellectual Property (IP) rights. The incentive for academics is to publish. When a new piece of research is published, the IP involved can quickly dissipate. If IP is not properly protected (and seen to be protected) it becomes even more difficult to secure the many millions of dollars of investment needed to bring a drug to market.
Expertise: Scientists are good at science. They are not always very experienced or knowledgeable about the process of translating a discovery into an investible product. That’s where BioCurate comes in. Collectively, the BioCurate team has over 150 years of combined biotech/pharma industry experience, has been responsible for 70 therapeutics that are currently in the clinic, and has experience in over 25 therapeutic areas.
Culture: Most scientists would like their work to have a real world impact. This is especially true in medical science, where a breakthrough could lead to a better life for untold numbers of people. At the same time, scientists at work need to concentrate on the task at hand. Pure research can only be done for its own sake, and not with a constant eye on the possible applications down the track (as these are impossible to predict). We do, however, need scientists to adopt a positive attitude to commercialisation, and to work constructively with industry and organisations like BioCurate. There is clear evidence among younger scientists that this is happening, which is very exciting for Australia’s scientific future.
How BioCurate works
The combined research strengths of BioCurate’s two shareholders, Monash University and the University of Melbourne, place these universities in the top five globally in pharmacology, metabolism and immunology, and in the top 10 in paediatrics, neurosciences, and cardiology. BioCurate focuses on very early stage work in therapeutics—that is, drugs that are placed inside a patient through injections or ingestion. There is understandably a very high bar to overcome before a new drug can be tested on a human being. The projects engaged by BioCurate are typically three to five years away from clinical trial.
BioCurate’s independent experts work closely with the universities to scout for potential projects. When a promising project is found it is subjected to careful evaluation on a number of criteria:
Unmet medical need: The new discovery must have the potential to meet an existing clinical challenge.
A regulatory path to market: Ultimately the regulators are the ones who determine whether a new molecule will be approved for clinical trial. BioCurate must see clear evidence that this will be a plausible outcome in time.
A clinical development path to market: At any given time there are many clinical trials underway. Clinical trials require time, resources and enough patients to make the trial worthwhile. Potential projects must be able to demonstrate that a trial is likely to be feasible when the project is ready to be tested in this way.
Robust data: Much published research is not yet up to the standard required for a clinical program. The research involved in discoveries that may be funded towards commercialisation by BioCurate must be of a quality beyond that which is required for initial publication.
Committed researchers: BioCurate needs to work with researchers who are committed to the long haul of getting a discovery from the laboratory to the bedside. Fortunately, most researchers today understand that commercialisation is a way their work can make a real difference in the world.
It is, of course, much too early to measure BioCurate’s impact. But I am very excited about the potential, and I know that our two university partners are too. International Pharma has also been exceptionally positive about BioCurate and numerous MOUs have already been signed. And while BioCurate is a Victorian project—funded in part and strongly supported by the Victorian Government—I believe that in the medium to longer term, BioCurate’s impact will be increasingly national. And as the line between therapeutics and medical devices becomes more blurred, we will also see programs that move beyond therapeutics to medical devices, and potentially digital technologies and many other areas of scientific and technological enquiry.
Governments need to be smart in their responses to technological change. Early movers benefit the most. BioCurate exists to harness the energies, talents and achievements of our scientific community, and direct these towards improving Australia’s record in bringing new discoveries to market. We’ve made a great start, but there’s much to do ahead of us.
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The short-term nature of Government (3 to 4-year terms), the short-term horizon of the business system (driven by shareholder value), the media culture (infotainment and ‘gotcha’ games), the general Australian population’s cynical perspective and a preoccupation with a lifestyle all create a malaise of strategic thinking and conversation. Ultimately, it leads to a leadership vacuum at all levels. 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