The notion of “Success” is relative and highly contextual. This is true of biomedical research and development. Depending on where you are in terms of the therapeutics development pipeline, both organisationally and functionally, you are likely to get a different definition of success.

For the academic researcher undertaking important wet lab research, who makes that initial breakthrough discovery, success is typically linked to the publication of a manuscript. Success is the novel, landmark or first-in-man finding; it is the paper that is accepted into a high-impact journal (Cell, Nature or Science- the holy trinity of biomedicine publishing). Publication in these high-impact journals is an accepted surrogate for the importance of the initial discovery, and the potential for changing research paradigms and benefiting patients. This achievement is appropriately seen as success: it is an important first-step along the way to something valuable for patients. As a consequence,  it also increases the chances of future funding, promotion, and international recognition.

For the entrepreneur, success is seeing a market opportunity and bringing capital and technology (often the technology is based on the breakthrough discovery in the academic research laboratory) together to address it. Through this process the entrepreneur creates value and value creation is the yardstick by which their success is measured. For the investor, success is the identification of opportunities (which are often generated by the entrepreneur) to deploy capital and achieve the greatest financial return. This may be achieved by securing an exit with an industry partner. These contributions can be considered a second-step along the pathway to ultimate patient benefit.

But for the biopharmaceutical industry, success is a viable commercial product on the market. As such, it can be seen the final step on the pathway to bringing benefit to patients. It is seeing drug development through to the very end, with new treatments in the hands of doctors and patients and seeing the many years of research finally make a positive impact on human health and quality of life. Within the company each function that contributes to the overall company goal has different definitions of success – for manufacturing it may be reducing the cost of producing the new drug (“cost of goods”), for clinical operations it may be efficient enrollment of patients in the clinical studies, for medical affairs it is ensuring patient safety, for regulatory it is expeditious approval by the Regulatory Authorities, and for the health economics and outcomes research team it is achieving reimbursement for the new therapeutic approach.

For the patient and society in general, success is an efficient use of taxpayer dollars that funds relevant research that can be efficiently transferred to the entrepreneur who brings it together with investor capital to create further value through an exit to an industry partner. Ultimately, this results in affordable access to cost-effective treatment that improve outcomes for all who need it.

Misalignment across players can cause delays, disputes over the allocation of resources, counterproductive competitive behavior, and can compromise the commercial viability of projects entirely. Our definition of success needs to be realigned to one that is mindful of the end goal – to see a novel treatment on the market and available to patients.

In this context, success for the academic, the entrepreneur, the investor and industry are but milestones in the continuum, each worthy of celebration – crucial interdependent steps towards societal success rather than ends in themselves.

For promising new projects, creating opportunities for effective partnering of all of these players is a fundamental premise for the development of novel therapeutics. In these partnerships, misalignment in the different parties’ understanding of success or a “zero sum game” mentality can be problematic. Our societal mission of bringing safe and effective therapeutics to patients does not stop with the success of one player in the development chain. Misalignment across players can cause delays, disputes over the allocation of resources, counterproductive competitive behavior, and can compromise the commercial viability of projects entirely.

Our definition of success needs to be realigned to one that is mindful of the end goal – to see a novel treatment on the market and available to patients.

This is why BioCurate exists. BioCurate is doing its part to bridge the gap between academia and industry by pursuing opportunities to align success metrics. BioCurate exists to further develop, for patient benefit, the outstanding fundamental research for which Australia is famous. It is acknowledged that there are systemic pressures that influence the way research is conducted in Australia. Changes to precarious funding models and the insidious pressure to publish are necessary. A more long-term, commercial mindset is critical to help our country realise the significant potential of its research community and achieve success in commercialising promising new discoveries.

BioCurate is striving to improve our collective understanding of the realities of translation, and to bring industry to researchers- to facilitate new collaborations. Creating a strong, multidisciplinary team of experts and supporting the entire drug development value chain will fortify the foundations for success and improve the likelihood of bringing novel treatments to market that improve the lives of patients.

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“As with most research institutes, the Monash BDI is making a concerted push to improve industry engagement amongst academics. I was acutely aware of BioCurate, as a few groups within the Monash BDI had already been interacting with members of their team,” said Roger.

As discussions evolved between Roger and BioCurate, a mutual understanding developed – that the rigour applied to interpreting certain types of data, even by scientific journals, is insufficient. Roger recalled, “The team at BioCurate were responsive, they saw the worth of our work and also thought our results were interesting.” However, a major problem was identified by both Roger and the BioCurate team – that the potential off-target effects of siRNAs are often underestimated.

“Glenn (Begley, CEO of BioCurate) and I agree- the standards applied when using siRNAs are not stringent enough. There are certain kinds of controls which are recommended, but to be honest, very few people actually take on these controls to the extent they’re supposed to. This is really where the problem resides,” said Roger. “Many journals simply request that the effect is replicated by at least two siRNAs. However, the effects of both can be off-target.”

Based on these discussions, Roger and his team are undertaking further experimental work using alternative approaches to strengthen their case, and this is already reaping dividends. “We’re keeping BioCurate informed as this validation work progresses, because the data are not only critical to our project, they have more general relevance to how BioCurate, and industry, assesses projects,” he said. This is what has pleasantly surprised Roger – the ongoing conversation that has developed following that initial presentation.

For Roger, this process has been and continues to be a positive and highly encouraging experience, and one that has galvanised his opinion on the best approach to translational research. “Labs going into translational research need to go in with eyes wide open, they need to be aware of potential problems as well as options and opportunities,” he explains. “If you want to complete a drug screen, it is important to ask- are we best placed to do it? Or can we outsource it?” Roger wants scientists to leverage the funding, skills, expertise and resources available to them, rather than ‘going it alone from scratch.’ This may prevent groups from taking on work that doesn’t match their skill base, and that may divert resources away from their strengths.

“Melbourne has outstanding facilities and a fantastic research community,” stated Roger “BioCurate is well-positioned to advise on how to tap into such resources and move projects down the development pipeline.” He added, “I’m looking forward to the prospect of this project reaching the point at which it’s ready to enter the BioCurate pipeline.”

All in all, it’s all about the big C – Collaboration – to help achieve real world impact.

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Helping this big picture come together is the big vision that BioCurate has, and it was what drew Cathy to the organisation. ‘I completely agree with Glenn [Dr C. Glenn Begley, CEO of BioCurate]. Australia is too small to compete on the global stage as individual parties. We need to work together.’ This emphasis on collaboration and cooperation was born from Cathy’s experiences during her PhD.

For Cathy, undertaking her PhD at the Howard Florey Institute was one of the best times of her life. ‘Of course, there was plenty of frustration, but by the time I was writing my thesis, I just enjoyed the feeling of having achieved a certain depth in my knowledge and the sense of completing something. I had a lot of autonomy and I revelled in being my own boss.’ For her, what was underrated about the entire PhD experience was the personal development that went beyond the confines of the lab. ‘You learn to become a team player, whether it’s negotiating equipment bookings or learning how to deal with different personalities. These skills are so valuable.’

After postdoctoral positions at Stanford University of School of Medicine and the Walter and Eliza Hall Institute of Medical Research, Cathy made the transition into industry. Beginning as a Principal Scientist at AMRAD Corporation (later Zenyth Therapeutics), Cathy was still actively involved in research. ‘However, in industry, it is research with a purpose. A purpose to develop new drugs,’ commented Cathy.

One of the starkest differences between academia and industry that Cathy noted was the motivation that drove research. ‘ It’s push vs pull: in industry, you know where you want to go – your work is being pulled through and guided by the end goal. In academia, new discoveries can push your research in different directions, sometimes with a lack of focus.’ It was also in industry where Cathy began to understand the importance of robust and reproducible research  data. ‘There is a necessary ruthlessness in industry. If we couldn’t replicate the data, we dropped the project. It just wasn’t worth pursuing.’ This focus on reproducibility is one that is very much at the forefront at BioCurate.

After her time as Project Manager at CSL, managing projects at various stages along the development pathway, Cathy moved back to early discovery projects at Cancer Therapeutics CRC, which she now continues at BioCurate. It’s a perfect fit for her. ‘I love being exposed to exciting new discoveries, although the slower pace of academic research can sometimes be a bit frustrating,’ she says. Despite this, Cathy is pleased to see scientists from both academia and industry beginning to act on the need for collaboration. Cathy comments, ‘Seeing multiple groups working on the same type of projects, but not talking to each other didn’t make sense to me. I’m so glad that it’s definitely changing now.’

Her extensive and expansive experience, as well as her expertise in endocrinology, neurobiology, oncology, immunology and inflammation, positions Cathy as an authority on early drug discovery, but also a leader in fostering stronger ties between the seemingly disparate worlds of academia and industry. She understands the needs and nuances of both.

For scientists who want to bridge this gap and to contribute to the development of novel treatments, she offers the following advice: ‘Be open to collaboration. Find people you can trust and who can offer you new ways of looking at your scientific problem. All my best successes have involved multidisciplinary teams.’

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