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Scaling up down under: Negotiating a rich but complex environment
The Australian market has plenty of potential, but for leaders to successfully navigate the whole process from clinical, regulatory and reimbursement through to sales and marketing, the right executive team is crucial.
The impacts of building a market-leading team will be visible in your growth and revenue
For the leaders of pharmaceutical, biotech or medtech companies, the Australian environment can be an attractive proposition. It comes with an internationally recognised regulator, a robust reimbursement system and world-class clinical trial facilities, just to name a few.
However, while opportunities can indeed abound – presenting potential high quality and high return – it’s not always a straightforward road for leaders to take. The expectations for clinical research, reimbursement, regulation and marketing often require a great depth of understanding and finesse.
Whether you’re a start-up looking to grow in the Australian market, or are an established pharma, biotech or medtech looking to build scale or enter the market, developing the right awareness and leadership is essential.
“There are certain skills that every leader needs, such as endless curiosity and the capacity to win trust with everyone including customers, stakeholders and employees. However, scaling into a market like Australia needs specific leadership skills as well. For example, if you’re a biotech or a medtech you need to have a leader who can work with a board. While for a pharma company a lot hinges on the general manager,” says Vanessa Meikle, CEO and founder of Hunton Executive, a dedicated executive search firm for the life sciences industry.
“Not only that, but the GM or CEO needs to navigate a rich and complex environment, which means building a great leadership team around them to cover all aspects from research and development, through regulatory and reimbursement and of course commercialisation.”
Hunton Executive spoke to some of the industry’s leading experts to get some key pointers on starting up in the Australian market, and how to build a leadership team that’s fit for purpose.
Starting with your patient
Marty Hayes from Hayes Healthcare has spent his career working in both devices and pharmaceuticals, in roles ranging from new product planning in corporate affairs and market access, and senior director roles in sales. The advice he has for leaders is to think about your patient.
“One of the biggest mistakes I see scale-ups and start-ups make is to think in chronological order – beginning with regulatory approvals and thinking about marketing and sales after. Instead, start with your end patient,” he says.
In Australia, it’s not just about how many people have a disease, he explains, because reimbursements under the Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) are often only granted for certain fractions of the patient population. For example, patients who’ve not been successful on the currently available treatment.
“Knowing your end market will inform everything from your clinical trials and regulatory approvals to your sales and marketing plans, giving you confidence you can deliver for patients and produce profit at the same time,” he says.
Nicholette Conway, principal of Pavilion Consulting, has had a career spanning clinical research, reimbursement and start-ups across pharmaceuticals, diagnostics and devices, and now works on accelerating access to highly specialised treatments and new and novel technologies. She has similar advice for leaders.
“Think: how will patients access these treatments? What will access mean to the patient and their families? If you understand a patient’s personal journey through diagnosis and treatment, you will get deep insight as to the complexity you’re facing in commercialising your product.”
For example, studies have shown patients with rare cancers and rare genetic disease face lengthy delays in getting a diagnosis.
“There are significant wait times for patients to see clinical geneticists, and delays in accessing appropriate genetic testing, depending on whether they’re using the public or private system, as well as where they happen to live in Australia,” Nicholette says.
Add to this the fact that diagnostics are often reimbursed via a separate system to treatments, and the jurisdiction for these are split between federal and state governments.
“You have to plan for reimbursement of both diagnostics and therapies simultaneously,” she says.
Meanwhile, after a career in pharma, including leading the Australian operations of Takeda, James Jones from Jones Pharma Insights says finding the end market is also about leaders gaining a deep understanding of the competition.
“How your competitors are operating might be different to how they operate in markets you’re more familiar with. Look at the history of the market, how it’s evolved and why. Why are those competitors here? What have they done to get them into this position? It will provide interesting insight around where the regulatory and reimbursement bodies are coming from,” he says.
“Think about it in the context of what your opportunity might be. If you have an innovative technology that’s more expensive than the currently reimbursed treatment – are you going to justify the difference in price?”
Companies also don’t need be wed to the idea that it must be reimbursed.
“The private market is not necessarily as big as in other jurisdictions, but I might still be a viable option,” he says.
He adds that once a company is making an investment then it’s worth thinking how to leverage this to get maximum value – both within Australia and in similar territories across the region.
“There are fantastic opportunities for companies to undertake lifecycle development programs in Australia such as new therapeutic indications as well as other clinical trial programs. Australia is recognised for its ability to undertake quality clinical trials,” James says.
“If you’re going to invest in submissions to regulators and reimbursement bodies, what efficiencies can you generate by targeting similar markets? Australia is an HTA (health technology assessment) market, for example, as are South Korea and Taiwan, while Thailand is also moving down that route.”
Building the right team
As leaders negotiate this complex mesh of regulatory, reimbursement and commercial considerations, assembling the best executive team is crucial – and really this all comes back to a good mix of expertise and experience, bolstered with external advisers where necessary.
“You do need local knowledge. And that’s not just for relationships, but the experience of having walked the process before,” Marty Hayes says.
“For example, there’s Australian geography and demographics. It’s four thousand kilometres from Perth to Sydney and you need to know how to make that work from a logistics and supply chain perspective. And there are cultural elements, like how you engage with Australian customers and KOLs,” he says.
“Build a cross functional, collaborative team early– your commercial, your regulatory, your market access and so on.”
Meanwhile, James Jones believes that while there’s nothing wrong with sending in executives from overseas, it’s not enough on its own.
“Leaders with experience in overseas jurisdictions have a lot to offer, but this needs to be complemented with local knowledge and experience – whether that’s in-house, or consultants, or a mixture of both,” he says.
“The broader the range of information that you can get put into the mix, the better.”
Nicholette points out that there’s a plenty of people in Australia who’ve gone overseas and then come back, so can provide both that international and local perspective. However, she also says leaders coming in from overseas need to listen and understand that Australian conditions are not the same.
“Often, they’ll be very focused on what they hear from the FDA or what they hear about the EMA and think that we just fit into those models neatly. But we don’t,” she says.
She adds that as our healthcare system continues to shift into precision medicine, workforce requirements are changing as well – and it’s difficult for companies and their leaders to keep up. To address this issue, the Industry Genomics Network Alliance (InGeNA) has developed a framework to help them keep pace with the ever-changing competency requirements. The framework is divided into four domains around technical competencies (medical science and technologies and translation and clinical application), governance and regulation, and professional practice.
Vanessa Meikle from Hunton Executive explains that help is available for start-ups or scale-ups looking for leaders who can tackle all the above challenges with regards to setting up in Australia.
“Executive search is a valuable service, and something which requires specialist knowledge, a solid vetting of candidates and deep consultation with clients in order to find the best leaders that are suited to each individual business. It involves looking at the whole matrix of your organisation and fitting all the puzzle pieces together to get the right leadership team in place,” she says.
“Also important – particularly if you intend to send in your executives and experts from overseas – is to consider hiring coaches and mentors who can bring them up to speed with independent, objective insights on the Australian market. If you start getting your executives ready in the months before they arrive, then they’ll be ready to hit the ground running.”
Vanessa concludes that an essential component of successfully entering the Australian or indeed any domestic market is the right leadership team.
“The impacts of building a market-leading team will be visible in your growth and revenue,” she says.
“We see a wealth of opportunity in the Australian market, and we’re lucky to have a great pool of talent and knowledge available to help companies realise this potential.”
For more information on executive search for your pharma, biotech or medtech business, or to be connected with any of the experts in this article, please contact Hunton Executive.
At some point in your career, you’re likely to find yourself in a period of transition – whether that’s redundancy, waiting for promotion, or simply