Kennet Brysting, General Manager of Gilead Sciences Canada, Inc. outlines the strategic significance of the Canadian affiliate to Gilead Sciences globally, including its manufacturing and R&D footprint, the challenge of managing the financial costs of breakthrough therapies, and Gilead’s success in advancing innovative therapies in the fields of HIV and Hepatitis C.
Kennet, as the new General Manager of Gilead Sciences’ Canadian affiliate, what mandate was entrusted to you upon your appointment in January 2017?
“A key challenge we have – at Gilead but also as an industry – is how to expedite access to medicines for patients in Canada.”
My mandate was primarily to step in as the new leader and extend the legacy that had already been established in Canada. My experience with another Gilead affiliate has also afforded me the opportunity to offer new thoughts on how the Canadian team could strengthen operational synergies. Gilead has a very matrix-based organization and our success ultimately depends on how well we can work cross-functionally, so I like to work on promoting diversity of thought in order to generate the best outcomes from our activities.
As a relative newcomer to the Canadian industry, I find that Canada has a leading healthcare system that is highly innovative and focused on delivering quality care to as many Canadians as possible.
From a broader perspective, the Canadian affiliate is within the top eight markets for Gilead globally, representing around 3 percent of global revenues so we are rather strategic and important. I am a member of the North American leadership team and we report directly into the US.
We are also unique in that we have a research and manufacturing facility in Canada that is fully integrated into Gilead’s global manufacturing network. This is rare for the local industry and we are very proud of that. From the research side, Gilead invests 17 percent of our Canadian revenues in R&D in Canada, far exceeding the industry target of 10 percent. This demonstrates that Gilead commits significant investment and resources to the Canadian market. In 2016, 23 new clinical trials were launched in Canada because Canada is really a perfect market for clinical trials. There is a high-quality healthcare system, world-class researchers and investigators that can drive clinical studies, and there are many excellent clinical sites that meet our company’s very high standards.
Gilead Canada is fairly well-established. From your perspective, what is the principal challenge the affiliate faces today?
A key challenge we have – at Gilead but also as an industry – is how to expedite access to medicines for patients in Canada. Benchmarking Canada against other major markets like the US and the EU-5, we are certainly lagging behind – it can take at least 18 months to receive public access in Canada for new medicines.
Certainly, the complexities resulting from the federal-provincial healthcare structure are a contributing factor. New initiatives like the pan-Canadian Pharmaceutical Alliance (pCPA) are seeking to promote greater inter-provincial collaboration with one of the stated intents being to improve time to listing. Nevertheless, approval processes must be expedited in order to ensure patients have timely access to the medicines they need. The pCPA process, as it stands, can be slow and lacks transparency on key aspects of the process.
As an industry and as a company, we offer lifesaving therapies. Our mission is to advocate for these therapies to reach patients as quickly as possible.
Gilead is known for advancing highly innovative therapies, particularly within the HIV and HCV space. How are these franchises performing within Canada?
HIV has been the cornerstone for the company. Gilead has recently launched a new generation of HIV products that we are preparing for launch. One has already been launched in Canada and there are three more upcoming. All of these new products focus on preserving long-term health of patients living with HIV. As you know, the HIV story is a hugely inspirational one. We have seen a stunning transition from the 1990s when HIV was essentially a death sentence, to today, where HIV can be managed simply and effectively as a chronic condition, with just one pill a day sufficiently suppressing the virus. However, these drugs still have side effects, so newer generations of HIV therapies will focus on addressing these side effects while remaining highly efficacious.
Gilead has also had a fascinating journey in HCV having launched the first curative therapy in 2015, Sovaldi®. Previous medicines were associated with severe toxicities and could not cure the majority of patients. The subsequent products which we launched – Harvoni® and Epclusa® – have really transformed this therapeutic area. We have a final product, Vosevi™, that received regulatory approval in Canada in August 2017. The previous products have been shown to cure 98 percent of all patients; this last therapy has been shown to cure 98 percent of the remaining two percent.
This also means that we can now turn our focus to the next challenge, which is to help eliminate the disease in Canada: screening, diagnosing and linking patients to the appropriate care. We consider ourselves leaders in Hepatitis C, so we need to take an active role in supporting initiatives within this space.
Looking forward, oncology is the next frontier for us. Gilead started to establish a presence in oncology care over two years ago with a product launch. The very recent announcement of our acquisition of Kite Pharma will position us as a leader in cell therapy and really boost our presence in oncology. Through Kite Pharma, we will have the latest platform technology in oncology based on hugely innovative CAR-T and TCR technology. This acquisition speaks fundamentally to our mission as a company to advance therapeutics and improve lives for patients.
We are also expediting our R&D program for our Nonalcoholic Steatohepatitis (NASH) compounds, because there is currently no treatment available for this condition. Given that our focus is on addressing unmet medical needs, we want to bring our R&D pipeline to market as quickly as possible.
It is clear that Gilead has managed to introduce truly innovative breakthrough therapies. With fiscal sustainability being an increasingly important issue across markets globally, how well can the Canadian system accommodate such disruptive new medicines?
It has been a challenge to launch these kinds of curative treatments from a payer’s perspective, because of the payer’s need to absorb the full cost upfront. However, because these products cure the disease, the system is relieved of the long-term costs of treating the patient – and this needs to be taken into consideration. Chronic diseases are different because the cost of the disease is spread over many years.
Do you anticipate any competition from generics within your key HIV and HCV franchises?
There are generics coming in to the market but ultimately, we are not competing against generics. I see it as part of the normal product lifecycle: generics enter once your patents expire. You have to allow market dynamics to develop. What it does require us to do is to continue to innovate – and Gilead has been exceptionally good at this. We have new products in our pipeline that are even better than our current ones, so as a company, we are incredibly excited about the future.
We have a strong pipeline in HIV, for instance, because this disease still has not been cured yet. There is still a need to continue innovating.
To begin wrapping up, what are your key priorities looking forward?
The common challenge for us – as an industry – is to come together to drive an innovation agenda. What does innovation mean? How does Canada and Canadians benefit from a high level of innovation in Canada? Both the biotech and the biopharma industries need to come together and drive a common vision for innovation. As an industry, I think we can do better to position the positives that people may not be aware of. We do a lot of good things for patients, we invest where there are high unmet needs, and we create innovative new therapies. As an industry, we need to tell our story much better to counter any negative perceptions.
Gilead is a member of Innovative Medicines Canada (IMC), and I routinely speak to my fellow CEOs to understand their thinking. I am convinced so far that we have one common denominator: we are all passionate about innovation. That passion needs to come through in our external communications with our stakeholders.
Ultimately, success is all about people. You need to make sure you have the right people in the right place at the right time, and to attract the right talents to your business. Gilead is a science-driven organization. We have top scientists leading our corporation, so our first priority is to continue to innovate and bring those therapies addressing high unmet medical needs to market, and ultimately, to patients and physicians.