Mark Hicken, managing director of the UK and Ireland operations of Janssen, the pharmaceutical arm of Johnson & Johnson, highlights the company’s long-standing R&D presence in the UK. He calls for more creativity in HTA processses in a collaborative effort to bring innovation to patients faster.
What is the scope of operations of Janssen in the region UK and Ireland that you oversee?
Janssen is the pharmaceutical arm of Johnson and Johnson (J&J), the largest diversified healthcare company in the world. Today, Janssen is the largest sector for J&J’s business, ahead of the consumer and medical devices sectors. In the UK, J&J directly employs more than 5,000 people. Through an indirect effect we are responsible for another 17,000 jobs. Amongst J&J’s 5,000 UK employees, approximately 1,000 are dedicated to Janssen, with 500 active in R&D related functions and as many in our commercial organization. J&J therefore remains the largest single foreign investor in life sciences in the UK. Janssen’s activity in the UK comprises both R&D and commercial activities; I am responsible for the commercial side of the business. In Ireland we also have a manufacturing activity and there too, we are the largest foreign investor in life sciences.
According to IQVIA rankings, we are a top 10 company in the UK. I am myself a board member of the Association of British Pharmaceutical Industry (ABPI) and vice chair of the American Pharma Group. This active contribution to industry associations is something we consider essential in shaping the conversation in the UK.
What significance does the UK hold for Janssen globally?
As one of the G5 countries, the UK has one of the largest economies in the world and is for us, a leading market when considering deployment of health technology appraisal. The sheer size of the NHS (National Health Service) as a single payer system holds extreme strategic importance for Janssen. We define the UK as a beacon and definitely a key market for Janssen globally.
From an R&D perspective, the UK also holds significant importance on a global stage for J&J, with research activity taking place across all of our sectors in the country; from medical devices, through to consumer goods and pharmaceuticals. London is also home to the J&J Innovation Centre – one of four global research centers responsible for identifying and accelerating early stage external innovation by establishing unique collaborations. The J&J Innovation Centre based in London constitutes our European hub, while the other centres are located in Shanghai, Boston and San Francisco.
Nowhere is the significance of the UK better illustrated than in our extremely active collaboration with Professor Sir John Bell on the crafting of the Life Sciences Industrial Strategy (LSIS) to which we were part of the advisory board. We also announced a collaboration with the University of Oxford in neurosciences, as part of the sector deal.
On a business level, we are happy that growth for Janssen has been healthy and constant for the last few years in the UK. Part of this comes down to our ability to work collaboratively both with NICE and the NHS to bring through transformational medical innovation for the benefit of patients. We are very pleased that we have not yet had a ‘no’ from NICE, but instead have brought some breakthrough innovation to the UK and we are fully committed to continue doing so.
How would you define access to innovation in the UK and how do you foresee Brexit impacting it in the future?
Compared to that of other countries, access to innovation can be slow in the UK. This is due to the delay between regulatory approvals and the reimbursement we get through NICE. In this, we are often facing challenging conversations.
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New medical technology with phase II data is often viewed as immature, in health economic terms. This entails a more challenging conversation with NICE, particularly in the oncology space. Our approach to these challenges is continued work with NICE, the NHS and the Department of Health & Social Care to find valuable solutions that can help to address these challenges.
We believe that Brexit will mainly impact access to innovation on a regulatory level. Beyond the British government, the EU has to provide clarity on the future of our regulatory environment. This will be most critical as it relates to the provision of new medicines. The ideal situation would of course be free trade and the ability to move our products freely around Europe. Moreover, the ability to move talent around freely is equally important.
The earlier we reach agreements on regulatory alignment, the better. However, we do of course understand that this is all part of a broader discussion between the EU and the UK government.
Janssen went through a long approval process for Imbruvica; first dismissed by NICE in 2016, it has now reached approval for some patients with Waldenström’s macroglobulinemia. 1 in 25 people are bound to have blood cancer at some point in their life. How does Janssen communicate the value its products bring?
Across the entire region, Janssen has been very active in raising awareness of blood cancers, often a silent disease until an important stage in disease progression is reached and it becomes symptomatic. We launched a very successful campaign in central London in October 2017, where we had an installation of 104 statues symbolizing the number of daily blood cancer diagnosis.
In order to have the greatest possible impact, we want to intervene early in disease progression. However, we face the challenge that our data is often only phase II. At this stage, regulators easily see positive life-saving and expectancy-augmenting effects, and we in general have a proactive collaboration with regulators. When it comes to collaboration with NICE however, immature data sets can become problematic.
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Our efforts are always on providing our HTA bodies with additional data but we also believe that there is a need to reform NICE processes in recognition of the fact that truly innovative products are going to come very early in disease progression. There is always an equilibrium to reach between being able to demonstrate the value of a drug at a given point in time and its potential. If a drug keeps you alive for ten years, but you have to wait for that amount of time to be able to collect the data, this has the potential to delay the entry of innovation into the system.
What we need to do is think more creatively about how we can evolve the HTA process so it recognizes true innovation at an earlier stage. NICE has a fair, transparent, fact-based operation base which we appreciate. Nonetheless, much of the process design still dates back to 1999 when NICE was first introduced. While science has significantly advanced, with new and important therapies being brought forward, processes have not evolved in accordance.
This is the reason why we call for more flexibility in NICE processes. Yes, a solid technology appraisal is an essential input, but the conversation should be broadened.
How is Janssen’s product portfolio represented in the UK?
We are broadly based in the UK across our five therapeutic areas: cardiovascular and metabolic diseases, immunology, neuroscience, oncology and infectious diseases.
Janssen has a long history in neuroscience, dating back to the 1950’s as Paul Janssen who built the company was a true innovator in this space. Today, we are one of the few companies with an active research interest in neuroscience, with products in phase III for which we hope to release data shortly. Currently, we are active in long acting therapies in schizophrenia and serious mental illness. We are also participating in the Dementia Discovery Fund and we have an exciting collaboration with the academic communities around Oxford in this space.
A lot of what is going to come through the Janssen portfolio in the next couple of years will be in oncology and immunology. In those spaces we have a very healthy pipeline, in solid tumors and blood-borne cancers in oncology specifically.
What are the expected product launches for Janssen?
All in all, we are looking at as many as 40 potential new indications and 12 new product launches between now and the end of 2020. This shows that our focus is and remains on transformational innovation, and that is why our participation in the LSIS has been so important. It is, but one part of our goal to continue driving the conversation on how we create the right environment for a healthy life sciences sector in the UK.
On a global level, you collaborate with Astex in the development of erdafitinib. In the US it has received breakthrough therapy designation and is said to target a USD one billion market. This highlights the UK strengths in academic-biotech collaboration. What does Janssen value so much about the British R&D ecosystem?
The UK boasts a very strong academic base, with a multitude of innovations in life sciences, and solid basic research. It also profits from an active finance environment; looking at the UK investment footprint, it ranks highly in international comparison. Then, there are great incentives around patents, intellectual property is well protected. Finally, companies see the promise of the NHS as a partner for their future development, a single payer system that provides the base to foster access for innovation.
Furthermore, the UK has important strengths in genomics, with huge capacity in connecting data sets and records. This information holds tremendous potential to accelerate drug development and bring new innovations to patients. We live in exciting times for data-driven innovation!
Many of the incentives are further underlined in the LSIS. While we have yet to see how the government will fully implement the strategy, the dialogue has for now been very encouraging. Janssen hence continues to see the UK as a great place to come and do research.
As managing director, what are your main ambitions looking forward?
My first priority as a managing director is to attract and retain the very best talent, as should be the priority of any head of company, to create an environment that attracts the very best people. Great products and strategies are one thing, but if you cannot execute or implement them, they serve no purpose. At Janssen, we are very keen to create an inclusive work culture where we have a diverse workforce, that encourages people to be themselves at work. This allows us to fish in a much larger and broader talent pool.
My second priority is to continue to partner with colleagues in other pharmaceutical companies to try and address some of the reputational issues we face as an industry. Finally, I think it is essential we continue to work with the charity sector and patient organizations in order to empower patients, as ultimately, we exist to try and help people live longer, healthier and happier lives.
