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Setting up for success in a post-Brexit, post-pandemic Britain

Creating a new biotech affiliate and seeking marketing authorisation for a new drug in the UK during a pandemic

The past year has been one of the most challenging on record, for all industries.

With society and business continuing to face a seemingly relentless stream of restrictions, national lockdowns, a worldwide race to find and now roll out the new COVID-19 vaccines, not to mention Brexit deal negotiations going down to the wire, we have truly found ourselves in an unprecedented situation.

With this backdrop, you may think it’s not the best of times to set up a new biotech affiliate and seek a marketing authorisation for a new drug in the UK. However, that is exactly what I joined Galapagos to do.

When looking back on 2020, I am reminded of the words of Albert Einstein: ‘In the middle of difficulty lies opportunity.’ The way that the pandemic has turned everything on its head has allowed us to take stock of the way that healthcare is delivered to patients. We are uniquely positioned to take advantage of the momentum and speed of change that has gathered pace during the pandemic and disrupt the old, outdated ways of working.

The rapid approval of the COVID-19 vaccines is a clear stake in the ground that the MHRA is prepared to act on its commitment to get medicines to patients faster. With Brexit, we face new challenges and opportunities.

The biotechnology industry is booming in the UK, with the number of biotech companies increasing by 65% between 2016 and 2019, showing that the prospect of Brexit has done little to dampen confidence in this sector. This presents an exciting opportunity for companies like Galapagos.

Opportunity presented by the pandemic

The healthcare and pharmaceutical sectors are in the spotlight now more than ever before. People from across the world have looked to the World Health Organization, the Department of Health and healthcare regulators such as the MHRA and the pharmaceutical industry for information, support and, above all, hope that a way through the pandemic is on the horizon.

In the UK, we are fully aware of the great work that our NHS delivers and, most importantly, the crucial need to deliver medicines to patients quickly and effectively. In many ways, vaccine innovations have improved the reputation of the pharmaceutical industry.

However, we must not neglect the fact that, for non-COVID patients, many people have faced delays and cancellations for the treatment of debilitating conditions, such as Inflammatory Bowel Disease (IBD) and Rheumatoid Arthritis (RA). These are two conditions that require urgent diagnostic and treatment input from healthcare professionals.

With IBD widely considered an ‘invisible disease’, patients cannot afford to be pushed into the background any longer. For Galapagos, it is essential that we continue to do pioneering work for patients, no matter what the situation is.

Key learnings from setting up a new team virtually

In my role as Country Head for Galapagos UK, my focus for the last few months has been getting the affiliate up and running, ahead of our UK marketing authorisation in IBD, through our partnership with Gilead. I’ve faced many challenges and have enjoyed the plethora of opportunities that have presented themselves.

In particular, the important task of assembling a team that embodies the Galapagos spirit has been hugely exciting. Building a team from scratch has allowed me to really think about the talent you need around you and shape that according to what you think makes a strong team.

At Galapagos, our purpose is always to ‘make it happen’, and the team needs to support each other to achieve that goal. While we’re one inclusive team, it’s important to remember that we are made up of many unique individuals – each contributing their own passions, strengths and ideas.

A key learning for me is that the location of work isn’t entirely important, with the traditional view of office-based pharma now seeming somewhat outdated. Face-to-face interaction will always be an effective channel of communication, but opportunities for collaboration and informal discussion are crucial, no matter where work
is located, especially during early bonding experiences in a new team.

When the going gets tough, these bonding experiences are a real acid test to see ‘if I trust/like this person’, which could be difficult to achieve via virtual channels. Flexible working is the new norm and I believe that the definition of ‘flexible’ is very interpersonal.

Ultimately, COVID-19 learnings offer the opportunity to make the workplace more flexible and therefore attract more talent, a catalyst if you will, for changes that had been suggested but not previously embedded. Not everyone wants to work from home, but this is about being responsive to individual needs and providing an environment and culture that allows people to bring their best selves to work, regardless of the location.

Putting the patient first is vital to our work at Galapagos and, as a senior biotech leader, it’s even clearer to me that I must balance commercial interests with those of the patients. By keeping this focus, we can ensure that the steps we take as we establish ourselves in the UK are the right ones.

For me, culture and attitude have been essential in ensuring Galapagos is in the position it is today. A ‘no fear of failure’ approach to set up activities has been vital in motivating myself and fellow teammates. Equally, learning, adapting and putting contingency plans in place have been crucial. Staying close to the process has been more important now than ever before.

Dealing with Brexit

Brexit has, and will continue to have, a significant impact on the pharmaceutical and healthcare sector. Fortunately, we now have a deal in place, which has helped alleviate the uncertainty attached to a ‘no deal’ scenario. Critically, it has provided a framework for the future. With some of the world’s brightest minds working within our industry, I am positive that, through close collaboration, we can confidently overcome any short-term and long-term challenges together.

What is most important to understand about Brexit is the fact that it is totally new to all of us, even the MHRA. No one can predict, with absolute certainty, what is to come. Take supply chains, for instance. Many stakeholders expected a major impact on the availability of medicines and equipment post-Brexit.

However, the government and industry have been working together for some time in order to mitigate such risks and make any disruption minimal and short-lived.

Similarly, long-term challenges around the licensing of medicines for use in the UK, as well as the expected additional workload and cost that this will entail for industry, on top of the EMA submission are real issues that we need to address.

We are one of the first companies to go through this process in 2021 and I am learning to take each day as it comes. If I can offer any tips to others about to embark on a submission this year, it is to stay close to the process, as it is a constantly evolving situation, as new to the MHRA as it is to us and requirements are being updated weekly.

Larger pharmaceutical organisations are fortunate in that they have the additional resource of teams that are dedicated to working through these issues, but as a smaller company, my team and I are navigating this on top of our day job. Having said that, EMIG (Ethical Medicines Industry Group) has been with us every step of the way and I am extremely grateful for its counsel and support, as we establish a new way of working with the MHRA.

Looking forward with positivity

At Galapagos, we are committed to delivering medicines to patients in the UK that tackle the root cause of a disease and not just moderate its symptoms. With a focus on inflammatory and fibrotic conditions, we have submitted a marketing application through our partnership with Gilead for a new treatment for ulcerative colitis (UC) to the MHRA in Q1 2021.

Recently, Galapagos and Gilead Sciences received a positive NICE recommendation for Jyseleca (filgotinib) for use on the NHS which, for the first time, will support access to an advanced therapy for people with moderate as well as severe rheumatoid arthritis – aiming to avoid irreversible damage as early as possible.

More than 400,000 people in the UK live with RA (around 380,000 in England), and it is recognised as a condition that can cause debilitating physical pain, affect mental health and require chronic care. Around 70% have moderate or severe disease and could benefit from access to Jyseleca.

Conclusions

As the pandemic rolls over to 2021, so too will the industry’s unquenchable drive for innovation. With three COVID-19 vaccines approved for use in the UK at the time of publication, positive NICE recommendations for medicines like Jyseleca, and significant investment in the UK biotech industry, I have no doubt that the UK market will enable us at Galapagos to continue to do pioneering work for patients in 2021 and beyond.

Equally, at Galapagos, we are confident that it is possible to make a success of Brexit, particularly in the context of the significant opportunity to scale-up investment and growth in the UK market to better support patient needs.

With a well-established NICE Technology Appraisal process and more autonomy over the timing of authorisation submissions, Brexit provides a unique opportunity for industry to bring medicines to patients in the UK faster.

Emma Chaffin (pictured) is Country Head of Galapagos UK

22nd March 2021

Emma Chaffin (pictured) is Country Head of Galapagos UK

22nd March 2021

From: Research, Regulatory

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