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Spotlight on Dr Karl Roberts, Chief Operating Officer

In the latest instalment of George Medicines’ Spotlight interview series, Chief Operating Officer, Karl Roberts, tells us what drew him to George Medicines and how the company’s pipeline, alongside its partnership approach with other healthcare companies and organisations, has the potential to change the treatment paradigm for people living with non-communicable diseases, wherever they live around the world.


What drew you to George Medicines?

I have enjoyed a long career in life sciences and the pharmaceutical industry. I studied chemistry at university and my subsequent PhD went very well but I quickly realised that the strong performing academics around me ate chemistry for breakfast, lunch and dinner! Academia wasn’t for me and industry beckoned. Over 35 years I’ve been lucky enough to gain hands-on experience in pharmaceutical sales and marketing, project management, strategic marketing (closely working with R&D colleagues and devising early-stage commercial plans), business development and M&A.

I was introduced to George Medicines through a former colleague – he said, ‘there is a really good opportunity which you should take a look at’.  Once I learnt a little bit more about the company and its approach, it seemed like a fantastic opportunity. This was very much a start-up and it was ripe for someone like me to bring 35 years’ experience to the table. But, more importantly, George Medicines was not just about dollars and market share. That was clear from the start. The company’s mission is embedded in addressing unmet need and enabling access to medicines, across the world, in developing markets and developed markets.

It’s quite unique in that it puts access to medicines before anything else. And that’s why it stood out as a great place for me to land, after more than three decades in the industry, by giving something back. That’s why George Medicines was the right place, at the right time. And I jumped at the chance!

A key focus of George Medicines is tackling the global disparity in access to medicines for non-communicable diseases. This is a long standing issue, how will George Medicines stand out?

From day one I have been struck by how George Medicines approaches things very differently.  If you go to any pharmaceutical company’s annual report or website you will get some reference to what they are doing in developing markets, but is it a priority? For us, it’s right at the top of our list. We have this unique approach where we put unmet need and access first and that’s what makes us different.

We are born out of The George Institute for Global Health whose mission is to improve the health of millions of people worldwide. That’s worldwide, not just in developed nations like the United States or across Europe. In order to succeed, we are building our approach to global access around a sustainable business model to ensure longevity. As part of that it’s important to closely evaluate the commercial opportunity of the medicines in our pipeline to make sure we have the right business model in place to support access. But ultimately, access is the driving force, not the dollars. That’s what George Medicines brings that’s different.

What does this practically mean for George Medicines?

We know that no two countries are the same. Global access to our medicines won’t come from simply securing the necessary regulatory approvals in each country. We need to understand countries’ health systems, infrastructure, patient behaviours and attitudes. So, alongside the work of our R&D organisation, gathering the clinical data needed to prove that our medicines are safe and effective, there is a huge amount of work going on to learn about local markets and identify the right partners who can work together with us to achieve our goals.

Our business model is to take our medicines through development and to secure regulatory approvals. The next step – equally, if not more, important – is to work with others to build sustainable, commercial strategies that will enable patients the world over to access our medicines. We need to work with commercial partners who understand different markets and populations, and to engage with governments and health systems directly. All of these stakeholders are key to successfully commercialising our medicines and getting them to the patients who need them, wherever they live.

We are born out of The George Institute for Global Health whose mission is to improve the health of millions of people worldwide. That’s worldwide, not just in developed nations like the United States or across Europe. In order to succeed, we are building our approach to global access around a sustainable business model to ensure longevity

What are your current priorities as Chief Operating Officer?

The whole organisation is very focused on getting GMRx2, our lead candidate, through its phase III trials. There is a lot of excitement about the potential of this single-pill, multi-mechanism, triple combination for the first line treatment of hypertension. The world over, there is a huge issue with the inadequate control of blood pressure – tens of millions need to start treatment, and tens of millions more need better treatment.

Our strategy is starting in the US, moving then into other regulated markets and developing markets. Positive data from our Phase III clinical programme would underpin our new drug application (NDA) to the US Food & Drug Administration (FDA) in the US and, hopefully, secure registration there. Alongside that we will be working with a commercial partner in the US – that partner is critical for the successful launch of GMRx2. And, in turn, that US approval and launch will be a key enabler to bring that medicine to non-regulated, developing markets and enable broad access, globally.

Working with the right partner is key for us – a company who shares our belief in the potential of our medicines and recognises the opportunity we have to transform how non-communicable diseases, such as hypertension, can be treated.

As a relatively new company, how is George Medicines building those relationships with others who can support its mission?

George Medicines is very fortunate in that we are often pushing against an open door, in fact often the door is already open. That’s because of our approach – because access is first. If we want to talk to the Clinton Health Administration, The Gates Foundation, Resolve to Save Lives, for example, these organisations are delighted to hear from us because we are very aligned in what we are trying to achieve, i.e., securing affordable access to medicines for people who are in need, whether they be in developed markets or in developing markets.

There is also lots of interest from commercial healthcare companies who recognise the potential of our approach – that by working together we have a real opportunity to improve the lives of millions of people suffering from the world’s leading causes of death and disability and we can achieve it in a commercially sustainable way.

GMRx2 is very important to us because it’s very much a proof-of-concept.  If we can get GMRx2 over the line – take it through clinical development, secure regulatory approval and launched in a developed market like the US, and subsequently other markets – that proves what we are doing actually works. It’s a rubber stamp on our business model from which things should get a lot easier. It should be easier to secure future investment, we will gain a revenue stream and we can make more progress on our pipeline, prioritising the next potential medicines for late-stage development.

Working with the right partner is key for us – a company who shares our belief in the potential of our medicines and recognises the opportunity we have to transform how non-communicable diseases, such as hypertension, can be treated

You joined George Medicines in 2018, what are you most proud of having achieved since then?

Getting GMRx2 to where it is. I think we have done very well as a small organisation with limited resources taking a medicine project from essentially a concept to where it is now. We have a fully worked up formulation, we already have 2.5 years of shelf-life on the product, it’s already viable as a commercial product from a CMC (chemistry, manufacturing and controls) perspective and we are halfway through the Phase III clinical programme which we expect to conclude in the next six months, before starting the registration process.

Alongside that, we have an interesting pipeline of other single-pill combination candidates with potential across several, major, non-communicable diseases. In July, we prioritised the second candidate in our pipeline – GMRx4, an ultra-low-dose, single-pill, triple combination candidate as a first-line treatment for type 2 diabetes. That has moved into phase II development and really shows the strength and breadth of our pipeline.  Prioritising which of our other programmes to rapidly progress through development is clearly an important part of our business, as we build George Medicines into a long-term, sustainable company.

Beyond your role at George Medicines, what’s exciting you now and keeping you busy?

With our two sons becoming increasingly independent, my partner Elaine and I are making the most of our newfound time together, in particular enjoying the outdoors — mountain walking, kayaking and even some wild camping!

 

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