Since joining Moderna as its first ex-US commercial employee in Spring 2020, Dan Staner has played a leading role in developing what is now one of the world's top 20 biggest pharma companies. Speaking exclusively to PharmaBoardroom, Staner describes how Moderna has been able to fashion a new, optimised company culture, free of the restraints of established Big Pharma; the most exciting projects in its mRNA-based pipeline beyond its blockbuster COVID vaccine; and his vision for Moderna in the Middle East, leveraging national initiatives and genomics projects to impact rare diseases in the region.
In an industry where leaders tend to speak in a very scripted way, your enthusiasm is a breath of fresh air! What keeps you so engaged?
Quite simply, our industry does meaningful work. Thankfully, especially post-pandemic, there has been a broader realisation of how we touch individual lives and countries in general.
On a personal level, I spent 27 years with Eli Lilly, which I loved. Developing my career with the company in Europe, the US, and the Middle East – where I lived for about seven and a half years – taught me a lot. After my time at Lilly ended in Spring 2020, I came across an opportunity to become the first ex-US commercial employee at Moderna. At that point, near the beginning of the pandemic, Moderna was little known, and its mRNA COVID-19 vaccine was only in Phase I clinical trials. This move, therefore, represented something of a personal gamble. However, it has paid off in terms of the company’s eventual major role in fighting the pandemic through our vaccine.
My father passed away from COVID-19 in the early days of the pandemic before vaccines became available, so I fully understand the seismic nature of our impact on individuals and societies. COVID-19 showed us that infectious diseases can impact anyone, anywhere, at any time, so we must be ready to respond rapidly. Having cut my teeth at Eli Lilly, which I would compare to the best school imaginable, I am privileged to now be part of Moderna, which is more like a speedboat! This company’s ability to pivot and make decisions quickly is invigorating.
This does mean that we only hire people with a wealth of industry experience. We need the scale to train staff extensively ourselves; instead, we need entrepreneurial spirits who can hit the ground running. This setup has led to us growing from 1,000 to 6,000 employees during my time with the company and has laid the groundwork for the 15 product launches we expect to carry out over the next five years.
How challenging has it been to create a unified company culture, given that Moderna is bringing in experienced staff with their own well-established ways of working?
Our culture is about innovation, entrepreneurship, bold moves, and disruption. When I joined Moderna, we had to build all the systems from scratch, and I initially rented an office space from Lonza. To avoid spending all our time in the small rented office, we spent an inordinate amount of time holding meetings in the pizzeria across the street!
At an established Big Pharma company, all the systems are already in place, but we had a fantastic opportunity to create our own, more optimal, systems from the bottom up. The dynamic and entrepreneurial culture we have created is allowing Moderna to optimise, maximise, and capitalise on its mRNA platform. We have built good processes but have not become process-oriented, as this risks diluting the culture.
Moderna’s COVID-19 vaccine, like its entire pipeline, is based around its mRNA technology platform. Why has Moderna placed such a massive bet on mRNA?
mRNA technology is a versatile platform with potential applications across therapeutic areas. It can be tailored to fight various diseases, including cancer, rare disorders, and autoimmune diseases, by instructing cells to produce specific proteins that can either fight the disease directly or stimulate a strong immune response. mRNA vaccines and therapies can be developed more quickly than traditional methods, which is crucial in responding to emerging health threats. Additionally, mRNA technology uses a non-live platform, reducing the risk of side effects associated with live-attenuated vaccines.
In oncology, we are working to grow our therapeutic modality by discovering mRNA medicines that harness the body’s immune system to identify and kill cancer cells in the same way the immune system identifies and targets infections. This includes individualized therapies and broad-based therapeutics.
mRNA technology also holds promise for treating rare genetic disorders by providing the body with the mRNA needed to produce proteins that patients are missing or producing in insufficient quantities due to their genetic condition. This approach could revolutionize the treatment of diseases like Cystic Fibrosis.
We’re committed to using mRNA technology to address global health challenges, including neglected diseases that disproportionately affect the poorest regions of the world. By developing vaccines and therapies for diseases like malaria and tuberculosis, we aim to significantly impact global health.
While Moderna’s pipeline looks highly promising, the company currently only has one product on the market – its COVID-19 vaccine. How keen are you to avoid being seen purely as a COVID company?
The pandemic accelerated our development, and while we would probably have eventually landed in the same place, it happened more quickly than expected. Our executive leadership had, and has, a firm belief in the potential of mRNA technology and the ability of our own body to defend against pathogens and disease. Let’s not forget that two recent Nobel Prizes have been given to scientists who worked on mRNA.
Revenues from our COVID-19 vaccine have allowed Moderna to open many new avenues. To this end, we are set to launch 15 new products in the next five years, starting with our RSV, before moving on to influenza, combination vaccines, rare diseases (vitally important in the Middle East), oncology, and latent viruses.
Will Moderna remain solely a vaccine company, or will it branch out into other areas?
Our pipeline includes vaccines and therapeutics. We are not only working on preventive treatments for people but also bringing forward therapeutics for diseases such as cancer. This is especially true of our cancer pipeline, where together with our partner MSD and in combination with immunotherapy, we have mRNA-based products for late-stage melanoma and non-small cell lung cancer patients. Additionally, at some point, we are exploring the move beyond injectables to provide medicines via nasal sprays.
While Tier One regulators in developed countries like the U.S. FDA and EMA might be appreciative of the science behind these vaccines and therapies, have you experienced a different reception in the Middle East?
Our reputation is strong in the region, especially in its leading countries. For example, Moderna has been providing its COVID-19 vaccine to Saudi Arabia since 2021, and a significant percentage of the Saudi population has been vaccinated with it. Maintaining an excellent relationship with local regulators was crucial in Saudi Arabia and elsewhere. We had a direct line to most regulatory agencies almost daily, with dedicated teams to the pandemic, and this allowed us to speed up the entire regulatory processes, reducing it from years to months and sometimes response timelines from weeks to days.
Additionally, thanks to our confidence in the technology we were bringing forward, we made the bold move to run Phase II and III trials in parallel. This was risky financially, but it helped speed up the process and showed our confidence in the mRNA platform from day one. Moreover, we were continuously able to monitor and demonstrate the safety of the vaccines despite the compressed timelines; few products in history have been studied as deeply as COVID-19 vaccines.
Now, post-pandemic, the speed at which regulatory bodies and our own regulatory teams are working is decreasing slightly, which is positive. These people did not take weekends or vacations for months due to the critical importance of their mission.
Do regulators in your region have a different opinion of Moderna in 2024 than they did back in 2020/2021?
The difference now is that regulators have the experience of dealing with Moderna not just for our COVID-19 vaccine but also for other products in our pipeline i.e. RSV vaccine and understand that we consistently deliver on expectations.
At the beginning of COVID-19, we were a relatively unknown player. Now, we are a valued partner. All of this proves that innovation does not necessarily come with size. You need the courage to disrupt.
What do you find engaging about the region you now manage (Middle East, Germany, and Switzerland)?
I love this region, and the opportunity to create Moderna’s footprint here from scratch was fantastic. I built up the firm’s European operations by opening eight affiliates and working on contracts with the European Commission and the Middle East. It is time to continue developing our business broader and stronger across the Middle East region.
What is the relevance of this part of the world to Moderna?
There are several highly promising initiatives underway in the Middle East, particularly in the GCC, which are very relevant to Moderna. Two examples come to my mind: M42 and the work on genomics in the UAE is one, and the Saudi Biotech National Strategy is another. For sure, in Kuwait and Qatar, countries that have partnered with Moderna from day one, we are also, as we speak, exploring strategic partnership initiatives. In Saudi Arabia, we have huge partnership opportunities ahead of us, with three of the four pillars of the National Biotech strategy (vaccines, bio-manufacturing, and genomics) aligning perfectly with Moderna’s expertise and ambition.
One important synergy in research in the Middle East is rare diseases. One of our upcoming therapeutic areas of focus will be rare diseases, which is especially relevant here, given the high levels of consanguinity in the region. After the US, Saudi Arabia could be the second largest market for these products worldwide, making it appealing to do more research here.
Can you expand on how you see Moderna contributing to this genomics piece in the Middle East, especially in Saudi Arabia?
The UAE started its genomics project several years ago, but Saudi Arabia is starting now, and there are huge opportunities for partnership. The beauty of mRNA technology lies in how it can be personalised and developed for individuals or specific populations. The more we know about the genomic profiles of these individuals and populations, the more effective and targeted the therapies and vaccines we develop will be. As a more agile and specialised organisation than our Big Pharma counterparts, Moderna is well placed to be a partner of choice in genomics in the Middle East, whether in terms of R&D or manufacturing.
What are the next simple, actionable steps to be taken as Saudi Arabia attempts to implement its vast and ambitious biotech strategy?
We need to work closely with the Saudi authorities. They have a very clear vision of what they would like to achieve. We are already testing out the Saudi Food & Drug Authority fast-track designation, and we must maintain mutual accountability and partner with them to properly road-test the new system.
The aim is for Saudi Arabia to become a MENA hub for biotech by 2030 and a global hub by 2040. This can be achieved by moving quickly regarding R&D, manufacturing, and market access for innovation while maintaining quality. Saudi Arabia has all the potential to become a regional Biotech Hub – where innovative products are often launched within days after U.S. Food & Drug Administration and European Medicines Agency (EMA) approval, covering Billions of people between the Middle East, Africa, and Asia – and achieve great success.
What is your vision and objective for Moderna in your region, and Saudi Arabia in particular?
In the short term (2024 and 2025), we must accelerate sales and engage in disciplined investment. This discipline is vital as we have more than 40 programmes in development, which will expect to soar to almost 100 in the next five years. We need to prioritise our investments to allow the R&D machine to bring those innovations to market. In the next five years, we expect to launch 15 new products in infectious diseases, oncology, and rare diseases.
Looking further ahead, we currently work through partners in the Middle East, including fantastic firms like Tabuk Pharmaceuticals in Saudi Arabia. However, our vision is to develop our own strong local presence. The best way to do this is to engage with key stakeholders and support the three aforementioned relevant pillars of the Saudi Arabia Biotech Strategy. Those three pillars are close to our hearts and perfectly fit our vision of development in this region.
