Ask the Experts Interview Series

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Fabio Fais

Fabio Faïs joined Auris Medical in 2017, now Altamira Therapeutics. He is responsible for the CMC technical development of Altamira Therapeutics’ pipeline.

Prior to his current role, he spent >14 years in various roles in Drug Product development in the Pharmaceutical Industry developing complex small molecule and biologic drug products. Fabio has also worked at Crucell (Janssen Vaccines), Ipsen and Merck-Serono.

He received his MSc degree in Medical Biotechnologies, Faculty of Medicine, from the University of Trieste, Italy.

Ask the Experts Interview Series

with Fabio Fais

Tell us more about your current role and Altamira Therapeutics

I am director of Technical Development / CMC at Altamira Therapeutics, which is a company which is dedicated to developing therapeutics in the field of otorhinolaryngology and recently expanded also into RNA based therapeutics. One of our major projects is a nasal spray, AM-125, which is currently in phase 2 development for the treatment of vertigo. 

Recently, another major effort has been around a nasal spray project coded AM-301 (trademarked as BentrioTM), which has been quite a challenge. This is a Class 1 medical device, which helps in preventing and/or mitigating viral infections in the nose, and also protects from airborne allergens. This is a product which we thought of in the first Covid-19 lockdown. 

How did you come up with a nasal spray against Covid and how does it work?

At that time, very few were thinking about potentially simpler solutions than drugs or vaccines, such as medical devices. The difference between a medical device and a drug is essentially this – a drug acts chemically, whereas a medical device acts physically. 

As a matter of fact, when we’re talking about viruses, we’re still talking about physical particles. The thought that came up was, “well, what if we just see the virus as a particle and not as something that is biologically active?” Because once the virus infects a cell, it actually expresses a powerful machinery that can hijack our cells. However, when we look at viruses in the phase before infection, it’s just a particle. 

BentrioTM is a thixotropic gel, which means that it that becomes liquid when you shake it such that you can spray it in your nasal cavity. It becomes like a scattered barrier on top of your nasal epithelium, and then it acts as very powerful mucus which reinforces your body’s own protection. 

Once the virus encounters this very special barrier, it is trapped – completely attached like velcro and a tennis ball. We’re basically applying a lot of ‘velcro’ that is chemically inactive and drug-free which has maximum biocompatibility. It doesn’t even have preservatives.

The nasal epithelium is an extremely important barrier because more than 90% of the air that you breathe passes through your nose daily. So, this is actually the main entry gate for airborne allergens and viruses into your body. Viral infections such as SARS-CoV-2 typically start in the upper respiratory airways, that is the nose, before spreading little by little reaching your lower respiratory airways. You can also catch it in the lungs especially when breathing through the mouth, but in terms of probability, most likely it is the nose where you will catch it. If you can block it there, it would importantly block or mitigate the impact of the infection minimizing the possibility to reach the lungs. 

Being a thixotropic gel, the gel has a long residence time in your nose, unlike other nasal sprays that have been developed. We have seen clinically that the barrier is functional for at least up to three hours or probably even more where this product was really challenged with allergic volunteers in a pollen rich environment. We look at it as having a preventive capability, which is much more than a mask – a mask is more of a macro system placed outside of your nose, but this product here acts exactly where you need it.

How has this been possible in such a short time? 

Firstly, you need the determination, a good dose of risk-taking attitude and courage. The determination also comes from the fact that there is a lot of scientific understanding and expertise as a basis. 

The very first proof of concept data was extraordinary, showing a decrease of more than 99% of infectious SARS-CoV-2 titre. When you see data like that, you must go for it. The second data was in a much more challenging setup where the product was used to protect a 3D model of human nasal epithelium from primary cells. Excitingly this showed even more encouraging data. That gives you a lot of force, will and determination.

For small companies like Altamira Therapeutics, it is necessary to rely on external service providers and engaging with these is essential. It’s not just a matter of signing a contract for a service, but also embarking on the same objective. Engagement is a must since you need a proactive and attentive approach and you cannot just wait for things to happen to solve them. You must anticipate things. It was a matter of bringing everybody on that mindset.

I have been in contact with approximately seven external service providers, who were found, brought in, engaged and finally were happy to support us. 

What is the difference working in a big pharma vs a small biotech/medtech? 

A metaphor I usually use to explain the difference is very much like traveling across the ocean. When you work in a large company, you’re one of the crew members of a very large ship. Everybody’s doing an essential part to move that big ship. 

However, when you work in a small company, you’re like a windsurfer. You feel the waves, the wind and also the sharks. You can fall but you can also quickly get up again. And especially when it comes to adapting the route and changing direction, on the windsurf all it takes is a snap in your mind. However, it’s going to take a long time when it comes to one of those cruise ships. 

Just to give you an idea, a Standard Operating Procedure in a small company can be changed in 1-2 days; in a large company, it can easily take up to 9 months. And this is just for processes – imagine strategic decisions about projects or therapeutic areas, etc.

What early career experiences have been vital for you to be where you are today?

Working on high pressure projects in multidisciplinary projects such as most of the pharmaceutical development projects are, was key. The need of working together is rather a need of performing together which then translates into growing together.

What drives you?

The possibility and potential. I think of myself as a possibilistic optimist. That means that if there’s the possibility for a thing to go well, you must go for it as it does have the potential to come out positive. And there are so many things that can go well in reality – you need to work for it. You cannot stop because there are some difficulties. 

I have decided to dedicate myself to innovation in healthcare and studied medical biotechnology at the University of Trieste. It gave me a glimpse and broad preparation on the many aspects of what biotechnology can do, specifically in the medical field. 

Can you share some career highlights? 

BentrioTM is definitely a highlight. I’m happy because it required a lot of out-of-the-box lateral thinking which I always try to do.

A second thing is the possibility to engage in very difficult technical or scientific challenges within pharmaceutical development. Typically, people in my role need to know a lot about procedures, experiences, best practices, guidelines – but all this also narrows down the possibilities. Keeping updated on novel opportunities and continuously evaluating them versus current health needs and regulatory requirements.

Once I supported a project about aseptic continuous manufacturing in a microfluidics setup for microparticles. So, typically experienced people in pharmaceutical development would say that this  is nearly impossible to accomplish. Well it was possible. You just have to go after it and have an open mind, and then fit it within the rules and inside the box. 

Another highlight is that I’ve been moving to different companies that deal with very different things such as Merck-Serono, Ipsen, Crucell (now Janssen vaccines) and Novartis. I started off in biotech, ended up in vaccines, and then in small molecules. I loved striving in all of these because there were so many opportunities to learn, to know people, to be engaged with new problems. People usually always tend to look for the comfort zone, but it is in the non-comfort zones where you grow.

Any advice for young scientists embarking on their career?

Understand what is critical and what is not and don’t get lost in minor details. The important thing is the major objective and critical points, which may well be details. When I started my career, I didn’t even know what pharmaceutical development was in reality, but the main objective was clear – there was an opportunity, and I went for it. There’s a lot to discover and a lot to be passionate about. It’s only by doing a job that you realise exactly what it is about. 

What is missing currently in the industry?

Diversity. I think that there always must be a very strong attention to diversity. 

If I were to build a team, I would focus on trying to make it as diverse as possible on the premise that there are the required technical and teamworking competencies to do the job. When it comes to technical competency, try to look for competent people that come from other fields. 

It’s only through having many eyes looking in different directions that you’re aware of where threats or opportunities can come from. If everybody has the same pair of eyes, then your group is blind and ordinary. This is very important because the important novel challenges are typically extraordinary. 

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