By Evan Henry

When it became obvious that COVID-19 was to utterly change how we live, few would have predicted that a company from Galway could play an instrumental role in returning life across the world to normality. Aerogen, an Irish medtech company, produces a drug distribution system that delivers medicine through aerosols in acute hospital settings. John Power, Aerogen’s CEO, formed Cerus Medical in 1997 when he recognised a major gap in the technologies used to deliver drugs in hospitals. While life-support machines were among the most advanced medical technology used in hospitals, the drug-delivery systems that assisted these machines were developed over fifty-years ago. Power believed there were better ways to target the delivery of drugs, and it was common knowledge that drugs are efficiently administered by ingestion through the lungs. Cerus Medical merged with Aerogen Inc. in 2000 and launched its first nebulisation product, the Aerogen Pro shortly afterwards. Twenty years on and the company exports to more than 70 countries and their products are used in 60 of the top one-hundred hospitals in the world, benefitting over ten million patients. Its clients include Medtronic, GE Healthcare and Philips Healthcare.

Aerogen and COVID-19 So Far

Aerogen was overrun when COVID-19 broke out, given the huge demand created for ventilators by the respiratory illness. In fact, Aerogen’s products were in greater demand  than those of competitors because they are the largest producer of closed-circuit nebulisation system devices on the market. A closed-circuit nebulisation system is one that delivers gaseous drugs to patients while leaving ventilation uninterrupted (Medical-aerosols), ensuring that healthcare workers are not exposed to any gases exhaled by the patient (patient-generated Bio-aerosols). Closed-circuit nebulisation devices are far safer and more efficient than conventional nebulisation devices. Aerogen is also working with various hospitals and research groups to adapt ventilators unsuitable for COVID-19 patients. Along with this, the company is involved with more than 20 drug companies and research institutions that deliver antivirals and drugs to patients in ICUs. Power has predicted that Aerogen will move around four million units this year, up from two million in 2019. But despite the outstanding role played by Aerogen in the treatment of COVID-19, the delivery of its cure could be the company’s true magnum opus. 

An Emerging Alternative to Liquid Vaccines

The race for a COVID-19 vaccine has left the pharmaceutical industry in a frenzy, with dozens of companies and research groups competing to produce the immunisation treatment. While a vaccine could potentially be produced by the end of 2021, the timeline is still unclear. The only certainty surrounding the vaccine is that demand for it will exceed supply, likely by a substantial margin. However, Aerogen claims to have the solution to this problem. On RTÉ’s The Business programme, Power revealed that Aerogen is also working with “a leading [unnamed] pharmaceutical company” to produce and distribute an aersolised vaccine. If successful, this will reduce the quantity of dosage required per patient, because drugs ingested through the lungs are generally absorbed more efficiently by the body.

How would aerosolisation address the supply-demand inequity that will occur when a vaccine is finally approved? The inequity will be caused by two things: an insufficient number of doses and an inability to accommodate massive numbers of people gathering to seek vaccination. Should Aerogen’s efforts bear fruit, they will provide meaningful solutions to the issues facing both sides of the market. The first piece of the mass vaccination puzzle Aerogen hopes to solve involves providing enough doses to meet demand. The company predicts that their partners will produce around 500 million liquid doses by the end of 2021, which is a far cry from the amount required to eradicate the virus. However, if a liquid vaccination can be aerosolised, Aerogen predicts that only a fifth of the amount of medicine will be required to treat the patient. If their estimates are accurate, the result would be two and a half billion doses available by the end of 2021. This number will not result in universal immunisation, but it would nonetheless reduce the virus’ rate of spread. The outcome would be fewer new cases, fewer deaths and reduced pressure on healthcare systems worldwide. However, from the initial solution to vaccine shortages springs another challenge: distribution. How can two and a half billion people be vaccinated in a safe, timely and cost-effective manner? Speed of delivery is imperative the alleviation of not only suffering, but also of pressure on healthcare systems. Aerogen claims to have found the answer to this inevitable complication.  The company has developed a station for the aerosolisation of a vaccine which will allow patients to be vaccinated in a quick and orderly fashion. If the station is employed, their estimates, based on data collected from Chinese COVID-19 treatment procedures, predict that 2.5 billion people could be vaccinated in 39 days if ten-hour shifts are worked at 55,000 centres. Such rapid and systematic delivery of a COVID-19 vaccination is as much as anyone could hope for.

Can It Be Done?

The size and scale of Aerogen’s ambitions are clear. They hope to have roughly one-third of the world’s population vaccinated by the end of 2021. Of course, any discussion of a COVID-19 vaccine and its distribution is a mother lode of suspicion and further questions. Will a vaccine even be produced at all, never mind by the end of 2021? If so, can it be aerosolised? Will aerosolisation really require only a fifth of a liquid dose’s quantity? Will aerosolisation prove to be more or less effective than liquid vaccinations? Can other countries work as efficiently as the Chinese in their administration of a vaccine? Will the vaccine be affordable? All of these questions raise valid points and will undoubtedly be the subject of future debate. The honest answer to most of them for now is that we simply do not know. What we do know is Aerogen is one company making substantive strides towards returning life to something like its pre-COVID configuration. Time will tell us whether or not it succeeds.

By Sinéad Flynn

Overview

Innovation and technology are the most prominent buzz words for firms and corporations around the world. The next big idea, next invention, and next discovery are waiting to emerge. Society has evolved from the 1880s, where it was once thought by Commissioner of US Patent Office Charles Duell that “everything that can be invented has been invented” to new advances exploding at our fingertips without limits. FinTech has received a great deal of attention, and it’s only in its infant stages.  Marc Andressen notes that ‘internet companies might end up in 180 countries before they have 180 employees.’ Globalisation and technology have had a huge impact on markets, and the role of Fintech is just a new stimulation.

What is Fintech?

Fintech is a financial technology that aims to compete with traditional financial methods. Fintech can take the shape of crowdfunding, cryptocurrencies, or blockchain, and notably is expanding into new markets rapidly. While online banking has been prevalent for years, fintech adds a new dimension to the payment’s services. Within seconds, users are sending and receiving money faster than ever before. Fintech has begun to dominate our everyday lives where it is commonly seen with those who use Apple Pay or Samsung Pay or those that have sent funds via GoFundMe. The limits to what may be considered Fintech can be unlimited, where most start-ups are embracing technology to create innovative products and services. FinTech is emerging throughout trading, insurance, and risk management as well, which has appeared quite disruptive to these industries that haven’t changed for quite some time.

Opportunity or Threat?

While business may be booming, and the financial crash seems to be forgotten, how does commercial law interact with this fast-paced business environment? It is argued that fintech firms receive a competitive advantage and create an attractive space for investors when they comply with regulations. Cryptocurrency companies and those that are an unregistered seller of securities have been hit hard in the US by the Security and Exchange Commission. These fines have diminished confidence in these certain start-ups and created financial loss through settlements and fines. There are concerns that fintech firms are utilising their institutions to harbour illegal assets utilised for criminal activity. While fintech firms have been embraced for their revolutionary growth and modern methods to business in this age of technology, it must be approached with caution due to poor ethical choices being made at times.

Striking the Balance

Countries such as Ireland that rely on a great deal of foreign direct investment must adequately strike the right balance between attracting new business, but also ensuring the system is not abused. Research shows that there is no specific legislation designed to regulate certain services that fall under this broad FinTech category, besides those concerning the Central Bank of Ireland and minimal EU Regulations. Ireland is a lucrative location for start-ups and businesses looking to set up a European hub, as they have more freedom to do so while then receiving this passport into the European market. Diversity in our financial markets reflects this growing desire to explore alternative mechanisms to enhance society. While research is ongoing for the limitations and effects FinTech firms bring to the table, these initiatives are looking primarily to law firms to structure and protect their interests.

A Closer Look

If one narrows the analysis of Fintech into electronic payment companies, the Payment Services Regulation 2018 will apply. This Regulation has effectively created a more level playing field for fintech start-ups to enter the market and develop their technology services further with an overall aim to increase competition for the benefit of consumers. At the moment, it is argued here that the EU is fully embracing these innovative and competitive practices. If one assumes that the market will regulate itself and that the legislature should be more laissez-faire, then more relaxed regulations should be welcomed. While this may be worrisome to those that appreciate the traditional style of banking and finance, this is ultimately a positive step, as time and time again, traditional banking models and financial institutions of the past have failed multiple sectors leading to dire losses.

Has the Balance Been Struck?

The right balance must be struck in order to protect investors, but also to facilitate this necessary development. The Central Bank of Ireland is conscious that there is a lack of legislation specific to Fintech entities, and that it has assumed the role as the main regulator where able. This leaves investors and innovators in a precarious spot. In one regard, there is little law guiding their activities, but in turn, this allows them to receive the freedom necessary to develop and surpass imaginable limits on their ventures. While the Payments Services Regulation may increase accountability and reporting, this may not be enough to accurately analyse how these institutions are operating.

What Next?

The embrace of the change in the financial markets may be a positive step, and a mechanism that may prevent future economic crashes and downturns as new perspectives and ways of managing the financial sector are introduced. Consumers must be wary for that this partially unregulated ecosystem may produce detrimental effects that hindsight may prove useful.