Finalists explore new ways to fight disease and help foreign pharmas access EU markets

Aalto Bio Reagents

Aalto Bio Reagents is an Irish company playing a global role in tackling serious tropical viruses such as Zika, dengue and yellow fever. Founded in 1978 to supply raw materials to the global diagnostics industry, the company now produces some 300 different reagents – 150 antibodies and 150 proteins – which are used for the diagnosis of a vast range of diseases.

CEO Philip Noone, an entrepreneur with a long track record in the diagnostics space, acquired the company in 2014. He was attracted by the company's existing product set as well as its potential.

"Aalto Bio had some interesting diagnostic products and I wanted to look at other areas, including dengue fever and the Zika virus," he says. "I also thought a good area to look at was the chikungunya virus and we launched a material for that in 2015. We then targeted the Zika virus, and the late 2015 outbreak in Brazil triggered enquiries from hundreds of companies around the world. When the noise died down, we were left with five or six key players building diagnostic solutions for the virus and we are working with all of them. The mosquito which carries the Zika virus also carries chikungunya and dengue. We have the materials to test all the diseases from that vector."

Quiet success story

This has been a quiet success story. “Our brand doesn’t appear anywhere, but we make the key component,” he explains. “When someone goes to be tested for a tropical disease the assay will probably use an Aalto Bio biomaterial. We supply the materials to all the main global players. What’s happening now is that our customers are asking us to build biomaterials specifically for them. They will identify a disease. We will go out, inoculate an animal, take a sample, grow the virus, build the antigen and then produce it synthetically to the scale required.”

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The company has grown rapidly, with staff numbers doubling and turnover rising in double-digit growth to €3.3 million. “Our target is to double the size of the business within the next five years through a combination of new product development and new customers,” he says.

“We are interested in looking for solutions to emerging pathogens and building materials that help patients get diagnosed faster. If you want to be at the leading edge you’ve got to move fast.”

Export markets remain the primary focus. "Exports account for 93-94 per cent of our sales. Almost all of our business is generated outside of Ireland, " he says.

"We are setting up partners in China at present and took part in an Enterprise Ireland trip there earlier in the year. We are now doing the same thing in Japan and we have just signed up a partner there as well. We are also working with a manufacturing partner in Brazil and are targeting Germany and France for future growth."

BrainWaveBank

Revolutionary new technology developed by Belfast-based BrainWaveBank has the potential to enable much earlier diagnosis of Alzheimer’s and other degenerative brain diseases with a view to facilitating earlier and, hopefully, more effective treatment of these conditions.

"If you look at neurodegenerative diseases like Alzheimer's there is no cure but there are some promising treatments out there if they are caught early enough," says BrainWaveBank chief executive Ronan Cunningham. "At present, the only way to diagnose these conditions is through PET [positron emission tomography] scans or spinal taps. These are very expensive and are not widely available nor are they easily accessible for patients."

BrainWaveBank technology addresses these difficulties with what Cunningham terms “a Fitbit for the brain”.

The company has taken proven science out of the laboratory and applied the latest sensor, connectivity, and mobile phone app technology to develop an electroencephalography (EEG) device to monitor brain function and in the patient’s own home.

The portable EEG is a lightweight headset comprising 16 sensors which are connected to a smartphone via Bluetooth. The patient wears the headset for 15 minutes a day while playing games on an app designed by the company that tests different aspects of cognitive function including memory, decision making and executive function. Responses to this gameplay are recorded and compared with a database of known responses and a detailed picture of the individual’s cognitive health is built up over a few weeks.

The phone app can also interface with devices such as Fitbits and other health trackers in order to add lifestyle information to the brain function data. “By adding lifestyle information such as how well the person has slept or how much caffeine they have consumed that day we can put the data in context to deliver a much better assessment of their cognitive health,” Cunningham says. “A person might just be tired during a particular week and that might explain what appear to be symptoms of a neurodegenerative disease.”

User friendly

Importantly, the technology has been designed for ease of use.

“We recently completed a 90-person trial with patients aged up to 79 years old. We were able to get very high-quality EEG data after just a few minutes training. Ninety per cent of the participants said they found it very easy to use at home on their own. Our ultimate goal is to have no training at all required. We will just pop the headset and instructions in an envelope and people will be able to get going on their own.”

The technology has been proven in a number of demonstrator trials and the company has just been asked by the Northern Ireland Department of Health to work on research into pre-psychosis in teenagers.

“We are still pre-revenue at the moment and we are looking at entering the commercial market next year,” says Cunningham. “We have four trials ongoing in the area of mild cognitive impairment and we are in active discussions with a number of contract research organisations to utilise our technology in their trials.”

Mias Pharma

With the prospect of a hard Brexit growing more likely by the day, Mias Pharma's offering to the market could hardly have been timelier. The company offers pharmaceutical firms from outside Europe access to the single market and European Economic Area (EEA) by providing them with the required manufacturing and importation authorisations.

“The timing is working out perfectly,” says CEO Ann McGee who founded the company in June of last year. “We didn’t establish the business with Brexit in mind, but it is generating great opportunities for us. In the past, companies targeting the EU market tended to look to the UK first as a stepping stone because of its large domestic market. They are now looking at Ireland instead and anticipating having two Brexit products live by the end of next year.”

Marketing a pharmaceutical product in the European Union is a difficult and complex undertaking, McGee explains. "When a company wants to come into the EU with a product such as paracetamol they have to set up a company in the EU and obtain a licence for the product. Making a medicine is like making a cake. A recipe containing active ingredients, excipients and other ingredients is used. All these ingredients might come from different manufacturers around the world and each has to comply with best manufacturing practice as laid down by the EU."

Highly regulated

All of that has to be audited and the process doesn’t stop there. “All of these materials come together in the manufacture of the finished product. The manufacturing process is highly regulated. We provide the auditing service and the oversight of the manufacturing process. We confirm that the manufacturer will product the product to the right standard every time.”

Packaging and distribution are also highly regulated and requires auditing and oversight. “The documentation that is included with a product has to meet certain standards and transportation has to be secure to prevent interception, counterfeiting and so on. A whole series of different documents are required to confirm that a batch of pharmaceuticals is in compliance with the various regulations. That’s what we do. It’s highly technical and complex.”

Market response has been very encouraging. "We spent our first nine months getting our licence from the Health Products Research Authority, " says McGee. "We were out introducing ourselves to potential clients at the same time. We are targeting companies from outside the EU who want to sell into Europe. We started with California and already have three active projects in place. We will have five or six clients by the end of the year. We are in a low-volume, high-value business and we only need three to four new clients a year to grow the business."

The company is also set up to scale rapidly should the need arise. “We operate a hub and spoke model with a small team at headquarters backed up by a network of professional consultant associates who are available to work on projects as required.”