A litmus test for Ireland’s biopharma and chemical sector

Biopharmachem Ireland (BPCI), the Ibec business association which represents the biopharma and chemical sectors in Ireland, has an ambitious vision for the industry. It wants Ireland to be the globally recognised centre of excellence for innovation and development in biopharmaceutical, pharmaceutical and chemical manufacture and supply, and the location of choice for the launch of new products.

Already, 13 of the world’s top 15 medical technologies companies have international operations in Ireland, while all of the top 10 global drug companies have facilities here. The industry has a huge impact on the economy, with over 50 per cent of goods exports by value coming from the life sciences sector. In addition, the sector has invested more than €10 billion in Ireland in the last decade – much of this in new or expanded manufacturing facilities.

The association has just published its new strategy for the industry, which addresses the key areas of talent, taxation, innovation, infrastructure and the development of an industry cluster in Ireland which will create a self-sustaining ecosystem involving multinationals in different sectors generating local spin-off SMEs and partnering with the indigenous sector along with higher education, health and research institutions.

"We publish a new strategy for the industry every two or three years," explains Biopharmachem Ireland director Matt Moran. "We take a snapshot of where the industry is at a particular time and highlight the strategic issues it faces. We published the first in 2010 and this is the fifth in the series.

‘Strong investment flow’

"The sector is very strong in terms of value, exports, innovation and so on, and the outlook is very positive," he adds. "Recent major investment announcements have included Takeda in Grange Castle, Dublin, BMS at Cruiserath in Dublin, WuXi in Dundalk, Alexion in Blanchardstown and MSD in Carlow and Swords. There is a very strong investment flow there and Ireland is a location of choice for biopharmaceutical manufacturing, but there are challenges for the industry as well."

Among those is the need for skilled employees.

“Talent is an ongoing issue and has been for some time,” says Moran. “The most interesting development in recent times has been the creation of the new laboratory apprenticeship programmes which allow companies an opportunity to grow and develop their talent pipeline and drive business growth into the future.”

We need the Government to invest more in the infrastructure to support Ireland's capability in this key area for the future

The laboratory apprenticeship programmes offer higher certificate and degree awards over a two- or three-year period.

"We created these non-traditional apprenticeships to allow people enter the industry and earn as they learn in the lab while being released for lectures in an institute of technology," Moran points out. "It's a vocational route into the industry as opposed to the traditional academic path. It's similar to Germany or Switzerland. We also spend a lot of time promoting STEM; that's a problem all around the world. As we move up the value chain new skillsets are required and NIBRT [National Institute for Bioprocessing Research & Training] is doing a lot of work on that."

Zone of opportunity

On innovation, he points to the advent of advanced therapy medicinal products (ATMP) as a zone of opportunity for Ireland.

“We need the Government to invest more in the infrastructure to support Ireland’s capability in this key area for the future,” he contends. “The obvious one is to expand NIBRT. The thing about ATMP is that the manufacture of the products is still at a very early stage and they still haven’t managed to figure out how to do it at an industrial scale. There is an opportunity for Ireland to get those early investments.

“Ireland is already a globally recognised biopharmaceutical manufacturing centre of excellence, and with the correct supports from Government would be ideally positioned to take on this challenge and position itself for the next wave of biopharmaceutical innovation and investment in Ireland.”

The regulatory sphere is another area to be addressed, and the strategy highlights the role of Regulatory Science Ireland. The organisation is committed to the development of an integrated Irish response to the global regulatory science effort by establishing an environment through which relevant research, training and communication creates a cohort of Irish-based regulatory science experts and further strengthens the value proposition of Ireland as an attractive location for healthcare products.

‘Good manufacturing practice’

“Regulators need to be on board with what the industry wants to do,” the strategy states. “It is important to make good manufacturing practice (GMP) risk-based as the old GMP is killing innovation. Regulation is getting in the way.”

Moran concludes by calling for a new approach to clinical trials in Ireland. “The number of trials being carried out in Ireland declined from 114 in 2007 to 96 in 2017,” he points out. “Clinical trials enhance Ireland’s innovation value proposition and in turn its attractiveness for future investment in manufacturing, but our clinical trials infrastructure is pretty light. We need to convince the Government to support the clinical trials industry. This would help create a virtuous circle of clinical trials, R&D and manufacturing all feeding into each other.

“We are very good at manufacturing, we are getting good at development, but we have some way to go in clinical research.”