Advancing manufacturing technologies and regulation in Europe is the main focus on (bio)Pharma Europe, an academic and industry-run initiative set to launch next week.
(bio)Pharma Europe – led by Ireland’s Synthesis and Solid State Pharmaceutical Centre (SSPC) – aims to drive regulatory change to support innovation in the small and large molecule manufacturing sector.
The project has already gained support from drugmakers Janssen, Eli Lilly, Roche, and Sanofi.
According to SSPC’s Aisling Arthur, (bio)Pharma Europe will advocate for regulatory change in order to secure and sustain the pharmaceutical manufacturing sector for the future.
“Without progressive efforts to support the end-to-end pharmaceutical product life cycle, Europe risks falling behind the so called “Pharmerging” economies, most notably China, Brazil and India,” she told us.
“The danger is that if we don’t innovate in Europe, we will lose manufacturing to those countries,” she added.
More specifically, the group hopes to engage with the European Commission to promote an “innovative funding and regulatory environment” that will sustain future industry needs.
“Industry is less inclined to invest in innovation if they feel that regulators are not going to approve such innovation. So it’s important for us to work hand-in-hand with regulators, industry and academia to see how we can move this sector forward,” said Arthur.
Filling the gap?
The initiative has received wide support from Big Pharma, leading pharmaceutical research centres, as well as state representatives.
Managing director of Hitech Health Brian Harrison – who has been involved in (bio)Pharma Europe since the outset – told us the initiative responds to a gap in government support.
“There is a lot of excellent research going on for personalised medicines and gene therapies, but very little research being done on how to make these products cheap and cost effective for patients,” he told us.
“Funding research to make sure we have a high quality supply chain is critical. The current situation is not sustainable,” he added.
According to Innopharma Labs CEO Ian Jones – another supporter of (bio)Pharma Europe – the initiative will give the European biopharmaceutical manufacturing sector a stronger voice.
Being a member of (bio)Pharma Europe enables Innopharma Labs to influence and provide input on Europe’s research agenda, he told us.
It is a “critical initiative” that will enable the EU to maintain its competitiveness: “There is significant research activity and regulatory engagement required to migrate [Industry 4.0] concepts within the highly regulated pharma sector,” he said.
(bio)Pharma Europe will launch on Tuesday May 22 at the European Parliament, Brussels, Belgium.