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Remarks by Minister for Research and Innovation, Sean Sherlock TD at Launch of NIBRT Waters Complete Product and Processing Characterization Facility (CPPCF) Tuesday 27 March 2012, UCD

Thank you Professor and good morning everyone.

I had the pleasure of opening this wonderful facility only last June and I am delighted to see that it is such a hive of activity already.

The Government, through IDA and via collaboration between four Irish Third Level institutions, made a very significant commitment of almost €60M to create NIBRT in order to underpin the continued growth of the biopharmaceutical manufacturing sector.

The Irish Biopharmaceutical Industry is one of the enormous success stories of recent years. Ireland exports over €55bn in pharmaceuticals annually and is seeing particularly fast growth in the biopharmaceutical segment of the industry.

I am pleased to hear from Professor Ian Marison that MSD (Merck Sharp Dohme) Ireland are working closely with NIBRT in both training and research to underpin the continued development of MSD’s manufacturing footprint here in Ireland.

In the past year the Irish Biotech sector has continued to go from strength to strength as evidenced by the announcements last year of the arrival of Amgen and Biomarin in Dublin and Cork.

Already in 2012, we have seen over €600M investment and creation of 400 new highly skilled jobs in the expansion of the Biotech facilities of Eli Lilly in Kinsale and Allergan in Westport.

I warmly welcome attendees from those companies and other stalwarts of the Irish biotech industry such as MSD, Pfizer, J&J, Genzyme and Bioniche to this event today.

The Government recently launched the Research Prioritisation Report and three of the priority areas identified in that report are closely aligned with the initiative we are launching today.

These priority areas for public investment in research are Therapeutic production, manufacturing competitiveness and data analytics.

Implementation of the recommendations of the research prioritisation report is a key part of the Government’s Jobs Action Plan.

Industry-academic collaborations, such as we see here today, are the kind of initiatives which will enhance Ireland’s global reputation and underpin continued growth in Ireland’s manufacturing and high value export sector.

Biopharmaceutical drugs are extremely complex and different methods of manufacturing can result in variation in the final product. In the highly regulated biopharmaceutical industry, it is vital that drug manufacturers can provide detailed analysis of the products that they manufacture and demonstrate that these products are of a consistently high quality.

International competition for mobile biotech investment is incredibly intense. One only needs to visit a Biotech trade show, such as “Bio” or “Bophirima Asia”, to realise that the number of countries and regions globally which are competing for Biotech investment vastly outnumbers the total number of Biotech drugs that are currently in large scale manufacture.

Ireland has consistently punched far above its weight in winning such biotech manufacturing investments and this is, in large part, due to the fact that the Irish Biotech industry has an exemplary track record in production of high quality biopharmaceuticals and consistent compliance with regulatory requirements.

Credit is due to the industry leaders here today for their commitment to excellence in manufacturing and process development. Credit is also due to the Irish Medicines Board (IMB), who we also welcome here today, as they have gained international recognition as a highly professional and credible regulator of this industry.

I know that NIBRT is committed to doing its part to further strengthen Ireland’s reputation in this regard and a major focus of NIBRT’s research strategy is to develop new and improved analytical methods to support complete product and process characterisation in the biopharma industry.

To this end NIBRT is working with technology companies like Waters, regulatory bodies like the FDA (Food and Drugs Administration Board) and IMB (Irish Medicine’s Board) and of course with biopharmaceutical companies such as Lilly, Roche, Shire, Pfizer, MSD and J&J to develop novel analytical methods that can help assure high quality, consistent manufacturing.

I want to give particular credit to Professor Pauline Rudd, and her team here today. Professor Rudd was recruited from Oxford University by NIBRT over six years ago due to her world-leading expertise and capability in analysis of the sugars (or glycans) that decorate Biopharmaceutical drugs.

These glycans are often very important for the efficacy and safety of biopharmaceutical drugs and hence it is strategically vital for the industry to be able to access the very best analytical methods to analyse these sugars.

In addition to core funding for Pauline’s research from NIBRT, Pauline has won very significant grant support from SFI, EU FP7 funding and industry partnership to support the continuous improvement of her analytical methodologies.

Her endless enthusiasm and tireless commitment to this work, combined with a superhuman ability to travel the world to build collaborations has helped to put NIBRT and Ireland on the map in the field of glycobiology. She is an inspiration to us all.

Waters hold a leadership position globally in the field of advanced analytics. The company have had an operation in Wexford since 1997 which is now the global production centre for a range of consumables (columns) for the company’s High Performance Liquid Chromatography instrument products.

The Wexford site contributes over one quarter of the total revenue of Waters Corporation and currently employs circa 170 people.

Waters products are for detailed analysis of very complex mixtures and are especially useful in analysis of complex biological samples. This technology is widely used in the Biotechnology industry for analysis of complex biopharmaceutical drugs.