FEATURE PHARMACEUTICALS & CHEMICALS
“STRATEGY IN ACTION”
Irish Manufacturing looks at Phase Three of the Pharmaceutical Ireland strategy
P
harmaChemical Ireland represents the interests of the
Biopharmaceutical and Chemical Manufacturing industry in Ireland and is part of Ibec, the representative body of Irish business. PharmaChemical Ireland covers a broad range of issues and topics for the sector - ranging from regulatory affairs and quality, innovation and education to operational excellence and supply chain management. At the end of last year Pharmachemical
Ireland launched Phase 3 of its strategy, entitled “Strategy in Action”. The document is phase three of the initial strategy plan “Innovation and Excellence” that PharmaChemical Ireland launched at the Drugs, Chemicals and Allied Technologies (DCAT) meeting in New York City. This represented the beginning of a journey when PharmaChemical Ireland and its member companies undertook to lead the transformation of the sector in Ireland. Prevailing global trends in the sector
such as the patent cliff, rising drug development costs, falling approvals of new medicines are key drivers in this transformation. The existing model of manufacturing is unlikely to deliver a long term future for the sector in Ireland so the industry needs to expand its mandate as well as sharpen up existing operations from a cost and efficiency perspective. The concept of development plus
manufacturing or “D&M” has been adopted by the sector. This means companies investing in product and process development activities close to existing manufacturing operations which in turn help to facilitate further development of existing manufacturing operations from a quality and cost
24 SUMMER 2014 | IRISH MANUFACTURING
perspective as well as attracting the development and launch of new entities or products. Against this global backdrop the sector
in Ireland faces particular challenges: Costs need to continue to decline, in
particular labour waste and energy charges; The skills gaps need to continue to be addressed; We need to address the fragmentation
in Ireland’s supporting infrastructures for clinical R&D and innovation; The lack of engagement by the healthcare system with industry, particularly in relation to research, clinical trials and the development and related manufacturing of innovative healthcare products and services. In summary, for a site to
be fit for purpose it needs to achieve excellence as a manufacturing unit by employing best practices in operational excellence. It also needs to maintain a close to perfect record of compliance across the entire regulatory spectrum. Where possible, operations need to be environmentally and economically sustainable. For multinational companies, on site process or product development capabilities are vital, if the site is to position itself as a location of choice for new investments. Indigenous sites need to base their own business models on significant investment in innovation. In June of 2011 PCI launched phase 2 of
its strategy – “Ireland a location for scientific Investment”. This report documented real progress by the industry
as it moved towards a more integrated model. The report also contained a series of compelling testimonies by global and local CEOs describing why Ireland remained a location in which they were prepared to invest. Since the launch of Phase 1 of the
strategy is early 2010 many PCI member companies have been implementing many elements of it. In fact in many cases Irish sites have undergone significant transformation since they first established in this country. This has helped Ireland to move from the status of being a sourcing location, primarily for Active Pharmaceutical Ingredients, to many sites becoming fully integrated operations offering a range of activities beyond pure manufacturing including process development, product development, manufacture for clinical trials and shared services. Phase three of the PCI Strategy
contains 12 compelling case studies outlining how Irish sites have evolved and transformed since establishing in Ireland. These cases are examples of the PCI Strategy in Action. A wide range of examples of how best practice is being applied comprise the main body of the report. Companies such as Sanofi Genzyme, Bristol Myers Squibb, GE Healthcare and GSK have led the way in lean manufacturing and six sigma making breakthrough progress in site productivity and efficiency. Eli Lilly, Janssen and Allergan have developed capacity and expertise in biotechnology where they continue to invest significantly in new facilities. Helsinn Birex and MSD have invested hugely in developing on site process and product development co-located with manufacturing. Undoubtedly the world
of pharmaceutical and chemical manufacturing will remain very challenging however the cases outlined in Phase 3 of the PCI Strategy point
National Institute for Bioprocessing Reseach & Training
to a sector that is flexible, adaptable and agile - a sector which is secure in this country for the long term, a sector capable of transforming to meet the challenges of the future. The wave of recent investments by
companies such as Alexion, Jazz, Biomarin and Regeneron support the idea that the sector is rapidly transforming in Ireland as it rises to meet the many challenges facing the sector.
Ibec
www.ibec.ie Enter 208
/ IRISHMANUFACTURING
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