Fill Finish Quality Agreement - DOC by fdg78416

VIEWS: 29 PAGES: 7

Fill Finish Quality Agreement document sample

More Info
									Contact: Samara McCarthy, IDA Ireland, Tel 646.321.4386 (Cell) / 212.750.4300 (Office)
                                         June, 2008


Life Sciences in Ireland

By Samara McCarthy / Trevor Holmes


Abstract
Much has been written about the Irish success story; the Celtic Tiger, the Irish Miracle;
the names and metaphors evolve as the country’s prosperity increases. Ireland certainly
continues to be a vanguard of industrial development, receiving top global recognition
from organizations including The Heritage Foundation, the Economist Intelligence Unit,
Harvard Business Online, and AT Kearney.


Introduction
In 2007, the life sciences sector in Ireland continued to thrive, both with indigenous and
overseas companies. Ireland is now in a leadership position in many key business
segments. In bio-pharmaceuticals, Eli Lilly joined Schering Plough, Wyeth, Genzyme
and Centocor in making Ireland the location of choice outside the US for the
development and manufacture of their newest drugs. Continued growth in the medical
technologies was evident from recent new investment announcements from Kinetic
Concepts Inc., Teleflex Medical and Integra Lifesciences in addition to further
investments from Merck, Wyeth, Baxter and Genzyme following key investments in
2006 from Cordis, USCI and Vistakon, among others.


Significant governmental planning and vision has also been underway. The Government
of Ireland established a strategic plan (2006-2013) for the life sciences sector. In addition,
a series of long term economic goals have been established to assure that business in
Ireland by 2020 will be more knowledge and capital intensive with a higher proportion of



                                            1 of 7
service activities while maintaining the focus on specific key high technology
manufacturing operations. The focus of activities will be on leveraging Ireland’s
expertise in the IT, life sciences (health/medical) and food sectors. Ireland is set to
establish a leadership role in integrating, managing and leveraging global value chains
and as a country with a well spring of innovation, with distinctive prowess in
commercialising ideas and in creating new business models.


Foreign Direct Investment in Ireland’s Life Sciences Sector
Through Foreign Direct Investment since the 1960s, Ireland has grown a globally
significant Life Sciences industry.       In 2006, over 170 companies in Ireland were
employing 35,000 people in this field. Together, this generated over $52 billion in
exports. This represents 42% of total exports from Ireland.


Further, Ireland has secured in excess of $5 billion of investment for projects in the life
sciences sector. A number of new initiatives relate to BioPharma (Genzyme, Centocor,
Pfizer); establishing new business models (Kellogg, Gilead and Merck); research &
development (R&D) (GlaxoSmithKline, Bristol-Myers Squibb, Smith & Nephew,
Olympus); and bio-manufacturing (Allergan, Schering Plough and Genzyme).


Building a Multinational Pharma-BioPharma Cluster
Ireland continues to build a pharma- and bio-pharma cluster, and has moved from a
predominantly manufacturing dominance to a more integrated sectoral approach
attracting activities across the life sciences value chain.


At present, nine of the world’s top ten pharmaceutical companies have significant
operations in Ireland. IDA Ireland, the government’s agency responsible for attracting
foreign direct investment to the country, continues to direct the international development
of the life sciences sector; its performance being driven by an emerging research-base,
operational excellence, strong infrastructure, government financial incentives and free
access to the large European Union market of 450 million people.




                                             2 of 7
Recently, Merck & Co Inc. the seventh largest global pharmaceutical company
commenced      construction    of   $300m     approx.    Strategic   vaccine   facility   and
GlaxoSmithKline (GSK) announced a further investment of almost $400m in its existing
production site.




The satisfaction of industry leaders with their decision to establish substantial operations
in Ireland has resulted in several examples of multiple investments. Highlights of these
include Abbott (with six operations) and Johnson & Johnson, Wyeth and Boston
Scientific each having four. In addition, Pfizer operates six manufacturing sites as well
as a corporate bank and European financial shared services from Ireland.


The Bio-Pharma Campus in Galway
One of the most interesting recent developments was the pre-approval for a fully
permitted, 67 acre BioPharma campus in Galway on the west coast of Ireland. The site
includes planning permission for water purification buildings, waste water treatment
facilities, a laboratory, fermentation, purification and fill finish buildings, along with all
other ingredients necessary to implement a fully operational BioPharma campus. The
flexibility of the planning permission allows for any combination of buildings to be
erected and significantly removes risks to a project. With a high quality manufacturing
environment, supported by a university city, and the ability to avail of low corporation
tax, this option will likely prove enticing for any new strategic business investment.


In recent years a significant amount of investment has been targeted at Research,
Development and Innovation collaborations with Irish Universities. GSK invested $22m
in a collaboration with the Trinity College Institute of Neuroscience (TCIN) and National
University of Ireland Galway, on a major R&D project for the discovery of novel
therapies to treat Alzheimer’s disease. Smith & Nephew entered into a four year R&D
agreement with the Regenerative Medicine Institute (REMEDI) at National University of
Ireland Galway focused on the development of groundbreaking new treatments for bone
and joint diseases, such as osteoarthritis. GSK are working with University College Cork



                                            3 of 7
and Alimentary Phramabiotic Centre (APC) a Science Foundation Ireland (SFI)
sponsored Centre for Science Engineering and Technology (CSET) on therapeutics for
gastro-intestinal disorders. Wyeth has also established a biotherapeutic drug discovery
research facility at University College Dublin.      This support of such prestigious
multinational investment is a testament to the leading science underway in Irish academia
and reinforces the caliber of Ireland’s offerings in the field of R,D&I within the
international community.

Impact of the Indigenous Sector
Enterprise Ireland (EI), the Irish development agency responsible for supporting
indigenous industry has invested over $15m this year in initiatives and research projects
to strategically commercialise biotechnology research in Ireland. This brings its
investment in this area to over $62m since 2001. Its Biotechnology Commercialisation
Group supports the commercialisation of applied bioresearch into technologies that will
form the basis of new start-up companies or licensed to established companies.



Nine technologies from Irish Research institutes were licensed in the biotechnology area
and this resulted in three new Irish high potential biotechnology companies emerging.
Stokes Bio from the University of Limerick primarily develops novel technology and
biomarkers for the diagnosis of cancer; Neuro Research Services from the Royal College
of Surgeons is a contract research organization that allows its clients to access the
expertise of world-renowned scientists at the forefront of research in neuroscience; and
Berand from University College Dublin focuses on the evaluation of promising drugs
directed against neurodegenerative conditions, such as Alzheimer's disease and
schizophrenia. In addition a number of significant collaboration agreements between Irish
companies and multinationals have occurred including an agreement between Opsona
Therapeutics, and Wyeth Pharmaceuticals. The companies will collaborate to discover
and develop new pharmaceuticals to treat inflammatory diseases, including multiple
sclerosis and rheumatoid arthritis.




                                          4 of 7
An EI supported bio-incubation facility has been established at St. James's Hospital,
Dublin. Designed to facilitate the translation of science and research into products that
are used to diagnose and treat disease, the bio-incubator is one of six that have recently
come on stream providing professional research and commercialisation services, as well
as access to financial, legal and marketing advice.


Nurturing Workforce Growth and Development
Developing and maintaining a skilled life sciences workforce Ireland is a major priority.
The share of the 25-34 year olds completing tertiary education in Ireland today is 40%, as
compared to an OECD average of 31%. In addition, Ireland has 24,200 new science &
engineering graduates age 20-29. The International Institute for Management
Development, Switzerland (IMD) 2007 yearbook rates Ireland’s education system
positively in terms of its educational infrastructure with University Education, Scientific
research, Human Development Index and Education system meeting the needs of a
competitive economy listed as infrastructural strengths. Overall, Ireland was ranked fifth
in the world for the educational system meeting the needs of a competitive economy.


Recognizing the need to continually innovate in this dynamic area, the Government of
Ireland established a National Bioprocessing Research, Education, Training and Service
facility (NIBRT). This followed wide consultation in the US and Europe with businesses
and academia in the biotechnology field, where it is accepted that bio-pharma globally is
restricted by skills shortages and technical bio-processing challenges.       Taking into
account the key educational and industrial issues identified, it is anticipated that the
facility, with a capital investment of more than $80 million, is expected to generate a
substantial workforce with highest levels of best practice skills across the spectrum of
bioprocessing activities readily applicable in a real-time scale-up environment.
Additionally, in conjunction with academic institutions, the NIBRT will focus on
academic/industry collaborative research with an emphasis on advancing knowledge in
bioprocessing technologies and techniques and the technical problems of scale-up and
related issues.




                                            5 of 7
Incentives for Companies to do Business in Ireland
The life sciences sector has been attracted to Ireland by a number of factors. Today,
Ireland has one of the world’s lowest rates of Corporation Tax with the maximum rate for
trading profits being 12.5%. Economic incentives for Intellectual Property (IP) which is
developed and licensed from the country include a patent royalty exemption, stamp duty
exemption, and a Research and Development tax credit. Other factors that help attract
bio-pharmaceutical companies to Ireland include the ready availability of the required
specialist skills. Output from the third level institutions is being continually refined to
meet the sector’s needs. Further, the considerable growth in the Irish economy over the
last 10 years has seen very significant repatriation of skilled people. In addition, Ireland
is seen as a desirable expatriate location with a minimum of bureaucratic obstacles and an
excellent educational system that facilitates family relocation. The free movement of
labor within the enlarged European Union has allowed for the swift acquisition of a
further pool of qualified people.


New Government Strategies for Science, Technology and Innovation (2006 – 2013)
Building on previous strategies to be a global leader in the life sciences, in 2006, the
Government of Ireland established a strategic plan that includes $12.7bn investment to
2013, of which $4.1bn to be made available by end of 2008.


The strategic objectives are
   1. Double the postgraduates
   2. Promote greater commercialization of ideas and know-how of universities and
       public research institutions
   3. Increase participation in fields of sciences
   4. Increase translational research activity
   5. Allocate significant resources to supporting enterprise R & D, in order to double
       corporate R & D spend by 2013 with a Business Expenditure in Research &
       Development (BERD) target of $3.9bn by 2013




                                             6 of 7
Summary
Ireland hosts a significant industry cluster of world renowned corporations across the
value chain which has resulted in a vibrant networked professional community. This
coupled with the depth of foreign and indigenous company and academic activity
currently taking place with the increasing involvement of Irish hospitals in clinical
research assisted by proactive Government support ensures Ireland is rapidly growing in
stature as a key participant in the development of the global biotechnology industry.


all exchange rates of 1 EUR = 1.55 USD. May 15th 2008


Endnotes
http://.www.idaireland.com IDA Ireland
http://www.biotechnologyireland.com - Biotechnology site for Ireland
http://www.sfi.ie - Science Foundation Ireland




                                                 7 of 7

								
To top