APROBACIÓN DEL CAMBIO

7.1 Main Findings

7 . 1 . 1

T h e I m p a c t o f B i o t e c h n o l o g y

The biotechnology industry is built upon a set of enabling technologies that have been developed in research centres and that have been commercialised over the past 25 or so years. For a number of reasons it is widely believed that over the course of this century, these technologies and other likely discoveries will revolutionise some of the most important and basic services and products in the economy. The gains to human welfare are likely to be enormous; indeed, at present the potential improvements seem incalculable. Correspondingly, the economic returns to companies, organisations, researchers and employees involved at the cutting edge of developments in these sectors and the economies within which they operate are likely to be very great.

Most of the potential of current developments (let alone future advances) remains to be realised. The sector is only emerging and, to date, the number of available biotechnology products in full-scale commercial production is relatively small. However, all indications are that the process of commercialisation of scientific discovery and associated accumulated knowledge will become more efficient, enabling the full economic potential to be realised into the medium and longer term.

7 . 1 . 2

I m p l i c a t i o n s f o r I r e l a n d

Current developments potentially offer huge scope for further expansion of the Irish economy. In this regard the economy has some significant strengths, most notably critical mass and global presence in the production of pharmaceutical products and medical devices and very recently, significant commitment by Government of financial resources in support of scientific research in Ireland. However, if Ireland is to develop a competitive and vibrant biotechnology cluster sector it will need to overcome a number of substantial challenges. This report concludes that amongst these is a substantial and widening deficit in required human resource skills that are available or likely to become available to meet the demand of an expanding international biotechnology sector.

The clustering aspect of the industry presents policy makers attempting to develop the industry in new areas with particular challenges and opportunities. It suggests that biotech firms are slow to move – at least in the current stage of development of the industry – while indigenous companies are most likely to emerge successfully in fully functioning clusters. The possible exceptions to this are where specific infrastructure requirements in bioprocessing mean firms locate where this infrastructure is available, and that as biopharmaceuticals move along the development process and become successful products the firms can be induced to relocate part of the value-added process to other centres.

In this context, it is well worth noting that currently, there are about 1,000 biotech drugs in all phases of development with almost 400 in Phase II and III clinical trials. It is estimated that about 25% of all newly launched medicines, devices and diagnostics are derived from biotechnology. Of these, about 150 to 200 are protein therapeutics, a sector that is growing at 15% per annum compared to 7% overall in pharmaceuticals. Due to the high risk that is associated with putting fermentation capacity in place, demand for manufacturing capacity in biologics will exceed current capacity up to 2005 by a factor of four. Currently, there are 250 to 400 monoclonal antibody-based products in the pipeline. In addition, of 133 marketed biopharmaceuticals, 10 approved mAbs (monoclonal antibodies) consume 75% of biologics manufacturing capacity. These products represent 20% of sales of biologics and are growing much more rapidly than biologics in total. In addition, the economics of the sector are skewed due to the presence of a large proportion of ‘orphan’ drugs in this sector that require low volume and flexible manufacturing technologies and processes. As a result, a major round of

T h e S u p p ly a n d D e m a n d fo r S kil ls in th eB io te c hn olo gy Se cto r

investment in fermentation capacity is underway at present. This programme has a global dimension and offers the possibility to countries such as Ireland to move towards critical mass, at least in manufacturing of protein drugs. The attraction of investment projects such as Genzyme (fill finishing, County Waterford) and Wyeth (fermentation, Clondalkin) represent a significant first step in securing a foothold in this development.

Current and prospective trends in Ireland’s education system in relation to science pose a number of challenges. Closing the skills gap projected in Chapter 6 represents a significant but surmountable challenge. Furthermore, the evidence from the US indicates that a key requirement for the growth of a biotechnology cluster is not that the minimum numbers of required skills are produced, but that sufficient personnel are available, particularly at PhD level, to create competition for places. This provides an incentive for entrepreneurial activity at this level and a stimulus to engage in commercialisation of new research output. If Ireland is to achieve the high equilibrium outcome that was described in Chapter 6, involving the establishment of a self-sustaining biotechnology cluster, then a very considerable commitment needs to be made to the development of relevant human resources. Moreover this commitment would need to be sustained for 15-20 years. Obviously, such a commitment entails opportunity costs, in terms of other choices foregone, with attendant risks to long-term growth if the potential rewards are not secured, or the expected potential of the sector is not realised. Against this, there are opportunities to be realised in the short-term from concentrating on meeting the prospective requirements of bioprocessing while also developing requirements for longer-term growth.

In meeting the skills requirements outlined here, it should be noted that Eastern European countries such as Hungary have many excellent scientists, particularly in areas of weakness in the West. These scientists tend to be mathematically orientated, although often with expertise in biological applications. In general, research institutes and universities in the Central and Eastern European Countries (CEEC) are good and will be a major source of competition following expansion of the EU. In addition, there are many highly skilled people in countries such as India and China. Employment of immigrants from these countries is a potential opportunity to redress skills deficits.

The particular skills that are required by the industry have been identified in Chapter 4. These do not always fit neatly into existing supply structures. A key to achieving a competitive edge here is an education system that observes requirements and is designed to be responsive and to lead development. Therefore, a new emphasis on flexibility in discipline boundaries in combination with academic excellence is required to produce the skill sets that will be required. There are three key areas in which flexibility is required:

• The design of postgraduate courses, which may be taught MSc or postgraduate diplomas, that

cross inter-disciplinary boundaries to produce people prepared for employment in biotechnology and specialist skills;

• A greater breadth of education during the PhD; and

• A range of courses for non-graduates and graduates in other subjects to prepare them for employment

in biotechnology. These should include conversion courses and, in particular, specially designed technician courses that closely match the identified requirements of the industry.

The third level sector has made significant strides in recent years in aligning its research activities more closely with the interests of industry. In addition, there is a growing appreciation by the institutions of the commercial value of the intellectual capital present within their research. The institutions are increasingly interested in unlocking this latent value. This trend is being encouraged by the various public policy initiatives attempting to evolve Ireland to a knowledge economy. Major developments within the institutions in recent years include the introduction of senior positions with responsibility for innovation, technology transfer and commercialisation of research, as well as the establishment of business incubators in many institutions. These initiatives have resulted in more strategic approaches to research planning; research (and teaching) is becoming more pan-institution and less department-focused.

Nevertheless, progress along these lines varies considerably between institutions and in many cases, these developments have arisen through the initiative of individual departments or researchers rather than as a result of an institution-wide policy.

It is important that any policy approach emphasises both the demand for and supply of places at third level. An examination is required of the extent to which the Irish university system is positioned to collaborate with industry in a manner that makes it responsive to industry’s needs. An example is a requirement for conversion courses and courses that combine study across traditional disciplines. Furthermore, it should be noted that a broad range of skill levels is required by the industry. An over concentration on producing the skills required to fill high value PhD positions, while important, would not be an adequate response to the biotechnology industry’s projected requirements to the end of the decade. It is also important that research activities are co-ordinated and industry focused. This will require close collaboration between all the relevant agencies within an integrated policy environment. In summary, there is a very widespread belief that the biotechnology industry is in its infancy and will continue to grow for many years, although the growth path remains very uncertain.

7.2 Recommendations on Skills Development and Supply

The key finding of this report is that there is a considerable gap between the demand for skills that would be implied by the development of a biotechnology cluster in Ireland in the medium-term and the projected output of relevant skills over this period. If Ireland is to be successful in developing this industry then this deficiency must be overcome. The recommendations put forwards to achieve this reflect three broad themes:

1. Initiatives to increase interest in the study of science and in careers in science;

2. Measures to improve the capacity of the Irish economy to supply suitably skilled personnel; and

3. Supporting interventions, particularly in the development of Ireland’s research competency.

These reflect the arguments that have been put forward: that intervention must increase the demand for training in science as well as the number of available places. In addition, the quality and structure of the skills that are produced must be appropriate.

In summary, the output of relevant skills by the education sector needs to be increased significantly if the biotechnology sector in Ireland is to realise its full potential over the period 2004-2010.