Clifford S. Mintz

Much has been written about the so-called 'brain drain' that has been plaguing Europe for the past decade. Brain drain is a term used to describe the loss of talented, young European scientists and engineers who are lured to greater opportunities in the US. The exodus of Europe's finest and most talented has been blamed on a variety of factors including a failure of the EU to make adequate R&D investments; outdated immigration policies; antiquated patent and intellectual property (IP) laws; and a lack of financial incentives and innovation that exist at many of Europe's top academic institutions. 

The brain drain dilemma has not gone unnoticed by policy makers at the European Commission. To that end, in 2001 the Commission mandated that all EU member countries should strive to spend no less than 3% of their GDP on research by 2010. Previous reports indicated that the EU spends less of its GDP on R&D (1.9%) than the US (2.8%) or Japan (3% [

]). This policy was designed to create approximately 400000 new jobs for European scientists each year (

). In 2006, the Commission adopted the use of tax incentives to favour R&D and create a new community framework for state aid to R&D and innovation. Unfortunately, only Finland and Sweden have reached the 3% GDP goal for research spending and it is unlikely that other member countries will be able to hit that target by 2010 (

). Not surprisingly, the gap between EU and US research spending continues to widen at an alarming rate. 

A number of EU countries recently enacted legislation to make it easier for foreign scientists to enter and remain in countries to conduct research. Also, some EU countries now offer reduced fees, subsidized accommodations and even fast-track language courses for their foreign researchers. Although these inducements are likely to prompt an influx of foreign nationals into some EU countries, they will do little to stop the exodus of native-born scientists who typically leave for opportunities in the US. 

Unlike the US, there is no uniformity among the patent and IP laws that have been crafted by different EU member countries. In general, these antiquated laws tend to financially reward individual scientists rather than the academic institutions that sponsor their work. The lack of financial incentives explains why European universities and academic institutions do not aggressively build patent and IP portfolios. This is in marked contrast with the US where academic institutions encourage patent application preparation, and cover all of the fee and costs associated with patent prosecution. In this case, patents are wholly owned by the sponsor institution and the inventors are awarded a small portion of the royalty payments that are made to the institution when a patent is licensed to a commercial entity. 

The culture at many EU universities and academic institutions rewards older, established scientists. Grants and other forms of funding have often been awarded to well-known scientists with established research track records. Not surprisingly, many junior faculty members are under-funded and frequently exploited by senior researchers because they lack financial independence. Thus, it is not uncommon for junior researchers to toil for many years in suboptimal working conditions and receive little or no recognition for individual scientific accomplishments. This is in stark contrast with the situation in the US where talented, young, academic researchers are nurtured by senior faculty members and are allowed to compete for early funding to 'jump start' their careers.  

So what is the EU to do? It must grant its younger researchers greater scientific autonomy and academic independence. This will encourage younger faculty members to become more competitive, which should drive greater European innovation. EU academic institutions must provide junior scientists with substantially more financial support early in their careers. Further, the salaries of European scientists must become more competitive! EU patent and IP laws must be harmonized and changed so that both academic institutions and individual scientists stand to benefit financially. Finally, all EU member countries must strive to allocate more of their GDPs to R&D to stimulate economic growth and create new jobs. The over-abundance of science jobs in the US, coupled with a shortage of qualified US scientists to fill them, is the single most powerful inducement for immigration of European scientists to the US. Until the EU addresses many or all of these issues, it is likely that the brain drain phenomenon will continue well into the 21st century. 

Articles

So what is the EU to do? It must grant its younger researchers greater scientific autonomy and academic independence.

Plugging the European brain drain to the US

Over the past 25 years, the biotechnology industry has transformed itself into one of the fastest growing and most vibrant sectors of the global economy. Although the US is still the world leader in biotechnology, many other countries have developed their own biotechnology industries. 

There are around 4000 biotechnology companies worldwide that employ more than 200000 people.

				  Recent reports indicate that an additional 286000 jobs are found at companies that provide goods and services to the biotech industry.

  Industry analysts predict that the biotechnology industry will continue to expand well into the 21st century. 

Historically, biotechnology companies have focussed almost exclusively on drug discovery and development activities. However, during the past few years, the focus at many biotechnology companies has shifted from drug discovery and development to bioprocess development and commercial manufacturing. This shift has been fuelled by large increases in the number of biotechnology companies that are either seeking or have gained marketing approval for their products.  

At present, there are as many as 1200 biotechnology products in the global pipeline.

  Although this would seem to be good news for the biotechnology industry, worldwide shortages of biomanufacturing personnel now threaten many biotechnology companies' ability to manufacture sufficient amounts of their products to meet market demand. 

Industry analysts estimate that job growth in biomanufacturing has averaged about 10% a year since 1990.

  This annual growth rate is expected to continue during the next decade. A quick perusal of the job opportunities at many biotechnology companies, contract manufacturing organizations and staffing/recruiting websites reveals that biomanufacturing jobs are plentiful. 

The degree requirements for these jobs range from a high school diploma to a PhD degree, with the majority of positions being filled by individuals with either associate or bachelor degrees.

 Table 1. Job types and degree requirements for bioprocess and biomanufacturing jobs.			

A recent report issued by Boston-based Education Development Center Inc. indicated that the majority of new biomanufacturing jobs will be for technical personnel in the following areas:

The functions and degree requirements for each of these positions is shown in Table 1. 

Biomanufacturing staffing shortages first appeared in California and the northeastern part of the US during the late 1990s.

  This was largely a result of increases in regulatory approvals for new biopharmaceutical drugs and an unprecedented demand for products manufactured by biotechnology giants such as Amgen, Genentech and Biogen (now, Biogen/IDEC). Although the demand for biomanufacturing employees in the US levelled off from 2001 to 2003, it is rising rapidly again.

Interestingly, biomanufacturing staffing shortages have also begun to appear in Europe and Asia. This is because of the rapid emergence of global contract biomanufacturing organizations (CBMOs) in these regions and the growth of indigenous national biotechnology industries.  

Unfortunately, similar to the late 1990s, the number of vacant biomanufacturing jobs currently exceeds the number of qualified employees to fill them.  

A 2004 survey conducted by BioPlan Associates, indicated that more than half of the biomanufacturing managers who were surveyed thought that the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.

There are a variety of factors that have contributed to current global biomanufacturing staffing shortages. First, as previously mentioned, there has been a sharp increase in the number of companies that have drugs in clinical development or have received marketing approval for their products. To keep pace with increasing biomanufacturing demands, many CBMOs and several large biotechnology companies have either expanded their existing facilities or built new ones.

  Unsurprisingly, this recent industry-wide expansion sparked a hiring increase, which, in turn, placed an enormous burden on an already small pool of prospective biomanufacturing job candidates. 

Second, biomanufacturing is a complex, labour-intensive process that requires unique skills and specialized training.  

				 Biomanufacturing employees are not only required to have a firm grasp of the scientific underpinnings of biotechnology, they must also learn how to operate specialized equipment and work in manufacturing environments that are tightly regulated by current good manufacturing practices (cGMPs). 			

Although many community colleges, technical schools and universities have recently created biotechnology training programmes, most concentrate on drug discovery and development, and pay little attention to biomanufacturing or cGMP training.

This is not surprising because many of these programmes were developed by academic scientists who typically lack industry experience and are unaware of the regulations or industrial skill sets that are required by biomanufacturing employees.  

Consequently, whereas many biotechnology programme graduates may be qualified for R&D jobs, they typically lack the requisite understanding and skills to be employed in biomanufacturing jobs.  

Finally, and perhaps most importantly, neither industry nor academia is willing to assume a leadership role in biomanufacturing workforce development training.  

Despite repeated labour shortages, the biotechnology industry, with few exceptions, has been reluctant to provide financial or institutional support for biotechnology workforce training initiatives. This is probably because of a belief held by many biotechnology executives and industry insiders that workforce development training should be the responsibility of academia, not industry.  

However, academic leaders acknowledge that more biomanufacturing training is necessary, but claim that their institutions cannot develop biomanufacturing training programmes because of high costs, lack of available space and a paucity of adequately trained instructors. 

In an effort to overcome this 'training stalemate', several governments, most notably the US, Ireland and Scotland have allocated substantial amounts of government funding for biomanufacturing workforce training.

  For example, in 2004, the US Department of Labor launched a $17.2 million nationwide biotechnology worker development training initiative.

  Nevertheless, biomanufacturing labour shortages will continue until academia and industry can agree upon who is responsible for training a biomanufacturing workforce. 

At present, there is little agreement on how to deal with shortages of trained biomanufacturing personnel. Some industry experts believe that the problem will resolve itself through competitive free-market pressures whereas others feel that direct corporate involvement will be required.  

Over the past 2 years, a variety of training initiatives have been launched to deal with biomanufacturing staffing shortages. These initiatives typically fall into three distinct categories: 					

The UK is currently the European leader in academically-driven biomanufacturing training and workforce development programmes. An outstanding example of this is The Scottish Colleges Biotechnology Consortium (SCBC). The SCBC is a four-college initiative that created a Bioprocess Workforce Development Programme to train bioprocessing and biomanufacturing technicians.

 This programme offers students or company employees hands-on, competency-based training. In addition, the SCBC recently crafted several e-learning training modules that can be used to complement its 'bricks and mortar' courses. These online courses were launched in 2003 and are currently available to the public on the SCBC website (

Other UK training programmes that deserve mention are the Masters degree in Biopharmaceutical Processing at the University of London and the MSc degree in Biochemical Engineering at the University of Birmingham. Finally, the University of Edinburgh committed £100 million towards the creation of a biomanufacturing facility that will offer hands-on training and has sufficient space to house 10 biotechnology companies. 

Table 2. Community colleges and universities that offer bioprocess development and biomanufacturing training.			

This will be Scotland's first dedicated biomanufacturing facility and it will create about 900 jobs when it is completed in the next few years.

In the US, academically-initiated biomanufacturing training has been largely championed by 2-year community colleges and technical schools.

  The US reliance on community colleges and technical schools to provide biomanufacturing training is consistent with the stated missions of these institutions, which are to provide technical training to individuals who want to join the American workforce. To that end, a number of community colleges (and a few 4-year institutions) in biotechnology-rich regions such as California, New England, Maryland and North Carolina currently offer hands-on biomanufacturing training to students in cGMP simulated environments (Table 2).

When possible, many of these programmes use local biotechnology company employees as instructors to insure that students are receiving industry-appropriate training. Students or company employees enrolled in these programmes receive either a biomanufacturing certificate degree (after 1 year) or an associate's degree upon completion of 2 years of training. 

Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.