MATERIALS
Advanced Centre for Biochemical Engineering, University College London, UK
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In November 2005, the United Kingdom (UK) published the world’s first blue print for the future of stem cell platform technologies and regenerative medicine therapies. The Report and Recommendations of the UK Stem Cell Initiative (UKSCI) had finally begun to crystalise a plan for the future of the entire sector, not just for the UK, but globally.1 The Report was enthusiastically welcomed by the UK government and it has received high praise internationally from all the major stake holders in this developing industry.
The UKSCI was established by the UK’s Chancellor of the Exchequer, Gordon Brown, in his March 2005 budget. The requirement was for the development of a 10-year plan, complete with costs to ensure that the UK remains at the forefront internationally in stem-cell therapies and technologies. Sir John Pattison was asked to chair the process and together with Dr John Connolly, Department of Health and Secretary to the UKSCI, they enthusiastically and thoroughly trawled through all the main stakeholders in the UK stem cells and regenerative medicine sector. The Report was completed on schedule approximately eight months later, which was a massive achievement.
The US perspective
Although the UKSCI has undoubtedly begun to focus the UK’s efforts in this field, it has also made a loud “rallying call” to everyone including those in the United States (US). Between 2004 and 2005, opinion in the US with respect to stem-cell technologies was at an all-time low. The US dominated the biotechnology industry globally, yet its stem-cell sector knew that “the US was in danger of falling behind in the regenerative medicine race because of near-paralysing limitations on the work that government-funded scientists were allowed to do. Academic scientists interested in embryonic stem-cell research were eligible for government grants only if they worked with cell lines derived before August 2001.”2 There had, of course, been much progress in the field since August 2001.
In addition, the situation was made worse because it appeared South Korea had raised the bar not once but twice with the now-discredited research of Professor Woo Suk Hwang at Seoul National University. Hwang claimed in 2004 to have cloned the world’s first therapeutic human embryonic cell line, and then a year later to have produced, with relative ease, a large number of patient-specific embryonic cell lines. South Korea seemed to be close to reaching the ultimate goal of successfully treating patients with human embryonic stem cell therapies whilst the US researchers were firmly stuck on the sidelines. It was a depressing time for scientists in the nation that produced the world’s first human embryonic stem cells.3
The US gets proactive
Given this predicament, the US Department of Health and Human Services launched its equivalent to the UKSCI recommendations: “2020: A New Vision — A Future for Regenerative Medicine.”4 The goals were the same, that is, to “secure leadership in the field of regenerative medicine.” Specifically, the US goal is to achieve “tissues on demand” within 20 years. To achieve this a Federal Initiative for Regenerative Medicine (FIRM) was proposed. By being able to provide “tissues and organs on demand, regenerative medicine serves a dual purpose: increasing quality of life and care for patients and reducing health-care costs by eliminating chronic disease.” These are worthy goals indeed.
The US has a solid track record in making industries “happen” especially when the belief is that the sector is potentially worth US$500 billion per annum. To quote the US report, “the benefits of realising regenerative medicine will be two fold. The first benefit will be bringing our Nation the next generation of health care by preventing and curing tissue and organ failure. The second will be to help grow the first new decade-defining industry of the millennium. Past Government initiatives such as SEMATECH (a semiconductor manufacturing technology consortium) helped grow the worldwide semiconductor industry from a US$8 billion annual industry to a US$170 billion annual industry with only approximately US$2 billion in government funding. FIRM offers the chance for a similar payoff, with the end product bringing a higher quality of life to Americans as well as growing a new industry.” Examples of FIRM’s “challenge problems” are to
• demonstrate a fully functional working organ by the year 2010
• cure diabetes through the successful growth and implantation of islets by the year 2015
• cure paralysis through spinal cord treatment by the year 2020.
A winning partnership
Both the UK and US plans are excellent and ultimately patients and each nation will potentially greatly benefit. The two nations have great strengths in this field, but in different areas. Many of the companies in the stem-cell technologies and regenerative medicine therapy arena already have bases in both countries including the leading public companies: Genzyme (www.genzyme.com), Geron (www.geron.com), Intercytex (www.intercytex.com), Isolagen (www.isolagen.com) and Stem Cell Sciences (www.stemcellsciences.com). Furthermore, big pharmaceutical companies, which are undoubtedly stakeholders in the paradigm shift, are even more multinational. There is also a history of collaboration between the two nations in the area of regenerative medicine, for example, the Department of Trade and Industry UK/Texas Bioscience Collaboration Programme (2002–2006).5 Therefore, in the interest of achieving the goal as soon as possible, that is, “to make tissue and organ failure a relic of the past,”4 collaboration and not aggressive competition is the way forward. Surely, the “special relationship” between the UK and US means that a worldwide market worth US $500 billion per annum could easily be split two ways!
2. J.C. Greenwood, Keynote address, “Enabling Conditions for Biotechnology,” BioJapan Conference, Yokohama, Japan, 7 September 2005.
3. J.A. Thomson et al., “Embryonic Stem Cell Lines Derived from Human Blastocysts.” Science, 282, pp. 1145–1147 (1998).
4. US Department of Health and Human Services, “2020: A New Vision — A future for regenerative medicine,” January 2005 www.hhs.gov/reference/newfuture.shtml
5. D.R. Headon, “Workshop on Tissue Engineering/Regenerative Medicine: Houston,” Tissue Engineering, 10, 3–4, p. 321 (2004).
Chris Mason, PhD FRCS, Regenerative Medicine Bioprocessing Unit, Advanced Centre for Biochemical Engineering, University College London, Roberts Building, Torrington Place, London WC1E 4JE, UK, tel. +44 20 7679 0140, fax +44 20 7209 0703, e-mail: chris.mason@ucl.ac.uk.





