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Feature

Singapore strives for success

Posted on: 22 Aug 04

Summary

As the pharmaceutical industry expands its global outlook, many companies have taken a greater interest in the region of South-East Asia. The emergence of this area as a centre for R&D activities is typified by Singapore, which has made a strong commitment to raising its profile and attracting major companies.

As the pharmaceutical industry expands its global outlook, many companies have taken a greater interest in the region of South-East Asia. Although the commercial potential of this region was quickly recognised by the major companies, its use as a base for R&D is more recent. The emergence of this area as a centre for R&D activities is typified by Singapore, which has made a strong commitment to raising its profile and attracting major companies (1).

 

The R&D environment

Singapore’s environment for R&D in the biomedical sciences has been recognised by the international pharmaceutical industry and a number of multinational companies have established themselves in the country (1). The Singapore Economic Development Board (EDB) has encouraged the presence of foreign companies and provides advice and guidance to market entrants (2).

 

Pharmaceutical companies that have invested in Singapore include Pfizer, GlaxoSmithKline, Merck & Co., Aventis, Roche, Novartis, Eli Lilly and Wyeth Pharmaceuticals (1, 2). In 2003, the output of Singapore’s biomedical sector was valued at $11.3 billion (local currency) having increased by nearly 16% over the previous year (2). Singapore has set itself the target of achieving $12 billion (local currency) in manufacturing output by 2005 (2). In 2003, pharmaceuticals accounted for 84% of total biomedical sector output and employment in the pharmaceutical area increased by 12.1% compared to 2002 (2).

 

Singapore opened the Biopolis research centre in late 2003. Biopolis cost $500 million (local currency) to build and has a capacity for 2,000 researchers (1). It will feature local companies, start-ups and major companies, which should create a vibrant atmosphere for collaboration and innovation. As well as attracting major companies Singapore is keen to develop local enterprises and the EDB is running various funding schemes to encourage researchers to commercialise their ideas for the market (1).

 

A high profile investment in Biopolis was the Novartis Institute for Tropical Diseases (NITD), which opened in July 2004 (3). Research at the NITD will focus on neglected diseases with initial work being concentrated on dengue fever and drug resistant tuberculosis (TB) (3). The centre is a welcome step forward into research for these diseases as the pharmaceutical industry has often been criticised in the past for having paid little attention to innovative R&D in these fields (4). As with many steps forward for neglected disease R&D, the NITD is a public-private partnership (4). In this case it has been set up between Novartis and the Singapore EDB. NITD has set itself the ambitious target of advancing at least two compounds to clinical trials by 2008 and making subsequent treatments available to patients by 2013 (3). Novartis has committed itself to making these treatments available on a non-profit basis to countries where these neglected diseases are endemic (3).

 

Apart from discovery R&D, a number of companies are carrying out clinical development in Singapore and using it as a base for overseeing studies being carried out in neighbouring areas. AstraZeneca, Aventis, GlaxoSmithKline, Merck & Co, Novartis and Schering-Plough have all followed this approach (1, 5). In 2003, Bristol-Myers Squibb designated Singapore as a hub for coordinating and managing its clinical studies in the entire Asia Pacific region and Novo Nordisk is also using a similar strategy for the clinical development of its new diabetes care products in the region (5).

 

Eli Lilly recognised the potential of Singapore for clinical development in 1996 when it set up the Lilly-NUS Centre for Clinical Pharmacology, which became operational the following year (6). It is a joint venture between Eli Lilly, the National University of Singapore (NUS), and the Agency for Science, Technology & Research (A*STAR) and represents the company’s only clinical pharmacology unit outside the USA with specialised facilities for conducting clinical trials with new pharmaceutical agents (6). A particular interest of the unit is exploring interethnic issues in man (6).

 

Improving the regulatory environment

As clinical trials become increasingly complex and more international, there has been a rise in the regulatory requirements that companies need to comply with. Although South-East Asian countries offer potential in terms of clinical development, it is important to make sure that trials are run to agreed international standards so that patients are protected and well cared for and so that the data generated in the region is acceptable to the major regulatory agencies elsewhere in the world. Having a well-established and well-respected regulatory agency is also in the interest of South-East Asian countries wishing to improve their standing as centres of R&D as it will provide companies with the confidence to carry out clinical trials in this region.

 

Singapore has recognised the importance of regulatory expertise and since 2001 it has been enhancing the capabilities of its Health Sciences Authority (HSA) so that it can act as a multidisciplinary agency (7). The HSA is now able to provide a comprehensive regulatory service for the evaluation and marketing approval of all therapeutic products (7).

 

The HSA has developed much of its regulation in line with global harmonization standards and has collaborated with other international agencies in order to achieve this (7). The most successful efforts to develop global harmonization standards have come through the work of The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH). ICH brings together pharmaceutical industry representatives and the regulatory authorities of Europe, Japan and the USA to discuss scientific and technical aspects of product registration.

 

In May 2002, the HSA signed an agreement with Australia’s Therapeutic Goods Administration (TGA) to formalise cooperation between the two agencies (7). The agreement with the TGA was the first of its kind for the HSA and was seen as the model for future collaborative efforts between Singapore and its Asia-Pacific counterparts (7). This was followed in September 2003, by an agreement between the HSA and China’s State Food and Drug Administration (SFDA) (7). The agreement between the two authorities broadly covered the exchange of information and expertise for areas such as pharmaceutical and biotech drugs, medical devices and traditional medicines (7). The two agencies also set up a joint Committee to oversee the collaborative efforts and set up working groups to study specific issues of mutual concern (7).

 

Staffing for success

As well as developing facilities for R&D, Singapore has been improving its education base so that talented individuals have the appropriate skills for success in the biomedical sector (8). Singapore’s A*STAR integrates public research within the growing industrial sector to nurture new talent. According to the Singapore Economic Development Board (SEDB), tertiary institutions produce around 35,000 graduates every year with qualifications suitable to the technology sector. Singapore has also launched several schemes to attract international staff to the country. According to official government information, if staff from overseas are required for a company, it takes no longer than two weeks to obtain the legal employment documentation (8).

 

The future

Singapore faces considerable obstacles in order to rival established centres for R&D in the world, but it is taking the right types of steps to create an environment that encourages innovation. As well as establishing appropriate research facilities and economic incentives to companies it is ensuring that the industry has a pool of talented staff to draw upon for the future. Whilst some areas of the world are reducing incentives for R&D-based industries and thus discouraging companies from further investment, Singapore is setting itself up as a promising alternative.

 

References

 

1.      Anon (2004). Singapore's biomedical sciences initiatives on track to meet targets. Singapore Economic Development Board press release. 19 Feb 2004. http://www.sedb.com/

 

2.      Kermani F and Gittins R (2004). Finding the Next Asian Pharma Sensation: Pharma potential in the Far East. May 2004. http://www.contractpharma.com/pdfs/05043.pdf

 

3.      Anon (2004). Novartis Institute for Tropical Diseases opens in Singapore’s state-of-the-art Biopolis research facility. Novartis press release. 5 July 2004. http://www.novartis.com/special/nitd_opening_pr.shtml

 

4.      Kermani F (2004). Time to Prioritize Neglected Diseases? Inpharm 16 August 2004. http://www.inpharm.com/External/InpH/1,2139,1-0-0-0-inp_intelligence_art-0-242855,00.html

 

5.      Singapore at a Glance. About Biomedical Sciences: Clinical development. Biomed Singapore. http://www.biomed-singapore.com/

 

6.      Lilly-NUS Centre for Clinical Pharmacology Pte Ltd. http://www.med.nus.edu.sg/lilly/

 

7.      Anon. Health Sciences Authority. http://www.hsa.gov.sg

 

8.      Kermani F and Gittins R (2004). Where will industry go to for its high-calibre staff? Journal of Commercial Biotechnology. Volume 11 (1): 1-9.

 

 

Dr Faiz Kermani

Last updated on: 27/08/2010 11:40:18

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