ASTRAZENECA'S maiden venture in Singapore is a sign of how the biomedical sector is evolving.
Unlike other pharmaceutical giants, the Anglo-Swedish company has not opened a manufacturing plant here.
Instead, its investment in Singapore, besides a sales office in Suntec City, will be to use the Republic as a drug test bed. And not just any drug, to begin with, but a potential blockbuster against liver cancer - a largely 'Asian' disease.
With AstraZeneca's entry, there will be at least 10 big pharmaceutical firms - those ranking among the top 30 in the industry - testing potential drugs in Singapore.
It underscores the gradual shift of Singapore's role in the drug development process from just manufacturing, albeit high-end precision manufacturing, towards generating important data by testing these drugs in humans.
Since 2000, when the biomed sector really took off, manufacturing output has more than trebled from $6.3 billion to $24 billion last year.
But clinical testing requires a different sort of efficiency. Clinical trials determine how safe and efficacious a drug is in humans. They proceed after tests on animals show encouraging results.
For drug companies, data from early clinical trials contribute towards critical make-or-break business decisions on whether to proceed with expensive further testing that must be done before a drug can be approved.
Three trial phases are required before approval is given, and data from each must be submitted to the authorities before the next can proceed.
Not only does the data have to show positive results, it also has to be statistically significant.
Too small a sample size, and the data cannot be used. This means no green light for the next stage and millions of dollars down the drain.
It costs a drug company US$1 billion (S$1.4 billion) to get a drug onto the market, most of it going towards clinical trials.
For the Asian market, drug companies say they like conducting clinical trials in Singapore because of the tight regulatory system here, as well as the good health-care infrastructure.
The number of new clinical drug trials has gone up each year - from 99 in 1998 to 253 last year. And there are about 500 being conducted now, through all phases of testing, including a fourth after a drug has been approved.
One of the biggest challenges in conducting a clinical trial is recruitment, and drug companies stand to lose millions of dollars if there are delays in recruiting trial participants.
The biggest difficulty here is in selecting participants for the trials.
Set the selection criteria too stringently and you may get very few who make the cut; too loose and the data may be inaccurate and unreliable.
Recruitment of participants is high on the agenda of two new bodies which have been set up here to coordinate clinical trials in the region.
One, the Investigational Medicine Unit, will focus on early-phase trials which typically test potential drugs in small numbers of healthy individuals.
The Singapore Clinical Research Institute, which will open later this year, will focus on late-phase trials. These require larger numbers of patients afflicted with the disease the drug is intended to treat.
Patients from around the region will be tapped to make up the numbers.
Though trials can be coordinated by large private companies here, the two new centres hope to lead the way in expertise - for example, in designing trials, says Dr Edwin Low.
He is the executive director of the Health Ministry's National Medical Research Council, which charts the direction of medical research in Singapore.
Said Dr Low, 49: 'We want those from all over the world who want to conduct a trial to see these centres as a one-stop concierge service.'
Aside from being a validation of its biomedical sciences efforts, there are positive spin-off benefits to being a clinical trial centre.
One is that it means quick access to new drugs for patients here.
Drugs do not always work the same way on different ethnic groups and being able to test them on Asians here is invaluable.
Another is the possibility of partnerships which could lead to precious intellectual property being developed.
For now, most big pharma firms here are testing their own drugs developed elsewhere.
But AstraZeneca's partnership with the National Cancer Centre Singapore gives the cancer centre the freedom to mix and match drugs to come up with a winning formula against liver cancer. It will play a part in developing a new line of drugs against a disease which has no effective treatment.
If more big pharma firms push ahead with this new strategy, Singapore will become more than a little red dot on the drug development map.
Catching the eye of a drug company with deep pockets is like hitting the jackpot for anyone with a potential drug on their cards.
As Singapore's eight-year-old foray into the biomedical sciences starts to bear fruit in the coming years, courting big pharma firms will become increasingly significant.
It helps to have them already in the backyard.
MILESTONES IN SEARCH FOR NEW DRUGS
Medical miracles
Penicillin, discovered in London in 1928 by Sir Alexander Fleming, was the world's first antibiotic to cure a wide range of infections caused by bacteria.
Cancer drugs - Gleevec for a certain type of leukaemia, Herceptin for breast cancer and Sutent for kidney cancer - have been hailed as breakthroughs in the last decade.
Studies have found these drugs to produce milder side effects and to prolong life.
Insulin, discovered at the University of Toronto in 1921, extended the life of a dying Elizabeth Hughes, then 14, by six decades.
It went on to save hundreds of thousands of diabetics worldwide. The team led by F.G. Banting and J. J.R. Macleod won the Nobel Prize in Medicine.
Successful ventures
GlaxoSmithKline's rotavirus vaccine, tested on 6,000 babies at the KK Women's and Children's Hospital since 2004, is the biggest known Phase 3 trial done here. It will be completed by year-end. Rotaviruses are the leading cause of vomiting and diarrhoea in children. The trial was done here, ahead of those slated for Europe or the US because many viruses that cause diarrhoea are endemic in Asia.
The trial for the cancer drug ABT869 was tested for the first time in the world at the National University Hospital. The new drug, developed by Abbott Laboratories and the Genome Institute of Singapore, prolonged the life of cancer patients for whom other kinds of treatment had failed. They were given a chance to try this drug at its trial stage instead of having to wait for other drugs to win approval in the US or Europe.
Disastrous trials
In 2006, a trial of TGN1412, a drug to treat multiple sclerosis, leukaemia and arthritis, went wrong in Britain. Six men in the trial fell very ill, with Mr Ryan Wilson, 20, the worst off: he suffered organ failure, went into a coma for three weeks and had to have most of his blackened fingers and toes amputated. The other trial subjects' heads and bodies swelled following injections of the drug developed by biotech company TeGenero. Their health prospects remain uncertain.
Last month, bodybuilder Peter Munro, 48, suffered massive heart attacks in Edinburgh while on a Phase I clinical trial for an arthritis drug called RhuDex. An autopsy revealed he had had several minor heart attacks which tests ahead of the trial did not detect. About 80 other subjects in the trial were unaffected.
Shobana Kesava
This article was first published in The Straits Times on August 16, 2008.
