Singapore is making gains in its bid to become a prime location for carrying out clinical trials in Asia, helped by a S$1.4 billion ($884m) government-backed research programme, which started in July and aims to drive discoveries made in the lab into clinical trials as quickly as possible.
Helped by a robust intellectual property regime, comprehensive regulatory infrastructure, pool of talented manpower and a business-friendly environment, pharmaceutical companies and contract research organisations have started to set up shop in the country, according to a report by the Singapore Economic Development Board.
Part of the S$1.4 billion warchest has been earmarked to set up the Singapore Institute for Clinical Sciences, to be headed by Prof Judith Swain, Dean of Translational Medicine of University of California San Diego. This institute has been charged with developing new technologies and capabilities for the study of therapies and diseases in man.
"Over the past two years, there have been approximately 200 Clinical Trial Certificates issued annually and on average, there would be approximately 300 ongoing clinical drug trials,” according to Dr Kerwin Low of Singapore’s Centre for Drug Administration, part of the island’s Health Sciences Authority (HSA) and responsible for regulating the conduct of clinical drug trials.
Before starting a clinical trial for a new medicine, Principal Investigators need to obtain ethics approval from the institutions' or hospitals' own Institutional Review Board (IRB) and regulatory approval in the form of a Clinical Trial Certificate (CTC) from HSA. Today, the application to the IRB and HSA is done in parallel, which shortens the lead time before a trial can commence. Typically, the processing time for both approvals is 30 working days.
Singapore has developed a strategy of focusing its clinical trials capacity into four key therapeutic areas - oncology, clinical pharmacology, gastroenterology/hepatology and cardiology - to lend some structure to the country’s activities and make it more attractive to sponsors.
Good Clinical Practice (GCP) Guidelines were set up by the Ministry of Health in 1998, to ensure patient safety and the integrity of the resulting data, and since then, Singapore's clinical trials market has doubled in size.
Singapore's biomedical research capabilities, clinical trials expertise and robust regulatory framework have attracted international pharmaceutical companies here. Companies like AstraZeneca, Bristol-Myers Squibb, GSK, Merck KgaA, MSD, Novartis, Novo Nordisk, Pfizer, Sanofi-Aventis, Lilly, Lundbeck, Schering AG and Schering-Plough have all set up their own clinical trials coordination centres in Singapore.
In 1997, Lilly set up the Lilly-NUS Centre for Clinical Pharmacology. This has its own clinical research unit for conducting clinical trials with new pharmaceutical agents and also explores interethnic issues in man.
And as Singapore gains its status as a clinical trials hub, many of the world's leading clinical research organisations (CROs) are also establishing operations here. The CROs' activities here include clinical trial management for trials conducted in Singapore and Asia Pacific, and central laboratory testing of patient tissue samples, collected from trial sites in the region.
Companies such as Quintiles, Covance, ICON, MDS Pharma, PPD and the home-grown Gleneagles Clinical Research Centre have set up regional centres in Singapore. All the CROs have experienced strong growth in number of projects, over the last several years, according to the SEDB.