When you talk about medical drugs, consumers tend to fixate on their effectiveness and price. Rarely do they consider the long drawn out process that any new drug has to meet before making the journey from the laboratory to the pharmacies or hospitals.
But the field of clinical research, which involves the discovery of new drugs, medical devices or protocols, has a major impact on healthcare and the economy. There is a constant demand to address unmet medical needs in numerous diseases including diabetes, cardiovascular and cancer.
The development of a new drug is a 10- to 15-year process and its research and development (R&D) comes with numerous downstream and upstream economic activities.
Investments in such R&Ds are huge; pharmaceutical giant Novo Nordisk, for example, invests 15% of its sales revenue in R&D.
According to its General Manager for Malaysia, Singapore and Brunei, Noha Shawky, in 2013 the company invested US$2.1 billion in clinical trials for diabetes.
The global clinical trial industry is worth US$51 billion a year and in the last five years, clinical research has moved from developed countries in the West to the East – due to delay approvals and as well as rising costs and the procurement of subjects. For drug companies, these delays are costly as the life of a patent starts at the point of discovery of a drug and any delay in getting it to the market can push companies back by up to US$10 million per day.
Fewer hurdles in Asian countries like China, India and Southeast Asia has seen this industry growing at the rate of 30% year on year in this part of the world, said PEMANDU’s Director of Healthcare NKEA, Fabian Bigar.
According to the Chief Executive Officer of Clinical Research Malaysia (CRM) Dr Akhmal Yusof, the pharmaceutical industry considers Malaysia as a potential hub for Industry-Sponsored Research (ISR), with the ability to deliver speed, quality and reliability.
Malaysia offers an excellent environment for clinical research with a sizeable pool of expert healthcare and research professionals conversant in English; genetic diversity through multi-ethnic population; and an extensive network of hospitals and clinics (government and private), which is among the best in the region. A consistent timeline for approval – typically about six to eight weeks for approval process – is extremely important, said Dr Akhmal.
Shawky, Bigar and Dr Akhmal were speaking at the Economic Transformation Programme Healthcare Link Event: Taking Industry–Sponsored Research to The Next Level: Is Malaysia Ready? held in Kuala Lumpur on Nov 16.
Malaysia has more than 80 ISR trial sites, which have been approved by the Ministry of Health (MOH), in conjunction with public and private hospitals as well as university hospitals. Trial cost per patients is at a competitive rate when compared with Singapore, Taiwan, South Korea and Japan.
ISR is not limited to research on pharmaceutical and medical devices; it includes novel hypothesis related to medicine, medical devices and clinical practices, with the objective of seeking clinical improvements for the management of diseases.
Despite some negativity surrounding ISR, the benefits to local industry are numerous, especially in the areas of technology transfer.
ISR exposes local investigators and research teams to the proper procedures for conducting a study in compliance with Good Clinical Practices. These include writing a clinical protocol, collecting empirical data and documentation procedures when reporting clinical case studies, explained Dr Akmar. He added that this knowledge is not taught in classrooms and is crucial to ensure good practice and quality of local research work.
All this would go towards the development of the local pharma and medical device industry, as well as increasing local R&D capacity to allow Malaysia to tap into our huge natural bio-diversity. For the patients, ISR provides access to new life-saving drugs and medical devices.
“Currently, there are 869 new and ongoing ISRs, which have brought in more than RM118 million in investments and created 562 skilled jobs,” he said. CRM’s 2020 target is to raise the number of ISRs to 1,000, garnering a GNI of RM578 million and creating 1,000 high-skilled jobs.
CRM was established in 2012 to position Malaysia as a preferred global destination for ISR. The non-profit organisation, which is wholly-owned by MOH, acts as a facilitator and enabler for both the pharma industry and medical fraternity by pushing for the development of an efficient eco-system to increase the number of ISRs in the country.
“Our efforts also include creating public and industry awareness on clinical research and developing a pool of capable investigators, support staff and trial sites for high-quality ISR trials.”
Currently, Malaysia comes third in ASEAN after Thailand and Singapore in the number of industry-related clinical research, said Dr Akhmal.