PUTRAJAYA, Jan 4 — Global pharmaceutical firm Roche Pharmaceutical has become the first to bring its first-in-human (FIH) trials under a rheumatology indication to Malaysia, Health Minister Datuk Seri Dzulkefly Ahmad announced today.
Noting the important milestone, Dzulkefly said the award by the Swiss-based multinational healthcare firm to bring its FIH trials to Malaysia was a testament to the country’s growing clinical trial capabilities in the region.
“Malaysia’s clinical trial ecosystem has developed rapidly, with over 2,300 sponsored clinical research conducted since the establishment of Clinical Research Malaysia (CRM) in 2012.
“The country has great potential in delivering multi-regional clinical trials, whereby we have world-class investigators, mature and comprehensive infrastructure as well as a robust regulatory landscape that ensured the safe conduct of trials for our patients,” he said during the Clinical Research Excellence in Early Phase and People Development event at the Health Ministry here.
Dzulkefly said the milestone was made possible following the completion of CRM’s Phase 1 Realisation project which had enabled the FIH ecosystem in the country.
As for the FIH trial, Dzulkefly said the study will take place at the Clinical Research Centre of Sarawak General Hospital — an accredited FIH facility under the National Pharmaceutical Regulatory Agency.
By definition, a FIH clinical trial is the first clinical study of an investigational new drug being administered to human volunteers for the first time.
Roche (Malaysia) Sdn Bhd country medical director, Dr Wendy Tay, said the FIH trial concerns a new experimental drug aimed at treating patients with Systemic Lupus Erythematosus (SLE) — an autoimmune disease in which the immune system attacks its own tissues.
She said Malaysia was among seven countries included for the study and is the first within the Asia-Pacific region.
At the same event, Dzulkefly also witnessed the signing of a Memorandum of Understanding (MoU) between CRM and Pharmaceutical Association of Malaysia (PhAMA).
The strategic partnership aims to further propel the development of clinical research talents and skills in the country, with Dzulkefly noting the importance of Malaysia remaining competitive amongst other global study sites.
“Through collaborative efforts, CRM and PhAMA are poised to contribute significantly to the advancement of healthcare and the pharmaceutical sector.
“The inking of MoU today further solidifies the organisations’ dedication to shaping the future of clinical research in Malaysia,” he said.
Also present during the signing were CRM chief executive Dr Akhmal Yusof and PhAMA president Kam Ai Teng.
Accordingly, the partnership will see the provision of protégés by PhAMA to CRM on an annual basis for the next three years through CRM’s Centre of Excellence that will see fresh graduates equipped with the needed skillset to pursue a career in clinical research.
