Veeda Clinical Research announced this week, from its Ahmedabad HQ, that the final steps had been put in place for the commissioning of its CRC Veeda (Malaysia) Phase I Unit in the Ampang Hospital in Kuala Lumpur in Malaysia, most likely to be called ‘CVM’ in everyday speak.

Dr Maurice Cross, the Group Medical Director who originally initiated the project was jubilant in his announcement that this “was the beginning of a major change in the way that Veeda functioned as a Global CRO with particular leadership in the field of early drug development.”

Dr Cross was especially concerned to praise the Commissioning Team led by Veeda’s Group Managing Director, Mr. Apurva Shah as well as the team from the Clinical Research Centre of the Malaysian Ministry of Health in Kuala Lumpur. “Without the help and support of Tan Sri Ismail Merican, the then Medical Director General, Dr Lim Tek Onn and Dato’ S.C Teoh in the early days this project would never have got started; then the final commissioning was led by Dr Goh Pik Pin and Dr Sia Koon Ket and his team working very hard to get the legalities and logistics right”

Dr Cross observed also that this was a unique collaboration between a private CRO on the one hand and a Governmental Agency and a National Health Service on the other. That such a, collaboration was even possible, is a reflection of the very positive and aggressive attitude of the Government of Malaysia in promoting the country as a player in the new order of drug development. The Government of Malaysia is encouraging the growth of a pharmaceutical industry within its boundaries by supporting infrastructure projects especially in the areas of drug manufacture and preparation and testing. Unlike India, Malaysia has never had a substantial indigenous pharmaceutical industry but a small industry geared to supporting its needs. So clients have to be attracted from abroad to Malaysia. Dr Goh Pik Pin, representing the Ministry of Health said “This has been a very special project close to the heart of those who initiated and developed it. It is very difficult, sometimes, to integrate the approaches of private CROs and Governmental agencies but with determination and the encouragement of the Ministry, we have succeeded and now look forward to beginning a planned series of studies intended to stretch and develop the Unit’s capabilities”

The 28 bed unit is placed in the Ampang Hospital in the suburbs of Kuala Lumpur. Although a large district general hospital it also houses the countries specialized facilities for haematology and haematological oncology. The unit is equipped with mostly GE medical equipment to the standards of any Western Unit and laboratory services are provided by Gribbles Laboratories in Kuala Lumpur who are very familiar with operating to current pharmaceutical industry standards. Infrastructure development has included arranging for cardiovascular data to be transferrable from the Malaysian Unit to the GE MUSE in Ahmedabad for analysis.

A team from Malaysia, spent some time in Veeda’s Unit in Plymouth in the UK to better understand fully how a modern Phase I Unit operates and the team members now some 30 strong will provide the day-to-day running of the unit. Veeda’s considerable expertise will be seen in the client-facing activities of the unit such as project management, monitoring of the conduct of the trials and QA/QC and data-management and statistics and bioanalysis as well as providing hands-on supervision in the early days in support of the Malaysian team.

Malaysia is not new to Veeda, nor Veeda to Malaysia; in the past two years, Veeda has been able to place studies in Malaysia through the highly structured CRC network and have found the Malaysian administrators, clinicians the Governmental and Regulatory agencies to be easy to collaborate with and highly motivated to secure work for the development of Malaysia. In particular, Veeda’s Oncology team has had frequent contacts with the CRC coordinator and his team. Regulatory and start-up times in Malaysia are very favorable even when compared with the Western Countries and are far faster than many evolving countries and the existence of the National Disease registry makes the identification of patient populations especially easy and efficient.

The next step, going forwards, is the evolution of a seamless drug development infrastructure utilising the full spectrum of services available in Malaysia from the capability to produce API (including large-molecule) through early exposure of man both in a conventional Phase I setting and utilizing the integrated CRC and Registry system of the Ministry of Health. Western drug-developers of all sizes have yet to fully grasp the concept of bringing their drugs to Malaysia for a fast one-stop drug development service fully supported by the expertise and support of Veeda Clinical Research.