One of the policies of Chulalongkorn University is the University-Industrial linkage  which will serve the industrial sector with the excellence knowledge matched with the needs of such sector. Moreover, the linkage will also bring in the support for further research either financial, personnel and equipments.  The more development in this policy is the spin-off or strart-up companies based on innovation or advanced knowledge created by our faculty members and partners.

Since there are limitations of management in the context of  being public university , Chulalongkorn University has founded the Chulalongkorn Intellectual Property Institute Foundation (CU.IPI.F) to take the responsibility in this business model since 1997 and has successfully delivered very impressive results.

 Last month (January 2008), the Chulalongkorn Intellectual Property Institute Foundation officially launched its collaboration with a so-called clinical research organization (CRO) from the Netherlands, IATEC BV, with a scientific luncheon meeting at the Queen Sirikit Convention Center in Bangkok. The event was attended by, amongst others, Professor Charas Suwanwela, Chair of the University Council of Chulalongkorn University and His Excellency Mr. Pieter Marres, Ambassador of the Netherlands to Thailand. The collaboration, which has taken a little less than a year to establish, goes by the name of Asia-Pacific IATEC CRO Co., Ltd. And also Dr. Siriwat Thiptharadol, the secretary of Thai FDA. Of the Ministry of Public Health.

Prof. Soottiporn Chittmittrapap, Chairman of the Board of Directors of the new company, opened the lunch meeting by explaining how Clinical Research Organizations are growing world wide but in Latin America and Asia in particular. Traditionally, clinical studies are initiated, organized and conducted by pharmaceutical companies, but outsourcing of these clinical study activities to CROs is proven to often be more efficient and more cost effective while leading to more reliable study data and faster registration of new medicines. For these reasons more and more pharmaceutical and R&D companies are eager to involve CROs in the development of new drugs. Also, clinical studies are growing both in numbers and size as regulatory authorities across the globe ask for more safety and efficacy data in order to register a new drug. Reasons for existing CROs to want to expand outside of the western world are better access to clinical study participants than in Western countries and lower costs involved in conducting clinical medication research here while not compromising quality.

Prof. Soottiporn said that Asia-Pacific IATEC CRO can help a client, usual a pharmaceutical company or R&D company, with all phases of development of a new drug in humans, so after all required test tube and animal studies have been completed. Such clinical studies in humans range from trying a tiny and single dose of a new drug in healthy volunteers in special study units to comparing effective compounds in late stages of development in regular clinics and hospitals to see if they are indeed an improvement over the current standard of care. Dr. Niwat Montreewasuwat, Director of Clinical Operations for Southeast Asia for Janssen Cilag Ltd., another speaker at the opening event, explained that such clinical studies need to be conducted in compliance with International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines. These guidelines were fully adopted by Thailand in 2000. Implementation of these guidelines assures that the volunteers participating in the studies are protected by the ethical and quality standards laid out by these guidelines and that the data generated by these studies are based on sound scientific and statistical principles.

Professor Kiat Ruxrungtham, one of the other five members of the Board of Directors of the new company explained that IATEC was drawn to Thailand because of the existing experience in ICH-GCP compliant clinical trial conduct in the country, the excellent reputation of its academic hospitals and public health care sector, the growing economic importance of (Southeast) Asia when it comes to purchasing medications.

Many different professions are combined in a CRO, ranging from staff with biomedical expertise who supervise the conduct of a clinical study, to staff with expertise in data management and biostatistics to appropriately gather, clean and analyse the large sets of data generated during clinical studies. Next to a desire to expand clinical research activities within Chulalongkorn Hospital and Thailand overall, it is transfer of IATEC’s expertise in which CUIPIF is interested.
A connection with the Faculty of Medicine of Chulalongkorn University provides the new CRO access to this institution’s outstanding clinical experts and opinion leaders and other excellent clinical centers in the Asia-Pacific region.

For the past 11 years, IATEC BV has been an active partner in the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), which is part of the Thai Red Cross Society and now a leading clinical research organization in the field of HIV. HIV-NAT is currently active in Thailand and Cambodia, conducting trials in both adult and pediatric populations. Through HIV-NAT, IATEC has built up extensive expertise in the region in regulatory affairs, Institutional Review Board (IRB) evaluation, site and investigator selection, site management, Investigational New Drug (IND) importation, ICH-GCP training, auditing of clinical sites, and data management.

The Asia-Pacific IATEC CRO co.,Ltd. is new company out of the three companies run by the Jarmjuree Innovation Holding company under the management of  CU.IPI.Foundation, which the university hope that this will be another source of income ot the university in the near future as many of the US universities have experienced.