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KDDF Project Team establishes MOU with KIT 10.04.2012
KDDF Project Team establishes MOU with KIT
- Following its MOU with PAREXEL, KDDF extends network to an international level non-clinical test institution -
 


□ The Korea Drug Development Fund has laid a foundation for special consulting in the non-clinical area, and is taking active steps to support the building of infrastructure for the development of new drugs that meet global standards.
 
□ On the 4th of October, 2012, the KDDF signed an MOU with the Korea Institute of Toxicology (Director Sangjun Lee, KIT), a government funded non-clinical research and test institution, to strengthen Korea's capacity to develop new drugs that meet global standards.
 
○ KIT is a government funded research institute that is dedicated to safety testing of agricultural chemicals, health functional foods, food additives, cosmetics and chemical materials, and is becoming an internationally-renowned toxicity and safety test institute thanks to its special test services and systems.
 
○ This MOU is one of many diversified support channels the KDDF is pursuing for its new drug development project and its efficient management. The two entities have pledged to cooperate actively in various ways for successful overseas market advancement, including ▲ Active support for a global level non-clinical test service ▲ Overseas permission/license consulting support cooperation and ▲ co-development of special personnel growth programs, such as non-clinical testing and global specialist networking.
 
□ Following its MOU last June with PAREXEL, a global CRO, the KDDF is reinforcing its special consulting role for the development of new drugs that meet global standards through its MOU with KIT, which has competitiveness in the non-clinical area, thus consolidating clinical and non-clinical area competitiveness.
 
□ Sangjun Lee, Director of KIT remarked that “KIT is the only institute available for primates and inhalation toxicity in Korea and is also an international level non-clinical test institute widely renowned in the USA and Europe,” adding “We will make every effort to enhance the success rate of new drug development projects, including candidate materials required for non-clinical tests.'
 
□ Dongho Lee, CEO of the KDDF, commented “Following our MOU with PAREXEL, a global CRO, our MOU with KIT, which has competitiveness in non-clinical areas, consolidates our clinical and non-clinical area competitiveness,' adding that 'We will also reinforce our special consulting role for the development of new drugs that meet global standards.' [Photo attached]
 

[Appendix] Introduction of Organizations

Korea Drug Development Fund (KDDF)
The KDDF officially started in September as a government-wide R&D project with the Ministry of Education & Science, the Ministry of Knowledge Economy and the Ministry of Health & Welfare. It is the largest new drug development project in Korea, and involves a total investment of 1 trillion, 60 billion won over 9 years until 2020 (Government 530 billion won: private sector 530 billion won) with the aim of constructing 10 new drug development systems and advancing a new drug development R&D investment platform.
A second aim is to avoid duplicated investment in all areas of R&D including pharmaceutical companies, venture companies, universities and research institutes by maximizing efficiency and connecting the whole cycle of development from selecting candidate materials to commercialization.
A supreme decision making board exists, under the Ministers of the three ministries, in which the director assumes a similar authority to that of a corporate CEO.
For internal decision making, an operations committee, investment committee and evaluation committee deliberate.


Korea Institute of Toxicology (KIT)
KIT is a government-funded research institute for testing the safety of agricultural chemicals, health functional food, food additives, cosmetics and chemical materials. Since its inception in 1988 as the first officially assigned research institute of the Ministry of Health & Welfare according to the GLP regulation for medicines, it obtained GLP certification from the Ministry of Environment (1998) and the Ministry of Agriculture & Forestry (2002). It later obtained GLP certification from Japan's Ministry of Agriculture, Forestry and Fisheries (1990) and underwent OECD mutual inspection in 2000 and US FDA inspection in 2005.
KIT began the operation of the Jeonbuk Primates Test Center, with an international level inhaling toxicity test and primate test unit in Jeongeup-si Jeonbuk in 2010, and Gyeongnam Environmental Toxicity Center in Jinju-si Gyeongnam in March 2012, becoming a world-class toxicity and safety test institute with a specialized test service and system.


 

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