Dear Business Development or Corporate Alliance Director/Manager,

Transcription

1 Korea Drug Research Association(KDRA) and Korea Health Industry Development Institute(KHIDI) cordially request the potential global outsourcing partners(cros, CMOs, CSOs & Consulting Firms) having contract research or services business targeting the Asian pharmaceutical market to participate in Korean governmental program for establishment of Global Outsourcing Group Directory 2014 Dear Business Development or Corporate Alliance Director/Manager, Korea Drug Research Association(KDRA) established by the Korean law in 1986 as non-profit organization representing the R&D based Korean pharmaceutical Industry leading the Korean pharmaceutical market and sharing over 60% of domestic pharmaceutical market and Korea Health Industry Development Institute(KHIDI), a public organization that consists of a group of experts dealing with various programs on promoting and developing health industry in Korea, while helping improve the national healthcare services are jointly in search of global outsourcing partners having abilities, experience, reliability and more than anything else much interest in good collaboration partnership with Korean pharmaceutical companies in several areas; contract research(cros), contract manufacturing(cmos), contract sales(csos) and contract consulting(in R&D, R&D strategy & management, clinical trials, statistics, regulatory affairs and sales & marketing etc). Project Overview This project, establishing the directory of global outsourcing group(cros, CMOs, CSOs, Consulting Firms) having contract research or service businesses targeting the Asian pharmaceutical market is performed by KDRA and KHIDI to the end of this year, 2013 with the Korean governmental agency, the Ministry of Health & Welfare, and then planned to be annually updated to provide the Korean pharmaceutical industry with the systematic informations of overseas contract-based research or service companies or organizations having enough abilities and experience in above-mentioned outsourcing areas in the Asian Market.

2 KDRA and KHIDI have successfully performed global survey with many outsourcing partners having much interest in participating in this program and operating contract-based research or services targeting the European market(2012) and the North American market(2011). The survey result, information of each outsourcing partner, has been listed in directory book published early in this year and provided to all the Korean pharmaceutical companies for their use in search of global outsourcing partners. The main informations of each participating partner have also been uploaded in the official website ( for far-reaching spread and promotion of practical use. This year, following the strong needs from the industry, we are to focus on searching for the information of overseas outsourcing partners operating contract-based research or services targeting the Asian market and hope for overseas partners' positive consideration and participation in this meaningful survey. Korean pharmaceutical industry jumping up to the world market with technology innovation As for the Korean pharmaceutical industry, during the past 30 years there has been marvelous advancement in new drug research and development; market-launched 32 new drugs approved by the Korean regulatory agency(kfda), US-FDA approved 2 drugs, world's first monoclonal antibody biosimilar, around 15 IND-approved(by US FDA, EMA) new drug candidates, 100 out-licenced(to 26 countries) new drug candidates & technologies, 150 or so finished drugs & APIs already launched in overseas market including US and EU, 700 or so leads or druggable candidates existing in Korean pharmas' labs, 124 to be commercialized in the global market by 2014~2016 etc. Considering the success possibility, 31 of new drugs are expected by Korean pharmaceutical industry owes these successful innovation activities and bright future vision to not only their own strong passion for growth strategy through innovation but also optimized & closely-linked R&D environment and strong governmental support. Accompanied by 150 or so universities and colleges having strong needs for R&D co-works with the industry with their excellent IP assets in early stage research & discovery areas, several major public research institutes(kist, KRIBB, KRICT, KBSI etc) with excellent research abilities in applied science and superior research infrastructure and 15 preclinical trial organizations & 142 clinical trial facilities, most of the R&D based Korean pharmaceutical companies have been pioneering the future with new drug R&D. Strong Support from the Korean government in Pharmaceutical Innovation There also exist strong support from the Korean government in R&D funding, preparing the law for supporting pharmaceutical industry and important R&D infrastructures. The Korean government has been supporting tremendous governmental fund to new drug R&D and biotechnology areas since 1987 and recently it amount to around 2.0 US B$ as of 2010 with the establishment of Korea Drug Development Fund, National OncoVenture and Hitech Medical Clusters in Osong & Daegu-Gyeongbuk as important national new drug R&D infrastructures.

3 Global Pharmaceutical Industry facing steep turning point Global Pharmaceutical Industry is now facing serious challenges resulted by the shift of mega trends in healthcare paradigm in its operation and innovation activities. Major blockbuster drugs of several Big Pharmas which enjoyed monopolistic market share during very long time are now facing patent expirations resulting in even over 20-40% of drain-out in annual sales revenue. Drain-out of pipelines has been increasing market needs for the alternatives of patent expiry products. The regulatory agencies are reinforcing the regulation on drug approval affairs emphasizing on safety issues of drug candidates. As the result reinforcement of regulation has come to result in dramatic increase of patients number in clinical trials for which pharmaceutical companies should pay more enormous expenses than in the past and has accordingly resulted in slow-down in R&D productivity and profitability. Healthcare paradigm shift calling for effective and fundamental measures Healthcare paradigm shift in the market also imposes immense burden on pharmaceutical industry. Life threatening, chronic and pandemic diseases are increasing because of climate changes, environmental pollution, westernization of dietary life etc. Increase of income level and desire for healthy life have led the healthy people and the patients to demand upgraded measures for prevent and management of diseases. The regulatory agencies, patients insurance companies & agencies and tax payers also call for more effective drugs with therapeutic benefits. The insurance agencies are trying to pay for the value and therapeutic benefit of drug instead of just quantity of products or services reinforcing pressure on drug price cut-down to avoid financial deficit of health insurance budget. These factors call for more effective and fundamental measures in opposition to diseases requesting the pharmaceutical companies not to just treat or control diseases but instead to approach to the life cycle management of disease. These kinds of market needs are resulting in a variety of missions to pharmaceutical companies guiding the industry to approach various kinds of business & innovation areas in healthcare boundary. Korean pharmaceutical industry approaching to the smart strategies Global pharmaceutical industry including Korean pharmaceutical industry is trying to approach to the smart strategies to cope with the slow-down in productivity, cut-down of innovation value, reinforcement of regulation, lack of real innovation, patent expiration etc through making value-based innovation and level-up of innovation meeting the market needs from the population and government.

4 To accelerate the innovation activities and meet the various kinds of call for innovative therapeutic agents having better therapeutic benefits from patients, the government, health insurance agency and market, Korean R&D-based pharmaceutical companies have been involving in pioneering unmet medical needs areas investing over 65% to their annual net profit with the strong support from the Korean government, continuous pursuit of R&D productivity & efficiency to overcome the disadvantageous R&D resources in comparision with the advanced nations, highly educated & experienced R&D manpower, strong passion for new drug development, strategic & dynamic nationwide collaboration network between the industry, academia and public research orgs. and strong will & vision for global market. Sir David Cooksey, founder of private equity fund, said in his report to the UK Parliament, A Review of UK Health Research Funding, Dec 2006, that "UK-based industry faces competition not only from other Western countries, but also from emerging economies. Asian countries, notably India, China, Singapore, Japan and South Korea, are becoming substantial contributors to global research output". Korean pharmaceutical industry emerging as an important innovation partner Accordingly Asian countries including Korea have been emerging as key contributor to the global pharmaceutical innovation and is being expected as important innovation partner of global pharmaceutical industry including MNCs. During the past several years, we could witness various kinds of motions and trials from the Korean pharmaceutical industry to successfully enter the global pharmaceutical market, with their strong passion for being substantial contributor to the pharmaceutical innovation and global healthcare market. To enter the global pharmaceutical market successfully and to provide advanced measures for the patients suffering from life threatening, chronic, pandemic and intractable disease with our own results from innovation or our own products, like many other pharmaceutical companies in the world the Korean firms should meet the needs of local regulations and follow the local standard and business atmosphere in R&D, manufacturing of APIs or finished products, sales & marketing etc. Korean R&D based pharmaceutical industry searching for global outsourcing partners When it comes to Korean R&D based pharmaceutical industry mostly composed of KDRA members(48 regular member companies & 240 associate member companies), in their several years of trials in entering the overseas market, most of all have come to feel the needs for having partnership with the outsourcing group(cros, CMOs, CSOs & Consulting Firms) and as the result the industry has come to be in need of systematic information of outsourcing partners with accredited certifications, enough competitiveness, reliablity and experiences keeping good communication with the regulatory agencies to support the Korean sponsors in pre-clinical & clinical stage, regulatory affairs, manufacturing(test sample & finished products), sales & marketing etc.

5 Of course there have existed several on-line and off-line outsourcing directory informations in global pharmaceutical industry published by private or public organizations. But, despite these, many of Korean pharmaceutical companies in their decision making process are still calling for somewhat detailed informations of overseas outsourcing group in their search of most appropriate collaboration partners to their R&D projects or business programs. Therefore this project is expected to meet the needs from the Korean pharmaceutical industry in their search & identification of most adequate collaboration partners and accelerate symbiotic collaboration & win-win partnership between the industry and global outsourcing group to level-up productivity and efficiency in R&D, manufacturing and marketing activities in the Asian market guiding the Korean pharmaceutical industry to adapt themselves to the local regulatory and market circumstances successfully. Global outsourcing partners cordially invited to be inserted in the outsourcing directory 2014 Accordingly we, Korea Drug Research Association(KDRA) and Korea Health Industry Development Institute(KHIDI), cordially request the global outsourcing partners(cros; Contract Research Orgs., CMOs; Contract Manufacturing Orgs., CSOs; Contract Sales Orgs. and Consulting Orgs.) having contract research or service businesses targeting the Asian pharmaceutical market to participate in this meaningful project done by Korean pharmaceutical innovators group(kdra) at the request of Korean Governmental Organization by filling out and submitting the attached official form to KDRA by November 8, Your information collected from this survey would be uploaded in the official website and listed in the global outsourcing directory book to be issued by early in 2014 and to be delivered & provided in the form of Directory Book by at least 1st Q, 2014 to the whole Korean pharmaceutical & biotech companies after report to and review from the Korean Governmental agency. And your information would be annually up-dated by KDRA and KHIDI through the annual survey from For more information of overview of this global survey to outsourcing group, Korea Drug Research Association(KDRA), and Korea Health Industry Development Institute(KHIDI) including the Korean pharmaceutical industry, please see the attachment or contact the following principal investigator of this project. For general information of the industry and related organizations you can also visit related website(korea Drug Research Association : Korea Health Industry Development Institute : the Korean Ministry of Health & Welfare :

6 Contact Hun Che Cho, Director, Research & Development Promotion Dept., Korea Drug Research Association(KDRA) , Dangsan-Dong, Yeongdeungpo-Gu, Seoul, , Korea T F URL. Woo, Hee-Dong, Team Head, Department of Pharmaceutical Industry, Pharmaceutical Information Team, Korea Health Industry Development Institute(KHIDI) 187 Osongsaengmyeong2(i)-ro, Gangoe-myeon, Cheongwon-gun, Chungcheongbukdo, Korea T F URL. We cordially hope for your well-understanding of the purpose and philosophy of this project and your positive cooperation with us and the Korean Pharmaceutical Industry. Sincerely Yours, Kang Choo Lee, Ph.D., President Korea Drug Research Association(KDRA) Kyung-hwa Ko, President Korea Health Industry Development Institute(KHIDI)