2009 korea lifescience resource_guidebook2009

26
KOREA , The Gateway to ASIA KOREA Life Science Services Resource Guide 2009 Contract Research Contract Development Contract Manufacturing

Transcript of 2009 korea lifescience resource_guidebook2009

Page 1: 2009 korea lifescience resource_guidebook2009

KOREA, The Gateway to ASIA

KOREA Life Science Services

Resource Guide 2009

Contract Research

Contract Development

Contract Manufacturing

Page 2: 2009 korea lifescience resource_guidebook2009
Page 3: 2009 korea lifescience resource_guidebook2009

KOREA, The Gateway to ASIA

KOREA Life Science Services

Resource Guide 2009

Contract Research

Contract Development

Contract Manufacturing

Page 4: 2009 korea lifescience resource_guidebook2009

5

About koreaBio

koreaBio is a non-profit organization representing Korea BiotechnologyIndustry. Our association was formed as a result of merge betweenthree different industry associations in biotechnology field November2008. Our missions are to become a supportive organization to servethe member companies more efficiently and a reliable partner ofthe government. Also we actively participate as a member of theinternational bio-industry communities and to develop varioustraining and policy making programs to support the industry andgovernment. Our members are over 250 companies as of Jun. 2009.

koreaBio Services

Industry development and support koreaBio has been planning and managing biotechnology R&Dprojects and development projects. Also we are supportingbiotechnology incubation such as establishment and operation of thebiotechnology transfer center, joint IR for IPO of biotech companies.

International cooperationkoreaBio supports a participation in international exhibition andpartnering meetings to provide opportunities to expand a businessthe worldwide. Also koreaBio hosts Road-shows to introduce KoreaBiotechnology products and technologies.

5 Korea Biotechnology Industry Organization7 AJOU UNIVERSITY MEDICAL CENTER Regional Clinical Center8 AMC CRC (ASAN Medical Center Clinical Research Center)9 AnC Bio, Inc.10 Amicogen, Inc.11 BEAMS BIOTECHNOLOGY CO., LTD.12 Biotoxtech Co.,Ltd.13 BIOTRION Co., Ltd.14 C&R Research Inc.15 Chemizon - A division of Optomagic Co., Ltd.16 Chemon co.,Ltd17 Chonbuk National University Hospital Clinical Trial Center (CNUH CTC)18 Chonnam National University Hospital Clinical Trial Center19 Chungnam National University Hospital Clinical Trials Center20 Clinical Trials Center, Seoul National University Hospital21 CMC Clinical Research Coordinating Center22 DNA Link, Inc.23 Dong-A University Hospital Clinical Research Center24 DramCIS Inc.25 GENOMINE, INC.26 Hubertbio27 INHA University Hospital Clinical Trial Center28 Inje University BusanPaik Hospital Clinical Trial Center29 Inje University Pharmaco Genomics Research Center30 Korea Institute of Toxicology31 Korea National Enterprise for Clinical Trials.32 KOREASTEVIA CO.,LTD33 Korea Testing and Research Institute34 Korea University Anam Hospital Clinical Trial Center35 Kyungpook National University Hospital Clinical Trial Center36 LSK Global Pharma Services Co., Ltd37 Medi Kinetics Co., Ltd.38 PharmaCRO39 Qu-BEST Consulting Co., Ltd.40 Samsung Medical Center Clinical Trial Center41 Seoul Clinical Laboratories(SCL), Central laboratory Services42 Seoul Pharma Laboratories, Inc.43 Solomon Medical Research, Inc.44 World Courier Korea Co.,Ltd45 YeBT46 Yonsei University Health System Clinical Trials Center47 Young In Frontier Co., Ltd.

Contents KOREA Life Science Services Resource Guide 2009

Page 5: 2009 korea lifescience resource_guidebook2009

6

address San 5, Wonchun-dong, Yeongtong-gu, Suwon, Korea 443-721

website http://rctc.ajoumc.or.kr

tel +82-31-219-4469 fax +82-31-219-4265

contact Lim Sewom

e-mail [email protected] start-up year 2005

CEO Park, Hae-Sim employees 30

company name AJOU UNIVERSITY MEDICALCENTER Regional Clinical Center

7

company profile

Welcome to the Clinical Trial Center(CTC) of Ajou UniversityHospital. Established in 1994, the CTC has consistently aimedthrough countless multi-center trials to provide researchers in thepublic and private sectors with optimal research environments thatenable ethical, scientific and systematic clinical investigations.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Information support and public relationskoreaBio publishes Korea’s biotechnology statistics and electronicnewsletter to approximately 12,000 subscribers. For further information, please visit www.koreabio.org.

EducationkoreaBio operates national educational programs for biotechnologydevelopment to professionals and scientists and engineers in Bio-industry.

address 9F., Unik Bldg, 706-13, Yeoksam-Dong, Kangnam-Gu Seoul, Republicof Korea135-918

Sector Non-profit organization Trade association

website http://www.koreabio.org

Contact1 InSuk(Lydia) Son, Assistant Managertel +82-70-8610-3537 e-mail [email protected]

Contact2 JongHoon Choi, Executive Director

tel +82-70-8610-3533 e-mail [email protected]

Page 6: 2009 korea lifescience resource_guidebook2009

address H.Q: 884-1 Eyon-ri, Cheongbuk-myon, Pyeongtaek, Gyeonggi, KoreaSeoul Office: H&S Tower 10th Fl., 119-2 Nonhyun-dong, Ganganam-gu,Seoul, Korea

website www.ancbio.com

tel H.Q: +82-(0)31-686-9450 Seoul Office: +82-(0)2-549-7088

fax H.Q: +82-(0)31-686-9451 Seoul Office: +82-(0)2-549-7044

contact Sean Choi / Senior Manager / Medical Team

e-mail [email protected] start-up year 1999

CEO Jong-Weon Choi employees 45

company name AnC Bio, Inc.

9

company profile

AnC Bio has established most advanced and massive cell culturingfacilities that include 30 cleanrooms. The company has made itfacilities complying with the world leading GMP standards. AnC Bio has exclusive manufacturing and distribution rights forMyoCell that is a novel cell therapy for CHF patients. The companyhas rich resources to meet various needs of the contract-givers forcell-based products.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 86, Asanbyeongwon-gil, Songpa-gu, Seoul 138-736 Korea

website http://crc.amc.seoul.kr/

tel +86-2-3010-7368 fax +86-2-3010-7171

contact Ha-Yeong Koo

e-mail [email protected] start-up year 2002

CEO Jung-Shin Lee(Executive Director: Dongho Lee)

employees 6,781

company name AMC CRC (ASAN Medical Center ClinicalResearch Center)

8

company profile

The AMC CRC is a top organization that makes patients andsponsors satisfied, and committed to clinical trial investigators fordevelopment of innovative medical treatment. We are pursuingcooperation and creativeness based on cutting-edge technologyand qualified system assured by Global QA Director.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 7: 2009 korea lifescience resource_guidebook2009

address B104 SuntechCity II, #307-2 Joongwon-ku, Sungnam, Kyoungki-Do,Korea 462-736

website http://www.beamsbio.co.kr

tel +82-31-737-4970 fax +82-31-737-4972

contact CHEOL KIM, President / DOYUN KIM, Director

e-mail [email protected] start-up year 2006

CEO CHEOL KIM employees 7

company name BEAMS BIOTECHNOLOGY CO., LTD.

11

company profile

BEAMS Biotechnology is one of the contract manufacturers forplasmid DNA and recombinant Protein produced by microbialfermentation. With an innovative and proprietary process design,we provide strictly quality-driven pDNAs or proteins with lot sizesfrom 10 milligram upto kg scale.We manufacture all kinds of pure plasmid DNA and recombinantProtein purified from microbial cultures. Also, we provide contractdevelopment service for scale-up and improvement ofmanufacturing process, documentation service of BPR for non-clinical test, and consulting service of manufacturing sample forclinical application including the technology transfer ofmanufacturing process to cGMP facility.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 694-4 Sangchon, Jinsung, Jinju 660-852, South Korea

website http://www.amicogen.com/english

tel +82-55-759-6161 fax +82-55-759-6094

contact Dr. Yong Chul Shin

e-mail [email protected] start-up year 2000

CEO Dr. Yong Chul Shin employees 30

company name Amicogen, Inc.

10

company profile

Our company has world-wide competitiveness in the developmentof specialty enzymes (proteins) by unique directed molecularevolution and enzyme engineering technologies. We also have goodexperiences and facilities (GMP) for the production of enzyme-based fine chemicals.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 8: 2009 korea lifescience resource_guidebook2009

address BIOTRION Co., Ltd. F2, KAST B/D, 7-1, Gumi-Dong, Bundang-Gu,Seongnam-Si, Gyeonggi-Do, Korea

website http://www.biotrion.com

tel +82-70-7508-2340 ~ 2353 fax +82-31-726-3978

contact Hyosil Lee

e-mail [email protected] start-up year 1999

CEO David Song employees 16

company name BIOTRION Co., Ltd.

13

company profile

BIOTRION is organized with experts who have more than 10 yearsof experiences and successfully commercialized variousbiopharmaceutical products. BIOTRION provides CONSULTING(product/business developmentand registration), CRO(CMC/pre-clinical study design and studymonitoring) and LICENSING(technology & product license-IN andOUT) Services.We do our best, putting ourself in client’s place, to acquire thebiggest achievement by optimizing strategy for product andbusiness development and participation in whole developmentprocess.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address Ochang science industrial complex, 686-2 Yangcheong-ri, Ochang-eup,Cheongwon-gun, Chungbuk province, 363-883 Korea

website http://www.biotoxtech.com

tel +82-43-210-7788 fax +82-43-210-7789

contact Marketing Team

e-mail [email protected] start-up year 2000

CEO Jong-Koo Kang employees 150

company name Biotoxtech Co.,Ltd.

12

company profile

Biotoxtech is a life science company and a Contract ResearchOrganization(CRO) that primarily conducts compliance studies forproduct safety.Headquartered in Ochang, Korea, biotoxtech owns and operates a146,300 sq. ft. facility. With 10 years of industry experience,Biotoxtech conducts compliance safety testing and researchfollowing Good Laboratory Practices (GLP).

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 9: 2009 korea lifescience resource_guidebook2009

address 3F 333-1, Sangdaewon-Dong, Jungwon-Gu, Seongnam-Si, Gyeonggi-Do, KOREA, 462-807

website www.chemizon.com

tel +82-31-777-7800 fax +82-31-777-7898

contact Seoyoung Yang

e-mail [email protected] start-up year 2005

CEO Anthony D. Piscopio employees 200

company name Chemizon - A division ofOptomagic Co., Ltd.

15

company profile

Chemizon is a collaborative drug discovery services organizationwith operations in South Korea, China and the United States. Ourgoal is to become the ‘partner of choice’ for Pharmaceutical andBiotech companies around the globe, that seek to cost effectivelyenhance their internal pipelines. Our experienced, repatriatedmanagement team and skilled scientists leverage a fully integratedplatform that includes medicinal chemistry, computationalchemistry/structural biology, discovery biology, ADME/DMPK andpharmacology, to help our partners discover novel small moleculesin the disease areas of oncology, metabolic disorders and CNS. Formore information on Chemizon, please visit our web site atwww.chemizon.com.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 2/FI, Yiyangwon BD, 63-7 Gyeongun-dong, Jongno-gu, Seoul 110-310Korea

website www.cnrres.co.kr

tel +82(0)2 6251 1500~3 fax +82(0)2 6251 1504

contact ByungIn Yoon

e-mail [email protected] start-up year 1997

CEO MoonTae Yoon employees

company name C&R Research Inc.

14

company profile

C&R Research, the first CRO in Korea established in 1997 andawarded the Korean CRO of the Year 2008 from Frost & Sullivan,has seen phenomenal growth since its foundation, with highlyqualified staff with international and domestic experience over 300clinical trials from around 80 customers in the pharmaceutical.biotech and medical device industries. We work to ensure ourclients meet their project obligations in a timely manner and withinestablished quality standards. Our large footprint and strongrelationships allows to rapidly initiate, manage and deliver researchresults. Particular experiences and expertise can be offered in thefollowing indications: Oncology, Cell therapy, Gastroenterology,Endocrinology, Cardiovascular Urology, Nephrology, Gynecology,Dermatology, Antiallergics, NeurologyImmunology, Device, Anti-infectives, Psychiatry, Respiratory

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 10: 2009 korea lifescience resource_guidebook2009

address 634-18, Geumam-dong, Deokjin-gu, Jeonju, 561-712, Republic of Korea

website http://www.jbctc.co.kr

tel +82-63-250-2345 fax +82-63-250-2349

contact Ji-Young Jeon, Pharmacist

e-mail [email protected] start-up year 2005

CEO Soo-Wan Chae, M.D.,Ph.D. employees 32

company name Chonbuk National University HospitalClinical Trial Center (CNUH CTC)

17

company profile

With our Clinical Trial Center as your partner, there are potentialbenefits, which are the evidence-based clinical trial design forinnovative discoveries. We offer a full array of services in all Phasesstudies on innovative discoveries. With these services, we can supportyou at every step along your study’s path to help you make the newmedicines that let us live longer and stay healthier than ever before.Yet beyond our extensive expertise, our time-proven processes, andour highly trained staff, we offer another advantage others cannot-thecommitment to intelligently apply our collective resources to ensurethat your study progresses quickly, seamlessly, and successfully. Inaddition, our proven strategies and techniques will not only help you torecruit participants. No other research organization equals ourknowledge, our capacity, or our commitment to your success. We’llalso save you a significant amount of time and money.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address Gyeonggi Bio Research Center (Headquarter) 11F, Gyeonggi BioCenter,864-1, Iui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, S.KoreaYangji Preclinical Research Center 334,Jeil-Ri, Yangji-Myeon,Cheoin-Gu, Yongin-Si, Gyeonggi-Do, S.Korea

website www.chemon.co.kr

tel +82-31-888-6633~6 +82-31-329-9900

fax +82-31-888-6640 +82-31-329-9901

contact +82-31-888-6634

e-mail [email protected] start-up year 2000

CEO Cheolseung Peck employees 80

company name Chemon co.,Ltd

16

company profileChemon is the first established GLP CRO company that secured compatibleabilities along with research staffs in Korea. Chemon’s GLP system hasbeen certified by KFDA, NIER and RDA. With many experts in diverse fields,we now are engaged in the test and analysis of drug effect along with toxicitytest. In cooperation with business partners, we provide distinctive and one-stop service including clinical research, agency work for diverse approvals,development and commercialization of new compounds, and so on.Chemon management and research team has developed strong position inthe field of toxicity, efficacy, BE test, in-vivo pharmacological screening, etc. Toxicity test -General toxicity, Reproductive toxicity, Genetic toxicity,

Antigenicity, Local toxicity, Carcinogenicity, etc.Efficacy test -Anti-cancer, Diabetes, Arthritis, Gastric Ulcer, Hair Growth,

Liver Function, Osteoprosis, Obesity, Dementia, Immunity

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Gyeonggi Bio Research Center

Yangji Preclinical Research Center

Gyeonggi Bio Research Center

Yangji Preclinical Research Center

Page 11: 2009 korea lifescience resource_guidebook2009

address 33 Munhwa-ro, Jung-gu, Daejeon, 301-721, Korea

website www.cnuh.co.kr/ctc/

tel +82-42-280-8700~1 fax +82-42-280-8726

contact Sun-Kyung Jung

e-mail [email protected] start-up year 2008

CEO Won-Hyung Lee employees 16

19

company profile

Chungnam National University Hospital Clinical TrialsCenter(CNUH CTC) was established in January 2008 to implementeffective clinical trials. We will provide a resource and assistancefor investigators and their staffs. Our mission is dedicated toenhance ethical and professional service in clinical trails,ultimately, this will contribute to human happiness.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 671 Jebongno, Donggu, Gwangju, Korea (501-757)

website http://www.cnuhctc.com

tel +82-62-220-5231~2 fax +82-62-225-9400

contact Geun-seong Lim

e-mail [email protected] start-up year 2002

CEO Jin-Sang Yoon employees 25

company name Chonnam National UniversityHospital Clinical Trial Center

18

company profile

CNUH CTC implements ethical and scientific clinical trials inaccordance with the guidelines of ICH-GCP and KGCP, andsupports clinical research activities by providing the bestenvironment. Researchers at Chonnam National UniversityHospital have been playing a leading role in conducting ethical andscientific clinical trials based on the spirit of ‘respect for life’ thathas been honored for the past 100 years, as well as their diverseeducational background and experience in the field of clinicalresearch.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name Chungnam National UniversityHospital Clinical Trials Center

Page 12: 2009 korea lifescience resource_guidebook2009

address 505 Banpo-Dong, Seocho-Gu, 137-701, Seoul, Korea

website http://cmccrcc.catholic.ac.kr

tel 82-2-2258-7854 fax 82-2-2258-7859

contact Eunkyong, Cheong

e-mail [email protected] start-up year 2004

CEO Kim. Kyung Soo employees 10

21

company profileWelcome to Clinical Research Coordinating center of Catholic MedicalCenter[CMC CRCC] !The mission of CMC CRCC is to provide an outstanding environmentthat will help CMC investigators conduct clinical researches of thehighest quality that are safe, efficient, and ethical through cooperationwith industry, academia and other research institutions. The CMC CRCC operates to foster multi-institutional clinical researchthrough the development, management, and reporting of clinical trialsas a coordinating center for the CMC affiliated general hospitals. Clinicalresearch related services provided by CMC CRCC are as follows:* Study design, development, implementation and enforcement of the

study protocol and manual of operations * Pharmacokinetics and pharmacodynamics modeling & simulation* Project management, data and safety monitoring, and quality assurance* statistical analysis and interpretation and dissemination of results* Education and training for clinical research investigators and coordinators

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 101 Daehak-Ro, Jongno-Gu, Seoul, 110-744, Korea

website http://ctc.snuh.org

tel 82-2-2072-1675 fax 82-2-3675-8334

contact Mr.Hyung-Rak Song

e-mail [email protected] start-up year 1995

CEO Dr.Kyung-Up Min employees 33

20

company profile

Clinical Trials Center, Seoul National University Hospital, wasestablished in 1995 and has supported many clinical trials. Withexcellent clinical researchers and research capabilities, CTC iscontinously enhancing ethical and scientific achievements inclinical research and implementing efficient clinical trial systemsby providing a state-of-the-art research environment.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name Clinical Trials Center, SeoulNational University Hospital

company name CMC Clinical ResearchCoordinating Center

Page 13: 2009 korea lifescience resource_guidebook2009

address 3-1Ga, Dongdaeshin-dong, Seo-gu, Busan 602-714, Korea

website none

tel +(82-51) 240-2611 fax + (82-51) 257-2616

contact YunYoung, Heo

e-mail [email protected] start-up year 2004

CEO MooHyun, Kim employees 14

23

company profile

Our Clinical Research Center gained approval of the “Phase1Clinical Medical Center” in 2003, which built infrastructure inaccordance with GCP principle, put forth our whole energy tosupport clinical research affairs in Busan, especially, we areestablished through cerebro-cardiac vascular disease relatedclinical research.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 3rd Fl, VICHEN CITY Bldg. Sungsan-dong 591-4, Mapo-gu, Seoul, Korea(121-850)

website www.dnalink.com

tel +82-2-3153-1500 fax +82-2-364-4778

contact Sujin Kim

e-mail [email protected] start-up year 2000

CEO Jong-eun Lee, Ph.D. employees 29

company name DNA Link, Inc.

22

company profile

DNA Link, Inc. is the Total Solution Provider of Genomic Research,from consulting project to statistic anlysis of huge data. We haveretained most updated platform, skillful technicians with over 10year experience and best bioinformaticians. DNA Link, Inc. has certified ISO9001 and approved as the Certifiedservice provider of Affymetrix, Agilent, RocheNimbleGen based onthe high quality performance.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name Dong-A University Hospital Clinical Research Center

Page 14: 2009 korea lifescience resource_guidebook2009

address Venture Bldg. 306 Pohang TechnoPark Pohang, Kyungbuk, 790-834, Korea

website www.genomine.com

tel +82-54-223-2461 fax +82-54-223-2460

contact Yong Suk Joh

e-mail [email protected] start-up year 1999

CEO Kyung-Mok Park employees 13

company name GENOMINE, INC.

25

company profile

Genomine has leading edge technology in discovering plant genes.We strive for mining of essential and novel plant genes in a large-scale and understanding of their function using plant functionalgenomics and proteomics approach.We have been successful in identifying the regulatory genes ofhigher plants involved in the circadian rhythms, yield increment,dwarfism and salt tolerance. And we are also working on Products & Services as follows.1) Plant transformation and Herbicide screening system 2) Proteomic Services(2DE, MS, Phospho protein analysis,

Glycoprotein analysis)3) Phospho Protein enrichment Kit 4) Phospho Peptide enrichment Kit

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 1010 Jeokseon-Hyundai Building, 80 Jeokseon-dong, Jongno-gu, Seoul

website http://www.dreamcis.com/new/eng/main/main.php

tel +82-2-2010-4500 fax +82-2-2010-4593

contact Joon-Young Lee

e-mail [email protected] start-up year 2000

CEO Won-Jung Choi employees 110

company name DramCIS Inc.

24

company profile

DreamCIS is a full service contract research organization(CRO) thatoffers services to the pharmaceutical companies, bioventures,medical device manufacturers and functional food producers.DreamCIS provides clinical trial services for a broad and detailedrange of therapeutic area in accordance with the standardoperating procedures consistent with both Korean regulations andglobal standards including ICH-GCP guidelines.Our key service areas include clinical trials, PVPMS, QA audit, datamanagement and biostatistical analysis and health fucntional foodstrials.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 15: 2009 korea lifescience resource_guidebook2009

address Jeongseok Bldg. 7-241 Shinheung-dong 3ga Jung-gu, Incheon ,400-712 Korea

website http://www.inhactc.com

tel +82-32-890-1103 fax +82-32-890-1120

contact Kim Eun Gyung

e-mail [email protected] start-up year 2008

CEO Nam moon suk employees 25

27

company profile

INHA-CTC was designated for Regional Clinical Trial Center by theKorean Ministry for Health, Welfare and Family Affairs in 2008.By building up the advanced and specialized infrastructure, INHA-CTC will be one of the major Clinical Trial Centers with internationalcompetitiveness. We will make our efforts to accomplish thebusiness model to create added values.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address Kyung-hee Clinical Trial Center, Kyung-hee Univ. Medical Center,Hoegi-dong Dongdaemun-gu, Seoul, KOREA

website www.hubertbio.com

tel +82-2-966-1120 fax +82-2-966-1132

contact Ju Hee, Kim

e-mail [email protected] start-up year 2007

CEO Il Su, Yuk employees 12

company name Hubertbio

26

company profile

Hubertbio is a leading CRO’s in Korea, mainly forcused on bioequivalencestudy in human. We perforrm all of the procedures in compliance withthe “Bioequivalence Test Guideline”(No. 2008-22 of the KFDA).Bioequivalence study means an in vivo study to verify the statisticalequivalence in bioavailability between two drugs with the sameactive ingredient and route of administration that are absorbed intothe systemic circulation and became available at the site of action.We can provide a practiced and professional consultation about drugdevelopment procedures in especially bioequivalence study. That isbecause we have lots of experiences and specialists in related fields,latest equipments and partnership with trustworthy institutions.But most of all, we always move toward win-win situation.We ensure that we will be your trusty companion. For more informations, please visit our website www.hubertbio.com.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name INHA University Hospital Clinical Trial Center

Page 16: 2009 korea lifescience resource_guidebook2009

address Inje University College of Medicine, Gaegeum2-dong, BusanJin-gu,Busan City, 614-735 South Korea

website http://pgrc.inje.ac.kr

tel +82-51-890-6415 fax +82-51-893-1232

contact Seok-Ki Lee

e-mail [email protected] start-up year 2003

CEO Director: Jae-Gook Shin, M.D., Ph.D. employees 60

29

company profile

PGRC is highly recognized as a top frontier research institute in thefield of PGx and personalized pharmacotherapy worldwide. PGRCResearchers are currently involved in various projects funded bygovernment and pharmaceutical industries, covering drugmetabolism and transport, personalized medicine, genotyping chipdevelopment, drug interactions, and biomarker discovery.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address BusanPaik Hospital, Gaegeum-dong, BusanJin-gu, Busan City, 614-735 South Korea

website www.paikctc.ac.kr

tel +82-51-890-6436~7 fax +82-58-891-6438

contact Eunyoung Yu / Inhe Hwang start-up year 1996

e-mail [email protected] / [email protected]

CEO Director: Jae-Gook Shin, MD, PhD employees 63

company name Inje University BusanPaikHospital Clinical Trial Center

28

company profile

The highest recognized, experienced clinical trial center in theSouth East Region of Korea(Busan, Kyungnam province) with8million population, the center provides all phase trials sponsoredor investigator initiated which was supported by state of the artfacilities, experienced staff, global accredited IRB, and high topCore laboratory processing system.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name Inje University PharmacoGenomics Research Center

Page 17: 2009 korea lifescience resource_guidebook2009

address 101 Daehakno, Chongno-gu,Seoul 110-799, Korea

website www.konect.or.kr

tel +82-2-3668-7609 fax +82-2-3675-4777

contact Ms Min Young KIM, External Affairs Manager

e-mail [email protected] start-up year 2007

CEO Sang Goo Shin employees 10

company name Korea National Enterprise for Clinical Trials.

31

company profile

Korea National Enterprise for Clinical Trials is the organizationendorsed by the Ministry of Health Welfare and Family Affairs andin collaboration with the Korea Food and Drug Administration tobuild up clinical trials infrastructure. KoNECT supervises andcoordinates a network of 14 Regional Clinical Trial Centers;develops and operates training programs for trial specialists andsupports and guides new development of technology in an effort tomaximize impact and dynamize synergy among infrastructure,human resources, and technology. Korea, the hub of global clinical trials. KoNECT, a global contributorto world healthcare.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address P.O. Box123, 19 Shinseongro, Yuseong, Daejeon, 305-600, KOREA

website www.kitox.re.kr

tel +82-42-610-8105 fax +82-42-610-8085

contact Vince Rubino([email protected])

e-mail [email protected] start-up year 2002

CEO Myung-Sang Kwon employees 240

company name Korea Institute of Toxicology

30

company profile

Korea Institute of Toxicology (KIT) is a world-class prestigious non-clinical contract research organization. We perform non-humanprimates toxicology test as well as carcinogenicity, reproductivetoxicology test in accordance with FDA, OECD guidelines. SecondCampus in Jeongeup will be constructed at 2010.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 18: 2009 korea lifescience resource_guidebook2009

address 88-2, Yeongdeungpo-dong 8 ga, Yeongdeungpo-gu, Seoul, 150-038Republic of Korea

website www.KTR.or.kr

tel +82 (0) 2-2164-0023~4 fax +82 (0) 2-2634-0016

contact Chung-hyup Lee, Yousun Ha

e-mail [email protected], and [email protected] start-up year 1969

CEO Kisung Cho, President employees 350~400

company name Korea Testing and Research Institute

33

company profile

Throughout testing, certifying, technology consulting andresearching, KTR helps industries ranging from chemicals,pharmaceuticals, metalworking, automotive to shipbuilding.KTR, as a certified GLP inspection institute with qualified experts, iscapable of simultaneously operating assessment and analysis onpreclinical trials, efficacy testing, environmental toxicology testingand medical device evaluation under GLP quidelines of whichstandard is acknowledged by OECD member countriescorresponding to the Safety inspection Data of EU’s REACH andGHS.KTR promises to advance one and all’s future with greater securityand extra comfort founded upon its high-precision technology,ceaseless endeavor and solid loyalty.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 538-12, jeopji-ri, lbam-myeon, jeongup-si, jeollabuk-do, korea

website www.koreastevia.com

tel +82-63-534-0333 fax +82-63-534-0222

contact JEONG ILL HWAN

e-mail [email protected] start-up year 2001

CEO JEONG ILL HWAN employees 50

company name KOREASTEVIA CO.,LTD

32

company profile

Koreastevia Co.,Ltd is using stevia which is herbal plant that havehigh sugar content, low-calorie, antioxidation that have an uniquespecial permission manufacture technology. Also, various effect receives proof and produce and export organicresources, feedstuff, food and sugar principal parts sweeteningmaterials, cosmetics, medicine raw material etc. is bio-venturebusiness.Spur more in current R&D will become international enterprisewhich is ‘The good company which responsibility exists to natureand mankind after 30 years’

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 19: 2009 korea lifescience resource_guidebook2009

address 200 Dongduk-Ro, Jung-gu, Daegu, 700-721, Korea

website http://ctc.knu.ac.kr

tel +82-53-420-6355,6(Adm Office) / +82-53-420-6941~7(CRU)

+82-53-420-5443(LAB) fax +82-53-420-5218

contact Jong Ha Kim

e-mail [email protected] start-up year 2005

CEO Sung Kyoo Hwang employees 34

35

company profile

Kyungpook National University Hospital Clinical Trial Center(KNUH CTC) wasestablished as a regional clinical trial center and certified by The Ministry of Health andWelfare, Korea in 2005. Since its inception, our center has offered a wide range ofservices for Phase I~IV Clinical trials. KNUH CTC is a complete service clinical trialfacility with 32 full-size research beds equipped with central monitoring unit, loungefor subjects and GLP-compliant bioanalytical laboratories. KNUH CTC provides aspecialized service for pharmaceutical product development and clinical managementfor domestic and global I~IV clinical trials. For the state of the art clinical trials, we arestaffed with highly trained and dedicated professional research personnel. Ourresearch team provides operational excellence through timely and precise clinicaldata which will help you make effective decisions about the safety and efficacy of yourcompound. All clinical trials are performed by ICH-GCP and Korean GCP guidelines.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 126-1, Anam-Dong, 5-Ga, Seongguk-Gu, Seoul 136-705

website http://ctc.kumc.or.kr

tel +82 2 920-6566 / 6466 fax +82 2 920- 6465

contact Young Hye, Kim start-up year 2003

e-mail [email protected] employees 14

CEO In, Kwang Ho Director of Clinical Trial Center

34

company profile

Korea University Anam Hospital is one of the largest medicalcenters in Korea, which has 950 beds. Korea University Anam Hospital Clinical Trial Center has beenoperated from September, 2003.The goal of Korea University Anam Hospital Clinical Trial Center isto establish the CTC as a role of supervision, research andeducation, and to be specialized for the late clinical trials ofenvironmental and metabolic diseases and early clinical trials ofhematologic and circulatory diseases.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name Korea University Anam HospitalClinical Trial Center

company name Kyungpook National UniversityHospital Clinical Trial Center

Page 20: 2009 korea lifescience resource_guidebook2009

address 1026-1 Yulbuk, Chung buk, Pyoungtaik, Gyounggi, Korea

website www.SPFPIG.com

tel +82-31-683-0643 fax +82-31-683-0647

contact Michael Kim

e-mail [email protected] start-up year 2000

CEO Michael J. Kim employees 30

company name Medi Kinetics Co., Ltd.

37

company profile

Non Clinical CRO service provider dealing with large sized animalespecially mini pigs. We provide PK, Medical Device Testing,Toxicology and Pharmacology study service.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address Pyeonghwan Bldg. 5F. 6F, 1579-6 Seocho-dong, Seocho-gu, Seoul 137-875 Korea

website www.lskglobal.com

tel +82-2-546-1008 fax +82-2-584-9008

contact Oh, Kyu Ho / Business Development Director

e-mail [email protected] start-up year 2000

CEO Lee Young Jack employees 75

36

company profile

Leading Clinical Trials in KoreaLSK Global Pharma Services Co., Ltd((LSK in short) originates from Westat-Korea, a US corporate, which opened its Korean branch on March 2,2000.Stat-Korea was incorporated as a Korean corporate in 2001, and tookover the Korean branch of Westat-Korea. It changed its name to Lifecord Stat-Korea, after business merger with Lifecord, and changed its CI to LSK in 2007.Since its establishment in 2000, LSK has been growing very rapidly. LSK hasbeen seeking clinical trial projects from global sponsors as well as workingwith domestic sponsors doing clinical projects abroad from the beginning. Ithas been audited numerous times for qualification by a number of globalCROs(Contract Research Organizations) and pharmaceutical companies. LSKis globally recognized, and its trials meet the standard of US and Europeanregulatory agencies.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name LSK Global Pharma Services Co., Ltd

Page 21: 2009 korea lifescience resource_guidebook2009

address #603-1 B-dong, Bundang Technopark, 148 Yatap-dong, Bundang-gu,Seongnam-si, Gyeonggi-do, 463-760, Korea

website http://www.qubest.co.kr

tel +82-31-706-2995 fax +82-31-706-2996

contact Jonghwa Go (General manager)

e-mail [email protected] start-up year 2008

CEO Soohyeon Kim employees 3

company name Qu-BEST Consulting Co., Ltd.

39

company profile

Qu-BEST Consulting specializes in contract research, projectmanagement and expert consultancy for the registration of NCEs,biopharmaceuticals, functional food, agrochemicals, veterinarymedicine and industrial chemicals, and consist of specialists formore than 10 years with specialized knowledge and relatedindustrial experiences. We basically collaborate in partnership withour clients and is not your ordinary contract research organization.We provide high quality outsourcing services with optimaldevelopment plan, cost-effective and in compliance withinternational guidelines.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 1F, 152-1 Bundang-dong Bundang-gu, Seongnam-si,463-030, KOREA

website www.PharmaCRO.co.kr

tel +82-31-707-1139~40 fax +82-31-707-1180

contact James Kim

e-mail [email protected] start-up year 2008

CEO James Kim employees 7

company name PharmaCRO

38

company profile

Clinical trials are one of the most important parts of the drug development processand also one of the most time-consuming processes. A Contract ResearchOrganization(CRO) is a service organization that provides support to thepharmaceutical, nutraceutical, biotech industry. PharmaCRO is leading clinicalCROs in Korea that provide a full range of clinical development services and conductresearch in Asian countries and approximately 15 clinical trials are conducted inKorea each year sponsored by both industry and government. The industry hasevolved from providing primarily clinical services or single- service support in clinicalmonitoring and data management to a full-service industry offering services fromthe earliest stages of development through clinical trials and commercialization ofproducts. We provide a wide range of clinical development services to researchsponsors, including consultation with study design, investigator recruitment, studymonitoring, data analysis, and IND/IRB/NDA documentation works. For moredetails, please visit our website www.PharmaCRO.co.kr

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 22: 2009 korea lifescience resource_guidebook2009

address Central Lab.; 5F, Venture Bldg., 76-6, Hannam-dong, Yongsan-gu,Seoul 140-886, Korea

website http://www.scllab.co.kr

tel Headquaters; +82-2-790-6500, Central Lab.; +82-2-790-6011(ext.670)fax Headquaters; +82-2-790-6509, Central Lab.; +82-2-790-6846

contact Young Ja Lee (Chief Manager)

e-mail [email protected] start-up year 1983

CEO Kyoung-Ryul Lee, M.D., Ph.D employees 400

41

company profile

SCL has led the medical diagnostic industry for 26 years with itsfundamental values of Service, Quality and Research. SCL,thereafter, established in 1983 as the pioneer reference laboratorywas a first company here to be named as an officially CAPaccredited facilities in 1997 in Korea. We started central laboratoryservices, a part of CRO business, from 2005 based on wideexperiences in laboratory medicine field. Further, we contractedservice agreement with MCM clinical trial division of MitsubishiChemical for asia-pacific global market. SCL C-lab will furtherexpand its CRO business to fulfill the unmet needs of thepharmaceutical industry.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 50, Irwon-Dong, Gangnam-Gu,Seoul,Korea 135-710

website http://ctc.samsunghosital.com

tel +82-2-3410-3695,3698 fax +82-2-3410-3699

contact Sung Hoon Jung

e-mail [email protected] start-up year 1999

CEO Han Yong Choi employees 115

40

company profile

The Samsung Medical Center Clinical Trial Center was establishedin Jan. 1999 to support the development of clinical research byproviding optimum research environment which enablessystematic accomplishment of research activities. As the PrincipleInvestigator friendly Core Center, our center will continuously striveto strive to be equipped with optimum clinical research environmentto provide customized research support.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name Samsung Medical CenterClinical Trial Center

company name Seoul Clinical Laboratories(SCL),Central laboratory Services

Page 23: 2009 korea lifescience resource_guidebook2009

address A-8F 906-5 Advanced Institte of Convergence Technolog, Iui-dong,Youngtong-gu, Suwon city, Gyeonggi-do, Korea

website www.solomonmed.com

tel +82-31-888-9250 fax +82-31-888-9259

contact Jihye Choi

e-mail [email protected] start-up year 2001

CEO James Kim employees 12

company name Solomon Medical Research, Inc.

43

company profile

Solomon Medical Research(SMR)’s expertise in drug developmentbegins with Phase I trials through to Phase IV. SMR has worldwidefull-service capabilities, including Clinical Trial Management, DataManagement, Biostastical Analysis, Site Selection and RegulatoryAffairs. SMR’s staffs comprise of personnels with a wealth ofexperience in clinical trials for approval in the local market.These highly trained and dedicated teams perform all-phaseclinical trials(Phase I, II, III and bridge trials) designed to obtainapproval, and post-marketing clinical trials.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 3F, Daerung Techno Town ?327-32, Gasan-dong, Geumcheon-gu,Seoul, Korea

website www.splab.co.kr

tel +82-2-866-5533 fax +82-2-868-5511

contact Bosung Ko

e-mail [email protected] start-up year 2005

CEO Hohyun Kim employees 40

company name Seoul Pharma Laboratories, Inc.

42

company profile

Seoul Pharma Laboratories(SPL) is a GLP-compliant drugdevelopment partner focusing on responsiveness anduncompromised quality. Core capabilities include PK/TK analysis,Bioequivalence Test and Peptide Sequencing based on cutting edgeinstrumentation such as UPLC, LC/MS/MS and Tof-MS.As a leading CRO services provider in Korea, SPL has numerousexperiences of supporting our clients with individually tailored andinnovative analytical methods. Most importantly, dedicated SPLemployees are committed to deliver scientific excellence andtimeliness together to every project as promised.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 24: 2009 korea lifescience resource_guidebook2009

address 1102-3 Happy World Dept. 917-6 Mok-dong, Yangchun-gu, Seoul, Korea

website www.yebt.co.kr

tel +82-2-747-9328 fax +82-2-747-9329

contact Boram Jung

e-mail [email protected] start-up year 2006

CEO Byoung Don Han employees 5

company name YeBT

45

company profile

YeBT has developed several diagnostic techniques for nucelic acidamplified test (NAT). The rapid growth of the knowledge in OMICSchanges the basic paradigm of molecular diagnosis. Moleculardiagnosis with array system is the first priority in YeBT researchand development. The current study of molecular diagnosis includes genetranslocations, identifying the Single Nucleotide Polymorphism,virus genotyping, differential expression patterns of biomarkers.Liquid bead array and microarray are employed for these projects. Innovational technologies are developed for molecular diagnosis.TotalPlex gene amplification, high yield labeling method are primeexamples. We believe their influences on molecular diagnosis willbe tremendous.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address #621, DMC Hi-tech Industry Center, 1580, Sangam-dong, Mapo-gu,Seoul, 121-270, Korea

website www.worldcourier.com

tel +82-2-6335-8538 fax +82-2-6335-8539

contact Ms. Hee-Yang(Linda) Kim

e-mail [email protected] start-up year 2003

CEO Wayne Heyland employees 18

company name World Courier Korea Co.,Ltd

44

company profile

Established in 1969, World Courier is the global leader in thetransportation of clinical samples, investigational drugs and clinicaltrial supplies, Infectious substances for the pharmaceuticalindustry, with over 35years of experience in the handling of time-critical and temperature controlled shipments. We have handledthe logistics for thousands of clinical trials worldwide, weunderstand intimately your timeline and demanding supply chainrequirements. World Courier has wholly owned global networkover 140 offices, 2,500 employees throughout the world.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

Page 25: 2009 korea lifescience resource_guidebook2009

address 11F Byucksan Digital Valley 5th Gasan-dong, Guemcheon-gu Seoul153-788 KOREA

website http://www.abfrontier.com/

tel +82-2-2140-3399 fax +82-2-2140-3320

contact WOON JAE JUNG

e-mail [email protected] start-up year 1994

CEO Jong Seo Lee employees 82

company name Young In Frontier Co., Ltd.

47

company profile

Young In Frontier Co., Ltd. is a leading antibody supplier in Korea interms not only of catalog & custom antibody, protein relatedproducts and ELISA kits manufactured by our research center butalso in catering to the requirements of the researcher, doctors andclinicians. This differentiates our organization from otherdistributors and companies. Also we have been registered intoKOSDAQ (Korean Stock Market) since 1994 and # 1 AntibodyCompany in Korea. In addition, we have served 6,000 antibody casesper year for HUPO Global ‘Human Protein Atlas’ as the largestantibody project in the world since 2006 until 2014.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

address 250, Seongsanro, Seodaemungu, Seoul, Republic of Korea (ZIP:120-752)

website sev.iseverance.com/ctc

tel +82-2-2228-0500 fax +82-2-392-0668

contact JANG, Seokjin

e-mail [email protected] start-up year

CEO Dr. PARK Minsoo employees 40

46

company profile

The clinical trials center of Severance Hospital, Yonsei University Health System has beenplaying a pivotal role in clinical development of new drugs for domestic and multinationalpharmaceutical companies. As a part of Severance Hospital, we carry the same value and highquality in clinical drug development as the hospital itself has its reputation in clinical practice,research and patient care. Our primary concern and goal in conducting trials is to protect therights, safety and welfare of human subjects participating in studies. Based on internationalmedical care standards, numerous clinical investigators in the hospital and pharmacologists atour center have closely collaborated for studies and care for participants. We provide servicesthroughout the whole process of clinical drug development such as planning and designing ofstudies as well as analyzing and reporting of results. The center probably has the bestenvironment and technologies in Korea for early stage clinical trials as well as bioequivalencestudies. Especially, the 55 bed research ward is the biggest ward exclusively reserved for clinicalstudies in Korea. For clinical trials in later stages, we do our best to assist the trials through ouractive supporting system and prompt and clear administrative services. We are constantlystriving to become the best clinical trials center in Asia.

business category

contract research contract manufacturing

contract development clinical research

support services non clinical

formulation development organization

company name Yonsei University Health SystemClinical Trials Center

Page 26: 2009 korea lifescience resource_guidebook2009