South Korea: Clinical Development Country Profile

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South Korea: Clinical Development Country Profile

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?2013 Industry Standard Research



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Report Overview

In this report, ISR provides insight into the clinical development environment, sponsor and service provider activities, and population "health status" for South Korea.

109 Pages

76

Charts and Graphs

Q2, 2013

Publication Date

Valuable for:

? Clinical Operations ? Medical Directors ? C-Suite ? Portfolio Management

Major Sections:

1. Introduction 2. Industry Interviews 3. Korea Health Statistics 4. Healthcare Technology and Medication Use 5. Service Provider Capabilities 6. Domestic Clinical Service Providers 7. Domestic Non-Clinical Service Providers

How you can use this report:

? Understand how sponsors and CROs view South Korea as a site for clinical trials ? Uncover logistical details for conducting South Korean trials ? Illustrate the benefits and drawbacks of conducting trials in South Korea ? Learn how South Korea compares to other countries on a variety of scales so the reader can best consider the areas

in which South Korea may be beneficial as a trial site for their particular company

What you will learn in this report:

? How population characteristics, qualified investigators, and government policies and incentives make South Korea the 8th most active and most valuable country for clinical trial activity

? On-the-ground insights from numerous high-level R&D employees in sponsor organizations and country heads from multinational CROs

? Health statistics in Korea, including disease incidence and prevalence, use of imaging technologies, and use of medicines in major therapy areas

? Contact details for pharma companies and principal investigators in South Korea

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Table of Contents

Copyright and Usage Guidelines Methodology Introduction

South Korea Background Population Health Care Expenditures Therapeutic Areas Market Landscape Insurance & Reimbursement Korean Investigator Capabilities

Industry Interviews Sponsor Interviews Global Head of Clinical Operations at Top 5 European Pharma Company Vice President and Head of Clinical Development at Top 50 Pharma Company CRO Interviews Quintiles ICON INC Research

Korea Health Statistics Health Status Summary Causes of death Cancer incidence Female breast cancer incidence Male prostate cancer incidence Diabetes prevalence AIDS & HIV incidence & prevalence Tuberculosis incidence & prevalence Dementia prevelance

Health Care Technology and Medication Use CT scanners CT exams MRI units MRI exams Antibiotic consumption Anti-cholesterols consumption Antidepressants consumption Anti-diabetics consumption Anti-diabetics consumption

Health Expenditure and Financing Expenditure on pharmaceuticals per capita Out-of-pocket expenditure Growth in real per capita pharmaceutical expenditures

Service Provider Capabilities Domestic Clinical Service Providers

Applied Biopharm Inc. Background / History Services Offered

C&R Research Background / History Master Agreement & Preferred Vendor Corporate Structure Services Offered Therapeutic Areas Press Releases

DreamCIS Inc. Background / History

Master Agreement & Preferred Vendor Corporate Structure Services Offered Therapeutic Areas Press Releases GDFI Co., Ltd. Background / History Corporate Structure Services Offered LSK Global PS Background / History Master Agreement & Preferred Vendor Corporate Structure Services Offered Therapeutic Areas Press Releases Medical Excellence Inc. (MediCROStar) Background/History Corporate Structure Services offered Therapeutic Areas Press releases Orient Bio Background / History Services Offered Financials Press Releases PharmaCRO Background / History Services Offered Therapeutic Areas Domestic Non-Clinical Service Providers Bio-Core Co., Ltd. Background / History Corporate Structure Services Offered Press Releases Biotoxtech Background / History GLP Certification Corporate Structure Services Offered Financials Chemon Inc. Background / History GLP Certification Services Offered Press Releases Korean Institute of Toxicology (KIT) Background / History GLP Certification Services Offered Domestic Service Provider Contact Summary International CRO List and Contact Details Domestic Pharma Company List and R&D Expenditure International Pharma Company List and Locations Clinical Investigator List and Contact Details About ISR

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Sample Page

Introduction

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participate is one thing, keeping them enrolled is another. Finding them with thMeosrteiqmupiascittefuml EeDdCicparotidouncthaitsttroibruyte(os rfolratcrkialthsuecrceeosfs) is challenging. Competing w"hFiatoshroeonatcyhhoeuorrfsatphbeoilitnEyDstoCorspuorocrcdCeuscRstfOuatlltcyriobrumuntepasacbnleinileoicswaal, tpdrlidealastshaeaditndudisitceioastneanahlEohDwuCmrdauplcephslicitmaotpiooancv.t"eeraccohme. O(Bvaeserc =o 1m00)in g all of these obstacles in a reasonable timeframe adds additional pressure. So it is no wonder sponsor and CRO organizations are expanding gOlof tbhae l lliyst toof anttoribtuotensl pyrofivniddedp, raetsipeonntdsenftos r incdlicinatiec tahlattr "itaelcsh,nbicualt suaplspoortt"o ancdo "mintmegreartcioina lize thcpaeeprifarobrpimlirtaioensdc"eu h. c adts le. ss of an impact on running clinical trial when compared to the software

This is where South Korea comes into play.

No impact Slight impact Moderate impact High impact

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clinical development activities.

The process for dealing with queries 4% 11%

39%

46%

Technical support from the vendor 5% 14%

Integra[on capabili[es with other 5% 20% applica[ons (ePRO, IVR)

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50%

40%

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25%

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Sample Page

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The regulatory requirements in Korea are similar to ICH countries. The Korean Food and Drug Administration (KFDA), which is reportedly soon to become the Ministry of Drug and Food Safety (MDFS), will have greater powers to initiate legislation and deal with food and drug safety issues. Reviews by the MDFS and Institutional Review Board (IRB) can be done in parallel which helps to expedite the process.

IND & IRB process in Korea

IND to KFDA

(e-submission)

Parallel Submission

IRBs 1-3 months

3-4 months

? Comment released at 30 WD after IND with 30 WD due date to treat comment.

? Due date can be extended up to 2 times (30 WD per one).

? Can import IP, CTM after IND approval.

Final Version/CTA

2-4 weeks

START!

1

Ms. Hyun predicts that Quintiles Korea will continue to see strong business growth over the next few years with an increasing number of clinical trials.

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Female breast cancer incidence

Age-standardized female breast cancer incidence rates of South Korea are well below the OECD average. South Korea reports a rate of 38.9 per 100,000 females while the OECD reports a rate of 71.6 per 100,000 females.

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Service Provider Capabilities Non-clNinoicna-lcCliRnOicasl CROs

AppliedApBpiolCipe&hdRaBrRmioeCpsI&nehcaRaDr.rcRmrheeasInemcaCDr.cIrSheGIanmDcF.CIICS oGIn.D,cLF.LtISdCK. oG.,loLLtbSdaK.Ml PGeSdloicbaalMlEPexSdcOeicrllaieelnnEctxeBcOeiIonrllicPee.hnnactreBmiIonaCcP.hRBaOirom-CaCoRreBOiCoBo-iC.o,oLtortedxt.CeBocih.oC, Lthotedxmt.eocnhCInhKceo.mreoanInIsnKtciot.ureteaoInfsTtoitxuitceoolofgTyoxicology

CliniCcalilnTicriaall Trial

PreclPinreiccalilnical

PhasPehIase I

PhasPehIIa-sIeII II-III

PhasPehIVase IV

PostPMoasrtkMetainrkgeting

Lab SLearbviSceersvices

BioanBaiolyasnisalysis

BioavBaioilaabvailiitlaybility

BioeBquioiveaqluenivcaelence

PharPmhaacromkainceotkicinetic

ToxicToolxoigcyology

ServiSceersvices

BiostBaitoissttiactsistics CliniCcalilnMicoanl Mitoorninitgoring DataDMaatanaMgaenmaegnetment

Drug Safety Drug Safety

Feasibility Studies Feasibility Studies

Medical Writing Medical Writing

PMS & Pharmacovigilance PMS & Pharmacovigilance Project Management Project Management Protocal Development Protocal Development Protocal/ CRF Review Protocal/ CRF Review

Site & Investigator Selection Site & Investigator Selection Study Design Study Design Regulatory A airs Regulatory A airs IRB IRB Global Studies Global Studies Quality Assurance Quality Assurance Consulting Consulting Training Training

Data available in full report

?2013 Industry Standard Research

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