Asia Pacific Clinical Trials

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1 Asia Pacific Clinical Trials ARCS Clinical IAC August

2 Global Drug Development Studies Commercial market potential Return on investment Speed to market potential Clinical trial capacity Patient availability Investigators & site availability Clinical trial capability Quality Ethics Regulatory environment Costs 2

3 Ref: Emerging Middle Class in Developing Countries March

4 Source: Applied Clinical Trials, August 2011, pages

5 Competitive Environment Map of All Studies in clinicaltrials.gov Data as of 5 October

6 Competitive Environment Industry Funded Studies 1 st Listed in Year Country Australia China Hong Kong India Japan Korea Malaysia Philippines Singapore Taiwan Thailand UK USA 3,279 3,192 3,456 4,082 2,946 2,455 2,730 Source: Clinicaltrials.gov; accessed 11 Oct

7 Clinical Trial Capacity Healthcare Professional Pool Number Annual Number of Medical Medical Schools Graduates Number of Physicians Percentage Physicians who are Specialists China ,577 1,507,032 61% Korea 41 3,816 88,214 69% Taiwan 11 1,336 34,864 70% Thailand 10 1,627 19,546 75% Ample Talent Pool Source:ESPICOM; China Education statistics (www. Stats.moe.edu.cn); Department of Statistics, Taiwan; Statistical Yearbook of Education, Ministry of Education and Human Resource Development, Korea; Report on Higher Education Public Institutions, Academic year 2002, Ministry of Education, Thailand 7

8 Clinical Trial Capacity Site Pool Concentration of sites in capital cities China - Beijing 26% - Shanghai 20% Korea - Seoul 51% Taiwan - Taipei 69% Thailand - Bangkok 69% Data

9 Clinical Trial Capacity - Patient Pool Mix of highly developed countries and developing countries Increasingly westernized lifestyle Increased prevalence of western disease High population density Site efficiency 9

10 Clinical Trial Capacity - Patient Pool Population (million) Asia 3,567 China (1) 1,343 India (2) 1,205 Indonesia (4) 249 Japan (10) 127 Philippines (12) 104 Vietnam (13) 92 USA (3) 314 World 7,022 Source: CIA The World Fact Book, Accessed 8 October

11 Clinical Trial Capacity - Patient Pool Accessible Patients (millions) COPD Diabetes Dyslipidemia China India Korea Philippines Taiwan Thailand data

12 Clinical Trial Capacity Patient Pool Limitations of developing Asian countries: Expensive biologicals may not be available or commonly used Standard therapy in the west may not be standard Placebo controlled studies where therapy is available 12

13 EC & Regulatory Overview China (~9 months) IRB: Local Regulatory authority: China Food and Drug Administration (CFDA). Hong Kong (~4-6 months) IRB clusters Regulatory authority: Hong Kong Department of Health (DOH) India (~5 months) IRB: Local or Central Regulatory authority: Drugs Controller General India (DCGI) 13

14 EC & Regulatory Overview (continued) Malaysia (~3-4 months) IRB: Government (MOH MREC) or Local Regulatory authority: National Pharmaceutical Control Bureau (NPCB) Ministry of Health (MOH) Philippines (~4-6 months) IRB: Local Regulatory authority: Food and Drug Administration of the Philippines Singapore (~5-6 months) IRB: Central or Domain Regulatory authority: Health Science Authority (HSA) 14

15 EC & Regulatory Overview (continued) South Korea (~4-5 months) IRB: Local Regulatory authority: Ministry of Food and Drug Safety (MFDS) Taiwan (~4-5 months) IRB: Local and/or Joint Regulatory authority: Department of Health (DOH) Thailand (~4-5 months) IRB: Local and/or central Regulatory authority: Thai Food and Drug Administration (TFDA) 15

16 Costs Investigators fees and grants generally significantly lower than US but increasing rapidly with competition Local staff costs significantly lower than the US but expatriate staffs very costly Needs to reimburse procedures and treatments normally considered to be standard in US 16

17 Blood Draw VDDI Presentation at TTC Conference Jan 2011 Procedure Country Flag Low (USD) Medium (USD) High (USD) Blood Draw USA China Hong Kong Korea Thailand Taiwan Source: GrantPlan ( 17

18 ECG VDDI Presentation at TTC Conference Jan 2011 Procedure Country Flag Low (USD) Medium (USD) High (USD) EC G USA China Hong Kong Korea Thailand Taiwan Source: GrantPlan ( 18

19 Initial Physical Exam (~60 min.) VDDI Presentation at TTC Conference Jan 2011 Procedure Country Flag Low (USD) Medium (USD) High (USD) Initial Physical Exam USA China Hong Kong Korea Thailand Taiwan Source: GrantPlan ( 19

20 Physical Exam (~15 min.) VDDI Presentation at TTC Conference Jan 2011 Procedure Country Flag Low (USD) Medium (USD) High (USD) Physical Exam USA China Hong Kong Korea Thailand Taiwan Source: GrantPlan ( 20

21 Summary Market Potential Availability of Patients Quality Data Cost 21

22 Any Questions?

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