Asia Pacific Clinical Trials

ARCS Clinical IAC August 2014

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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

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Ref: Emerging Middle Class in Developing Countries – March 2010

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Source: Applied Clinical Trials, August 2011, pages 24-31

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Competitive Environment Map of All Studies in clinicaltrials.gov

Data as of 5 October 2012

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Competitive Environment Industry Funded Studies – 1st Listed in Year Country

2011

2010

2009

2008

2007

2006

2005

Australia

301

327

323

346

306

293

321

China

217

211

183

163

140

123

85

Hong Kong

56

69

89

80

74

66

79

India

154

279

220

233

181

144

97

Japan

369

324

274

234

182

148

132

Korea

375

362

294

263

206

157

113

Malaysia

40

63

66

65

58

46

51

Philippines

54

85

73

86

65

64

60

Singapore

76

102

111

87

70

71

84

Taiwan

141

178

184

169

150

117

131

Thailand

60

90

94

107

73

73

73

UK

632

639

628

642

488

481

502

USA

3,279

3,192

3,456

4,082

2,946

2,455

2,730

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Source: Clinicaltrials.gov; accessed 11 Oct 2012 www.novotech-cro.com

Clinical Trial Capacity – Healthcare Professional Pool

Number Annual Number of Medical Medical Schools Graduates

Number of Physicians

Percentage Physicians who are Specialists

China

115

202,577

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

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Clinical Trial Capacity – Site Pool Concentration of sites in capital cities China - Beijing 26% - Shanghai 20% 51% Korea - Seoul

Taiwan - Taipei

69%

Thailand - Bangkok

69% 8

2006 Data

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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

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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 Source: CIA The World Fact Book, Accessed 8 October 2012

7,022 10 www.novotech-cro.com

Clinical Trial Capacity - Patient Pool Accessible Patients (millions) COPD

Diabetes

Dyslipidemia

China

21.10

5.18

6.00

India

12.7

9.4

87.0

Korea

2.30

1.50

9.30

Philippines

3.4

1.7

1.0

Taiwan

1.24

0.80

1.70

Thailand

1.06

0.50

1.45

11 2006 data

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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

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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)

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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)

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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 www.novotech-cro.com

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

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Blood Draw VDDI Presentation at TTC Conference – Jan 2011 Procedure

Country

Blood Draw

Flag

Low (USD)

Medium (USD) High (USD)

USA

22

26

33

China

5

6

7

Hong Kong

7

7

10

Korea

5

6

7

Thailand

2

3

4

Taiwan

10

11

12

Source: GrantPlan® (www.ttc-llc.com)

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ECG VDDI Presentation at TTC Conference – Jan 2011 Procedure

Country

EC G

Flag

Low (USD)

Medium (USD) High (USD)

USA

99

103

128

China

38

42

56

Hong Kong

32

47

49

Korea

14

21

34

Thailand

17

23

30

Taiwan

32

47

49

Source: GrantPlan® (www.ttc-llc.com)

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Initial Physical Exam (~60 min.) VDDI Presentation at TTC Conference – Jan 2011 Procedure

Country

Initial Physical Exam

Flag

Low (USD)

Medium (USD) High (USD)

USA

202

239

260

China

61

97

151

Hong Kong

111

162

204

Korea

87

91

108

Thailand

53

67

80

Taiwan

55

98

101

Source: GrantPlan® (www.ttc-llc.com)

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Physical Exam (~15 min.) VDDI Presentation at TTC Conference – Jan 2011 Procedure

Country

Physical Exam

Flag

Low (USD)

Medium (USD) High (USD)

USA

130

151

152

China

36

50

60

Hong Kong

63

88

105

Korea

40

48

55

Thailand

39

56

89

Taiwan

51

73

94

Source: GrantPlan® (www.ttc-llc.com)

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Summary – – – –

Market Potential Availability of Patients Quality Data Cost

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Any Questions?

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