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Clinical Trial Costs in Emerging Geographies: China R. Stephen Porter,  Pharm.D President, CEO and Chairman VDDI Pharmaceuticals Director & Co-founder Dragon Bio-Consultants, Ltd. Hong Kong, SAR
VDDI Pharmaceuticals ,[object Object],[object Object]
Xemilofiban Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],PROPRIETARY
Strategy for Development ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],PROPRIETARY
Dragon Bio-consulting: Services Currently Being Provided ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why China ,[object Object],[object Object],[object Object],[object Object],[object Object]
Why China ,[object Object],[object Object]
CRO’s – clinical development ASIA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Business environment - China ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Business environment - China ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory environment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Market Attractiveness Matrix for Asia Country Patient Access Cost Market  Opportunity  Regulatory Approval timelines Australia ++ + +++ 2 - 3 months India +++++ ++++ ++ 3  -4 months  China +++++ +++ +++++ 10 - 12 months  Korea +++ ++ ++++ 3 - 4 months Taiwan ++ ++ ++ 3 – 4 months Singapore + ++ + 1- 2 months  Indonesia +++ ++++ + 3 – 4 months  Malaysia ++ +++ ++ 3 – 4 months Thailand +++ +++ + 3 – 4 months  Philippines +++ ++++ + 3 -  4 months  Vietnam +++ +++++ + 4 – 5 months
Business environment ,[object Object],China India AstraZeneca  $100 M  investment, R&D Center May06 Apr07 Mar07 Feb07 Jan07 Dec06 Nov06 Novartis  $100 M  investment, R&D Center in shanghai, 400 FTEs Merck / Advinus risk sharing deal on metabolic disease target Amgen sets up clinical development center in Mumbai Eli Lilly /  Nicholas Piramal $100M  risk sharing partnership AstraZeneca sets up process R&D lab in Bangalore Roche plans to expand R&D center in Shanghai GSK plans to establish a fully integrated R&D center  GSK / Ranbaxy  $100 M  risk sharing partnership AstraZeneca China R&D center will be located in Shanghai Lilly  $100M  investment in 5 years BMS/ Biocon / Accenture  $300M  partnership GSK / Tata  Consultancy Service partnership Jun07 GSK sets up a R&D center (CEDD)  in neurodegenerative disease in Shanghai
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Recommended Second Tier Cities
Blood Draw Source: GrantPlan® ( www.ttc-llc.com )  Procedure Country Flag Low (USD) Medium (USD) High (USD) Blood Draw 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
ECG Source: GrantPlan® ( www.ttc-llc.com )  Procedure Country Flag Low (USD) Medium (USD) High (USD) EC G 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
Initial Physical Exam (~60 min.) Source: GrantPlan® ( www.ttc-llc.com )  Procedure Country Flag Low (USD) Medium (USD) High (USD) Initial Physical Exam 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
Physical Exam (~15 min.) Source: GrantPlan® ( www.ttc-llc.com )  Procedure Country Flag Low (USD) Medium (USD) High (USD) Physical Exam 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
Keys to Success Factors : China ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Risks: China ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Contact Information Steve 斯蒂夫 R. Stephen Porter, CSO Dragon Bio-Consultants, Ltd. Suite 55, 5/F New Henry House, 10 Ice House Street Central,   Hong Kong SAR HK Registered Company No.: 1429099 SKYPE: virtualdoc77 +86.15021242314 (Cell China) +1(615)445-5761  (Cell USA) http://dragonbio-consultants.com 香港中環 雪廠街 10  號 新顯利大廈 5  樓  55  室 香港公司註冊號碼: 1429099
Dragon Bio-Consultants, Ltd. Suite 55, 5/F New Henry House, 10 Ice House Street Central,   Hong Kong SAR HK Registered Company No.: 1429099 SKYPE: virtualdoc77 +86.15021242314 (Cell China) +1(615)445-5761  (Cell USA) [email_address] http://dragonbio-consultants.com 香港中環 雪廠街 10  號 新顯利大廈 5  樓  55  室 香港公司註冊號碼: 1429099  VDDI Pharmaceuticals Chairman, President and CEO 115 Penn Warren Drive  Suite 300-389  Brentwood, TN 37027  (615)445-5761 (cell) +86.15021242314 (Cell China) [email_address] http://www.virtualdrugdevelopment.com R. Stephen Porter, Pharm.D., FCP MRCP

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Clinical Trial Costs in Emerging Geographies - Stephen Porter

  • 1. Clinical Trial Costs in Emerging Geographies: China R. Stephen Porter, Pharm.D President, CEO and Chairman VDDI Pharmaceuticals Director & Co-founder Dragon Bio-Consultants, Ltd. Hong Kong, SAR
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  • 12. Market Attractiveness Matrix for Asia Country Patient Access Cost Market Opportunity Regulatory Approval timelines Australia ++ + +++ 2 - 3 months India +++++ ++++ ++ 3 -4 months China +++++ +++ +++++ 10 - 12 months Korea +++ ++ ++++ 3 - 4 months Taiwan ++ ++ ++ 3 – 4 months Singapore + ++ + 1- 2 months Indonesia +++ ++++ + 3 – 4 months Malaysia ++ +++ ++ 3 – 4 months Thailand +++ +++ + 3 – 4 months Philippines +++ ++++ + 3 - 4 months Vietnam +++ +++++ + 4 – 5 months
  • 13.
  • 14.
  • 15. Blood Draw Source: GrantPlan® ( www.ttc-llc.com ) Procedure Country Flag Low (USD) Medium (USD) High (USD) Blood Draw 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
  • 16. ECG Source: GrantPlan® ( www.ttc-llc.com ) Procedure Country Flag Low (USD) Medium (USD) High (USD) EC G 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
  • 17. Initial Physical Exam (~60 min.) Source: GrantPlan® ( www.ttc-llc.com ) Procedure Country Flag Low (USD) Medium (USD) High (USD) Initial Physical Exam 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
  • 18. Physical Exam (~15 min.) Source: GrantPlan® ( www.ttc-llc.com ) Procedure Country Flag Low (USD) Medium (USD) High (USD) Physical Exam 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
  • 19.
  • 20.
  • 21. Contact Information Steve 斯蒂夫 R. Stephen Porter, CSO Dragon Bio-Consultants, Ltd. Suite 55, 5/F New Henry House, 10 Ice House Street Central,   Hong Kong SAR HK Registered Company No.: 1429099 SKYPE: virtualdoc77 +86.15021242314 (Cell China) +1(615)445-5761 (Cell USA) http://dragonbio-consultants.com 香港中環 雪廠街 10 號 新顯利大廈 5 樓 55 室 香港公司註冊號碼: 1429099
  • 22. Dragon Bio-Consultants, Ltd. Suite 55, 5/F New Henry House, 10 Ice House Street Central,   Hong Kong SAR HK Registered Company No.: 1429099 SKYPE: virtualdoc77 +86.15021242314 (Cell China) +1(615)445-5761 (Cell USA) [email_address] http://dragonbio-consultants.com 香港中環 雪廠街 10 號 新顯利大廈 5 樓 55 室 香港公司註冊號碼: 1429099 VDDI Pharmaceuticals Chairman, President and CEO 115 Penn Warren Drive Suite 300-389 Brentwood, TN 37027 (615)445-5761 (cell) +86.15021242314 (Cell China) [email_address] http://www.virtualdrugdevelopment.com R. Stephen Porter, Pharm.D., FCP MRCP

Editor's Notes

  1. " Measures for the Administration of Drug Prices" is making its way through the NDRC. Early reports suggesting that off-patent originator pricing may be in jeopardy have set nerves on edge in the MNC Pharma sector. At the same time, the NDRC has reported that central drug bidding has caused unreasonable price increases, even as hospitals and distributors suggest that there have been insupportable price drops On the healthcare delivery front, the MOH has announced its intention to continue to reduce medical costs by regulating and standardizing medical practice which includes use of clinical pathways, prescription practice review, and elimination of excessive treatment/testing. China's new medical liability laws also contain prohibitions on unnecessary testing and diagnostics
  2. Thailand’s exempt for GPO!!! The rumor is that JnJ Shanghai may be involved in the latest SFDA