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Drug Development in China: Opportunities and Challenges – A Clinical Trial Perspective

Drug Development in China: Opportunities and Challenges – A Clinical Trial Perspective. The China Life Sciences Partnering Forum - Beijing. By Mark Engel President and CEO Excel PharmaStudies The Leading CRO in China Beijing – Shanghai – Guangzhou – Chongqing – Chengdu - Nanjing.

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Drug Development in China: Opportunities and Challenges – A Clinical Trial Perspective

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  1. Drug Development in China: Opportunities and Challenges – A Clinical Trial Perspective The China Life Sciences Partnering Forum - Beijing By Mark Engel President and CEO Excel PharmaStudies The Leading CRO in China Beijing – Shanghai – Guangzhou – Chongqing – Chengdu - Nanjing www.excel-china.com

  2. Summary • Our Experience Today – Key Drivers • Quality of Data – More Acceptable to the FDA • Costs • Patients • Marketing Opportunities • Developing an Employee Base • Other Factors • Summary on Drug Development in China www.excel-china.com

  3. Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China • Quality of Data – More Acceptable to FDA • Investigators • Motivated • Monitors • Normally former physicians • Queries • Low compared to US/Western Europe • FDA Perspective • Familiarity + Quality = Greater Acceptability www.excel-china.com

  4. Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China • Costs – Macro View • Pre-Clinical (estimates) • Chemistry – 30% to 60% of the cost of West • Other Pre-clinical • Toxicology – 30% of the cost of the West • Animal Testing – 30% of the Cost of the West • Clinical (estimates) • Phase I – 15% of the cost of the West • Phase II/III – 20% of the cost of the West • Time Equals Money • Patient Recruitment • Pre-clinical Regulations www.excel-china.com

  5. Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China • Costs – Micro View www.excel-china.com

  6. Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China • Availability of Patients for Trials • Numbers: • Population – 1.3 Billion • 250 million covered by insurance • 250 million partially covered by insurance • 800 million not covered by insurance • Concentration of Patients in a few centers • Specific Indications – Oncology and Hepatitis www.excel-china.com

  7. Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China • Market Importance and the Role of In-Country Trials • The importance of the China Market • 5th largest by 2010; 3rd largest by 2020 • 28% Growth in 2004 – IMS • Value of Clinical Trials as a marketing tool • Examples: • Using Global Data for Local Registirations • Cost of clinical trials vs. listing costs • Importance of clinical trials in actual usage www.excel-china.com

  8. Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China • Future Staffing • The Role of Education – Long Term Prospects: • The Sciences Education Pool • Est. Undergrad/Grad Students Enrolled: Chemistry (100,000/20,000); Medical Sciences (120,000/15,000); Biological Sciences (60,000/15,000) • Government Investment in Biotech • Result: More Chinese being trained in drug development www.excel-china.com

  9. Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China • Acceptability by FDA – Ethnicity Issues • “Ethnicity in Drug Development and Therapeutics” by E. Frackiewicz • Personalized medicine is “leading to the need for understanding genetic polymorphism and for promoting racial and ethnic diversity in clinical trials.” • “ICH, FDA and NIH guidelines and recommendations have been instituted to encourage participation in clinical trials.” • Many drugs have ethnic differences in pharmacokinetics of drug metabolism • Aniti-hypertensives, psychotropics, anti-diabetics, Cytochrome P 450 enzymes • Additionally, there are often differences in the pharmacokinetics of drugs in absorption, distribution, elimination www.excel-china.com

  10. Contacts • Mark Engel, President • Office: (8621) 5383-4000 • Beijing Office: (8610) 8203-1400 • Mobile: (86) 1391-738-0834 • E-Mail: mark.engel@excel-china.com • Xu Ning, COO • Beijing Office: (8610) 8208-1400 • Mobile: (86) 1391-171-7641 • E-Mail: ning.xu@excel-china.com www.excel-china.com

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