MarkEngel11606

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

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

Summary: 

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

Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China: 

Our Experience Today – Key Drivers for 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

Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China: 

Our Experience Today – Key Drivers for 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

Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China: 

Our Experience Today – Key Drivers for Rapid Increase in Number of Global Trials Being Conducted in China Costs – Micro View

Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China: 

Our Experience Today – Key Drivers for 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

Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China: 

Our Experience Today – Key Drivers for 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

Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China: 

Our Experience Today – Key Drivers for 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

Our Experience Today – Key Driversfor Rapid Increase in Number of Global Trials Being Conducted in China: 

Our Experience Today – Key Drivers for 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

Contacts: 

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