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

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
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

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

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

5
Our Experience Today Key Driversfor Rapid
Increase in Number of Global Trials Being
Conducted in China

• Costs Micro View

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

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

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

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

10
Contacts

• Mark Engel, President
• Office (8621) 5383-4000
• Beijing Office (8610) 8203-1400
• Mobile [phone]
• E-Mail mark.engel_at_excel-china.com
• Xu Ning, COO
• Beijing Office (8610) 8208-1400
• Mobile [phone]
• E-Mail ning.xu_at_excel-china.com