CRO Industry in Japan 2008
11
2008 Industry Update: Contract Research Organizations in Japan Tom Furlong Senior Consultant- Life Science Practice The Ingenium Group
-
Upload
tom-furlong-cpc -
Category
Health & Medicine
-
view
2.913 -
download
1
Transcript of CRO Industry in Japan 2008
2008 Industry Update:Contract Research Organizations
in Japan
Tom FurlongSenior Consultant- Life Science PracticeThe Ingenium Group
2008 Industry Update- CRO in Japan
Outline
CRO Operations CRO Resistance Factors Current Environment Future Opportunities and Challenges
2008 Industry Update- CRO in Japan
Established Domestic CRO Operations
Domestic Pharma & BioVenture Companies Gaishikei Pharma Manufacturers Medical Universities CMIC EPS Fledgling Private CRO
2008 Industry Update- CRO in Japan
Gaishikei CRO Operations
Established Operators:– Quintiles– Parexel/APEX– Asklep
New CRO Entrants:– MDS Pharma– Covance
2008 Industry Update- CRO in Japan
CRO Resistance Factors- Personnel
Limited CRA Candidate Pool Difficult to Attract Quality Talent
– Wariness of New Business Operations– Explicit Multi-Year Career Track
Mixed Loyalties of Employees/Consultants
2008 Industry Update- CRO in Japan
CRO Resistance Factors- Investigators
Preference: Work Directly with Pharma Not Willing to Deal with CRO Limited Incentive to Change Limited Patient Enrollment
2008 Industry Update- CRO in Japan
CRO Resistance Factors- Pharma Manufacturers
Risk Averse Lack of Trust Regarding External Research Unwillingness to Knowledgeshare Lack of Respect for CRO Personnel Bushido Respect for Management
2008 Industry Update- CRO in Japan
CRO Resistance Factors- Government
Knowledge of MHLW & PMDA Process Drug Lag in Review Procedures Hyper Sensitive to Effects on Japanese
"Population" Post-War Protectionist Policies Legacy
– 20th Century Process in 21st Century Environment
2008 Industry Update- CRO in Japan
Factors Driving Change
Rapidly Aging Population Cost Effective Medical Care Need to Streamline PMDA Process
– Deregulation of Marketplace Free Trade Pressures Increased Acceptance of Foreign Products Domestic/Gaishikei Mergers
2008 Industry Update- CRO in Japan
CRO Business Development Opportunities
2007: Business Market ¥9.6 Billion Established Domestic Pharma
– Outsourcing Operations to Reduce Costs Domestic CRO/Research Universities BioVenture Upstarts Talent Attraction
2008 Industry Update- CRO in Japan
CRO Future in Japan
Increased PMDA Acceptance of Industry Increased Acceptance of Foreign Trial Data CRO Growth Market Activity Shift
– China (Mainland & Taiwan)– Korea– India– Australia
