Trends and Issues: Integrating Clinical Research in China with Global Development Programs

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1 Trends and Issues: Integrating Clinical Research in China with Global Development Programs Bruce N. Garrett, MD President and CEO Global Research Services, LLC Global Medical Consulting Services (Shanghai) Co. Ltd. Pharma China Seminar May 3, 2012 Princeton, New Jersey

2 GRS History In China 1987 US Parent Company Founded 2002 Established Shanghai Biometrics Center 1998 Opened Subsidiary in Shanghai, China 2012 Continued Growth as global CRO 2

3 CURRENT STATUS Look How Far We ve Come Why Sponsors are considering China as part of global programs (Western versus Asian) Types of studies being conducted Asia only versus China as part of package Shifts in clinical research in China 1998 versus 2012 Acceptance of Western concept of patient informed consent form, evolution of doctor/patient relationship in research GCP Staff and site training for acceptance of data into Western clinical submissions 3

4 Major Drivers Of China s Life Science Industry China s Life Science Industry Drivers in 2011 and Beyond* 1. Government Investment-over $250B in 5 years 2. Commercial Investment-$10B in VC, M&A, IPO in China Pharma Market Growth-22% /year for last 5 years 4. Financial Growth-9.2% GDP in Urbanization-adding 300M to cities in 15 years 6. Returnees-430,000 in last 5 years; 150,000 in life science 7. Aging Population-growing from 13% to 31% by Chronic Disease-increasing 20-30% per year *Source: ChinaBio Consulting 4

5 China Life Science Clusters and Industry Statistics 4 major clusters of innovation 7,500 life science companies 500 universities and institutes 2,500 top researchers 200+ life science incubators 100+ life science parks 3,200 novel drugs patented 250,000+ industry staff 150,000+ life science graduates each year Source: ChinaBio Consulting 5

6 CURRENT STATUS Look How Far We ve Come Current Number of Global Clinical Research Trials Registered in the U.S. that Include China Total Citations in Clinicaltrials.gov: 3,122* Therapeutic Area Total Open Recruiting Cancer Cardiovascular Diabetes *source: March

7 Trends Western Sponsors Large Pharma, Biotech, Generics Asian clients-china, Japan, Korea International Regulatory Authorities - FDA, EMA Professional Organizations DIA Off shoring R&D from the West to China-Roche, Novartis, Merck 7

8 Big Pharma R&D* Big Pharma are committing to R&D in China based on market size and talent availability Major shift from virtual to brick and mortar Most MNCs have or are planning R&D operations in China: o Global centers: AstraZeneca, Eli Lilly, GSK, Merck o Regional centers: Bayer, Merck, Novo Nordisk, Novartis, Pfizer, Roche, Sanofi-Aventis Significant increase in partnering and M&A activity *Source: ChinaBio Consulting 8 8

9 US$ Billions Pharma R&D Growing Rapidly* More than doubled in last two years and set to nearly triple in next five $7.2B $1.2B $2.5B *Source: ChinaBio Consulting, China Science & Technology Statistics 9

10 Government Funding Programs* Healthcare Reform Program o $200B+ (11th & 12th 5-year plan) Science and Technology Development Program o $309B, $3B drug dev., 1M new jobs (12th 5-year plan) National Biotechnology Development Program o $???B (12th 5-year plan) 162 Drug Development Programs - $15B+ o 75% provincial and municipal level o $150,000 to $10M+ o Mega New Drug Dev. Program $12B+ *Source: ChinaBio Consulting 10

11 Class 1 IND & NDA Submissions* Approvals up, submissions down IND submission NDA submission *Source: ChinaBio Consulting 11

12 Clinical Trials Sponsored by MNCs* Multi-national trials up 4-fold since 2004 *Source: SFDA, clinicaltrials.gov; Analysis: ChinaBio Consulting 12

13 Clinical Trials ( ) by Indication* #1 Infectious disease / #2 Oncology / #3 CCVD Reproductn 5, 2% Hematology 16, 5% Immunology & Allergy 15, Endocrine & 5% Metabolic 23, 8% Others 12, 4% CNS 29, 9% Infectious Diseases 93, 30% Cerebral Cardiovascula r Diseases 45, 15% Oncology 69, 22% Note: Percentage of drugs in the clinic from (307) *Source: ChinaBio Consulting 13

14 Clinical Trials ( ) by Drug Type* Small molecules both in trials and approved drugs Small Molecule 165, 63% Others 5, 2% Vaccine 32, 12% Protein/ Peptide 58, 22% Gene Therapy 3, 1% Note: Percentage of drugs in the clinic from (307) 14 *Source: ChinaBio Consulting 14

15 Issues: Real and Perceived Regulatory issues timelines, process, people, relationships Costs, Language, Culture, Infrastructure - Are these still issues? Patent Protection Fear of IP violations Traditional Chinese Medicine lack of overall basic information, drug/drug interactions, conflicts Do Western Sponsors or international regulatory authorities negatively perceive China data as different? Require additional guarantees? 15

16 Future Predictions Will it be easier to go to China for clinical programs? Will Chinese government/sfda relax guidelines shorten regulatory timelines? Will China make it easier to accept Western data for registration? Who will or won t be going to China for global programs. Will there be increased interest in China data with future availability of electronic patient data, i.e. development of Electronic Medical Records (EMR)? 16

17 Conclusions Develop Winning Strategies-training, protocol adherence, compliance What type of global programs benefit from incorporating China? What type fails? From the past to now, what have we seen as an emerging pattern? Where do we see clinical research in China going in the future? 17

18 Thank you Bruce N. Garrett, MD President and CEO Global Research Services, LLC Global Medical Consulting Services (Shanghai) Co. Ltd.