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The Research Relevant to Biobank GWAS in China

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The Research Relevant to Biobank GWAS in China China Biobanking Strategy for Integrated Translational Research Rongxing Gan, Professor, MD, Director Shanghai Clinical Research Center ISBER 2014; May 21, 2014 31 Outline of Biobank Development in China 32 The strategy for China Biobanking 3 Translational Researches based on Biobank Initiatives Background Vast resources: clinical specimen on a large scale with clinical information One of the basic platforms for Translational Medical Research & New Drug Development Promote the investigation in disease mechanisms & biomarker identification Bench Bedside 2010 Clinical Specimen Repository was initiated in the 1994 The Chinese Academy of context of Significant New Drugs Development with the Medical Sciences started to work on support of the MoH and MoST establishing a bank of immortalized cell lines of Chinese ethnic groups. 2009 Beijing Municipal Science and Technology Commission launched the 1998 The Ministry of Science and construction of Beijing clinical data and Technology of China (MoST) and the sample repository of major diseases. Ministry of Health of China (MoH) drafted Human Genetic Resources 2007.9 NICGR was published online. Managements for Trial Implementation 2012 Human Genetic Resources 1998 The Office of Chinese Human 2006 MoST initiated Standardized Management Regulations (draft) was Genetic Resources Management was set organization, integration and shared formulated by the Office of Chinese under the Ministry of Science and pilot of genetic resources for Human Genetic Resources Technology of China. Significant diseases (2005-2007). Management. 1990-1995 1996-2000 2001-2005 2006-2010 2011-2015 2003 The National Infrastructure of 2008, Shanghai Municipal Science and Technology Commission Chinese Genetic Resources(NICGR) was 2012 Shanghai Biobank initiated as an important part of the launched the project of Shanghai Clinical Biobank Research Center Engineering Research Center has National Science and Technology officially granted as Shanghai Infrastructure Program by the Ministry Municipal Biobank Center by of Science and Technology of China. Shanghai municipal government, and the construction of Shanghai 2010 Shanghai Municipal Science and Technology Clinical Biobank for Major Commission launched a project for the setup preparation of Diseases was launched Shanghai Biobank Engineering Research Center. Year Project 1994 Immortalize Cell Bank of Different Chinese Ethnic Groups Human Genetic Resources Managements for Trial 1998 Implementation 2003 National Infrastructure of Chinese Genetic Resources Standardized organization, integration and shared pilot of 2006 genetic resources for Significant diseases (2005-2007). 2009 Beijing clinical data and sample repository of major diseases. Clinical Specimen Repository in the context of Significant New 2010 Drugs Development Shanghai Biobank Engineering Research Center. Human Genetic Resources Management Regulations (draft) 2012 Shanghai Clinical Biobank for Major Diseases. Shanghai Biobank Engineering Research Center National Diseases-based Biobank Project (2011-2015) Platform-based Establishment System integration of of Chinese innovation, Specimen government clinical sustainable resources and local biobank and model of sharing resources database development mechanism New drug discovery Cardio-cerebro- Malignant tumor vascular diseases Major disease mechanism research Metabolic Neuropsychiat diseases Standardization ric diseases Reflect the epidemic characteristics The National Biobank Network in China Beijing: Shanghai: Other regions: • Peking Union Medical College • Shanghai Clinical Research Center • Guangzhou: China Hospital • Shanghai Cancer Center national gene bank • Xuanwu Hospital, CMSU • Zhongshan Hospital • Taizhou: large-scale • Cancer Institute, Tianjin • Huashan Hospital cohort study University • Obstetrics and Gynecology • Yunnan: Immortalized Cell • Cancer Institute, Beijing Hospital Line Bank University • Reijin Hospital • …….. • Fuwai Hosp. of Cardiovascular • Renji Hospital Diseases, CAMS • Shanghai 6th people’s Hospital • 1st Hospital, Beijing University • Shanghai 9th people’s Hospital • General Hospital of PLA (301 • Xinhua Hospital Hosp.) • Shanghai Chest Hospital • Beijing Anzhen Hospital, CMSU • Shanghai Children’s Medical • …… Center • Shanghai Mental Health Center • Chang Zheng Hospital • Shanghai Pulmonary Hospital • …… Major diseases (2011-2015) 1.잠재 고객 Malignant tumor Fudan University ( 10 Hospitals) Shanghai Jiao Tong University (14 Hospitals) Metabolic diseases Tongji University (6 Hospitals) Neuro-psychiatric diseases Shanghai University of Traditional Cardio-cerebro-vascular diseases Chinese Medicine (5 Hospitals) The 2nd Military Medicine University (3 Hospitals) Other diseases & Cohort Study Clinical Research Coordination Support Translational Research Standardization QA & QC Central Storage Training Central IEC Data & Info Technical service Public Service Platform (SCRC) 31 Outline of Biobank Development in China 32 The strategy for China Biobanking 3 Translational Researches based on Biobank Initiatives Basic Principles for China National Biobank Non-profit/independent Services Medical Government Social Institutions Resources Technical Support Performance Assurance Operating Assurance • Technical standards • Central Government： • Resource Integration • Standardized sample Plan, Project, Policy • Full-time Staff and data collection • Local Government: • Maintenance • QA/QC Place, Fund, Personnel • Service • Research outcomes • Supervise Platform for National Biobanks Standard Comprehensive Biological Normal Other specimen diseases information specimen Biobank Chinese Minority Regional Epidemi Cell Myco- Major gene populati popula- Virus Bacteria -ology line plasma diseases bank on tion Animal Plant Human National Biobank Projects supported by MOST and MOH One of 16 National Key Projects: New Drug Discovery and Development The National Disease-based Biobanks in China Step 1: National Biobank in Beijing and Shanghai Step 2: Spread to other regions when matured Peking Union Medical College Hospital as organizer Urumchi Shenyang Beijing SCRC as Wuhan Shanghai Chongqing organizer and third-party platform Guangzhou High Quality Sample High Quality data The Working Flow for China National Biobanking Disease maps for health Hospitals management The Central Bank Reference for bio- translational sample research Key resources for medicine industry National Key Projects: New Drug Discovery & Development New Drug Discovery & Development for 4 Major Diseases Peking Union Medical College Hospital Beijing Biobank for Major Diseases Coalition Hospitals Phase I target (2009-2012) Clinical cases 45,930, total samples th 6 People’s Hospital, Shanghai 422,489 Xuanwu Hospital, CMSU Promoted 863, NSF, BSF projects Cancer Institute, Tianjin University Phase II target (2013-2015) Cancer Institute, Beijing University 14 biobanks Fuwai Hosp. of Cardiovascular Diseases, 100,000 cases &1,000,000 samples 1st Hospital, Beijing University General Hospital of PLA (301 Hosp.) Collection of high quality specimens Beijing Anzhen Hospital, CMSU Complete clinical information …… Informatics platform Shanghai Disease-based Biobanking Project Coordinator: Shanghai Shenkang Third Party Service: Hospital Development Center Shanghai Clinical Research Center Quality control systemQuality Standardized Standardized system Informatics Third party platform service(SCRC) Centralized biobank Entrust Public Backup Storage Storage Storage 24 hospitals satellite banks Bio -sample Storage Three Models: Public Common Disease Storage Sample Sharing Orphan Disease Backup Special Samples Storage Remote backup Community Hospital Entrust Institution and Pharma. Storage Storage and Management Quality Management Works Stage I Stage II QM 1. Normative work flow 1. ISO 9001accreditation Quality System 2. Detailed SOP and forms 2. ISO 27001 accreditation Manual 3. Man、 Machine、Material、 3. ISO 15189/17025 accreditation Environment and Method 4. CAP accreditation Quality 1. ISBER PT program 1. QC items checklist Procedure Files Control 2. DNA Qualification 2. Method Validation & PT 42 Files 3. RNA Integrity 3. Quantitative VS Qualitative 4. Cell Viability 4. Cell Viability 5. Temperature Monitory & Alarms 5. Tissue Antigenicity & Histology SOPs Inspection 1. Professional team 1. Documents / onsite Inspection 107 Files • BEC-QH-01 Quality Target and Quality Policy for Biobank Record Forms • BEC-PF-01 Confidentiality Control Procedure 102 Files • BEC-PF-10 Preventive Measures Management Procedure • BEC-PF-23 Sample Management Procedure • BEC-SOP-GA-4007 Liquid Nitrogen Container SOP • BEC-SOP-ML-1004 White Blood Cells Collection SOP • BEC-SOP-ML-1009 Sample Transfer SOP • BEC-SOP-ML-1005-01 Sample Reception Form • BEC-SOP-ML-1008-01 Sample Delivery Form 17 Technology Support Clinical Pathology Division Clinical Laboratory Testing Division Anatomic pathology Cytopathology Clinical Immunology Lab Molecular pathology Clinical Biochemistry Lab Clinical Microbiology Lab Central Lab Clinical Molecular Biology Lab Hematology/Urianalysis Lab CAP & ISO15189 Molecular Analysis Division Flow Cytometry Lab Elemental Analysis Lab Real-time PCR Cytogenetics Lab SNP analysis Gene sequencing Analytical Chemistry Division Pharmacokinetics/dynamics lab Chemistry/Drug analysis LC-MS technologies 18 Quality Control Shanghai Disease-based Biobanking Project (SCRC + up to 24 clinical biobanks) Working flow QC protocol Ethical Guidance Ethics Committee is chaired by Dr. Ching-Li Hu • Member of the UNESCO
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