沈志华博士
沈志华 统计学博士
罗氏药品开发中国中心生物统计、数据和临床管理总监
通讯地址：上海罗氏药品开发中国中心
个人简介
学习经历：
1978年，在台湾的中原大学获得化工专业的学士（B.E., Chemical Engineering）
1985年，在美国德克萨斯州的拉马大学（Lamar University，Texas）获得硕士学位（M.E.S., Chemical Engineering）
1987及1993年，在美国天普大学（Temple University）获得统计学硕士学位（M.S., Statistics）及博士学位（Ph.D., Statistics）
工作经历
自何年月 | 至何年月 | 工作部门 | 任职 |
June 1980 | Dec. 1982 | CTCI Engineering Co., Taipei, Taiwan 台湾台北中鼎工程公司 | Piping Designer 管线设计师 |
Jan. 1984 | May 1985 | Exxon Co. (Texas) 美国德州Exxon石油公司 | Petroleum Engineer 石油钻探工程师 |
Sept. 1986 | Apr. 1989 | School of Medicine, Temple University (美国天普大学医学院) | Pharmacological Statistician 药理学统计师 |
May 1989 | Oct. 1993 | Biometrics, Wyeth Research (美国惠氏制药全球药品开发生物统计） | Research Biostatistician 研发生物统计师 |
Nov. 1993 | June 1996 | Biometrics Research, Merck Co. (美国默沙东制药全球药品开发生物统计） | Manager 经理 |
June 1997 | July 2002 | Nonclinical Biostatistics, Global Biometric Sciences， Bristol-Myers Squibb Co. | Director 总监 |
July 2002 | June 2007 | Exploratory Drug Development, Global Biometric Sciences， Bristol-Myers Squibb Co. （美国施贵宝制药全球药品开发生物统计） | Executive Director 执行总监 |
June 2007 | Present | Biometrics and Study Management, Roche Pharmaceutical Development Center in China 瑞士罗氏药品开发中国中心生物统计及临床管理 | Head 总监 |
代表论文与著作
时间 | 名称 | 成果鉴定与采用部门或发表刊物与出版单位 |
2008 | The First Workshop on Adaptive Trial Design in China, Shanghai (中国首届诺本临床研究适应性设计研讨会) | Naseba Lnoppen Co., Ltd. |
2007 | Innovative Approaches for Designing and Analyzing Adaptive Dose-Ranging Trials; White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Studies | J. of Biopharm Statistics |
2005 | Complex Adaptive Systems, Human Health and Drug Response: Statistical Challenges in Pharmacogenomics (with Zerba, K.) | Statistics in the Pharmaceutical Industry. 3rd. Ed. Marcel Dekker Inc. |
2002 | Nuclear Magnetic Resonance (NMR) Method for Identifying Ligands to Target Compounds (with Mueller et al.) | US Patent Application No. 10/159,351. |
2002 | Testing Non-additivity of Biological Activity in Combinatorial Chemistry (with Ge et al.) | Combinatorial Chemistry & High Throughput Screening, 5, 147-154. |
2000 | Binary Formal Inference-Based Recursive Modeling Using Multiple Atom and Physicochemical Property Class Pair and Torsion Descriptors as Decision Criteria (with Cho et al.) | J. Chem. Inf. Comput. Sci., 40(3), 668-680. |
1998 | Experimental Autoimmue Encephalomyelitis Is Exacerbated in Mice Lacking the NOS2 gene (with Mudgett et al.) | J. of Immunology, 160(6): 2940-2946. |
1998 | Susceptibility of Stromelysin 1-deficient Mice to Collagen-Induced Arthritis and cartilage destruction (with Mudgett et al.) | Arthritis-and-Rheumatism, 41/1. 110-121. |
1997 | Inhibitors of Stromelysin-1 (MMP-3) by P-1 Biphenylethyl Carboxyalkyl Dipeptide (with Esser et al.) | J. of Medicinal Chemistry, 40(6): 1026-1040. |
1997 | Use of Toxicokinetic and Toxicodynamic Data to Reduce Uncertainties when Setting Occupational Exposeure Limits for Pharmaceuticals (with Naumann et al.) | Human and Ecological Risk Assessment, 3(4), 555-565. |
1997 | The use of bioavailability data in setting occupational exposure limits (with Weideman et al.) | Fundamental and Applied Toxicology: Supplement (The Toxicologist), 36(1) Part 2: 169. |
1994 | Robust and Bootstrap Testing Procedures for Bioequivalence (with Iglewicz B.) | J. of Biopharma. Statistics, 4(1), 65-90. |
1993 | The Use of Cluster Analysis in Molecular Design (with Mason et al.) | Proceedings of the 18th Annual Conference of the SAS Users Group. |
1993 | Rapamycin’s Inhibition of Thymocyte Proliferation, Unlike that of Cyclosporin A of Prednisolone, is not Associated with Cytotoxicity (with Bansbach et al.) | Annals of the New York Academy of Sciences, 685: 114-116. |
学术任职
美国统计协会的会员的院士（Fellow）
全球华人统计协会主席
美国药物研究及生产协会（PhRMA）生物统计和数据管理指导委员会主席
Frank Shen, Ph.D.
Dr. Shen has joined Roche in 2007 as the Head of Biostatistics, Data and Study Management for the new Pharma Development Center in China. Prior to join Roche, Frank was the Executive Director of Global Biometric Sciences, Bristol-Myers Squibb (BMS), who led a group of biostatisticians, statistical geneticists, pr-ogrammers, and data managers in a mission to accelerate quality drug development by integrating data flow and statistical collaborations in drug discovery, early clinical development, pharmacogenomics, and pharmacovigilance through close partnerships with scientists. Frank was also a member of the BMS Clinical Science Committee (CSC) and Development Excellence Council (DEC) that reviews clinical protocols and governs processes in clinical operations. Frank is also on an assignment starting from 2003 as the Asia Pacific BDM liaison to focus global integration in Japan, China and India.
Frank joined the pharmaceutical industry in 1989 and worked at Wyeth-Ayerst Research as a Research statistician until 1993 and then joined the Biometrics Research group at Merck & Co. as a manager.
Frank joined BMS in 1996 as Associate Director and progressed with increasing responsibilities. Frank received his B.S. and M.S. degrees in Chemical Engineering from Chung-Yuan University, Taiwan, and Lamar University, Texas, respectively, and a Ph.D. in Statistics from Temple University. He has focused his career Pursuits in the areas of biostatistics, early drug development, and clinical trial designs and operations.
Frank is well respected in his profession and has been named a Fellow of the American Statistical Association in 2003, and elected as the 2004 President of the International Chinese Statistical Association (ICSA). From 2005 to 2006, Frank was also a member of the Clinical Leadership Committee (CLC) of US PhRMA and chaired the Biostatistics and Data Management Technical Group (BDMTG) that leads biometric interactions between US pharmaceutical industry and the FDA for many initiatives such as the Critical Path. He was also a member of the PhRMA Benefit/Risk Action Team.