团队


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Yan-Bo Yang, PhD, President & CEO

杨彦博博士在化学分析,特别是在分离科学和色谱技术在医药及生物制药的开发应用方面有30多年的经验。杨博士非常熟悉药物产品的研发过程及要求,cGMP的质量系统,以及向美国FDA申报新药的材料准备。在成立美国生物制药研发公司BioPharmaDev, Inc)前,杨彦博博士任德国贝朗集团美国药物研发中心部门高管经理和多个项目负责人, 负责医药研究开发全部方面的工作,属于该技术领域的领军人物,他所带领的团队已成功研发出了几十种新药产品。尤其是在杨博士负责贝朗医药集团美国药物研发中心的10多年期间,他所领导的研发实验室以及向FDA递交的几十个申报材料,没有发现与化学研发相关的问题(deficiencies)及cGMP的问题(inspection observations或 483s)。德国贝朗集团公司具有170多年的历史及4万多员工。

杨博士现任国际分析化学家学会南加州(AOAC International, SCS)会长和美中生物制药专业协会(SABPA)洛橙部会长。 杨博士非常了解美国FDA 和USP的法规并与FDA 和USP有着紧密的联系,为及时了解现实的法规要求及变化提供了极有力的条件。在过去二,三十年中,杨博士一直致力于色谱理论、技术、材料及应用方面的研究,并应用分析化学知识解决药物研究的问题,是一个顶级色谱分离 科学专家, 领衔成立了北美华人色谱学会(CACA)并担任首届两任会长。

鉴于杨博士对质量标准的严格要求及过去的优良记录,我们完全可以保证让您对您的项目满意,放心

 

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Paul A. DeRidder, MD, MBA, Business Advisor

Dr. DeRidder is a board-certified Urologist, having received his medical training at the University of Michigan Medical School.  He was in private clinical practice for twenty-two years, and is a past Assistant Clinical Professor of Urology in the Department of Surgery, at the University of California-Irvine.

Dr. DeRidder is a Diplomate of The American College of Physician Executives.  He has been a co-founder and CEO of several specialty management organizations, and was a co-founder and Board member of Urotherapies, Inc.; a nationally based single specialty management group dedicated to the enhancement of Urologic specialty care.

Dr. DeRidder presently is a member of the Board of Directors, Compensation Committee for Numira, Inc, a specialty R&D tools company for drug development. Dr. DeRidder is past  Vice Chair of the Board of Directors, SABPA(Sino-American Biomedical and Pharmaceutical Professionals Association).  He  holds several patents on various medical devices.

Dr. DeRidder is presently CMO at  Cold Genesys, Inc. a specialty pharmaceutical company that focuses on fulfilling unmet medical needs in cancer treatment with a present emphasis on bladder cancer.

Dr. DeRidder was a charter member of the University of California, Irvine, Healthcare Executive MBA program, and completed his MBA in November, 1997.

Dr. DeRidder is a member of the Tech Coast Angels, a Southern California group of investors in early stage companies. Dr. DeRidder has particular expertise in the healthcare and technology sectors.

 

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Steven S. Kuwahara, PhD, Quality Advisor

Originally from Hawaii, Dr. Kuwahara holds degrees in Biochemistry from Cornell and the University of Wisconsin. Starting as an Assistant Professor of Chemistry, he began his industrial career in the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here he developed expertise in the testing of blood derivatives, viral and bacterial vaccines. He moved to the Hyland division of Baxter Biotech where he was in charge of assay development and quality control. He later became responsible for quality systems for a biological device. After a short period with a contract testing laboratory and another blood fractionator, he became the director of quality control with a gene and cell therapy company. In recent years he has worked as the director of assay validations for a large contract testing laboratory and as a GMP consultant to a start-up cell therapy company. His last position was Director of Quality Control and Assay Development with Titan Pharmaceuticals. He is currently the head of his company, GXP BioTehnology LLC.

Dr. Kuwahara is an experienced analytical biochemist who has applied his academic knowledge to quality control in the pharmaceutical industry. His work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors.

Dr. Kuwahara has written several papers and book chapters and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

 

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Prof. Fred E. Regnier, PhD, Technology Advisor

Dr. Fred E. Regnier is a Distinguished Professor of Chemistry Emeritus at Purdue University, having spent more than 40 years at Purdue.  He is generally regarded as an authority in liquid chromatography and the analysis of proteins. Additionally, he is an accomplished entrepreneur, cofounding several companies such as BioSeparations, PerSeptive Biosystems, Beyond Genomics, Novilytic, and Perfinity Biosystems.  He has published more than 300 journal articles and 70 book chapters and reviews, is an inventor on 50 patents, has edited two books, and has received numerous national and international awards and distinctions for his research in analytical chemistry and biochemistry. Dr. Regnier received his B.S. from the Nebraska State College and holds a Ph.D. from Oklahoma State University. He did his postdoctoral training at the University of Chicago and Harvard University under the direction of John H. Law and Edward O. Wilson, respectively.