Team


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Yan-Bo Yang, PhD, President & CEO

Dr. Yan-Bo Yang has over 30 years of experience in analytical chemistry, particularly in separation sciences and chromatography technology for pharmaceutical, nutrition supplement, medical device, and biotech applications for both small molecules and large biologics. Dr. Yang is knowledgeable in drug product development, cGMP, quality systems, and preparation for FDA submissions. Prior to founding BioPharmaDev, Inc., Dr. Yang was Director of the Pharmaceutical Development at B. Braun Medical, Inc. Throughout his over 13 years of leadership and responsibility, no chemistry-related deficiencies, particularly those related to analytical methods, and no inspection observations (483s) for the Pharmaceutical Development Lab were given by the FDA from a large number of submissions and many inspections. Before joining B. Braun Medical, Inc., Dr. Yang was Director of Research at The Separations Group, Inc. developing various novel HPLC columns and studying separation theories and applications. The technical knowledge, quality standards, and track record of Dr. Yang help assure you that your job and project will be done to your satisfaction with peace of mind.

Dr. Yang serves as the president of AOAC International Southern California Section, member of the USP Prescription/Nonprescription (PNP) Stakeholder Forum Planning Committee, and chair of the USP 2012 PNP Stakeholder Forum. Dr. Yang helped found the Chinese-American Chromatography Association (CACA) and served as founding president for its first two terms. Dr. Yang is also the president of the Sino-American Biomedical and Pharmaceutical Professional Association (SABPA) OCLA chapter.

 

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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.