Tabletting, Pat and Controlled Release Technologies
(Chinese Version)

Workshop 3

Dr. Stephen R. Cammarn is the Associate Director of Pharmaceutical Development with Procter & Gamble Pharmaceuticals in Cincinnati and Norwich. Dr. Cammarn holds a BS ChE and a PhD in Industrial Pharmacy. Dr. Cammarn has worldwide responsibility for P&GP’s drug product development work, including Pharmaceutics, Formulation, Process, Clinical Supplies, Package Development and Technical Support. In these capacities, Dr. Cammarn has been responsible for drug product aspects of numerous successful NDA’s and launches, and currently has the drug product responsibility for more than 20 projects in the portfolio. Dr. Cammarn holds several patents, and is the author of several publications.

Dr. Debbie Hausman is a Senior Engineer in the Process Development Department of Procter & Gamble Pharmaceuticals, Norwich, New York. She has 7 years of experience in drug product and process development. She holds a Ph.D. in Pharmaceutical Sciences from the University of Cincinnati, focusing on Industrial Pharmacy, and a B.S. in Chemical Engineering from the University of Michigan.

Dr. John Hu is Vice President, International-China for the United States Pharmacopeia (USP) and General Manager, U.S. Pharmacopeia Research and Developme nt (Shanghai) Co., Ltd. In his management role at Shanghai, Dr. Hu provides public health and allied support to USP’s constituencies in mainland China, Taiwan, Hong Kong and Singapore. Dr. Hu was formerly a Director in Science, Technology and Outsourcing at Novartis and worked in various research and development capacities not only at that company but also at Bayer AG and Hoffman La-Roche. His expertise lies in project management, formulation research and analytical development.

Dr. Sandra Klein is a pharmacist. She got her Ph.D. from the University of Frankfurt and did her post-doc at Eastman Chemical Company, USA. She is presently working on the improvement of biorelevant dissolution test methods for Modifi ed Release dosage forms, the miniaturization of compendial dissolution test methods and on enhancing the solubility of poorly soluble drugs.

Dr. Ping I. Lee is Professor and GlaxoSmithKline Chair in Pharmaceutics and Drug Delivery at the University of Toronto. He holds a BS ChE and a PhD in Physical Chemistry. He has held research and management positions with several major pharmaceutical companies. Prior to returning to Toronto in 2004, he was Senior Director of Pharmaceutical R&D at Schering-Plough. His publications and patents are in areas of modifi ed release, hydrogels and drug delivery systems. He co-founded the AAPS Modifi ed Release Focus Group and serves on the
Editorial Board of several international journals. He is a fellow of the AAAS.

Dr. Jian-Xin Li is Pharmaceutical Projects Manager in FMC Biopolymer, USA. He is responsible for Excipient R&D projects and technical service activities in China. He has doctorate degree in pharmaceutics, bachelor and master degrees in chemical engineering. Dr. Li has over 20 years research and development experiences in polymer materials and formulations; is the 2005 chair and 2006 co-chair of the AAPS Modifi ed Release Focus Group. Dr. Li was the co-chair of 41st AAPS Arden Pharmaceutical Technologies Conference (2006) and a Steering Committee Member of the Handbook of Pharmaceutical Excipients. His research interests include solid dosage forms, drug delivery, controlled release and polymer excipients.

Dr. Mary A. Murray is Senior Research Scientist in the Supplement Product Development division of The Nutrilite Health Institute in Buena Park, California. She has 10 years industrial experience in the research, design and development of nutritional supplements. Dr. Murray is a global spokesperson representing the science behind the Nutrilite brand and holds numerous patents in the formulation and development of nutraceutical products. She holds a PhD in Pharmaceutical Sciences from the University of Cincinnati focusing on Industrial Pharmacy and a BS in Biological Sciences also from the University of Cincinnati.

Mr. Dale Natoli is vice-president of Natoli Engineering and has over 25 years of experience training the tablet compression industry worldwide. Dale currently presents lectures for universities, pharmaceutical associations and tablet manufacturers on topics related to tablet designs, tool confi gurations and troubleshooting. He authored many articles for major pharmaceutical trade publications in the United States as well as in Europe. Dale is the driving force behind establishing new technologies and special tool confi gurations to the tablet compression industry; providing enhanced tablet quality as well as extended tooling and press longevity.

Dr. Hamid Rezaei is currently a Scientist at the small molecules pharmaceutics division at Genentech, Inc. Previously he worked for more than six years as a Formulation Senior Scientist at AstraZeneca Pharmaceuticals. While at AstraZeneca, he worked in the product design and process engineering (PAT) teams, and was an AAPS visiting scientist for three years. He has extensive industrial experience with contributions to several INDs, sNDAs, and NDAs. He holds a Ph.D. in Pharmaceutics/Industrial Pharmacy from University of Cincinnati, and a M.S. in Pharmacology from the Ohio State University.

Dr. Ali Rajabi-Siahboomi is Global Technical Director for Modifi ed Release Technologies at Colorcon, based in the USA. He obtained his B.Pharm. PhD in Pharmacy from University of Nottingham (UK). Ali has held various academic positions (7 years) in Nottingham and Liverpool JM Universities before joining Colorcon as Technical Director (Europe, Middle East and Africa). His main research interests are in the area of solid dosage form pharmaceutics and pharmaceutical technology with emphasis on modifi ed release drug delivery systems. He has published over 120 full papers, abstracts and patents.

Dr. Harald Stahl owns a diploma in Physics and a PhD in Chemical Engineering. He worked for 3 years in the Pharmaceutical Development of Schering AG in Germany. At that time his main interest was the aseptic production of pellets. Since 1995 he served within GEA Powder Technology in various positions. Presently he owns the position of a Senior Pharmaceutical Technologist of NIRO Pharma Systems. He has published more than 20 papers on various aspects of solid dosage form production.

Dr. Roger L. Williams is Executive Vice President and Chief Executive Offi cer of the United States Pharmacopeia. Dr. Williams also serves as Chair of the Council of Experts, USP’s scientifi c standards-setting body, which: continuously revises the United States Pharmacopeia and National Formulary and, with USP’s recent acquisition, the Food Chemicals Codex; sets the Model Guidelines in support of the Medicare Modernization Act’s Part D Benefit; and creates other standards and information on behalf of USP’s constituencies. He has authored or co-authored over 200 reports in the areas of clinical pharmacology, patient safety, biopharmaceutics, pharmaceutical chemistry, and compendial science.

Dr. Qian Wang obtained her Ph.D. in Physical Chemistry from Boston University in 1990, after which she joined Boston Advanced Technologies as a research scientist. Since 1995 she has worked at Bruker Optics on applications of NIR. She currently holds the position of Vice President of NIR and Process.

Prof. Zhong-Yuan Yang graduated from China Pharmaceutical University in 1964. He is a Senior Chemist, and was the former Director of Wuhan and Guangzhou Municipal Institute for Drug Control. He was invited by the Chinese Pharmacopoeia Commission as a member of the current Executive Committee. He is a member of Drug Evaluation Board of the State Food and Drug Administration, an advisor to the Guangdong Provincial FDA, a member of the WHO Panel on International Pharmacopoeia and Pharmaceutical Preparations, a member of United States Pharmacopoeia Expert Committee of International Health (2005-2010), a member of editorial board of Acta Pharmaceutica Sinica and some other scientifi c journals.