题目：The Role of the Chemical Engineer in Pharmaceutical Process Research and Development

报告人： Steve Shiyann Wang, PhD

              （Senior Principal Scientist，Bristol Myers Squibb Company）

时间：2012年11月10日下午15:30

地点：南京工业大学江浦校区笃行楼316（东）   

欢迎光临

理 学 院

报告人简介

Steve Wang obtained his PhD studying heterogeneous catalysis from Pennsylvania State University under Professor M. A. Vannice in 1980. He gained broad experience in powder dynamics and large particle fluidization while working at CSIST in Taiwan. In 1990, he joined BMS and initiated the process safety evaluation laboratory which provided support throughout pharmaceutical Research Institute and Manufacture.  In subsequent years, he became the research manager, and the group leader. Under his leadership, detailed knowledge of the reaction mechanism was used to derive kinetics and drive reaction engineering. In the course of his work, his group was also one of the pioneers within the company in the use of in-line process analytical tools (PAT) for process studies.  Steve implemented Quality Risk Assessment /FMEA methodology into overall QbD program in BMS which provide linkage to ongoing industry initiatives in the area of risk assessment and integrating with quality system (ICH Q9, Q8).

Steve has diversified technical and management experience in pharmaceutical industry. His main expertise lies in the areas of reaction engineering, heterogeneous catalysis, reactive and dust hazard evaluation, API downstream processing and methodologies for pharmaceutical material characterization. He supported numerous projects including Taxol, Abilify , Reyataz, Avapro and Baraclude. He is currently in the material science group and works in bridging API chemical processing and drug product process development. He is also working on innovative technologies to improve Saxagliptin(Diabetes), HIV integrase inhibitor (HIV/AIDS) and SGLT-2 inhibitor (Diabetes).

Research and conference presentations( in the most recent 10 years)

Steve S.Y. Wang, Steven H Chan “ Spray Coating of Saxagliptin HCL using Vibratory Acoustic Mixer” (Patent Application in progress)   Sept. 2012

Steven H. Chan, Steve S.Y. Wang, Chiajen Lai, and John Grosso “ A new perspective on the mechanical evaluation of granular material” Drug Development and Industrial Pharmacy, 2012; Early online:1-7

D.S. Hsieh, Dong Lin, Steve S.Y. Wang, R. O. Cann, J. B. Sausker, and S. Kiang, “ Asymmetric Hydrogenation of an Amino Acid Intermediate in the Synthesis of Complex Drug Targets: From Kinetic Modeling to Process Development,” Catalysis of Organic Reactions, 2008.

Steve S.Y. Wang, Steven H Chan, and S. Kiang “ Quality Risk Analysis of a Tablet Coating Process” 2007 AIChE Annual Meeting : Pharmaceutical Process Development Scale up and Implementation. (Presentation)

Steve S.Y. Wang “Mechanical Property Characterization of Active Pharmaceutical Ingredients”, 2006 AIChE Annual Meeting: Pharmaceutical Process Development Scale up and Implementation.

Steve S.Y. Wang, W. Merkl, H. Chung, W. Doubleday, S. Kiang  “Catalytic hydrogenation of Imine via Schiff’s base over Pd/Carbon Catalysts: Kinetic Prediction of  Impurity Fate and Byproduct Formation,” Catalysis of Organic Reactions, 2006.

Steve S.Y. Wang, R.S. Kotnis, J.H. Simpson, W. Merkl, D. Domina, and S. Kiang, “A Safe and Practical Procedure to Prepare Ethyl Diazoacetate,” AIChE Proceedings of the 39^th Loss Prevention Symposium 309-315, 2005.

B. O’Reilly, F. Okuniewicz, R. Schild, Steve S.Y. Wang, L. Rossano, D. Chen, and S. iang, “Chlorine Dioxide: Green or Mean? An Oxidation Under Biphasic Conditions,” AIChE Proceedings of the 38^th Loss Prevention Symposium 286-294, 2004.

Steve S.Y. Wang, J. Li, K. TenHuisen, J. Muslehiddinoglu, S. Tummala, S. Kiang, and J.P. Chen, “Selective Debenzylation in the Presence of aromatic chlorine on Pd/C catalysts: Reaction Kinetics and Catalyst Types,” Catalysis of Organic Reactions, edited by J.R. Sowa Jr., 2004.

Jun Li, Steve S.Y.Wang, G. Crispino , K. TenHuisen, A. Singh, J. Grosso, “ Selective Gaseous and Transfer Hydrogenolysis of Benzyl Protecting Group in the Presence of Aromatic Chlorine in the synthesis of BMS-223131,”  Tetrahedron Letter, 44(21) 4041-4043, 2003

Steve S.Y. Wang, and S. Kiang, “Thermal Characterization of Cyclopropylacetylene, a Key Intermediate in the Manufacturing of Sustiva,”  Managing Chemical Reactivity Hazards and High Energy Release Events, AIChE CCPS Proceedings of the 18^th Annual International Conference 331-342, 2003.