個(gè)人簡(jiǎn)介：
? CEO, Sinotherapeutics June 2012-present
– Founder and CEO. Has lead the company to grow to now about 160 staff, focusingon developing and marketing high barrier and high commercial value generic andinnovative formulation products. The company has filed 4 high-end genericproducts with US FDA, and have several additional products in the pipeline to befiled with US and Chinese FDA. The company also provide formulation CRO/CMOservices to companies with new drug candidates, has helped client companiesfiled several products with US and Chinese FDA.
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? VP of Pharmaceutical Sciences – Wuxiapptech, March 2011– April 2012.
– Responsible for all aspects of operations and profit & loss for following threebusiness units of about 300 staff
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? Pharmaceutical Development Services involving pre-formulation andformulation development, and pilot plant GMP clinical manufacture
? Analytical Development Services involving method development /qualification, stability and CMC data package for global filing, etcl.
? Product Development Services for international and domestic clients
– In charge of client development and interface,
– Staff recruiting and talent retention and training
– Head of Exploratory Formulation Development, Merck 2006-2011
– In charge of Schering Plough / Merck Exploratory formulation development– allaspect of development activities –12 staff in Summit, New Jersey, 42 staff inMexico.
– Problem solving for difficult-to-formulate compounds and provide prototypeformulations with enhanced in vivo PK performance for many early drugcandidates and phase II and III compounds.
– Conceive new product concepts as life-cycle management LCM candidates forseveral marketed products, and develop/demonstrate their technical feasibilities.
– Interface with external CRO / technology vendors for outsourcing /in-sourcingopportunities, and apply applicable venues for internal project development
? Head of Drug Delivery Assessment Group at Michigan, as part of Pfizer global drugdelivery network, 2002-2006
– Evaluated many external delivery technologies and applied several of them tolocal development projects.
– Provided prototype CR formulations for internal drug candidates
– Developed a patented CR formulation for Lyrica, a Key Pfizer drug
– Senior Investigator and Scientists at Alza Research Institute, 1996-2002; and atSyntex (Roche Bioscience) 1991-1996
– Developed many CR formulations for challenging molecules, includingcyclosporine A, Cirpro, Acyclovir, paclitaxel, and others
– Developed several IR formulations through phase II and III
?Educations:
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– B.S. & MS, Shenyang Pharmaceutical Univ. 1982; and 1985; Ph.D. PharmaceuticalSciences, USC,1991; MBA, University of Michigan at Ann Arbor, 2006
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Sinotherapeutics Inc (SinoT) was founded in August 2012 by a group of scientists returning to China from US. The companyhas it’s headquarter located in 99 Haike Rd, Bldg #3, Pudong District,Shanghai, China. The company is classified as a high-tech enterprise in China.The company was funded with about $50 million USD from private investors.
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Leveraging its established R&D infrastructure and advanced technologicalplatforms, and its regulatory know how in China and AP region，the companyis currently engaged in following lines of businesses: (1) develop, register,manufacture and distribute high-end generic products within China and aroundthe globe. (2) Provide pharmaceutical R&D know-how and high-end formulationproduct development and all walks of CMC services to global clients as well asaccess to many other local established CRO services/facilities for drugdiscovery/development activities.
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SinoT has registered four controlled releaseproduct with US FDA, and two complex products with Chinese FDA. It is onschedule to register many more complex products with both Chinese and US FDAthis year. The company’s R&D facility as well as manufacture facility havesuccesfully passed FDA audit without any 483 observations.
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SinoT has alsoestablished a list of clients, including Roche, GSK, Wuxiapptec, HuchingsonPharmaceuticals, and Hisun Pharma and Chengxin Pharma and many other localChinese pharma companies
公司簡(jiǎn)介：
宣泰醫藥成立于2012年8月，是一家專(zhuān)注于高端藥物制劑研發(fā)、商業(yè)化生產(chǎn)和銷(xiāo)售的高科技型企業(yè)。公司致力于藥物制劑產(chǎn)品的國際化，為全球市場(chǎng)提供高性?xún)r(jià)比的醫藥產(chǎn)品。公司成功開(kāi)發(fā)多個(gè)產(chǎn)品于全球多地區獲批上市銷(xiāo)售，在研產(chǎn)品治療領(lǐng)域涵蓋代謝，抗腫瘤，中樞神經(jīng)等。公司總部及研發(fā)中心位于上海張江藥谷，配備有先進(jìn)的藥物制劑處方開(kāi)發(fā)實(shí)驗室、GMP 中試車(chē)間和GMP 分析實(shí)驗室。全資擁有的現代化藥物生產(chǎn)基地位于江蘇海門(mén)經(jīng)濟開(kāi)發(fā)區，占地面積5.5萬(wàn)平方米，涉及固體口服制劑，高活性制劑生產(chǎn)車(chē)間。多次通過(guò)NMPA 及FDA 等官方現場(chǎng)審計。
公司業(yè)務(wù)同時(shí)涉及高端營(yíng)養品及膳食補充劑等產(chǎn)品的研發(fā)、生產(chǎn)和銷(xiāo)售。
公司官網(wǎng)：http://www.sinotherapeutics.com/
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