俱乐部会员
万建胜,宣泰医药,CEO

万建胜,宣泰医药,CEO

日期: 2018-03-23
浏览次数: 299

个人简介:


• 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.

 

• 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

 

• 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:

 

– B.S. & MS, Shenyang Pharmaceutical Univ. 1982; and 1985; Ph.D. PharmaceuticalSciences, USC,1991; MBA, University of Michigan at Ann Arbor, 2006

 

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.

 

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.

 

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.

 

SinoT has alsoestablished a list of clients, including Roche, GSK, Wuxiapptec, HuchingsonPharmaceuticals, and Hisun Pharma and Chengxin Pharma and many other localChinese pharma companies


公司简介:


上海宣泰医药科技有限公司(简称“宣泰医药”)是一家主要从事高端药物制剂技术及其产品的研发、创新、工业化生产、销售的高科技型企业。公司研发中心为上海高等研究院内的新药创制实验室,生产基地位于全资子公司-上海宣泰海门药业有限公司。另外一个全资子公司——上海宣泰生物科技有限公司是高端营养品及膳食补充剂等的研发销售中心。与浙江海正药业股份有限公司成立合资公司-浙江海正宣泰医药有限公司,建立高端制剂创新中试基地,实现原料药到成品药转型,完成研发及技术到工业化身材的产品转化。与上海博风企业集团及上海金源东和化学有限公司成立合资公司——上海博璞诺科技发展有限公司,专注于国际标准的绿色合成化学制药技术,为宣泰提供高品质原料药。


公司的研发管理团队由具有丰富行业经验的资深知名专家组成。主要骨干有20年以上的制药行业从业经历,在多家大型跨国制药企业的管理经历和产品研发经验,曾领导和参与过多种药剂产品的研发并使其成功上市。公司在产品生命周期管理(LCM)、项目管理及现代企业管理方面均具有丰富的实战经验。


公司官网:http://www.sinotherapeutics.com/


 


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