Our 2 primary R&D operations(Nanjing & Hongzhou) are expert in designing unique & practical multi-step synthetic schemes to achieve either a fast target completion, &/or an efficient scalable route, depending on project requirements. We are also comfortable in repeating or optimizing our customer's provided synthesis scheme, & providing the same above deliverables.

The project type we typically work on includes 5-15 chemistry steps, urgent/short lead time requirement, & some process optimization as preparation for a possible next scale-up requirement. Quantity deliverables range anywhere from grams to Tons; our facilities can support the full range. Our customer type is typically the Pre-clinical – phase II Pharmaceitical Project Manager/Chemist, & so we are keenly aware of the primary & ancillary project goals we are required to meet. This deep understanding allows us to arrange our work efficiently & communicate with our customers effectively.

Typical deliverables related to our product & FTE services include:

• A) Gram - Kilo quantities of target product
• B) Project R&D reports & final technical package
• C) Conclusion assessments on process commercial scalability & impurity profile characteristics.
• D) Pilot & commercial scale production continuity in our 3 complimentary facilities.

 

Our R&D Operations Leader:

Chief Scientific Officer: Dr Wensen Li

Based in Nanjing China, Wensen is responsible for fully managing all R&D operations in China. Wensen's senior leadership & in-depth knowledge of western Pharmaceutical R&D is an invaluable asset to our projects & Laboratory chemists. Hi background & Chemistry highlights include:

BS Chemistry: National Tsing-Hua University, Hsinchu, Taiwan

Ph.D. in Organic Chemistry from UNIVERSITY OF PENNSYLVANIA, Philadelphia PA USA. Advisor: Professor K. C. Nicolaou; research focused on organic synthesis of amphotericin B, forskolin, and ethanoarachidonic acid.

16 years work experience in Bristol-Myers Squibb Company, New Brunswick, New Jersey USA. Promoted several times & finally as Process R&D Group Leader-Senior Principle Scientist. Project management work included design, development/GLP & cGMP scale-up of many different multistep API synthesis schemes, significant contributions to CMC submissions. His work also included representing cross-departmental development teams (comprising Process R&D, Biopharmaceutics, and Analytical R&D, CMC Regulatory & X-ray crystallography) to develop technology, desired crystalline polymorph, and also provide timely drug supplies and regulatory dossiers to support clinical studies on early drug candidates. Significant contributions to the development of BMS multi-billion dollar drug "Taxol".

Co-recipients of three BMS Pharmaceutical Research Institute Presidential awards.

His participation in a PLP-IND company-wide productivity and incentive program resulted in the early involvement of process research & ultimately a faster set of IND filings.

Organizing and contributing author to 22 peer review papers, one book chapter and 25 applied /granted patents with focus on the anti-cancer area which are partially listed as follows.

• "Stereoselective Microbial Reduction of 2-Keto-3-(N-Benzoylamino)-3-Phenyl Propionic Acid Ethyl Ester: Synthesis of Taxol Side-Chain Synthon" Enzyme Engineering XII, Ann. N. Y. Acad. Sci., Vol. 673, 1993.
• "Trifluroacetic Acid Mediated Cleavage of a Triethylsilyl Protecting Group: Application in the Final Step of the Semi-Synthetic Route to Paclitaxel (TaxolÒ)." Organic Process Research and Development, 2003, 7(1), 25-27.
• "Development of an Efficient and Practical process for the Preparation of Ixabepilone: A Semisynthetic Epothilone B Analog", manuscript in preparation, 2008.
• "A Novel Trans-Cis Isomerization via an Allylic-Azido [3,3]-Sigmatropic Rearrangement Observed in the Azidation of Epothilone B", manuscript in preparation, 2008.

• "Novel beta-Lactams, Methods for the Preparation of Taxanes, and Side chain-bearing Taxanes"; U.S. Patent 6,310,201, 10/30/2001; U.S. Patent 6,350,866B10, 2/26/2002; U.S. Patent 6,350,887B1, 2/26/2002.
• "Phosphonooxymethyl Ethers of Taxane Derivatives", US Patent 5,646,176, 7/8/97.
• "Phosphonooxymethyl Ethers of Taxane Derivatives" US Patent 6,455,575B2, 09/24/02.
• "Preparation of Phosphonooxymethyl Taxane ethers as Neoplasm Inhibitors"EP 604910(1994) US 2001023255 (2001)
• "Reduction and Resolution Methods for the Preparation of Compounds useful as Intermediates for Preparing Taxanes," U. S. Patent 5,602,272, and 5,817,867, 02/11/97.
• "A process for the preparation of epothilone analogs", WO 0170716, 2001 & US Patent 6,518,421, US patent 6,518,421 B1, Feb/2003.
• "A process for the preparation of epothilone analogs and intermediates",European patent, 07020071.2-1521, Feb 2008.
• "Stereoselective Synthesis of beta-nucleosides" US Patent Application, 60/592,412, July/2004
• "Stereoselective Synthesis of Gemcitabine" US Patent Application, 60/880,607, Jan/200

"Novel Intermediates in Synthesis of Gemcitabine" US Patent Application, 60/881,752, Jan/2007