Dr. Boke Zhang     


Dr. Boke Zhang is the Founder and CEO of Mayly Life Science , a biotech company specialized in advanced nano-transdermal delivery technology development and applications in X-ceutical products ( i . e . : pharmaceuticals , cosmeceuticals and nutraceuticals) with lines of more than 40 cosmeceutical products currently on market . His is also the Chairman and CEO of Hangzhou Fuyuan Biotechnology Co . Ltd . and Hangzhou Meiyi Biotechnology Co . Ltd. He is the former Vice President of Product Development of Anterios Inc. , managing both large ( biologics ) & small drug molecules with company's proprietary novel drug delivery system for product development from preclinical to clinical phases . The novel technology platform developed can cut product development cycle time to market down to less than 4 years . Dr. Zhang has been responsible for Non-clinical Development ( API dev. , analytical , formulation, process dev., quality and manufacturing ) , Preclinical Development ( DMPK , Toxicology & Pharmacology ) , and partially responsible for Clinical Development ( human clinical trials Section in IND/NDA filing : design and data management ). In the past he also held various senior management positions such as Director of Analytical Development in Millennium Pharmaceuticals , and Deputy Director & Site Head of Analytical R&D of Baxter’s Cherry Hill site in NJ , both responsible for oral and injectable product development from RD to commercial . Prior to that , he was the Senior Manager of Global Analytical Development of Pfizer for products from discovery , development to commercial scales . Overall , Dr. Zhang has more than 25 year pharmaceutical industry experience in developing drug candidates from discovery through development to commercial market . His work experience includes Hua Bei Zhi Yao ( 华北制药 ) in China , Apotex in Canada , Pfizer , Baxter , Millennium and Anterios in US . His area of expertise includes method / process development and validation , formulation development , tech transfer , quality control , CRO / CMO management , GMP manufacturing , FDA inspection and regulatory submissions from phase 0 to phase 4 product developments in both non-GXP and GXP ( GLP , GMP , GCP and GDP ) environments . Representative Products Developed and Approved onto Market ( NDAs ) include Celebrex ® ( oral solid ) , Granisetron ® ( injectable ) , Synarel ® ( nasanyl metered-dose ) , Inspra ® ( Eplerenone ) , Covera – HS ® , Daypro ® ; Development Candidates ( phase 1-3 , INDs ) include Topical Botox Line of Products! MLN518 , 897 / 701 , 415 , 8054 , 8237 , 4924 , 6095 , 0002 , 1202 ; Generic Products ( ANDAs ) include ranitidine , misoprostol , doxazosin , paroxetine , arthrotec , verapamil HCl . Dr. Zhang received his Ph. D. degree in organic chemistry from University of Western Ontario , Canada in 1993 , M.Sc. degree in biochemistry and B.Sc . degree in organic chemistry from Lanzhou University in China in 1986 and 1983 , respectively .