This article was originally published in PR Newswire website.
PharmaBlock (300725.SZSE), an innovative chemistry products and services provider to support drug discovery, development, and commercialization, announces the appointment of Dr. Zhengtian (Titan) Gu as Senior Vice President of Quality and Regulatory Affairs, responsible for corporate quality management and regulatory affairs.
Dr. Gu has more than 20 years of R&D and management experience in pharmaceutical development. He has worked at Proctor & Gamble, GSK, 3M, and Theravance Biopharma in the fields of analytical chemistry and drug metabolism & pharmacokinetics. Prior to joining PharmaBlock, Dr. Gu served as Vice President of Analytical Development & Quality Control at Theravance, spearheading critical efforts for new drug development and management. He led the CMC team for the Vibativ (Telavancin for injection) project from Phase II to regulatory approval and commercialization in US, EU, Canada, Russia and other countries. Since 1998, Dr. Gu has participated in or led over ten new drug development projects, with five of them achieved market approval.
Dr. Gu has experience in CMC aspects of new drug registration spanning markets including the US, China, and the EU, among others.
Dr. Gu obtained his Ph.D. in Biophysical Chemistry from Department of Chemistry at Columbia University. Dr. Gu also completed his postdoctoral fellowship at Memorial Sloan-Kettering Cancer Center in New York and University of Pennsylvania in Philadelphia.
"Dr. Gu has deep understanding of the quality management and regulatory affairs of new drug development, especially with many years of experience in global drug R&D companies. He will lead our team to further improve the quality management system and provide greater support to clients' CMC filing project." said Dr. Wenfang Miao, CEO of PharmaBlock. "We hope to continue to strengthen CDMO capacity by bringing in industry veterans. Our management team and senior technical experts with diverse backgrounds covering the entire CMC process can better guide the team to provide clients with fast, consistent quality, and fully compliant drug development and manufacturing solutions."