MENLO PARK, Calif., Dec. 7, 2011 /PRNewswire/ -- Jia-Hwa Fang, Ph.D., has joined SRI’s Biosciences Division as Director of Clinical Manufacturing. In this new role, he will lead a team to transfer and scale-up R&D, Good Laboratory Practice (GLP), and pilot formulations for early stage clinical trial materials in compliance with Good Manufacturing Practices (GMP). He will be responsible for developing technical, quality, and project specifications for studies in SRI’s pharmaceutical clinical manufacturing facility.
Dr. Fang has a broad range of expertise in process development and manufacture of small molecules and biologics for drug products such as parenterals, tablets, capsules, transdermals, and topicals. He has extensive experience in all phases of clinical manufacturing, including process development, scale-up, trouble-shooting, and validation. In addition, he has worked in technology and manufacturing process transfer for late stage products. He has authored and reviewed regulatory documentation and submissions such as manufacturing and validation protocols and chemistry, manufacturing, and controls sections for IND and NDA filings in the United States and EMA filings in Europe.
Dr. Fang has more than 20 years industry experiences at small and large biotech companies. Prior to joining SRI, he was a consultant for Impax Laboratories, Inc. Previously, he was director of formulation and manufacturing at CMC Technology Management Group and responsible for formulation and manufacturing at APT Pharmaceuticals. Earlier, he was a senior scientist at Novartis, Chiron Corporation, and TheraTech Inc. He has successfully developed and manufactured microparticles under aseptic conditions for Phase I clinical trials, including a proprietary adjuvant manufacturing process for Fluad® vaccine and transdermal formulations for Theraderm®.
Dr. Fang has a Ph.D. from the University of Missouri-Rolla and completed a postdoctoral fellowship at Clarkson University, where he developed and transferred a process for the manufacturing of perfluorohydrocarbon blood substitute emulsions.
About SRI’s Biosciences Division
SRI’s Biosciences Division carries out basic research, drug discovery, and drug development, and provides contract services. SRI has all of the resources necessary to take R&D from Idea to IND®from initial discovery to the start of human clinical trialsand specializes in cancer, immunology and inflammation, infectious disease, and neuroscience. SRI’s product pipeline has yielded marketed drugs, therapeutics currently in clinical trials, and additional programs in earlier stages. In its CRO business, SRI has helped government and other clients and partners advance well over 100 drugs into patient testing. SRI is also working to create the next generation of technologies in areas such as diagnostics, drug delivery, medical devices, and systems biology.
About SRI International
Silicon Valley-based SRI International, a nonprofit research and development organization, performs sponsored R&D for governments, businesses, and foundations. SRI brings its innovations to the marketplace through technology licensing, new products, and spin-off ventures. Commemorating its 65th anniversary in 2011, SRI is known for world-changing innovations in computing, health and pharmaceuticals, chemistry and materials, sensing, energy, education, national defense, and more.
SOURCE SRI International
