Currently Chief Technology Officer at Porton Pharmatech/J-Star Research, Inc. San Kiang is an SME in continuous processing API, continuous processing DP, particle engineering, pharmaceutical composite material, co-processing and pharmaceutical process scale up in both API and DP. He is also a Research Professor at Rutgers University Department of Chemical Engineering. San does research projects on continuous manufacturing and material science related to pharmaceuticals. While he championed workflow in pharmaceutics development that eliminates DS/DP boundary, he also gained 35 years of pharmaceutical development and technology transfer experience in Bristol-Myers Squibb covering both Active Pharmaceutical Ingredient (API) and Drug Product (DP) areas. His expertise lies in crystallization, particle engineering, reaction engineering, continuous processing (both DP and API), pharmaceutical composite material (PCM) and co-processing. PCM is a relatively new technology in which API and excipients are combined under controlled conditions to produce a composite material with unique properties that can be used to address some common issues in formulation development, such as content uniformity, stability, powder flow, taste, drug release profile, bioavailability, and material handling containment requirements.
Moreover, San is a PhD chemical engineer with experience in directing multi-disciplinary teams in the scale-up of pharmaceutical, chemical and biochemical processes from development to manufacturing. He participated in 11 NDA projects that were eventually commercialized and achieved success in QbD filing with the inclusion of risk assessment and process modeling to emphasize fundamental approach to process design. Focused on problem-solving through mechanistic understanding, San is a results and execution oriented manager. He has comprehensive knowledge of cGMP, advanced development techniques, strategic sourcing, plant facilities and issues at the API-DP interface. He is a recognized pioneer in pharmaceutical engineering and the application of PAT as well as an expert in crystallization and particle engineering issues. He holds an extensive network with FDA, universities, research centers and technology consortia.
Workshop: Enabling Technologies for Tox/FIH Formulation