I-lan Sue

Biography

 Ms. Sue joined PharmTak in February 2011. She has more than 20 years of experience in pharmaceutical product development and in retail pharmacy as a pharmacist. Her expertise includes solid dosage form development and manufacturing, process scale up and validation, cGMP regulations, and FDA IND, NDA, and ANDA submissions. Ms. Sue has product development experience in both branded and generic pharmaceutical products. As a consultant for several US pharmaceutical companies in the early 2000s, Ms. Sue assisted with drug development programs, conducted experimental design and data analysis to evaluate processing parameters, and developed products for several challenging new drug candidates. Before going into consulting, she was a senior scientist at Oread, Inc. responsible for project management, drug development problem solving, product manufacture for clinical studies, and preparation of product development reports. Prior to joining Oread, Ms. Sue served in various management positions at Impax Laboratories, Inc. Her responsibilities included generic drug development focusing on controlled-release technologies, patent application, technology transfer, process scale up, and regulatory document preparation for FDA filing. While at Gilead Sciences, Inc., Ms. Sue was heavily involved in their first oral dosage form program from IND to NDA stages. She developed products suitable for toxicological assessments, clinical trials, and market launch. Prior to joining Gilead, Ms. Sue was a senior research chemist in Syntex Research. She was involved in a wide variety of formulation development projects of new chemical entities and participated in a team of senior scientists to develop strategic plans applicable for drug development process optimization. Ms. Sue received her B.S. in Pharmacy from National Taiwan University in 1981 and her M.S. in Pharmaceutics from the University of Texas at Austin in 1984. She has six patents and seven publications.  

Research Interest

 solid dosage form development and manufacturing, process scale up and validation, cGMP regulations, and FDA IND, NDA, and ANDA submissions