About me
Dr. Chyi-Hung Hsu is a highly skilled pharmacokineticist and statistician, with 25+ years of experience in the pharmaceutical industry where he has supported drug development at every stage – from preclinical through all phases (0-4) of clinical trials.
Dr. Hsu is well versed in identifying opportunities for innovation via participating in CDP reviews/discussions, interacting with clinical teams and therapeutic area representatives for early identification of opportunities for innovation, and assessing feasibility to help establish prioritization of identified opportunities. Dr. Hsu’s vast experience in modeling and evidence synthesis provides support for key decision during the drug development process. With a deep understanding of disease progression, population PK, population PK/PD, dose-response, exposure-response, and longitudinal dose-exposure-response modeling, he plays a major role in supporting any drug development project.
His statistical prowess in supervised and unsupervised leaning for data explorations, as well as MBMA and Bayesian approaches, for evidence synthesis and decision supports have been essential to several major projects. He can apply his statistical knowledge to clinical trial design – using modeling, trial simulations, and machine learning techniques to assist population selection, endpoint selection, dose regimen selection, trial duration determination, and model-based sample size calculations. He has vast knowledge in designing and analyzing adaptive designs, including CRM, seamless Ph1-2, seamless Ph 2-3, adaptive Ph 2, and Ph 3 trial designs. He brings to the team an ability to utilize Bayesian methodology in design and analysis of basket and platform trials. His skills are also applicable to pediatric trial designs and analyses – by leveraging external and adult data, he can enhance pediatric Ph1 and Ph 3 trial efficiency.
