These proceedings from the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana, from May 16th to 18th, 2016, consist of selected, invited, enhanced, and reviewed papers on topics that range from statistical applications in drug discovery and CMC to biomarker, clinical trial, and statistical programming. All contributions feature original, peer-reviewed research, and the selected papers cover the spectrum of pharmaceutical R&D - with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup...