MIDD: Vaccine R&D Gets a Shot in the Arm from Pharmacometrics Jeffrey R. Sachs, PhD Senior Principal Scientist at Merck & Co. Wednesday Jan 22, 2020, 12:00 to 1:00 pm EST Register for free at https://www.rosaandco.com/webinars Abstract: The objective is to (1) inform the audience about pharmacometrics (PMX) opportunities in vaccine discovery and development (D&D), and (2) to motivate, by examples, PMX practitioners to impact vaccine D&D. Prophylactic vaccines are safe and effective and have made an immense contribution to human and animal health [1]. Pharmacometrics (PMX) has only recently been introduced to vaccine discovery and development, and is now becoming fully integrated into, and impactful on decision-making. This has resulted in better scientific understanding, increased POS, substantial savings, and other benefits that have been seen in the other therapeutic areas that have adopted PMX. The impact of this work has included go/no-go decisions, design of efficient pre-clinical and clinical trials, integration of preclinical and clinical data, quantitative prediction for go/no-go and dose-level decisions, and integration of data across multiple trials for more informed decision-making. The methods used include QSP modeling, trial simulation, Bayesian inference, and model-based meta-analyses ("comparator modeling"). The presentation will start with a background on vaccine discovery and development including a brief overview of: the risk/benefit considerations in vaccines, the choices and uses of biomarkers to mitigate risk, vaccine terminology, the immune system, and vaccine platforms (DNA, protein, VLP, etc.). This will be followed by examples across the spectrum of applications from discovery through development and across the many kinds of decisions impacted and methods used. These will include applications of M&S that
* supported both Go and No-Go decisions * increased power in trial design while saving considerable cost by optimizing sampling of subjects' disease state. * providing a novel phase 3 endpoint substantially increasing power of a proposed trial design
