Diane Mould is currently president of Projections Research Inc., a pharmacometrics consulting company.
Brian Moyer is president and principal of BRMoyer & Associates and a full-time senior science advisor for the Biomedical Advanced Research and Development Authority (BARDA), of the Assistant Secretary for Preparedness and Response (ASPR).
Shashi Amur is currently the Scientific Coordinator of the Biomarker Qualification Program at the Office of Translational Sciences, CDER, FDA.
Arnab Mukherjee is currently director, clinical pharmacology, at Pfizer Inc.
Advances in molecular medicine, genomics, imaging, pharmacometrics, and clinical research have generated a wealth of new methodologies expected to improve the safety and efficacy of pharmaceutical therapeutics by explaining variability in patient response to therapy. The ultimate goal is to utilize new information to optimize therapy for individual patients—that is, treating patients with the right dose of the right drug at the right time—to maximize benefit and minimize risk. Terms such as personalized, individualized, or stratified medicine are used interchangeably to describe this concept. Identification, qualification, and approval of patient factors predictive of efficacy or safety are typically performed by academic researchers, drug developers, and regulators during drug development or post-approval. Using the information for individual patient care is the prerogative of the clinical care provider, who must be equipped to collect, organize, and interpret the large volume of patient-centric information. Ensuring consistent and efficient utilization of data remains a challenge, requiring multidisciplinary collaboration and communication between scientists and clinicians working in academia, drug development, regulatory organizations, and clinical care settings. Continue reading