Ebook: Pharmaco-Imaging in Drug and Biologics Development: Fundamentals and Applications

The volume aim to be a comprehensive overview of the drug and biologic development process that is often called “the valley of death” (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape. Imaging tools can serve in this period by adding high value data, the images and the kinetic information they can provide, and cost-effective development alternative tools which potentially improve pivotal study designs. Imaging may identify safety issues early such as unwanted organ or tissue distributions, and then can serve advanced development with added certainty of a drug or biologic’s success to senior corporate management and investors. There are numerous textbooks, reference texts and treatises on medical imaging technologies, teaching tools on medical cases and physics books on the science of detector and computer interface systems. Rarely, in each of these are examples of medical imaging protocols and animal models of disease i.e. a text on methodology in drug development is currently unavailable.

Advances in drugs and biologics to mitigate or cure some of nature’s most complex medical problems have been incredible to behold. These accomplishments are due to the actions of a wide theatre of participants from biologists, pharmacologists, geneticists, chemists and manufacturers, molecular biologists, toxicologists, clinicians, nurses, program managers, quality assurance personnel, regulatory professionals and — a new group of innovators — the Imaging Scientists. Imaging has grown from the microscopy sections put on slides with special stains to now in vivo “slices” created with innovative physics, imaging tracers and contrast agents, and incredibly fast and accurate computational systems. The world of biology has become one of witnessing the actions of drugs and biologics through the window of mechanical and electrical engineering — creating instruments and reporter molecules that can help us “see” into our bodies and “paint” them with medical information needed to resolve disease. This book will inspire imagination and elicit even more innovations in the development of new and novel drugs and biologics through imaging.