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Pharmaco-Imaging in Drug and Biologics Development

Fundamentals and Applications

Beschreibung

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.

Mr. Brian R. Moyer is Owner/President of BRMoyer & Associates, LLC, Bedford, NH, consulting in medical imaging, radiation/chemical injury, and PK/TK services. He is under contract as a Sr. Science Advisor for HHS/BARDA, Washington, D.C., for Radiation-Chem countermeasure development. Mr. Moyer earned an M.S. in Pharmacology (Univ. of California, San Francisco), an M.S. in Toxicology (Univ. of San Francisco), and is board-certified in Nuclear Medicine Technology (CNMT).  He has over 40 years in the imaging field with over 80 publications and has contributed toward six drug approvals.

Dr. Narayan Cheruvu is Sr. Principal Clinical Pharmacologist at Covidien, St.Louis, MO.  He earned a B.S. in Pharmacy (Andhra Univ.), an M.S. in Pharmacy (Institute of Technology-Banaras Hindu Univ., India) and a Ph.D. in Pharmaceutical Science (Nebraska Medical Center, Omaha, NE).  Dr Cheruvu has more than 9 years in preclinical/clinical pharmacology, more than 20 publications and has contributed toward three drug approvals.

Dr. Tom C.-C. Hu is a Project Officer at HHS/BARDA, Washington D.C., overseeing contracts for Radiation-Chem countermeasure development and rapid radiation biodosimetry. He is an Asst. Professor of Radiology (Medical College of Georgia) and served as Principal Scientist at GlaxoSmithKline PLC.  Dr. Hu earned a B.S. in Chemistry (Univ. Pittsburgh), an M.S. and Ph.D. in Chemistry (Carnegie Mellon Univ), and an M.B.A (Villanova Univ).