Pharmaco-Imaging in Drug and Biologics Development

1. Front Matter

   Pages i-xvii

   PDF

2. Imaging Platforms and Drug Development: An Introduction

   • Brian R. Moyer

   Pages 1-43

3. Imaging in Drug Development: Animal Models, Handling and Physiological Constraints

   • David B. Stout

   Pages 45-62

4. Considerations for Preclinical Laboratory Animal Imaging Center Design, Setup, and Management Suitable for Biomedical Investigation for Drug Discovery

   • Brenda A. Klaunberg, H. Douglas Morris

   Pages 63-94

5. Pharmaco-Imaging in Translational Science and Research

   • Immanuel Freedman

   Pages 95-112

6. The Role of Pharmacokinetics and Allometrics in Imaging: Practical Issues and Considerations

   • Brian R. Moyer

   Pages 113-131

7. Quantitative Imaging Using Autoradiographic Techniques

   • Eric G. Solon, Brian R. Moyer

   Pages 133-185

8. Preclinical Imaging in Oncology: Considerations and Recommendations for the Imaging Scientist

   • Daniel P. Bradley, Tim Wyant

   Pages 187-213

9. Use of Radiolabelled Leukocytes for Drug Evaluation in Man

   • Chrystalla Loutsios, Neda Farahi, Charlotte Summers, Prina Ruparelia, Jessica White, Jonathan Potts et al.

   Pages 215-247

10. Application of Bioluminescence Imaging (BLI) to the Study of the Animal Models of Human Infectious Diseases

    • Hana Golding, Marina Zaitseva

    Pages 249-270

11. Preclinical Imaging in BSL-3 and BSL-4 Environments: Imaging Pathophysiology of Highly Pathogenic Infectious Diseases

    • Lauren Keith, Svetlana Chefer, Laura Bollinger, Jeffrey Solomon, Srikanth Yellayi, Jurgen Seidel et al.

    Pages 271-290

12. Magnetic Resonance as a Tool for Pharmaco-Imaging

    • Brian R. Moyer, Tom C.-C. Hu, Simon Williams, H. Douglas Morris

    Pages 291-326

13. Technologies and Principles of Mass Spectral Imaging

    • Kevin A. Douglass, Demian R. Ifa, Andre R. Venter

    Pages 327-353

14. Regulatory Considerations Involved in Imaging

    • Brian R. Moyer, Narayan P. S. Cheruvu, Tom C.-C. Hu

    Pages 355-390

15. Back Matter

    Pages 391-401

    PDF

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.

• Applications
• Cheruvu
• Development
• Discovery
• Drug
• Imaging
• Moyer
• Pharmaco

• BRMoyer & Associates, LLC, Bedford, USA

  Brian R. Moyer

• Covidien, Hazelwood, USA

  Narayan P.S. Cheruvu

• Health and Human Services Office of the Asst Secretary of Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), Washington, USA

  Tom C.-C. Hu

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).  

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