Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease (eBook)

Andrew J Krentz, Senior Research Fellow at ProSciento, is a clinical academic with more than three decades of experience in diabetes and cardiometabolic medicine. He is currently a visiting professor at the University of Reading, UK. Prior to this he was a senior physician and senior lecturer at University Hospital Southampton, UK. He has held research positions at the University of California San Diego and the New Mexico School of Medicine, USA. He is editor-in-chief of ‘Cardiovascular Endocrinology & Metabolism’ and has published more than 100 articles in peer-reviewed medical journals.Christian Weyer is a pharmaceutical executive with over 20 years of experience in the drug development focused on diabetes, obesity, and NAFLD/NASH.  As head of R&D at Amylin Pharmaceuticals and Intercept Pharmaceutics, he has contributed to the development, regulatory approval and/or life cycle management of several first-in-class medicines in the areas of type 1 and type 2 diabetes, lipodystrophy, and progressive non-viral liver diseases, as well as to the mid and late-stage development of novel drug candidates for obesity and NASH. Dr Weyer previously served as President and Chief Development Officer at ProSciento and as visiting fellow with the National Institutes of Health, NIDDK, and has authored over 100 peer-reviewed publications in the field of endocrinology and metabolism.  Marcus Hompesch, Chief Executive Officer and Chairman of the Board, ProSciento is a recognized expert in the field of metabolic diseases, a licensed physician and entrepreneur. His experience in designing, performing and publishing clinical studies in metabolic diseases has been gained through over 20 years of work as clinician and clinical researcher. To date Dr Hompesch has authored more than 90 publications, has been editor and author of a textbook on translational research methods and is editor-in-chief of the journal ‘Endocrinology, Diabetes & Metabolism’. He established ProSciento, Inc., CA in 2003

Part 1: Review of Clinical Investigative MethodsChapter 1: Quantifying Insulin Action in Humans Chapter 2: Assessment of Islet Alpha- and Beta-Cell FunctionChapter 3: Pharmacokinetic and Pharmacodynamic Assessment of Novel and Biosimilar Insulins Chapter 4: Measurement of Energy ExpenditureChapter 5: QUANTIFYING APPETITE AND SATIETYChapter 6: Non-invasive quantitative magnetic resonance imaging and spectroscopic biomarkers in nonalcoholic fatty liver disease and other cardiometabolic diseases associated with ectopic fat depositionChapter 7: Structural and Functional Imaging of Muscle, Heart, Endocrine Pancreas and Kidneys in Cardiometabolic Drug DevelopmentChapter 8: Positron emission tomography and computed tomography measurement of brown fat thermal activation: key tool for developing novel pharmacotherapeutics for obesity and diabetesChapter 9: Isotopic Tracers for the Measurement of Metabolic Flux RatesChapter 10: Role of Tissue Biopsy in Drug Development for NonAlcoholic Fatty Liver Disease and Other Metabolic DisordersChapter 11: Utility of Invasive and Non-invasive Cardiovascular Research Methodologies in Drug Development for Diabetes, Obesity and NAFLD/NASH Chapter 12: Omics: Potential role in early phase drug developmentPart 2: Preclinical Drug Development and Transitioning to Clinical StudiesChapter 13: Peptide Drug Design for Diabetes & Related Metabolic DiseasesChapter 14: ANIMAL MODELS OF TYPE 2 DIABETES, OBESITY AND NONALCOHOLIC STEATOHEPATITIS – CLINICAL TRANSLATABILITY AND APPLICABILITY IN PRECLINICAL DRUG DEVELOPMENTChapter 15: Drug Development for Diabetes Mellitus: Beyond Hemoglobin A1c Chapter 16: Emerging Circulating Biomarkers For The Diagnosis And Assessment Of Treatment Responses In Patients With Hepatic Fat Accumulation, Nash And Liver FibrosisChapter 17: Quantitative Approaches in Translational Cardiometabolic Research: An OverviewChapter 18: Transitioning from Preclinical to Clinical Drug DevelopmentChapter 19: Regulatory Considerations for Early Study and Clinical Development of Drugs for Diabetes, Obesity, NonAlcoholic Steatohepatitis (NASH) and other Cardiometabolic DisordersChapter 20: Early Phase Metabolic Research with Reference to Special Populations