Translational Research Methods in Diabetes, Obesity, and Nonalcoholic Fatty Liver Disease: A Focus on Early Phase Clinical Drug Development
暫譯: 糖尿病、肥胖症及非酒精性脂肪肝疾病的轉譯研究方法：聚焦早期臨床藥物開發

本書旨在協助選擇最適合用於新藥臨床研究早期階段（第1和第2期）的方法，針對糖尿病、肥胖症、非酒精性脂肪肝病（NAFLD）及相關的心代謝疾病。

臨床研究方法用於評估新糖尿病藥物的藥物動力學和藥物效應學，例如，穩定血糖夾鉗技術（euglycemic clamp technique）在機制驗證研究中已變得相當成熟。然而，選擇最合適的技術並非易事。此外，這些方法的應用必須符合新藥的監管要求。

本書討論了對於糖尿病、肥胖症和NAFLD的新藥物治療的需求，以及目前正在開發的藥物的分子靶點。新興技術，包括功能影像學、循環生物標記物和組學（omics），將與涉及心代謝疾病受試者的早期臨床試驗的實際和倫理問題一起考量。

《糖尿病、肥胖症及非酒精性脂肪肝病的轉譯研究方法》對生物醫學科學家、藥理學家、參與代謝研究的學者以及在這些專業領域執業的臨床醫生具有興趣。

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

安德魯·J·克倫茨（Andrew J Krentz）是ProSciento的高級研究員，擁有超過三十年的糖尿病和心臟代謝醫學經驗。他目前是英國雷丁大學的訪問教授。在此之前，他曾擔任英國南安普敦大學醫院的高級醫生和高級講師。他曾在美國加州大學聖地亞哥分校和新墨西哥醫學院擔任研究職位。他是《心血管內分泌學與代謝》（Cardiovascular Endocrinology & Metabolism）的主編，並在同行評審的醫學期刊上發表了超過100篇文章。

克里斯蒂安·韋耶（Christian Weyer）是一位擁有超過20年專注於糖尿病、肥胖和非酒精性脂肪肝病/壞死性肝炎（NAFLD/NASH）藥物開發經驗的製藥高管。作為Amylin Pharmaceuticals和Intercept Pharmaceutics的研發負責人，他對多種一流藥物在1型和2型糖尿病、脂肪異常症以及進行性非病毒性肝病的開發、監管批准和/或生命週期管理做出了貢獻，並參與了針對肥胖和NASH的新藥候選者的中期和晚期開發。韋耶博士曾擔任ProSciento的總裁和首席開發官，並作為訪問研究員在美國國立衛生研究院（NIH）NIDDK工作，並在內分泌學和代謝領域發表了超過100篇同行評審的出版物。

馬庫斯·霍姆佩施（Marcus Hompesch）是ProSciento的首席執行官和董事會主席，是代謝疾病領域的公認專家，持有醫師執照並且是一位企業家。他在設計、執行和發表代謝疾病臨床研究方面的經驗來自於超過20年的臨床醫生和臨床研究者的工作。至今，霍姆佩施博士已發表超過90篇出版物，並擔任過轉化研究方法教科書的編輯和作者，還是期刊《內分泌學、糖尿病與代謝》（Endocrinology, Diabetes & Metabolism）的主編。他於2003年成立了ProSciento, Inc.，加州。