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Tools and Techniques TRANSLATIONAL MEDICINE: TOOLS AND TECHNIQUES Edited by AAMIR SHAHZAD President, European Society for Translational Medicine (EUSTM), Vienna, Austria; School of Medicine University of Colorado, Aurora, CO, USA AMSTERDAM • BOSTON • HEIDELBERG • LONDON NEW YORK • OXFORD • PARIS • SAN DIEGO SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO Academic Press is an imprint of Elsevier Academic Press is an imprint of Elsevier 125 London Wall, London EC2Y 5AS, UK 525 B Street, Suite 1800, San Diego, CA 92101-4495, USA 225 Wyman Street, Waltham, MA 02451, USA The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK Copyright © 2016 Elsevier Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval system, without permission in writing from the publisher. Details on how to seek permission, further information about the Publisher’s permissions policies and our arrangements with organizations such as the Copyright Clearance Center and the Copyright Licensing Agency, can be found at our website: www.elsevier.com/permissions. This book and the individual contributions contained in it are protected under copyright by the Publisher (other than as may be noted herein). Notices Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary. Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility. To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein. ISBN: 978-0-12-803460-6 British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress For information on all Academic Press publications visit our website at http://store.elsevier.com/ Typeset by TNQ Books and Journals www.tnq.co.in Printed and bound in the United States of America List of Contributors Adriana Amaro Molecular Pathology, IRCCS AOU San Martino–IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy Giovanna Angelini Molecular Pathology, IRCCS AOU San Martino–IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy Laurent Audoly Pierre Fabre Pharmaceuticals, Toulouse, France Pierre Ferré Pierre Fabre Pharmaceuticals, Toulouse, France Parviz Ghahramani Chief Executive Officer, Inncelerex, Jersey City, NJ, USA; Affiliate Professor, School of Pharmacy, University of Maryland, Baltimore, USA, [email protected] Dimitris Kalaitzopoulos Oracle UK, Health Sciences Global Business Unit, Reading, UK Ross D. LeClaire The Translational Bridge, LLC, Albuquerque, NM, USA Elizabeth K. Leffel Leffel Consulting Group, LLC, Berryville, VA, USA Alexandre Passioukov Head of Translational Medicine, Pierre Fabre Pharma- ceuticals, Toulouse, France Ketan Patel Oracle UK, Health Sciences Global Business Unit, Reading, UK Andrea Petretto Core Facility, Istituto G. Gaslini, Genova, Italy Ulrich Pfeffer Molecular Pathology, IRCCS AOU San Martino–IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy Benedikte Serruys Department of Pharmacodynamics & Translational Medicine, Ablynx, Ghent-Zwijnaarde, Belgium Thomas Stöhr A2M Pharma, Monheim, Germany Hans Ulrichts Department of Pharmacodynamics & Translational Medicine, Ablynx, Ghent-Zwijnaarde, Belgium Maarten Van Roy Department of Pharmacodynamics & Translational Medicine, Ablynx, Ghent-Zwijnaarde, Belgium Katrien Vanheusden Department of Pharmacodynamics & Translational Medicine, Ablynx, Ghent-Zwijnaarde, Belgium Gabriel Vargas Neuroscience Early Development, Amgen Inc., Thousand Oaks, CA, USA Stephen Wood Neuroscience Discovery Research, Amgen Inc., Thousand Oaks, CA, USA Erfan Younesi Fraunhofer Institute for Algorithms and Scientific Computing, Bioinformatics Department, Schloss Birlinghoven, Sankt Augustin, Germany ix About the Editor Dr Shahzad is currently serving as the president for the European Society for Translational Medicine. Moreover, he is the chairman, Steering Committee for the Global Translational Medicine Consortium. Dr Shahzad is a management committee member of the European Commission’s COST action to Focus and Accelerate Cell-based Tolerance-inducing Therapies (A FACTT) and also for the European Commission’s COST action on the Development of a European-based Collaborative Network to Acceler- ate Technological, Clinical and Commercialization Progress in the Area of Medical Microwave Imaging. Dr Shahzad is affiliated with the School of Medicine, University of Colorado, USA. He is visiting professor at the Basic Medical School, Harbin Medical University, and also holds visiting professorship at the First Affiliated Hospital, Harbin Medical University. Dr Shahzad is serving as an editor-in-chief for the “New Horizons in Translational Medicine” (NHTM) and “Translational Medicine Case Reports” (TMCR) journals, published by the Elsevier. Dr Shahzad has advised and participated in establishing translational medicine infra- structure for several organizations. Dr Shahzad has organized several international conferences and is invited chair for numerous international life sciences conferences. xi Preface In recent years, Translational Medicine (TM) has emerged as a powerful interdisciplinary field. To help clarify the many facets of TM the European Society for Translational Medicine (EUSTM) defined TM as an interdisci- plinary branch of the biomedical field supported by three main pillars: benchside, bedside, and community. The goal of TM is to combine disciplines, resources, expertise, and techniques within these pillars to promote enhancements in prevention, diagnosis, and therapies. Thus, the primary objective of TM is to combine available resources within the individual pillars in order to improve the global health care system. Translational Medicine: Tools and Techniques is a further initiative of the EUSTM to provide the scientific community with concise knowledge about TM tools and techniques. The initiative was undertaken to reduce confusion about techniques, tools, and applications. This book is intended to help professionals both in academia and industry as well as students and young investigators perusing careers in TM field. The book is divided into seven chapters and written by the internation- ally respected authors from both academia and industry. New approaches for biomarkers discovery, development, and validations are discussed in the Chapter 1. Chapter 2 presents advancements in data mining and management tools. Chapter 3 discusses the modeling and simulation applications in drug development process. Advancements in omics sciences are described in Chapter 4. Chapter 5 provides an overview of the regulatory process in United States of America, Europe, China, and Japan. A pearl of this book is the inclusion of case reports and studies, which will help the reader better understand TM applications. Chapters 6 and 7 include translational medicine case studies and reports. I am thankful to all the authors for their valuable time and contri- butions for this timely book. Moreover, I am very grateful to Ms Mica Haley and Ms Lisa Eppich from Elsevier for their continuous support and kindness during all stages of book production; without their help the pub- lication in such a short duration of time would not have been possible. Aamir Shahzad October 2015 xiii Acknowledgments Prof. Randall J. Cohrs Prof. Got t fried Khler USA Austria This book is dedicated to Prof. Randall J. Cohrs and Prof. Gottfried Köhler. Randall’s application of basic molecular virology findings to clini- cal problems demonstrates the many facets within translational medicine. Gottfried’s scientific journey from biophysics to molecular diagnostics is an inspiration to all endeavoring to succeed in translational medicine. Together, their excellent contributions and achievements in their fields, continuous encouragement, and support are always a source of inspira- tion. Special thanks to Ms Sandra Oberhuber for her wonderful support. The Acknowledgments section would remain incomplete without men- tioning my family: Mahrose Aamir and Sarah Shahzad as they sacrifice their time for completing the book. xv CHAPTER 1 New Developments in the Use of Biomarkers in Translational Medicine Benedikte Serruys1, Thomas Stöhr2, Hans Ulrichts1, Katrien Vanheusden1, Maarten Van Roy1 1Department of Pharmacodynamics & Translational Medicine, Ablynx, Ghent-Zwijnaarde, Belgium; 2A2M Pharma, Monheim, Germany OUTLINE Introduction 2 Biomarkers as Part of a Translational Strategy 4 New Types of Biomarkers 6 From Blood- to Tissue-Specific Biomarkers 6 From Static to Functional Biomarker Assays 9 From Static Ex Vivo Monitoring to In Vivo Continuous Imaging 10 From Single Protein Molecules to Nonbiochemical
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