Regulatory Aspects of Gene Therapy and Cell Therapy Products A Globa
Medical literature for health care practitioners on the evaluation and treatment of breastfeeding issues has been disjointed, conflicting, and difficult to find. The field of breastfeeding medicine itself is nonexistent—there are no "breastfeeding doctors
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Maria Cristina Galli Mercedes Serabian Editors
Regulatory Aspects of Gene Therapy and Cell Therapy Products A Global Perspective
Advances in Experimental Medicine and Biology American Society of Gene & Cell Therapy Guangping Gao, University of Massachusetts Medical School, Worcester, MA, USA Dirk Grimm, University of Heidelberg, Heidelberg, Germany
Volume 871 Editorial Board: IRUN R. COHEN, The Weizmann Institute of Science, Rehovot, Israel ABEL LAJTHA, Nathan S. Kline Institute for Psychiatric Research, Orangeburg, NY, USA JOHN D. LAMBRIS, University of Pennsylvania, Philadelphia, PA, USA RODOLFO PAOLETTI, University of Milan, Milan, Italy
More information about this series at http://www.springer.com/series/5584
Maria Cristina Galli • Mercedes Serabian Editors
Regulatory Aspects of Gene Therapy and Cell Therapy Products A Global Perspective
Editors Maria Cristina Galli Department of Cell Biology and Neurosciences Istituto Superiore di Sanità Roma, Italy
Mercedes Serabian Pharmacology/Toxicology Branch US Food and Drug Administration/ Center for Biologics Evaluation and Research/Office of Cellular, Tissue, and Gene Therapies Silver Spring, MD, USA
ISSN 0065-2598 ISSN 2214-8019 (electronic) Advances in Experimental Medicine and Biology ISBN 978-3-319-18617-7 ISBN 978-3-319-18618-4 (eBook) DOI 10.1007/978-3-319-18618-4 Library of Congress Control Number: 2015946741 Springer Cham Heidelberg New York Dordrecht London © American Society of Gene and Cell Therapy 2015 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper Springer International Publishing AG Switzerland is part of Springer Science+Business Media (www.springer.com)
Preface
Discoveries in the fields of gene therapy and cell therapy continue to be reported at a rapid pace around the world, resulting in potential therapies that may help treat many unmet medical diseases and conditions. We were invited by the American Society of Gene and Cell Therapy (ASGCT) to participate in a unique
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