Contract Research and Development Organizations Their Role in Global
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed wit
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Shayne C. Gad Charles B. Spainhour ●
Contract Research and Development Organizations Their Role in Global Product Development
Shayne C. Gad Gad Consulting Services 102 Woodtrail Lane Cary, NC 27518, USA [email protected]
Charles B. Spainhour Spainhour Consulting Services 27 Briarwood Way Clarks Summit, PA 18411, USA [email protected]
ISBN 978-1-4614-0048-6 e-ISBN 978-1-4614-0049-3 DOI 10.1007/978-1-4614-0049-3 Springer New York Dordrecht Heidelberg London Library of Congress Control Number: 2011931956 © Springer Science+Business Media, LLC 2011 All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
To my brother Scott Michael Gad and sister-in-law Rosa Gad, who left us too soon. Shayne C. Gad To my beloved wife, Joan, who is my best friend and who has been very devoted and supportive in all that I do; my good friend Shayne Gad, an outstanding professional and even more admirable human being for his friendship and always being there for me; and finally the Big Black Boys Amos, Andy, Tim, Jinkx, and Mike whose cold noses, wagging tails, and wild tongues make life tolerable. Charles B. Spainhour
Preface
Dr. Gad was privileged to start his career in toxicology more than 30 years ago in a testing laboratory that was a hybrid of a company lab and a contract testing lab. The Chemical Hygiene Fellowship of Carnegie Mellon Institute of Research (later known as Bushy Run Labs) was a near perfect environment to learn the practical aspects of regulatory toxicology testing while also being pushed to stay abreast of the then rapidly flowering science of toxicology. Though he has not worked in the contract research environment full time since then, the insights, work ethic, and friendships from those days have been invaluable. Alternatively, Dr. Spainhour started his career working for a small ethical pharmaceutical company by the name of Smith, Kline & French Ltd. During his tenure there managed to work in a variety of different disciplines in drug development, providing opportunities to understanding the mechanics of how drugs were discovered and developed. Eventually, Dr. Spainhour opted for an opportunity to work for a very small CRO, Pharmakon Research Laboratories and learned first-hand what contract research is all about and successfully grew and de
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