A Pitfall in Drug Discovery

SOCIAL ASPECTS OF DRUG DISCOVERY, DEVELOPMENT AND COMMERCIALIZATION ODILIA OSAKWE, MS, PhD Industrial BioDevelopment Laboratory, UHN-MaRS Centre Toronto Medical Discovery Tower and Ryerson University, Toronto, Canada SYED A. A. RIZVI, MSc, MBA, MS, PhD (Pharm), PhD (Chem), MRSC Department of Pharmaceutical Sciences, Nova Southeastern University, Fort Lauderdale, FL, 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 50 Hampshire Street, 5th Floor, Cambridge, MA 02139, USA The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK Copyright © 2016 Elsevier Inc. All rights reserved. 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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 ISBN: 978-0-12-802220-7 For information on all Academic Press publications visit our website at http://store.elsevier.com/ Typeset by Thomson Digital Publisher: Mica Haley Acquisition Editor: Kristine Jones Editorial Project Manager: Molly McLaughlin Production Project Manager: Lucía Pérez Designer: Vicky Pearson To Philomena and Chioma PREFACE A considerable number of textbooks have delivered substantial information on the scientific and technological aspects of drug discovery and development, but very few have touched upon the social aspects. The idea of writing this book was stimulated by this necessity along with an emergent notion, which grew out of my experience as a lecturer on this subject, in Ryerson University. The Social Aspects of Drug Discovery, Development and Commercialization presents a holistic overview of the entire drug discovery process, as it tran- sitions from inception, to a pill in the hands of the patient. It explains the importance for it to be addressed comprehensively, to include all areas that interact with the society. This will enable a proper understanding of the workings of the pharmaceutical enterprise, from which springs forth the medical products that are supplied to the wide public. This will serve as a knowledge base to streamline ideas and perspectives about how drugs are created and distributed; for a regular citizen, an investor in the pharmaceutical business, or students or professionals who need to be updated on pharmaceutical affairs. In other words, this information helps the reader in decision making on the proper approach to healthcare and its products; and provides for the scholar or professional, a strong grounding in this subject area. One outstanding characteristic of this textbook is that, it provides defi- nitions and explanations of the relevant background information to serve as a framework for understanding the social aspects, making it a user-friendly resource for a wide range of readers. It details the key participants, rela- tionships, and processes involved in the full drug discovery programs that span the pharmaceutical product lifecycle that are necessary for creating the medical solutions delivered to the public, as represented in the pharmaceutical ecosystems. Analysis of the paths of pharmaceutical innovation is within the context of the pharmaceutical ecosystem. For example, pharmaceutical policy and laws have emanated from extensive debate by a hierarchy of government-appointed groups, agencies, social groups, such as patient representative groups, representatives of charities and consumer associations, pharmaceutical and allied professionals, and other groups from various strata of the healthcare systems who are the voice of command in these decision making activities. Pharmaceutical ecosystems embrace the stakeholders, the xiii xiv Preface processes, and technologies whose cross-interactions strengthen the drug discovery programs. What type of knowledge is gained by the readers of this book? The introductory chapter gives a general overview of the whole process, which serves as a foundation for the rest of the 13 chapters. Every chapter sequentially builds from the previous and all of which represent a progressive pathway in the discovery of an investigational drug molecule as it morphs into a full drug product that is accessed by the public. This book attempts to answer certain exemplary questions. Chapter 1: What is the origin, meaning, and relevance of the pharmaceutical laws and regulations? Chapter 2: What is the pharmaceutical productivity landscape? Is pharmaceutical innovation sustainable? What is the technological flow, applicability, and effectiveness? What is the economic landscape for emerging pharmaceutical firms? What are the prospects and trend over the years? Chapter 3: What is responsible for hiatus or demise of the drug discovery pipeline in the initial stages of the drug discovery events? What are the re- lationships between the emerging and the big pharmaceutical companies? Chapters 4-6: How is the drug discovery pipeline advancing toward pro- viding the needed medical solutions to diseases, especially the deadly ones? What are the hopes of families that have to grapple with life-threatening diseases? What is new in finding disease pathways and new drug mol- ecules? Chapter 7: The animals chosen for testing of drug candidates, does this decision directly correlate with therapy pursued or are animals over utilized? How do the different species differ in pharmacological response? Chapters 8 and 9: Are drugs manufactured to precision? What is the reason for drug recalls? Chapter 9: Are clinical trials conducted to reflect specific public interests? What are the patients’ rights as participants in clinical trials? What are the opportunities and setbacks in multinational clinical trials? Chapter 10: Why are certain drugs more compatible with certain individuals and the experienced adverse events in only certain individuals? What is the applicability of individualized or precision medicine? Chapter 11: How does patents alter drug accessibility? What are the legal factors that affect patents and emergence of generics? How fast could generics be reached? Chapter 12: How does drug marketing benefit the end user? Chapter 13: What is the flow of drug pricing around the globe? This book could serve as a training tool or reference guide for students and professionals in most of health science and allied disciplines; pharmacy, pharmaceutical sciences, pharmacology, clinical and translational research, medicine, nursing, and more. This also applies to those in pharmaceutical Preface xv law and policy, health policy and management, and pharmacoeconomics. It can also be a useful information base for students and professionals in regulatory affairs, who are expected to be thorough in the knowledge of drug discovery. The text is delivered in a concise, direct, and soft language to stimulate interest and enliven your readership. I would like to extend my personal gratitude to Dr Syed A.A. Rizvi for his valued contribution to this work. Most and foremost, my hearty thanks goes to He who is the pillar of my life and who supplied the knowledge, courage, and strength that carried me throughout this process. Introduction 1 TRENDS IN DRUG DISCOVERY The pharmaceutical industry is of tremendous value to society, mainly be- cause of the active discovery and development of pharmaceuticals, which have increased quality of life through both ameliorating pain and suffering, and the treatment of diseases. Major landmarks in drug discovery that preceded the thalidomide trage- dy in the 1950s have led to a total overhaul of regulatory systems. Extensive federal governance has been deemed necessary to address the unsatisfactory efficacy and safety standards that characterized earlier drug manufactur- ing systems, which underlie

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