Social Aspects of Drug Discovery, Development and Commercialization

Odilia Osakwe, Syed A.A. Rizvi

• Publisher: Academic Press
• Year: 2016
• Print ISBN: 9780128022207
• eBook ISBN: 9780128024973
• Topic: Medicine
• Subtopic: Pharmacology

Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society. - Organized in a sequence of interrelated theories and principles that provide the foundation for increased understanding of the relevant social aspects - Includes analysis of important new advances, key scientific and strategic issues, and overviews of recent progress in drug development - Provides a global perspective with examples from developed areas, such as the US, Japan, Canada and Europe, as well as faster-growing and emerging economies including Brazil, Russia, India, and China - Serves as an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society

Section II

Drug Discovery Cycle I: Discovery and Preclinical Drug Development

Chapter 4: Prediscovery Research: Challenges and Opportunities

Chapter 5: The Significance of Discovery Screening and Structure Optimization Studies

Chapter 6: Preclinical In Vitro Studies: Development and Applicability

Chapter 7: Animal Utilization in Drug Development: Clinical, Legal, and Ethical Dimensions

Chapter 8: Pharmaceutical Formulation and Manufacturing Development: Strategies and Issues

Chapter 4

Prediscovery Research: Challenges and Opportunities

Odilia Osakwe

Abstract

The modern pharmaceutical industry is wary of low drug discovery rates, and, most importantly, the diminishing efficiency in identification of viable disease-linked molecular targets as drug targets and lead compounds continue to emerge in large numbers. The cumbersome task of tackling progressively more complex, multivariate forms of disease in target populations coupled with the nature of research technology underlie this pitfall. Insufficient predictive power has been a high impact factor in drug discovery, particularly as basic research is the starting point. This chapter presents the level of knowledge developed in identification and selection of drug targets, and the opportunities and hurdles encountered.

Keywords

drug targets

discovery research

molecular networks

pathological pathways

systems biology

polypharmacology

disease pathways

omics technology

Contents

4.1 Introduction 85

4.2 Models of Human Disease Biology 88

4.2.1 Target-Based Drug Discovery 88

4.2.2 Phenotypic Drug Discovery 89

4.3 Diseases Considered in Biopharmaceutical Research and Development 91

4.4 Modern Trends in Drug Discovery 91

4.4.1 Extracellular RNA Communication as an Emerging Paradigm in Drug Discovery 91

4.4.2 The Applicability of Systems Biology in Drug Discovery 92

4.4.3 The Omics Technology 93

4.4.4 Network: A Systems Biology Approach to Drug Discovery 95

4.4.5 Mapping the Disease Association Networks 96

4.4.6 Polypharmacological Profiling: A Novel Approach to Drug Discovery 98

4.4.7 Multiple Transporters Drug Targeting 101

4.5 Current Challenges in Early Drug Discovery 101

4.5.1 Setbacks in Identification and Selection of New Targets 101

4.5.2 Network/System Biology Application-Limitations 103

4.5.3 The Impact of the Pharmaceutical Ecosystem 104

4.5.4 Effect of Size and Capability 104

References 105

4.1. Introduction

Drug therapies are generated through manipulation of the activity of human proteins, known in the industry as targets that have been implicated in disease pathways. Pharmaceutical firms have encountered several roadblocks in the drug discovery of novel drug molecules, especially those that work against new targets.

Prediscovery research investigations are carried out to understand disease and its causes at the level of cell genes and proteins in order to identify novel targets of therapeutic value. Many diseases are modulated at the gene level. A well-understood genetic root of a disease enables the determination of risk factors to recommend a therapy. For example, genes could be activated or deactivated by drugs or totally replaced through gene therapy. The advent of molecular science brought remarkable breakthroughs in disease diagnosis and therapy. The understanding of the disease mechanism provides the first “green light” to seeking intervention and possible treatment options. The Human Genome Project, which discovered the 3 billion bases of human DNA, enabled an advanced understanding of human biology and is the foothold for the “omics” technology that has revolutionalized the science of drug discovery. The project moved the fledgling field of genomic science, characterized by its slow pace and cost, toward an enhanced and highly efficient approach currently applied in biomedical research [1,2]. The posthuman Genome Project era enabled identification of compounds that...

Table of contents

• Cover
• Title page
• Table of Contents
• Copyright
• Dedication
• Preface
• Introduction
• Section I: Pharmaceutical Industry, Society, and Governance
• Section II: Drug Discovery Cycle I: Discovery and Preclinical Drug Development
• Section III: The Drug Discovery Cycle II: Clinical Development
• Section IV: The Drug Discovery Cycle III: Authorization and Marketing
• Index