Intro
Foreword
Preface
Acknowledgments
Contents
About the Editor
Abbreviations
List of Figures
List of Tables
Blockchain Uses and Real World Evidence
Introduction to Blockchain
1 Introduction
2 Blockchain Core Characteristics
2.1 Ledgers
2.2 Cryptography
2.3 Immutability (Tamper Evidence and Tamper Resistance)
2.4 Distribution
3 Blockchain Features
3.1 Permissionless Versus Permissioned
3.2 Permissionless
3.3 Off-Chain Versus On-Chain Storage
3.4 Smart Contracts
4 Blockchain Benefits for Life Sciences
4.1 Trust

4.2 Audit Trails-Provenance
4.3 Data Transparency Versus Privacy
4.4 Security
4.5 Performance
5 Conclusions
6 Key Terminology and Definitions
References
Blockchain in Pharmaceutical Research and the Pharmaceutical Value Chain
1 Brief Overview of Pharmaceutical Research
1.1 Drug Delivery and Discovery
1.2 Challenges Associated with Drug Delivery and Discovery
1.3 Challenges Associated with Preclinical (i.e., In Vitro, In Vivo) and Phase 0/I-IV Studies
2 Introduction of the End-To-End Pharmaceutical Value Chain

2.1 Five Main Categories: (1) Research and Discovery, (2) Clinical Development, (3) Manufacturing and Supply Chain, (4) Launch and Commercial Considerations, and (5) Monitoring and Health Records
2.2 Differentiating Pharmaceutical Value Chain from Pharmaceutical Supply Chain
3 Blockchain Efforts Within Pharmaceutical Industry
3.1 Pharmaceutical Users Software Exchange (PhUSE) Blockchain Project
3.2 Innovative Medicines Initiative (IMI) Blockchain-Enabled Healthcare

3.3 The MELLODDY Project and Millions of Molecules Blockchain + Smart Contracts for Human Participant Regulations and Consent Management
3.4 Information Exchange and Data Transformation (INFORMED) Initiative
3.5 Moneyball Medicine
4 Mapping Blockchain Characteristics to Pain Points in the Pharmaceutical Value Chain
4.1 Adapted Fit-For-Purpose Framework and Design Elements
4.2 Matching Characteristics (e.g., Decentralized, Distributed, Conditionally Immutable, Scalable, Cryptographically Secured) to Identified Pain Points in Each of the 5 Categories

5 Blockchain-But Not in a Vacuum
5.1 Blockchain-Complementary Established and Emerging (e.g., Machine Learning, Artificial Intelligence) Technologies for the Pharmaceutical Value Chain
6 Debunking Myths Around Challenges with Blockchain
6.1 The Myth of the Technical Challenge
6.2 The Reality of Challenges Tied to Change Management, Resource Allocation, Paradigm Shift, and Reaching Consensus
7 Blockchain and The Idea Pipeline
7.1 Pharmacogenomics
7.2 Collaborative Pharmaceutical Development
7.3 Patient Access, Medication Reclamation, and Prescription Waste Reduction