Blockchain in Life Sciences

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
7.4 The Evolution of the Traditional Retail Pharmacy
8 Future Directions
9 Conclusions
References
Blockchain-Based Scalable Network for Bioinformatics and Internet of Medical Things (IoMT)
1 Introduction
1.1 Data Ownership
1.2 Data in Blockchain-Based Network
2 Case Implementation of Internet of Medical Things (IoMT) with Real Ownership
2.1 The Synsal Network
2.2 Sensors, Device Engineering, and Scaling in the Synsal Network
3 Tokenization and Value Scaling in the Blockchain-Based Network of Hardware Devices
3.1 Tokenization and Value Scaling
3.2 Basic Stabilization Tokenomics
4 Future Directions
5 Conclusions
References
Blockchains and Genomics: Promises and Limits of Technology
1 Introduction: A Brief History of Capitalization on Genes
2 The Scientific and Market Value of Genomic Data
2.1 On the Nature of Data, and the Data of Nature
2.2 Fair and Sustainable Data Use
3 Democratize, Decentralize, and Disintermediate Data (The Three Ds)
3.1 Blockchain Genomics: The Current Slate
4 Why Genomes Cannot Be Owned
5 How Shall We Treat Genes?
6 What About Non-Fungible Tokens, NFTs?
6.1 The Need for Regulation
7 Future Directions
8 Conclusions
References
Convergence of Blockchain and AI for IoT in Connected Life Sciences
1 Introduction
1.1 Fueling the Digital Transformation in Health and Life Sciences
1.2 Technology Unification
2 Harnessing the Power of Data-Driven Technologies in Life Sciences
2.1 Data-Driven Technologies in Life Sciences
3 Innovating in a Highly Regulated Industry
4 Essential Elements for Data Strategy in Life Sciences
4.1 Data Building Blocks
5 Prioritizing Risk Management in Life Sciences
6 Opportunities and Challenges for Emerging Digital Technologies in Life Sciences
6.1 Major Milestones in Life Sciences Product Development
7 Strategic Planning Frameworks
7.1 Blockchain and AI to Mitigate Risks of IoT/BYOD
7.2 Blockchain-AI Platforms and Infrastructures
8 Future Directions
8.1 Human as a Platform
8.2 Thinking Beyond the Adoption of Technology
9 Conclusions
References
A Blockchain-Empowered Federated Learning System and the Promising Use in Drug Discovery
1 Introduction
2 Overview of Federated Learning and Blockchain
2.1 Federated Learning
2.2 Barriers and Challenges in Drug Discovery
2.3 Challenges in Federated Learning
2.4 Blockchain Benefit for Federated Learning
2.5 The Benefits of Blockchain-Empowered Federated Learning for Drug Discovery
3 The Rahasak-ML Platform
3.1 Overview
3.2 Key Components
4 Rahasak-ML Federated Learning Process
4.1 Overview
4.2 Incremental Training Flow
4.3 Finalizing Model
4.4 The Use Case of Blockchain-Empowered Federated Learning in the Medical Field
5 Future Directions
5.1 Data Heterogeneity
5.2 Efficiency and Effectiveness
5.3 Model Interpretation
6 Conclusions
References
Considerations for Ensuring Success of Blockchain in Life Sciences Research
Valuing Research Data: Blockchain-Based Management Methods
1 Introduction
1.1 Nature of Health Data
1.2 Health Data Management
2 Data as an Asset
2.1 How to Value Data Assets
3 Data Sales Methods
3.1 Data Brokers
3.2 Centralized Data Marketplaces
3.3 Decentralized Data Marketplaces
3.4 Non-Fungible Tokens
4 Considerations
4.1 Ethical Considerations
4.2 Ownership
4.3 Data Considerations
5 Recommendations
5.1 Ethical Recommendations
5.2 Data Recommendations
5.3 Legal Recommendations
6 Future Directions
6.1 Regulations
6.2 Future Research
7 Conclusions
7.1 Key Terminology and Definitions
References
Blockchain Adoption in Life Sciences Organizations: Socio-organizational Barriers and Adoption Strategies
1 Introduction
2 Background Literature
3 Research Methods
4 Findings
4.1 The State of the Blockchain + Life Sciences Ecosystem
4.2 Socio-organizational Barriers for Blockchain Adoption in Life Sciences
4.3 Barrier 4: The Lack of an “Ecosystem” Mindset
4.4 Adoption Strategies
5 Discussion
5.1 Limitations and Future Directions
6 Conclusion
References
Blockchain Governance Strategies
1 Introduction
2 Defining Governance
3 A Deeper Dive: Blockchain Governance
3.1 On-Chain Governance
3.2 Off-Chain Governance
4 Types of Ecosystem Governance Decisions
5 Common Blockchain Governance Strategies
5.1 Founder Led/Benevolent Dictator
5.2 Core Development Team
5.3 Federations or Alliances
6 Ecosystem Roles
7 Typical Ecosystem for Life Sciences Blockchain
7.1 Special Considerations for Life Sciences
8 Recommendations
9 Future Directions
10 Conclusions
References
Life Sciences Intellectual Property Through the Blockchain Lens
1 Introduction
2 The Emergence of Blockchain in Life Sciences
3 The Intersection of Blockchain and Life Sciences IP Rights in the United States
3.1 Patents
3.2 Trademarks and Trade Dress
3.3 Trade Secrets
3.4 Copyrights
4 Transferring IP Rights Through Blockchains
5 Managing IP Rights Through Blockchain
6 Blockchain in Adversarial Proceedings Involving IP Rights
6.1 Anticounterfeiting
7 Future Directions
8 Conclusions
References
Regulatory Compliance Considerations for Blockchain in Life Sciences Research
1 Introduction
1.1 Regulatory Agency Uses of Blockchain
1.2 Regulatory Applicability
2 Regulatory Review and Documentation
2.1 System Design and Documentation
2.2 System Protection Features
2.3 Record and Signature Integrity
2.4 Verification and Validation
2.5 Training
3 Outsourcing
4 Future Directions
4.1 Standards
4.2 Blockchain Education
4.3 Research
5 Conclusions
5.1 Key Terminology and Definitions
References
The Art of Ethics in Blockchain for Life Sciences
1 Introduction
2 Digital Ethics Programs Design for Blockchain in Life Sciences
2.1 General Application of Digital Ethics Across the Life Sciences Continuum
2.2 Research
2.3 Genomics and Precision Medicine
2.4 Digital Identity
3 Cultural, Legal, and Socioeconomic Influences
4 Blockchain Ethics and Purpose in Life Sciences
5 Future Directions: Disruption, Innovation, Evolution
6 Conclusions
References
Cybersecurity Considerations in Blockchain-Based Solutions
1 Introduction
2 Blockchain Solution Architecture
2.1 Network and Architecture Types
2.2 Design Decisions
3 Future Threats
3.1 Quantum-Based Attacks
3.2 Forking
3.3 Interoperability
3.4 Consensus Flaws in New Methods
3.5 Collision Existence
4 Conclusion
References
The Future of Blockchain
1 Future of Blockchain
1.1 Predictions of Future Blockchain Trends
1.2 Quantum Computing
1.3 Digital Twins
1.4 The Metaverse
1.5 The Carrier Wave Principle
2 Future Research
3 Conclusions
References