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Developing a Blockchain-Based Supply Chain System for Advanced Therapies: Protocol for a Feasibility Study.

Ching Lam¹, Michelle Helena van Velthoven¹, Edward Meinert^1,2

¹Digitally Enabled PrevenTative Health (DEPTH) Research Group, Department of Paediatrics, University of Oxford, Oxford, United Kingdom.

JMIR Research Protocols

|December 14, 2020

Summary

This summary is machine-generated.

This study proposes a blockchain-based platform to enhance the supply chain and manufacturing of cell and gene therapies. The goal is to create a secure, transparent, and cost-effective delivery system for these advanced treatments.

Keywords:

IOT blockchain digital health internet of things regenerative medicine

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Area of Science:

Biotechnology and pharmaceutical sciences
Health informatics and supply chain management
Advanced therapy medicinal products (ATMPs) logistics

Background:

Advanced therapies like cell and gene therapies offer cures for severe diseases but face delivery challenges.
Complexities include environmental sensitivity, material sourcing, and stringent regulatory hurdles.
Current delivery systems are often fragmented, impacting patient access and treatment efficacy.

Purpose of the Study:

To develop a novel, blockchain-integrated platform for connected supply chain and manufacturing management.
To establish a secure chain of custody for autologous cell and gene therapies from collection to administration.
To evaluate the feasibility of blockchain for standardized manufacturing and reduced regulatory compliance costs.

Main Methods:

Utilizing blockchain technology to digitally link supply chains and manufacturing processes.
Implementing an agile software development methodology for system creation and evaluation.
Ensuring adherence to EU and US Good Manufacturing Practices (GMP) and regulatory standards.

Main Results:

This section outlines a proposed study protocol; results are pending execution and funding.
The study aims for successful implementation of an integrated blockchain solution.
Anticipated outcomes include enhanced security and transparency in therapy delivery.

Conclusions:

Successful implementation of the blockchain solution can significantly improve the safety and security of advanced therapy delivery.
This innovation has the potential to set new industry standards for complex biologic treatments.
The platform aims to streamline operations and reduce costs associated with advanced therapy logistics.