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Blockchain in Life Sciences
Jayanthi Repalli, PhD
Table of Contents
• What Is Blockchain?
• Blockchain Benefits
• Applications in Life Sciences
• Use Cases
• References
2
What is Blockchain?
3
Wikipedia
A blockchain — originally block chain — is a distributed database that maintains a
continuously-growing list of ordered records called blocks. Each block contains a
timestamp and a link to a previous block.
Investopedia
A blockchain is a public ledger of all Bitcoin transactions that have ever been executed. It
is constantly growing as 'completed' blocks are added to it with a new set of recordings.
The blocks are added to the blockchain in a linear, chronological order.
Melanie Swan, Institute for Blockchain Studies
Beyond digitizing money, payments, economics, and finance, blockchains are a
singularity-class technology that enables the secure, trackable, automated coordination
of very large-scale projects, fleets, and swarms. The implication could be an orderly
transition to the automation economy and trust-rich human-machine collaboration in the
digital smart network societies of the future.
Harvard Business Review
A blockchain is a vast, global distributed ledger or database running on millions of
devices and open to anyone, where not just information but anything of value – money,
titles, deeds, music, art, scientific discoveries, intellectual property, and even votes – can
be moved and stored securely and privately.
Blockchain Benefits
4
Decentralized Secure Irreversible
Ubiquitous Real Time Visibility
Dis
intermediation
Data is stored across
network – no single
point of failure
Uses unique
public/private key based
on cryptography – a
randomly generated
string of numbers
No centralized official
copy, transactions are
broadcast across the
network
Transactions can not be
reversed once verified
or accepted
Transactions or blocks
are verified in near real
time
Peer-to-peer network,
eliminates
intermediaries in
transactions
Anyone can add or
review blocks from its
inception
Trust &
Consensus
Each contributor is
trusted equally and
collective consensus is
key in verification
Source: See references
Personalized medicine
Patient health records
Counterfeit protection
Connectome (personal
mind files)
Smart payments
Beyond the pill
Applications in Life Sciences
5
Preclinical Clinical
Regulatory
Approval
Manufacturing
& Distribution
Patients
Smart IP platform
Peer-Peer IP sharing
Royalty payments &
copyrights mgmt.
Tech transfer offices IP
transactions
Due diligence &
commercialization
IP protection
Secure data transmission
Data integrity
Peer-Peer data sharing
Genomic data sharing
Smart contracts Data sharing & tracking
Verification – smart
contracts
Records mgmt. –
methods & results
IP registration and
exchange
Proof of existence for
patents filing
Smart contracts with external
partners (CRO, etc.)
Digital track and
traceability
Payment transactions
across supply chain
Inventory mgmt. systems
Effective & efficient
targeted recalls
Regulatory compliance
requirements
Value
Chain
Strategic
Value
Levers
• Improved patient engagement
• Better treatment outcomes
• Increased safety
• Increased quality of life
• Continuous manufacturing
• Inventory optimization
• Supply chain visibility
• Faster regulatory approval
• Faster drug discovery
• IP protection and sharing
• Open science framework
• Speed to market
• Cost efficiency
• Data transparency
• Data Integrity
Bilateral communications
with all industry players
Smart contracts and
health insurance
Publications
Blockchain could be used in many applications across the value chain
Source: See references
Tech transfer office
submits time stamped
blockchain records as
proof of existence
Use Case: Preclinical
6
Researcher A Researcher B
Trying to find an Cancer drug
in the USA
Around the same time, ‘B’ starts experiments
on similar Cancer drug in Asia
1
2 “A “ uploads the protocol to
blockchain and performs
experiments according to it.
But, experiments are failed and
finds a fault in the protocol
“B” is planning to do similar
experiments and learns that protocol
will not yield positive results from A’s
results and abandons the plan; saving
time and funding
3
3
Tech Transfer Office
Scenario 1: Open Data Sharing
Scenario 2: Proof of Existence
A&B decide to collaborate on the
research, share research funding using
smart contracts on the block chain.
Together they accelerate the discovery
process
4
“A” uploads the drug
discovery (for Influenza)
experimental data on
blockchain after each
experiment. After a couple
of years, ‘A’ invents a lead
molecule
Pharma
2 Tech transfer office decides to
partner with a pharma company
to commercialize drug Pharma and University
negotiate royalty
payments and IP sharing
using smart contracts on
blockchain
4
5
Blockchain
Researcher A
U N I V E R S I T YU N I V E R S I T Y
1
Blockchain
Peer-to-peer network, data storage, and file sharing could accelerate drug discovery and remove many inefficiencies
Source: See references
Use Case: Clinical Trials - Smart Contracts
7
• Timothy Nugent et. al. demonstrated the usage
of smart contracts on a private Ethereum
blockchain network for Tamiflu drug clinical trials
management.
• The private network consisted of regulators,
pharma, and contract research organizations
(CROs).
• Smart contracts have two layers – regulatory and
trail.
• The regulatory contract consists of trial
protocol, end point, time lines, and
methods.
• Trial subjects and data are appended to trail
contract, which is owned and managed by
CRO.
• Trial protocol on the network ensures protocol
adherence and timelines. Each trial data entry is
verified, accepted, and stored in all of the nodes
the network.
Trial 1 Trial 2 Trial 3
Regulators (FDA,
MHRA, EMA, etc.)
Blockchain Network
Regulator contract
(trial proposal)
submission
Regulator
contract
approval
Pharma
Companies
Regulator contract, proposal
& trial contract, data
CROs
Trial contract
(subjects,
data)
Regulator contract, proposal
& trial contract, data
1 2 3
4
Source: https://f1000research.com/articles/5-2541/v1
Smart contracts could be a solution to clinical trials issues such as end point switching, data dredging, etc.
Use Case: Manufacturing and Distribution - The BlockRx Project
8
• The BlockRx Project: the first Pharma-
Blockchain project, formed in collaboration
with various players of pharma industry.
• The members include providers, regulatory
compliance, legal, scientists, investors,
pharma companies, and tech experts.
• The project aims to develop solutions to
improve drug development life cycle and
pharma supply chain.
• The solutions combine advanced digital ledger
technology (ADLT) and AI to create and
manage digital ledgers of the transaction
across parties.
• These can be used in many applications
including due diligence, inventory
management, recalls process, etc.
Source: Picture taken from http://www.blockrx.com/
Blockchain based supply chain could provide transparency and optimize integrated operations
Use Case: Patients - Connectome or Blockchain Thinking
9
Blockchain could enable storing, sharing, and mining of the personal big data such as genomes and
connectomes – blockchain thinking
Personalized medicine
Patient engagement
Market access
Regulatory approvals
Person Thinking Chain
• Storing and processing of personal data
including personal connectome files, digital
identities such as Facebook and LinkedIn,
physical property registrations, etc.
Health Data Commons
• Public sharing of personal health data,
EMRs, quantified self-tracking data,
and mental performance data
Blockchain Based Advocates
• Digital mind files and smart contracts on
the blockchain invoke advocacy services
on one’s behalf and act as third party
mediators
Source: http://www.the-blockchain.com/docs/Blockchain%20Thinking%20-%20The%20Brain%20as%20a%20DAC%20-%20Decentralized%20Autonomous%20Organization.pdf
Benefits to PharmaSome futuristic applications
References
1. https://en.wikipedia.org/wiki/Blockchain_(database)https://www.oreilly.com/ideas/blockchain-enabled-open-science-framework
2. https://hbr.org/2016/05/the-impact-of-the-blockchain-goes-beyond-financial-services
3. http://www.investopedia.com/terms/b/blockchain.asp
4. http://www.blockchainstudies.org/
5. https://isolve.io/2016/04/20/4-reasons-why-pharma-serialization-needs-the-blockchain/
6. http://www.bio-itworld.com/2016/5/4/how-blockchain-is-helping-genomics-research.aspx
7. http://www.santacruztechbeat.com/2016/06/04/david-haussler-speak-using-blockchain-june-15/
8. https://bitcoinmagazine.com/articles/how-blockchains-can-further-public-science-1457972964
9. https://zenodo.org/record/60223#.WEu_DrU8KEc
10. https://f1000research.com/articles/5-2541/v1
11. http://www.blockrx.com
12. http://www.globalpmsystems.com/how-the-blockchain-is-becoming-a-better-fit-for-pharma-the-blockrx-project/
13. http://www.the-blockchain.com/docs/Blockchain%20Thinking%20-%20The%20Brain%20as%20a%20DAC%20-
%20Decentralized%20Autonomous%20Organization.pdf
14. http://www.slideshare.net/lablogga/blockchain-health-and-crypto-wellness-futures
10
Thank you!
11

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Blockchain in life sciences

  • 1. Blockchain in Life Sciences Jayanthi Repalli, PhD
  • 2. Table of Contents • What Is Blockchain? • Blockchain Benefits • Applications in Life Sciences • Use Cases • References 2
  • 3. What is Blockchain? 3 Wikipedia A blockchain — originally block chain — is a distributed database that maintains a continuously-growing list of ordered records called blocks. Each block contains a timestamp and a link to a previous block. Investopedia A blockchain is a public ledger of all Bitcoin transactions that have ever been executed. It is constantly growing as 'completed' blocks are added to it with a new set of recordings. The blocks are added to the blockchain in a linear, chronological order. Melanie Swan, Institute for Blockchain Studies Beyond digitizing money, payments, economics, and finance, blockchains are a singularity-class technology that enables the secure, trackable, automated coordination of very large-scale projects, fleets, and swarms. The implication could be an orderly transition to the automation economy and trust-rich human-machine collaboration in the digital smart network societies of the future. Harvard Business Review A blockchain is a vast, global distributed ledger or database running on millions of devices and open to anyone, where not just information but anything of value – money, titles, deeds, music, art, scientific discoveries, intellectual property, and even votes – can be moved and stored securely and privately.
  • 4. Blockchain Benefits 4 Decentralized Secure Irreversible Ubiquitous Real Time Visibility Dis intermediation Data is stored across network – no single point of failure Uses unique public/private key based on cryptography – a randomly generated string of numbers No centralized official copy, transactions are broadcast across the network Transactions can not be reversed once verified or accepted Transactions or blocks are verified in near real time Peer-to-peer network, eliminates intermediaries in transactions Anyone can add or review blocks from its inception Trust & Consensus Each contributor is trusted equally and collective consensus is key in verification Source: See references
  • 5. Personalized medicine Patient health records Counterfeit protection Connectome (personal mind files) Smart payments Beyond the pill Applications in Life Sciences 5 Preclinical Clinical Regulatory Approval Manufacturing & Distribution Patients Smart IP platform Peer-Peer IP sharing Royalty payments & copyrights mgmt. Tech transfer offices IP transactions Due diligence & commercialization IP protection Secure data transmission Data integrity Peer-Peer data sharing Genomic data sharing Smart contracts Data sharing & tracking Verification – smart contracts Records mgmt. – methods & results IP registration and exchange Proof of existence for patents filing Smart contracts with external partners (CRO, etc.) Digital track and traceability Payment transactions across supply chain Inventory mgmt. systems Effective & efficient targeted recalls Regulatory compliance requirements Value Chain Strategic Value Levers • Improved patient engagement • Better treatment outcomes • Increased safety • Increased quality of life • Continuous manufacturing • Inventory optimization • Supply chain visibility • Faster regulatory approval • Faster drug discovery • IP protection and sharing • Open science framework • Speed to market • Cost efficiency • Data transparency • Data Integrity Bilateral communications with all industry players Smart contracts and health insurance Publications Blockchain could be used in many applications across the value chain Source: See references
  • 6. Tech transfer office submits time stamped blockchain records as proof of existence Use Case: Preclinical 6 Researcher A Researcher B Trying to find an Cancer drug in the USA Around the same time, ‘B’ starts experiments on similar Cancer drug in Asia 1 2 “A “ uploads the protocol to blockchain and performs experiments according to it. But, experiments are failed and finds a fault in the protocol “B” is planning to do similar experiments and learns that protocol will not yield positive results from A’s results and abandons the plan; saving time and funding 3 3 Tech Transfer Office Scenario 1: Open Data Sharing Scenario 2: Proof of Existence A&B decide to collaborate on the research, share research funding using smart contracts on the block chain. Together they accelerate the discovery process 4 “A” uploads the drug discovery (for Influenza) experimental data on blockchain after each experiment. After a couple of years, ‘A’ invents a lead molecule Pharma 2 Tech transfer office decides to partner with a pharma company to commercialize drug Pharma and University negotiate royalty payments and IP sharing using smart contracts on blockchain 4 5 Blockchain Researcher A U N I V E R S I T YU N I V E R S I T Y 1 Blockchain Peer-to-peer network, data storage, and file sharing could accelerate drug discovery and remove many inefficiencies Source: See references
  • 7. Use Case: Clinical Trials - Smart Contracts 7 • Timothy Nugent et. al. demonstrated the usage of smart contracts on a private Ethereum blockchain network for Tamiflu drug clinical trials management. • The private network consisted of regulators, pharma, and contract research organizations (CROs). • Smart contracts have two layers – regulatory and trail. • The regulatory contract consists of trial protocol, end point, time lines, and methods. • Trial subjects and data are appended to trail contract, which is owned and managed by CRO. • Trial protocol on the network ensures protocol adherence and timelines. Each trial data entry is verified, accepted, and stored in all of the nodes the network. Trial 1 Trial 2 Trial 3 Regulators (FDA, MHRA, EMA, etc.) Blockchain Network Regulator contract (trial proposal) submission Regulator contract approval Pharma Companies Regulator contract, proposal & trial contract, data CROs Trial contract (subjects, data) Regulator contract, proposal & trial contract, data 1 2 3 4 Source: https://f1000research.com/articles/5-2541/v1 Smart contracts could be a solution to clinical trials issues such as end point switching, data dredging, etc.
  • 8. Use Case: Manufacturing and Distribution - The BlockRx Project 8 • The BlockRx Project: the first Pharma- Blockchain project, formed in collaboration with various players of pharma industry. • The members include providers, regulatory compliance, legal, scientists, investors, pharma companies, and tech experts. • The project aims to develop solutions to improve drug development life cycle and pharma supply chain. • The solutions combine advanced digital ledger technology (ADLT) and AI to create and manage digital ledgers of the transaction across parties. • These can be used in many applications including due diligence, inventory management, recalls process, etc. Source: Picture taken from http://www.blockrx.com/ Blockchain based supply chain could provide transparency and optimize integrated operations
  • 9. Use Case: Patients - Connectome or Blockchain Thinking 9 Blockchain could enable storing, sharing, and mining of the personal big data such as genomes and connectomes – blockchain thinking Personalized medicine Patient engagement Market access Regulatory approvals Person Thinking Chain • Storing and processing of personal data including personal connectome files, digital identities such as Facebook and LinkedIn, physical property registrations, etc. Health Data Commons • Public sharing of personal health data, EMRs, quantified self-tracking data, and mental performance data Blockchain Based Advocates • Digital mind files and smart contracts on the blockchain invoke advocacy services on one’s behalf and act as third party mediators Source: http://www.the-blockchain.com/docs/Blockchain%20Thinking%20-%20The%20Brain%20as%20a%20DAC%20-%20Decentralized%20Autonomous%20Organization.pdf Benefits to PharmaSome futuristic applications
  • 10. References 1. https://en.wikipedia.org/wiki/Blockchain_(database)https://www.oreilly.com/ideas/blockchain-enabled-open-science-framework 2. https://hbr.org/2016/05/the-impact-of-the-blockchain-goes-beyond-financial-services 3. http://www.investopedia.com/terms/b/blockchain.asp 4. http://www.blockchainstudies.org/ 5. https://isolve.io/2016/04/20/4-reasons-why-pharma-serialization-needs-the-blockchain/ 6. http://www.bio-itworld.com/2016/5/4/how-blockchain-is-helping-genomics-research.aspx 7. http://www.santacruztechbeat.com/2016/06/04/david-haussler-speak-using-blockchain-june-15/ 8. https://bitcoinmagazine.com/articles/how-blockchains-can-further-public-science-1457972964 9. https://zenodo.org/record/60223#.WEu_DrU8KEc 10. https://f1000research.com/articles/5-2541/v1 11. http://www.blockrx.com 12. http://www.globalpmsystems.com/how-the-blockchain-is-becoming-a-better-fit-for-pharma-the-blockrx-project/ 13. http://www.the-blockchain.com/docs/Blockchain%20Thinking%20-%20The%20Brain%20as%20a%20DAC%20- %20Decentralized%20Autonomous%20Organization.pdf 14. http://www.slideshare.net/lablogga/blockchain-health-and-crypto-wellness-futures 10