- Collaborating with 17 companies across the industry - Understanding the landscape in the pharma and healthcare settings - Exploring the areas where Blockchain could be used - Presenting two detailed use cases (a. Smart Contract: Vendor and Site - Oversight; b. Distributed Asset Ledger: Patient Data Access/Transparency) to support future development and implementation for proof of concept.

1. Evaluating How Blockchain Can
Transform The Pharmaceutical And
Healthcare Industries
Aji Barot Disa Lee Choun
Business Development Director Director, Head Data Acquisition
HealthUnlocked UCB
Global Cyber Security in Healthcare & Pharma Summit - Blockchain in Healthcare
3rd of May 2018

2. Agenda
1
2
3
Industry collaboration via
PhUSE
Introduce blockchain
Pre-requisites to adopt
blockchain
4
6
Proposed Use Cases
Next Steps…

3. 1. Industry collaboration via PhUSE

4. PhUSE Blockchain Workstream
• Initiative started in 2017
• Independent, Non-Profit Organisation run by volunteers
• Neutral grounds for collaborations
• Workspace and wiki page
http://www.phusewiki.org/wiki/index.php?title=Blockchain_Technology
• Meeting organization and minutes (Admin Support)
• FDA and EMA Collaboration

5. Cross-Functional Team Members
• Co-leads:
– Disa Lee Choun (UCB)
– Adama Ibrahim (Biogen)
– Christopher Hart (Manchester Informatics Limited)
• Members:
– Hariprasad Radhakrishnan (AstraZeneca)
– Eric Wu (Gilead)
– Anders Bergkvist (Merck)
– Aji Barot (HealthUnlocked)
– Fernand Maes (Johnson & Johnson)
– Will Ivy (Johnson & Johnson)
– Zakaria Arrassi (UCB)
– Marc Casals (UCB)
– Yusuf Ghadiali (Biogen)
– Imran Shakur (Biogen)
– Mayur Joshi (Biogen)
– Richard Shute (Curlew Research)
– Bob Clay (Highbury Regulatory)
– Kenneth Ng (Hashed Health)
– Philip Clothiaux (Hashed Health)
– Kenneth Getz (Tufts University)
– Selina Lee (IBM)
– Nicole Tay (Mercantis)
– Jim Nasr (CDC, Acoer)
– Karin Beckstrom (ERT)
– Maria Palombini (IEEE)
24 Project
Members!
Academia
Biometrics
Business Process
Clin Ops
Clinical Supply
Consultants
eCOA Provider
IRT
Medical Affairs MD
Regulatory
PE Provider
Standards
2 FDA key
reviewers

6. Objectives of the White Paper
• Landscape
• ImplicationsEducate and share knowledge
• Supply Chain, Vendors and Site
• Patient Data Access/Transparency
Present and analyze two detailed use
cases
• POC
Recommendations for implementation

7. Why Now?
Regulatory environment
Industry interoperability
and accountability
Transparency
Privacy
Worldwide demand for
patient oriented healthcare
Inefficiencies of traditional
R&D process
Unsustainable industry
wastage, fraud and
mounting costs
Massive amounts of
investments and rapid
improvements in Blockchain
technology
Low trust and reputation of
industry with the general
public

8. Timelines and Milestones
Jul ‘17Apr ‘17 June ‘17Mar ‘17 Sept ‘17 Jan ‘18 Mar ‘18 May ‘18

9. 2. Introduce BlockChain

10. General Characteristics
Decentralised distributed
ledger
Digital
Recording who
owns what and
who transacts what
Technology behind
the notorious
cryptocurrency
Bitcoin
Secure
Cryptography
Private (vetted
participants) or
Public (anyone)
Sharing and storing
registry of assets
and transactions
across peer-to-peer
network

11. Centralised/decentralised ledgers and
Business benefits

12. Strengths:
Trust, secure, transparency, full audit
trail, real-time data
Weaknesses:
Technical immaturity, not all data is
digitalized, scarcity of skills, replaces
part of current applications
Threats:
Industry not ready and regulations not
in place, complex R&D processes, lack of
knowledge, long-term ROI, change
management, no standardization
Opportunities:
Empower patients and increase trust,
accelerate drug development,
improved treatment and care, reduce
fraud
SWOT analysis

13. Jim Nasr, former CDC Chief Software
Architect
“Blockchain cannot operate on its own and requires
off-chain technologies to enable it to access data
sources or tap into additional functionality needed for
the delivery of a realistic healthcare application.
Therefore, blockchain is just one playground in the
software theme park of interoperable software”.

14. 3. Pre-requisites to adopt BlockChain

15. Key Considerations
Problem
Statement in
Existing
Technology
Infrastructure
Job
Competencies
Sponsorship
Barriers and
Risk
Assessment
Culture
Change
Investment
Trade offs/ROI
Regulations

16. Stakeholders

17. 4. Proposed Use Cases

18. Criteria for Selection of Use Cases
Demonstrable characteristics of Blockchain e.g. Trust
Practical and Attractive
Generalizable
Modular
Scalable and cost Saving

19. Use Case 1: Drug Supply Chain
Problem Statement
Poorly drafted contracts
Compliance with strict regulations
Negotiation cycles
Global contracts
Payment triggers
Value Proposition
End to End tracking in supply chain
Transparency and trust
Automation
Streamlining of processes and audit
Contracts can be executed in a timely manner
without human delay or disputes
Clear automated payment triggers

20. Use Case 1: Drug Supply Chain – track & trace

21. Use Case 2: Patient Data
Problem Statement
High development costs (NME)
Delay in enrolment
Delay in database lock
Virtual trials
Data transparency, disclosure and
privacy laws (GDPR)
Low level of trust and reputation
Value Proposition
Secure encryption for privacy
Audit of patient data journey
Patient control and access
Access to higher volume of data
Access to real world data
Build on trust and reputation
Enable pragmatic trial design
Enables dynamic Day 1 enrolment

22. Use Case: Identifying patients to participate in
clinical research

23. Use Case: eCOA Work Flow in Clinical Trials

24. Use Case: Incentivizing patients and enabling the
access of patient data

25. Maria Palombini, IEEE-SA
“alluring feature of blockchain is the
ability to negotiate the tension
between patient data privacy and
sharing”

26. 5. Next Steps...

27. Planned Publications

28. Collaborative Proof of Concept
Develop Core
Team With
Senior
Leadership
Sponsorship
•Perform Deep
Dive Needs
Analysis
•Gain
Consensus on
Problem
Statement
Find and Join
Cross-Industry
Collaborative
Group Working
on Similar Use
Case
•Non-profit
Group e.g.
PHUSE or
IEEE
•Industry
Incubator e.g.
Pfizer&Deloitte
Determine with
Collaborative
Group if
Standards Exist
•Select
Blockchain
Protocol
•Select
Standard
Integrations
and
Nomenclatures
Prepare
Relevant
Agreements for
Proof of
Concept
•Vendor
Partner
Selection
•Blockchain
Technical
Partner
Selection
Perform Proof
of Concept
• Document and
Share Results
• Scale up
Perform
Proactive
Change
Management
on Adoption
Process

29. Thank You