A Trust-Centric Healthcare Journey | Full Presentation of PharmaLedger's 1st Open Webinar

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992.
This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA
are responsible for any use that may be made of the information contained herein.
Open Webinar
A TRUST-CENTRIC HEALTHCARE JOURNEY
24
NOV
2
DEC

Open Webinar
A T R U S T - C E N T R I C H E A L T H C A R E J O U R N E Y
INTRO
Ly n n Wa n g ( J o h n s o n & J o h n s o n )
P h a r m a L e d g e r D o m a i n L e a d S u p p l y C h a i n
24
NOV
2
DEC

P H A R M A L E D G E R I N A N U T S H E L L
Who? PharmaLedger partners comprises of pharmaceutical
companies, hospitals, universities, patient organizations, tech
companies... building an ecosystem!
Why? To empower patients, increase digital trust among
healthcare stakeholders, support medicine drug traceability and
data privacy, and build a new culture of collaboration in
healthcare.
What? A scalable blockchain based platform validated
through reference use cases in supply chain, clinical trials and
health data that will serve trendsetters for the industry, enabling
early adopters.
How? Pharmaledger will design, validate and provide agile
delivery of innovative blockchain enabled healthcare applications
across the industry, from manufacturers to patients; while creating
an innovative governance approach for sustainability.
Duration
3 years
Jan 20 – Dec 22
Consortium
29 partners
Budget
22 million
Euros
Focus Areas
Supply Chain,
Clinical Trial, and
Health Data

Copyright © 2020 PharmaLedger - All Rights Reserved
S U P P L Y C H A I N U S E C A S E S W E B I N A R
Clinical
Supply UC
15min
Finished
Goods
Traceability
UC
15min
Epi-eLeaflet
UC
15min
Anti-
Counterfeiting
UC
15min
Live Q&A
App 20 min

Open Webinar
A TRU ST- C E N T R IC HEALT H C A R E J OURNE Y
TOPIC 1 | Clinical Supply Tr aceability
Fr ancesco Spoto (Nov artis )
Chad Sklodosky (Pfiz er)
24
NOV
2
DEC
With the contribution of GSK, MSD,
Onorach, OPBG and RomSoft

C L I N I C A L S U P P L Y C H A I N U S E C A S E
Clinical Supply Chain Pr ocess
The Pain Points
Raw Materials
Manufacture
Drug Product
Manufacture
Packaging &
Labeling
Warehousing Logistics Clinical Site
Operations
Patient
Consumption
A typical clinical supply chain process
involves dozens of partner
organizations and thousands of
data transactions
Organizations only have “one up, one
down” data visibility, meaning they can
see information from adjacent partners
but not the entire supply chain
Regulatory compliance across multiple
legacy systems results in paper-based
manual processes that are slow and
costly
Sponsors have little insight into if and
how their product is being consumed,
reducing the ability to improve
processes
Patient
Traceability
Lack of
Real Time
Visibility
Data
Hand-offs
Among
Partners
Regulatory
Compliance

U S E C A S E V I S I O N & S O L U T I O N D E S C R I P T I O N
Blockchain
Inputs
Analytics
Capabilities
S O L U T I O N
FUT U R E STAT E
Y
C L I N I C A L S U P L B
P L O C K C H A I N
Identify Record Report Future
Needs
Sponsor CMO* Courier Clinical
Site
Raw Materials
Manufacture
Drug Product
Manufacture
Packaging &
Labeling
Operations
Patient
Consumption
Actors
*Contract Manufacturers

S O L U T I O N V A L U E A D D B Y A C T O R
C u r r e n t S t a t e I m p r o v e m e n t A r e a s
S o l u t i o n V a l u e P r o p o s i t i o n
W h o d o e s t h i s s o l u t i o n b e n e f i t ?
Sponsors CMO*s Couriers Sites Patients Regulators
Creates trust between partners through the use a common platform ✔ ✔ ✔ ✔ ✔ ✔
Increased process efficiency by automating manual or paper-based processes ✔ ✔ ✔ ✔
Interoperable data points (e.g., disposition of products) drives business decisions ✔ ✔ ✔ ✔
Immutable record-keeping reduces burden of audits and inspections ✔ ✔ ✔
Improved ability to track drug accountability and reconciliation ✔ ✔ ✔ ✔
Reduced product waste through true end to end visibility ✔
Increased trust in product quality for all actors in the clinical supply chain ✔ ✔ ✔ ✔ ✔ ✔
This solution creates value for all actors by developing trust, enhancing efficiencies, and eliminating key pain points that
improve our ability to get critical medicines to patients around the world
Data
Hand-offs
Among
Partners
Lack of
Real Time
Visibility
Regulatory
Compliance
Patient
Traceability
Raw Materials
Manufacture
Drug Product
Manufacture
Packaging &
Labeling
Operations
Patient
Consumption
*Contract Manufacturers

F R O M C L I N I C A L S U P P L Y T O C O M M E R C I A L I Z A T I O N
& T R A C K I N G O F F I N I S H E D G O O D S
The commercialization of approved products requires massive scale up and traceability of
Finished Goods that involves transfer of value between a whole new set of stakeholders with
different incentives, regulations and patient concerns, however PharmaLedger aims to connect
these important supply chains through a common Trust-Centered Healthcare platform.
Clinical Supply UC
15min
Finished Goods
Traceability UC
15min
Epi | -eLeaflet UC
15min
Anti-Counterfeiting
UC
15min
PharmaLedger aims to improve Clinical Supply Track and Trace capabilities that will enable clinical
trials to be conducted in a more efficient, compliant and patient centric way that will help bring
innovative new therapies to market quicker... but the supply chain does not end there.

Open Webinar
TOPIC 2 | Finished Goods Tr aceability
Dr. Jan Wor tmann (Bay er)
Ber nhar d Salb (Roc he)
24
NOV
2
DEC
With the contribution of abbvie, GSK, J&J,
MSD, Novartis, Pfizer, PDMFC & Romsoft

C O N T E X T | T H E P H A R M A S U P P L Y C H A I N
• No end-to-end visibility
• Delayed and distorted demand signals
• Manual reaction on recalls
• Siloed information & high number of IT interfaces
PharmaLedger connects the supply chain eco-system
for trusted and accelerated information sharing and
facilitates incorporating new partners into the eco system,
including patients
A
P H A M E
R L D G E R
T h e P h a r m a S u p p l y C h a i n To d a y
Drug Maker Wholesale Pharmacy
… a n d t h e B l o c k c h a i n

F I N I S H E D G O O D S T R A C E A B I L I T Y
T H E V I S I O N
PharmaLedger leverages
Blockchain technology
connecting the supply chain
eco-system for trusted and
accelerated information sharing.
✓ Leveraging established industry
standards and promote industry
solutions
✓ Introducing digital identities
✓ Defining on-boarding
procedures for partners
A
P H A M E
R L D G E R

V A L U E P R O P O S I T I O N
Patients
• Increased patient safety through full product control over the entire supply chain (end-to-end)
• Fast efficient recalls
• Optimized cost over the board for the benefit of the health systems
• Simplified IT interfaces & unlocking previously siloed information
Distributor and wholesale Drug makers
• Secure & timely supply of product
• Unhampered product
• Product meeting all regulations
• Reliable demand signals
• On time in-full delivery
• Adjusted inventories
• Optimized working capital
• Reduced returns for expired stock
• Near real-time access to seamless and
accurate supply information.
• Reliable demand signals optimizes
› production
› inventory levels
› customer service
› reduced returns for expired stock

F R O M F I N I S H E D G O O D S T r a c e a b i l i t y
T o E P I a n d b e y o n d
Clinical Supply UC
15min
Finished Goods
Traceability UC
15min
Epi | -eLeaflet UC
15min
Anti-Counterfeiting
UC
15min
PharmaLedger uses blockchain to connect the supply chain eco-system for trusted and
accelerated information sharing and facilitates incorporation of new partners and patients into
the digital value chain
... but the PharmaLedger does not end there.
Electronic production information (ePI) complements supply chain traceability in the
next section of our webinar

Open Webinar
TOPIC 3 | ePI | elec tronic produc t information
Patr ick Maher (Nov artis )
Ken Thur sby (MSD)
24
NOV
2
DEC
With the contribution of Democritus University of Thrace, EKON, GSK,
J&J, Novartis, PDMFC, Pfizer, MSD, Novo Nordisk, Romsoft, UCB,
Universidad Politécnica de Madrid

e P I * | I N T R O D U C T I O N
• Every package contains PI,
typically a paper leaflet, billions
are used every year
• Paper Leaflets provide valuable
Product Information to HCP’s
and Patients about their medicines
• They are closely regulated and
updated over the product life
Readability of print
Updates not instant… linked
to production and may limit
availability
Cost to produce
Environmental impact
e-Product Information
is not a new idea.
Can blockchain
help realize the
promise of ePI?
✓ Enable trusted
transactions between
multiple entities
✓ Enable trusted and secure
content
✓ Allow interoperability with
other digitally enabled
services and systems

C U R R E N T S T A T E P R O D U C T I N F O R M A T I O N
( L E A F L E T ) L I F E C Y C L E
Current
Situation:
• Health Authorities and
Manufacturers want to move
from a paper to ePI
• EMA published 10 principles
for ePI in Jan 2020, but do
not have a digital solution yet
• Some National pilots have
emerged for ‘ePI on a phone’
• Will require changes across
the life cycle
E M A / H M A k e y p r i n c i p l e s
* EMA > European Medicines Agency
* HMA > Heads of Medicines Agencies
ePI and EU common
standard definition
Expansion of access to
information on medicines
Accessibility to users with
diverse abilities
Creation of efficiencies for
regulatory systems
Complementary to paper leaflet
Open access to regulatory
approved information
Data protection
Flexibility in implementation
Support for multilingual PI
Interoperability with EU
and global initiatives
1
2
3
4
5
6
7
8
9
10
Create & Update
Manufacturers, 100+
Review & Approval
Health Authorities, 20+
Publish & Version Control
Manufacturers, 100+
Access
HCP & Patients, millions

F U T U R E V I S I O N
Health Authorities, 20+ Manufacturers, 100+ HCP & Patients, millions
GOAL
KEEP IT
STANDARD
AND SIMPLE
R e v i e w a n d A p p r o v a l D i s s e m i n a t i o n
e-leaflet versions
Resolver
(Blockchain)
T r a n s a c t i o n I n f r a s t r u c t u r e ( B L O C K C H A I N )
PC 9938251672557
SN 753328375613
Exp 07-2024
Lot AF4368
GTIN
• Serial Number
• Batch Number
• Expiry Date
Recall Warning
This Batch is being
recalled. Please return

GTIN
“Product Number”
Product Master Data, Leaflet,
Artwork, Transport Docs,
Customs Docs
Batch Genealogy,
Recalls
Order Information, Returns,
Chargebacks and Rebates,
Inventory,
Track & Trace,
Authentication
Batch Genealogy,
Batch Record,
Inspection Results,
COA
Regulatory Reporting,
Track & Trace
Product Master Data,
Leaflet, Commercial Data
Batch Genealogy,
Recalls
Batch Genealogy,
Recalls
Shelf Life / Inventory
Management
Product Quality
Inquiry
“Pharma to Table”,
Authenticity, Adverse
Events
Track & Trace,
Authentication, Adverse
Events
Product Master Data,
Leaflet/Label
C O N N E C T I N G T H E S U P P L Y C H A I N
T H R O U G H T H E 2 D D A T A M A T R I X
Manufacturing Quality Regulatory Transport Export/
Import
Fulfilment Dispenser Payer Provider Patient
EXP DT
“Expiry Date”
LOT #
“Lot/Batch Number”
SER #
“Unique Serial Number”
Data embedded in
the 2D barcode

R E A L I Z I N G T H E O P P O R T U N I T Y …
BLOCKCHAIN
2020 2021 2021-2023 2021-2027 202?
Blockchain
Solution
• User Stories Complete
Aug-20
• Prototype agile
development
commenced Sep-20
• First prototype target
end Dec-20
ePI Review &
Approval
• HA review and
approvals of
eLeaflet by
blockchain
• eLeaflet “soft-
launch” for patient
packs, in parallel to
paper inserts
ePI Pilot
• Pharmaledger
consortioum in
conjunction with
Health Authority
agree on selected
market for ePI Pilot
Other Use
Cases
• Recall functionality
• Product Verification
• Paper inserts
phased out
Blockchain Enabled
Healthcare
• The ultimate goal is to
enable Digital
Healthcare
Value Capture
HA’s: ePI lifecycle review
and approval efficiencies
Patient/HCP: Improved
safety and access
Value Capture
HA’s: Expansion beyond
Pharmaledger initiative 2020-2023
Patient/HCP: Recall functionality,
improved access when label changes
Manufacturers: Environmental & Cost benefits
...Our journey so far
Remote
work

S T A K E H O L D E R S & V A L U E P R O P O S I T I O N
P a t i e n t G r o u p s :
• Faster availability of breakthrough
medicines as new indications are approved
• Latest trusted and transparent information
• Improved access to product information
• Digital Heath
H e a l t h A u t h o r i t i e s :
• Supports EMA and EU strategy for digitizing
Healthcare
• Efficiencies in review and approval processes
• Low cost to serve, because of decentralization
M a n u f a c t u r e r s :
• Production line efficiencies
• Purchase costs for the leaflets
• Eliminate handling of leaflets, sampling and
inspection
C i t i z e n s :
• Clarity of information, by searchable
content, language specific
• Less waste material
E n v i r o n m e n t a l :
• Paper industry is very energy intensive
• Less waste material
H C P ’ s :
• Latest approved version of
the leaflet always
available
• Improved access to
product information
• Clarity of information, by
searchable content,
language specific

B U I L D I N G F O R T H E F U T U R E
B U I L D I N G F O R T H E F U T U R E
Blockchain Enabled Healthcare Value Chain
Clinical Decision Support Systems
Finished Goods Traceability
Electronic Health Records (eHR)
Adverse Event Reporting
Batch Recall
Anti Counterfeit Check
ePI

A L L A B O U T C O N N E C T I N G

Open Webinar
A Tr ust - Centr ic Healthc are J ourney
TOPIC 4 | Anti - Counter feiting
Daniel Fr itz (Nov artis )
Alber to López (Imprensa Nacional Casa da Moeda)
24
NOV
2
DEC
With the contribution of Bayer,
NovoNordisk, PDMFC, TVS and GSK

T H E P R O B L E M :
C O U N T E R F E I T I N G I S C R I T I C A L L Y H A R M F U L
Patient Safety
Public health
Economic impact
• Fake drugs lead to therapeutic failure, disease complications, and death.
• Counterfeits decrease trust and efficiency of health care systems, leading
to less access
• Loss of income on companies impacting innovation and jobs
• Loss of tax income for National Revenue authorities
(i.e. Counterfeit goods are almost always smuggled)
• General impact on the global and local economy
In 2016, the total value of
counterfeit pharmaceuticals
traded internationally is
estimated to be worth USD
4.4 billion
1 in 10 medical products in
developing countries is
substandard or falsified
Rapid increase of rogue
online pharmacies—96%
of websites offering
pharmaceuticals operate
illegally.
WHO
November 2017
EUIPO-OECD
April 2020
EUIPO-OECD
April 2020

A N T I - C O U N T E R F E I T I N G I N F O R M A T I O N F L O W
M u l t i - F a c t o r P r o d u c t A u t h e n t i c a t i o n ( M F P A ) a n d A n t i - C o u n t e r f e i t D a t a C o l l a b o r a t i o n ( A C D C )
C U S T O M E R S
S U P P L I E R S I N P U T S O U T P U T S
P R O C E S S
Patient
DataMatrix
scan with
app
Access eLeaflet
(ePI)
eLeaflet Patient
Manufacturer
Global Trade
ID Number Batch
Expiry
Serial Number
Perform MFPA checks:
1. Valid product?
2. Valid serial No.?
3. Valid prod. status?
4. Feature available?
5. Suspect product?
Results Patient
Patient
Authentication
Feature
Input
Manufacturer
verifies feature(s)
Results or Patient
Patient
Manufacturer
Results of checks &
Business rules
Anti-Counterfeit Data
Collaboration (ACDC)
Analytical reports and real-time
alerts
Manufacturer
Law Enforcement

Anti-counterfeiting use case
Users Users Interface Data Input MFPA
Functionality
ACDC
Functionality
ACDC Users
ANTI -
COUN TE R F EIT
USE CASE VISION
• Building on current legislation:
- Falsified Medicines
Directive in EU
- Drug Supply Chain
Security Act in the USA
• Empowering Patients to be
part of the solution
• Interoperable and trust driven
• Leveraging Big Data to
generate real time insights
Private User
HCP/HCO
Dispensary
Distributor
Law Enforcement
Manufacturer
Product Status
ePI
Multi-Factor
Authentication
Authentication
Feature
Serial Number
ACDC
Data Analytics
Permissioned
Multi-flow
Smart Contracts
Law Enforcement
Regulatory
Authorities
Pharmaceutical
Industry
2D Data Matrix
Authentication
Feature
GTIN (01): 0345312000011
EXPIRY: 2019-11-25
BATCH/LOT (10): ABCD1234

T Y P I C A L
E X A M P L E :
B A N K N O T E S
A N T I - C O U N T E R F E I T I N G E X A M P L E
A c o m m o n e x a m p l e y o u c a n f i n d i n y o u r p o c k e t

E X A M P L E A U T H E N T I C A T I O N F E A T U R E :
UNIQODE® PHYSICA L AND DIGITAL SECU R IT Y
UNIQUE
NUMBERING
VARIABLE UNIQODE®
HOLOGRAM
MICRO TEXTS
SECURITY INKS
STATIC UNIQODE®
S TA M P S A N D
E M B E D D E D
A N T I -
C O U N T E R F E I T
PA C K A G I N G
HOLOGRAM
encodes unique and
irreproducible optical
features
PRINTED GRAPHIC CODE
encodes a message
GLITTER INKS
encodes a unique and
irreproducible pattern
B R A N D
P R O T E C T I O N
T R A C E A B I L I T Y

A C D C | A n t i - c o u n t e r f e i t i n g D a t a C o l l a b o r a t i o n
✓ Analytics
✓ Reports
✓ Alerts
✓ SGTIN & Authentication Feature
✓ Environmental Data
ACDC
End User
✓ Device data
✓ Scan data
✓ MFPA Checks result data
✓ ePI
✓ Serial Number
✓ Traceability status
✓ Feature check
Legal & Regulatory
Authorities
✓ User registration
✓ Business rules
Manufacturer A
✓ Business rules
Manufacturer X
✓ Business rules
Why Blockchain for
anti-counterfeiting
Trusted Source of Truth
The authoritative and trusted answer
on a medicines authenticity
Privacy and Security
Decentralized identities (DIDs) could
guarantee anonymity in read-only,
public access scenario
Interoperability
The same solution can be adopted by
all manufacturers and markets without
lock-in to proprietary solutions
Scalability to additional
use cases
Link to eLeaflet / ePI, digital recall,
alerts, etc…

O u r V i s i o n
• Patient empowered with packaging authentication
• Reduced patient safety risks
• Guaranteed privacy of patient data
OPPORTUNITY
Objectives:
• Leverage emerging technologies to give patients and supply chain actors a powerful tool for multi-factor product authentication,
increasing supply chain security.
• Collaboration to collect and analyze related data to gain insight on macro trends of pharmaceutical crimes.
Patients
I n d u s t r y
H e a l t h c a r e
AMBITION
• IMI Blockchain scope: Europe
• Our ambition: to ensure scalability of the solutions to regions most
affected with falsified medicines i.e. Sub-Saharan Africa and SE Asia
• Strengthened supply chain security with a single source of truth
• Interoperable industry architecture with a common application
• Reduced loss prevention related to theft and diversion
B L O C K C H A I N A N T I - C O U N T E R F E I T I N G U S E C A S E VA L U E P R O P O S I T I O N
E m p o w e r i n g p a t i e n t s t o f u r t h e r e n h a n c e s u p p l y c h a i n s e c u r i t y
P a t i e n t s

T H A N K Y O U

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