A Trust-Centric Healthcare Journey Part II | Full Presentation of PharmaLedger's 2nd 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 PART II
Clinical Trial & Health Data Use Cases
24
FEB
3
MAR

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 P A R T I I
INTRO
M a r i a E u g e n i a ( X e n i a ) B e l t r a n | P r o j e c t
C o o r d i n a t o r / D R A a n d U s e C a s e c o - l e a d
( U n i v e r s i d a d P o l i t é c n i c a d e M a d r i d )
24
FEB
3
MAR

Copyright © 2021 PharmaLedger - All Rights Reserved
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
EEAB
External expert
advisory board
10 members
Budget
22 million
Euros
Focus Areas
Supply Chain,
Clinical Trial,
and Health Data
Ethics Board
6 members

V A L U E C H A I N - U S E C A S E S V I E W
Anonymized matching of
qualified patient to trial
requirements
Enable voluntarily enrollment
Less dependency of
intermediaries
Lower time and cost
Auditable and immutable ICF
Dynamic and real time ICF
management
Less protocol deviations
Specific versions can be
managed
Administratively agile
Pilot real study with Pediatric
heart failure patients
Dynamic acquisition and
processing of data
Remote patient monitoring
Real-time notifications
Pilot real study with Pediatric
heart failure patients and 2
devices
Establishes a trusted
environment for patient-centric
decentralized applications
Uses blockchain’s trusted
network to leverage RWE for
research
Uses Machine Learning and AI
Value-Based health delivery in
clinical practice
Clinical Trial
eRecruitment
Clinical Trial
eConsent
Clinical Trial
IOT devices
Personalized
Medicines

Open Webinar
A TRU ST- C E N T R IC HEALT H C A R E J OURNE Y PART II
TOPIC 1 | Clinical Trial Recruitment - Patient Matching Solution
Ken Nessel (Pfiz er)
Despina Daliani (Onorac h)
24
FEB
3
MAR
In collaboration with Bayer, CERTH,
EFGCP, J&J, UCB, UPM, PDM, RomSoft

C L I N I C A L T R I A L S I N T R O D U C T I O N
How do they work?
• Several phases, 10s to >1000s
participants
• Scope of research increases at each
phase
• Multiple independent bodies ensure
participants’ safety
Phase I Phase I/II Phase III
Human Safety
Expanded
Safety
Efficacy &
Safety
Days or Weeks Weeks or Months Several Years
Tens Hundreds Thousands
What are clinical trials?
• Research study with participants
• New medical knowledge
• New, safe and effective, treatments
• Research, not routine care
What is clinical trial recruitment?
• Set of participation criteria carefully
chosen
• Patient-doctor discussion
• Patients recruited must…
- want to participate and
- meet inclusion criteria
Problem: Recruiting for clinical trials has
been a substantial challenge historically

S I T U A T I O N | C L I N I C A L T R I A L R E C R U I T M E N T
To unlock the potential of patient-centric approaches,
we will need to make trial pre-screening more accessible.
5%
or less of cancer patients
enroll in clinical trials
$5.9B
spent annually on clinical trial
recruitment
30%
of clinical trials’ timeline is
spent on patient recruitment
80%
of trials fail to meet
enrollment timelines
Clinical trial recruitment poses significant challenges to clinical research
TODAY
Study-centric recruitment.
Recruitment via Principal Investigator (doctor) or direct advertising.
EMERGING TRENDS
Enabling of patient-centric recruitment.
The patients find studies.
1
Patient access to health data
is expanding
In the US, the Cures Act mandates patient
access to their health information
2
New tools help patients
put their data to use
Mobile apps give users access to partner
health institutions in US, UK and Canada
3
Demonstrated willingness
to participate in research
80% of EU citizens say they will share their
health data if privacy and security are ensured

C L I N I C A L T R I A L R E C R U I T M E N T
C U R R E N T S T A T E C H A L L E N G E S
Study Website
Pre-screen
Trial B “Sorry, no”
Joe
Patient:
“Any trials for
diabetics?”
P a i n p o i n t s
Not patient-friendly High cost and
inefficient
Duplicative
processes
Information
locked in silos
Patient:
“Any trials for
diabetics?”
Joe
Trial A
Investigator
Pre-screen
“Sorry, no” Trial C
Investigator
Pre-screen
“Yes”
Joe
Patient:
“Any trials for
diabetics?”

F u t u r e S t a t e
F U T U R E V I S I O N
Key Features
Patients are in control of their data
Patients have increased visibility into how their
data is used
A blockchain ledger maintains trust between all
parties
Redundant workflows are eliminated
Patient data privacy requirements met (GDPR,
etc.)
Concept Description
• Create a neutral, industry-wide utility to help
patients (or their providers) efficiently find clinical
trials which match their health profiles and interests
• Any sponsor (industry or academic) and any patient
or physician would have equal access to the
matching utility
Trial Permission to be matched
Patient Matching
Utility
Joe
Patient:
“Any trials for diabetics?”
“You match to
these 3 trials”
Pre-screen
Studies
Studies
Studies
Studies
1
2
3
4
5

F U T U R E P A T I E N T E M P O W E R M E N T E X P E R I E N C E
1.
Patient enters
medical history
2.
Patient sets data
sharing permissions
3.
Patient views list of
potential matching
trials
4. Patient answers
trial specific
questions
5. Patients request to
be contacted by
clinical site
6. Patients views
dashboard of
metrics

W H Y B L O C K C H A I N ?
Permissions
Pre-screening
Criteria
Matching
Algorithm
Match Results
Sponsors publish
pre-screeners
Patient
requests to be
matched
Matching
algorithm
executes
Match results
displayed to
patient
Blockchain Trust Layer
The full provenance of
matching transactions
would be anchored on the
blockchain, bringing trust
to all parties
hash
The matching utility won’t work without trust
• Patients will only share their data, if they trust the matching utility will protect their privacy and security
• Sponsors will only share their clinical trials, if they trust the matching utility is fair and equitable in matching patients
• Operating the utility through a decentralized network will increase trust that no single party has undue influence
hash hash hash

V A L U E P R O P O S I T I O N T O S T A K E H O L D E R
Patients Patient advocacy
groups
Sponsors Clinical Research
Organization Clinical Sites Physicians
✓ Accelerates recruitment for clinical trials
✓ Reduces recruitment cost by pooling investment
✓ Simplifies operations
✓ Demonstrates ‘patient-first’ imperatives
✓ Simplifies the patient journey
✓ Encourages patient participation
in clinical research
✓ Patient retains control over their
health data
✓ Enables
physicians to
stay current
on clinical
trials
✓ Helps
physicians
support their
patients in
finding clinical
trials

R O A D M A P
1
2
PILOT
Implement proof of
concept to demonstrate
value proposition
EXPANSION
Expand to support different
markets, languages and
indications
3
EHR INTEGRATION
Enable integration with a
patient’s electronic health
record
4
PRIVACY
PRESERVING TECH
Expand use of emerging
technology to further
preserve privacy
2021 2022
5
ADJACENT USE CASES
Enable other use cases
requiring the exchange of
real-world data

Clinical Trial
eRecruitment
Clinical Trial
eConsent
Clinical Trial
IOT devices
Personalized
Medicines

Open Webinar
TOPIC 2 | Clinical Trial eConsent
Despina Daliani (Onorac h)
Her nand o Gir aldo (Boehringer Ingelheim)
24
FEB
3
MAR
Use Case in collaboration with EFGCP, ICS, RomSoft, NVS,
TVS, CERTH, UPM, AVO, HES, OPBG, PFE, EPF

F L O W O F C L I N I C A L T R I A L S | P R O B L E M
>50%
Inadequate processes
to ensure the quality of
clinical trials
>50%
Inaccurate or
incomplete clinical trial
records.
5-10%
Compliance with the
clinical trial protocol
make up
Key Component
Informed
Consent
Screening
Data Collection,
Procedures and
Analyses
Secondary data
Sharing

F L O W O F C L I N I C A L T R I A L S T H R O U G H B L O C K C H A I N
B L O C K C H A I N P L A T F O R M
One trusted, immutable and shared source of consent and trial data
Process automation in a trusted environment
Permission access to data specified by role in near real-time
Key Component
Informed
Consent
Screening
Data Collection,
Procedures and
Analyses
What is impacted by the
Informed Consent? Everything!
No participant consent = No trial
Secondary data
Sharing

Purpose of Trial and
Description of
Procedures
I N F O R M E D C O N S E N T | K E Y I N F O R M A T I O N
P R O V I D E D T O P A T I E N T S I N C L I N I C A L T R I A L S
Description of Risks and
Benefits for
Participation in Trial
Alternatives
Treatments
Rights and privacy of
Trial Participants
It’s a cumbersome but KEY process
• Important to have easy-to-understand language
• Allow patient to ask as many questions as necessary
• Give as much time as needed to potential
subjects to make decision
Blockchain
technology can
ensure adherence
to a patient’s
consent and their
rights and safety
during the trial.
2-7%
Informed consent related
issues observed by Good
Clinical Practice
inspections

C U R R E N T S I T U A T I O N
Challenges:
• Complex, and inefficient
• Non-compliance risk
• Siloed information – less
transparency and more
confusion
• Spot-check inspections
are limited to post non-
compliance
or
Clinical
Research
Associate
Authorized
Clinical
Research
Organisation
Trial
Participant
Laboratory
Regulatory
Authority
Ethics
Committee
Flow 1
Flow 2
Flow 3
Clinical
Sites
Sponsor
Complex, and
inefficient

F U T U R E S T A T E | B L O C K C H A I N P O W E R E D C O N S E N T
Conducting a clinical
trial in a blockchain
ecosystem
Sponsor
Clinical
Research
Associate
Authorized
Clinical
Research
Organisation
Trial
Participant
Laboratory
Regulatory
Authority
Ethics
Committee
Clinical
Sites
Blockchain
Transparency
Security
Trust
Efficiency

W H Y B L O C K C H A I N
• Immutable record of participant consent
• Immediately visible to appropriately permissioned users (Patients,
Sponsor, Clinical Research Organizations, Ethics Committee, etc.)
• Decreased fraudulent data
• Ensured adherence to compliant procedures
• Automated processes in line with Good Clinical Practices (GCP)
• Consistency of information viewed by relevant participants
• Patient ownership and ability to decide which information is shared
• Changes in study protocol provided to patient in near real-time
• Awareness and visibility of consent status changes applied in near
real-time
U s e s + Va l u e o f B l o c k c h a i n
Security
Trust
Efficiency
Transparency

Trial Participant
• Correct versions used
• Re-consent needs notified in
real-time
• Withdrawal of consent in
real-time
• Clearer explanation of clinical
trial’s information
• Trial efficiency
• Patient empowerment
Clinical Site
• Reduced time required for
document review
• Ensures correct current
version used and recorded
correctly
• Any re-consent needed
notified
• Ensure auditability,
traceability of data
Sponsor / Clinical Research
Associate / Clinical Research
Organization
• Reduced time required for
document review and
verification
• Confidence in use of correct
versions
• Ensure patient safety
• Simplifies management of
different versions of document
as used at different locations
• Site / country / language
specific versions can be
managed
• Ensure auditability,
traceability of data
Laboratory
• Compliance demonstration
following consent provided
• Real-time changes in sample
testing following consent
withdrawal
Regulatory Authority /
Ethics Committee
• Confidence in informed
consent being obtained and
recorded as per GCP, using
correct versions
• Immediate notification of
new versions submitted for
approval
• Real-time approval of new
versions (time saving)
eConsent advantages to all
• Patient Empowerment & Engagement
• Reduced process time
• Trust, safety and Integrity and traceability
• Reduced Operational Expenses
• Real-time updates and changes

Clinical Trial
eRecruitment
Clinical Trial
eConsent
Clinical Trial
IOT devices
Personalized
Medicines

Open Webinar
TOPIC 3 | IoT Medical Device
Disa Lee Chou n (UCB)
Fr ancesca Rocchi
(Os pedale Pediatric o Bambino Ges ù)
24
FEB
3
MAR

Current State
B A C K G R O U N D
• Disconnected Ecosystems’ Applications
• Security and Data Breaches (Ad-Hoc Cybersecurity Mechanisms)
• Centralization & Access Limitations: Manufacturers essentially are data silos.
• Lack of Data Standards & Formats: Emergence of EHR
• Time Delays: Data Updates, Notifications
• No smart analytics with traceable and verifiable notification over large data
volumes
Weekly download
Data analysis
Research/ Investigator
Patient Patient ID
Devices 1
Patient ID
Devices 2
Patient ID
Devices 3
Device
Company 1
Device
Company 2
Device
Company 3
Processed &
Aggregated in
Proprietary platform
Gathering information
and applying the
standards
Aggregated Data in
template formats
(CRF – AE)
Challenges

I N T R O T O I O T
Connected Health Devices + Remote Monitoring Technology
Innovative strategy to promote health and improve patient management and care.
Physiological data of the patient and their data
related to the disease are digitally transmitted
to a healthcare center providing clinical
information
Early detection of diseases enables:
• Early intervention
• Reduction of mortality and hospitalization
• Allows patient education and self management
Even within the framework of a clinical trial, remote patient monitoring can improve
Patient Outcome Reduce healthcare
utilization Decrease costs
Provide abundant
data for research
Increase physician
satisfaction

A D V A N T A G E S O F I O T
The devices
Intelligent and Noninvasive
biosensors
Wearable
health devices
Implanted monitoring
devices
Specially now we feel the importance of tele-medicine in the clinical and research setting and secure data sharing avoiding unnecessary
access to the hospital during the Covid era.
REAL TIME DATA
potential to improve
care, boost treatment
adherence and improve
health outcome
This use case aims at validating how blockchain
enhances and supports the dynamic acquisition and
processing of data from patients and medical devices in
one consolidated view, to accelerate clinical development
and bring solutions to patients earlier.
Connected health devices and remote patient
monitoring (RPM) technologies can facilitate and
enrich healthcare decisions made by doctors,
principal investigators and other stakeholders in
clinical trials, through continuous health
monitoring.

T H E C L I N I C A L S T U D Y U S I N G I O T
• 20 patients
• from 1-18 years of age
• Chronic heart failure
• 3 months of telemonitoring
A non-Interventional Study will
be used to validate the use
case. The study will be
sponsored by Ospedale
Pediatrico Bambino Gesù
(OPBG), Italy.
H E A R T F A I L U R E I N P E D I AT R I C A G E G R O U P
A recent analysis has shown that structure telephone support and telemonitoring significantly reduces the risk
of mortality and re-hospitalization related to heart failure.
Currently we have no telemonitoring data in heart failure in pediatric patient age group.
The aim is to measure the tolerability and clinical impact of telemonitoring in the management of heart failure.
Validate how blockchain enhances and supports the dynamic acquisition and processing of data from patients and medical devices.
The study

I O T M E D I C A L D E V I C E
U S E D O N O P B G P E D I A T R I C C L I N I C A L T R I A L
Noninvasive health data monitoring devices
used in the study:
• Transcutaneous in patch type for the chest*
• Oximeter applied to the finger*
• E-diary to discuss device satisfaction
ECG Oxymeter eDiary
Devices used on the
clinical trail
*sent to a private cloud stored in a medical patient record
The trial is currently under review of the
ethic committee and will start soon.

F U T U R E S T A T E | P R O P O S E D S O L U T I O N
Clinical Trial Participant
PharmaLedger Patient
Mobile Application
IoT Medical /
LifeStyle Devices
PharmaLedger
Platform
Data transmission
Data transmission
Device
provider Cloud
Hospital
Database
PharmaLedger
User Interface
Clinical Trial Staff

Cybersecurity Framework using
decentralized identifiers (DID)
and verifiable credentials (VC)
Trusted & verifiable data
retrieval from multiple sources
Verifiable and traceable
real-time notifications for
Patients & Clinicians
Encryption and access control
ensuring security & privacy
Verifiable history of
updates on patient's data
Decentralization &
permissioned access
Transparency on data
ownership by relevant
participants
Standardized and traceable
data for enhanced analytics

IoT Enabled Clinical Trial
• Patient Empowerment & Engagement
• Integral info. Trial Design*
• Higher Data Quality & Integrity
• Reduced Operational Expenses
• Remote patient monitoring
Patients
• Reduce burden for patient
• Less visits to trial site
• Flexibility to participate in
clinical trials
• Secure access
• Improved visibility of own
data
• Ownership and
empowerment
• Self management of health
data
Clinical Sites
• Real time data visibility
for all devices
• Reduce site burden
managing multiple
platforms
• Eliminate complexity of
data access management
• Efficiency in patient safety
matters
• Traceability and
auditability of data access
and exchange
Sponsors
• Continuous, remote and
trusted trial progress
overview
• Long-term outcomes
traceability and auditability
• Transparency over the
safety and efficacy of the
treatment
• Real time access to key
aggregated data
• Cost reduction
• Quicker decision making
and safety reporting
Device Company
• Reduced efforts of system
integration
• Increased traceability
• Simplified qualification
process and due diligence
• Device certifications in
multiple countries
• Harmonized data standards
and analytics
Regulatory Agency
• Simplified validation
• Simplified verification of
devices
• Reduced audits and
inspections efforts
• Transparency of certified data
• Compliance to data privacy
and legislation
* Essential or fundamental information collected part of the trial design.
These IoTs are collecting patient assessments which will be used to
determine patient’s health.

Open Webinar
TOPIC 4 | Per sonalised Medicine
B e a t r i z M e r i n o
( U n i v e r s i d a d P o l i t é c n i c a d e M a d r i d )
C h r i s t o s K o n t o g i o r g i s
( D e m o c r i t u s U n i v e r s i t y o f T h r a c e )
24
FEB
3
MAR
In collaboration with UCB, TVS, CERTH, ICSI, OPBG

Negative impacts
P R O B L E M | C U R R E N T S T A T E
Real World Data (RWD) | Global healthcare data
Hospitals
(EHR)
Pharmacies Devices
Other medical
specialty
Health data
from other
patients
Patients
X Lack of direct or
indirect information
from data custodians
about the use of their
data in research
Hospitals
X No access to all medical
records with a complex
X Complex, costly and
time-consuming
process.
Current State
Application of
prediction model
1 2
Approved application:
Use population health data
to support diagnosis
Data
Prediction
Artificial
Intelligence or
multivariate
regression
3

O V E R A L L O B J E C T I V E
The Personalized Medicine use case aims at establishing a trusted environment that supports
patient-centric solutions for
(a) a value-based health delivery in clinical practice
(b) the generation of Real World Evidence (RWE) for research purposes.
This will be applied to improve the diagnosis, prevention and personalized treatment of patients.
Introduce new civil rights for
patient ownership and right of
portability.
Use integrated health data,
compliant with data privacy
regulations, for research
purposes to generate RWE.
Implement dynamic
permissioning for use in the
platform.
Leverage blockchain in combination
with Machine Learning and Artificial
Intelligence for the creation of
algorithms that can assist in
improving healthcare provision.

F U T U R E S T A T E
Real World Data (RWD) | Global healthcare data
Hospitals (EMR) Pharmacies Devices Optometrist
Patients
✓ Why and how my data is being used?
✓ What are they using my data for?
✓ Who has access to my data
Healthcare professionals
✓ Better prevention of risk factor
✓ More accurate diagnosis
✓ Personalized and effective treatment
Researchers
✓ Request access to patient’s
health data
Application prediction model
Based on data automatically gathered
from information collected from patient
Prediction
AI or multivariate regression

Transparency Security Trust Interoperability
Grants complete
overview over own data
Allows data privacy
and security through
blockchain,
de-identification
Healthcare provision is
improved by better
clinical decisions,
making value-based
healthcare more
achievable
Improves the ability to
connect data and
reduces the delay time
from provision of RWD

Patients
✓ Enables patient data ownership
and right of portability
✓ Enhanced Trust: Grants complete
overview over own`s data
✓ Allows data privacy and security
through blockchain, de-
identification and encryption
✓ Better & personalized treatment
→ Less toxicity in polypharmacy,
less drug interaction, better health
outcome, improved wellness QoL
Data providers
✓ Increased confidence in data
integrity & Increased efficiency
automating process → no
integration
✓ Potential cuts to the healthcare
budget + hospital
decentralization + remote
diagnostics → e.g. better reaction
in epidemies
Physicians, researchers
✓ Allows better informed decisions→
avoid medical errors
✓ Better access to patient data→
granted access, through patient
permission→ full and accurate
medical records
✓ Healthcare provision → clinical
decisions & practice improved
✓ Reduce burden on integration
process (easier, less time &
resourceless)
✓ Improved ability to connect data
+ Reduces the delay time from
provision of RWD, coming as close
as possible to real time research
and provides more opportunities for
prospective studies.
S T A K E H O L D E R V A L U E P R O P O S I T I O N
Other
✓ Smart and secure healthcare
ecosystem
✓ Reduce incidence of fraud and
errors
✓ Healthcare provision is improved
by greater support of clinical
decisions, making value-based
healthcare more achievable
✓ Decentralized healthcare data
management (e.g. GDPR
compliance)
✓ Low cost of data management +
Fast retrieving data

T H A N K Y O U

A Trust-Centric Healthcare Journey Part II | Full Presentation of PharmaLedger's 2nd Open Webinar |

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