In this Clinical Trial eRecruitment Use Case presentation, you will find: An introduction to Clinical Trial eRecruitment use case presented by: Despina Daliani (Onorach) and Ken Nessel (Pfizer) The current Clinical Trial Recruitment process Pain points of the Clinical Trial eRecruitment PharmaLedger’s Clinical Trial eRecruitment solution for the future state Value added by PharmaLedger per actor involved 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.

1. 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.
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A TRUST-CENTRIC HEALTHCARE JOURNEY PART II
Clinical Trial & Health Data Use Cases
24
FEB
3
MAR

2. 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 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

3. Copyright © 2021 PharmaLedger - All Rights Reserved
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

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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

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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?”

6. Copyright © 2021 PharmaLedger - All Rights Reserved
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

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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

8. Copyright © 2021 PharmaLedger - All Rights Reserved
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

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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

10. Copyright © 2021 PharmaLedger - All Rights Reserved
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

11. Copyright © 2021 PharmaLedger - All Rights Reserved
Clinical Trial
eRecruitment
Clinical Trial
eConsent
Clinical Trial
IOT devices
Personalized
Medicines
V A L U E C H A I N - U S E C A S E S V I E W

12. 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.
T H A N K Y O U