Imagine...

1. Forecasts for the future of DCTs and
Digital Clinical Trials
Emily (Kunka) Lewis, MS, CCRP
Digital Business Transformation, Neurology
UCB Biopharma

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UCB is a global
biopharmaceutical
company focused on
solutions for people
living with severe
diseases.
By putting people at the
heart of everything we do,
we enable people to live
their best lives, as free
as possible from the
challenges of disease.
From Solution
to Patient
We strive for a unique
patient experience,
providing solutions
with the highest
possible impact.
From Patient
to Science
We pursue a deep
understanding of patient
sub-populations to
develop an original
scientific hypothesis.
From Science to Solution
We aim to translate scientific hypotheses into
innovative solutions and engage patients in the journey.

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UCB’s patient value ambition
UCB Team Name [XXXXXXX] - UCB - Approval [XX-XX-XXX] - Approval date [XX Month XXXX] ! GO TO INSERT>HEADER FOOTER to change.
Creating value for patients now and into the future
Unique outcomes that
help specific patients
achieve their goals
Best individual
experience
Ensuring access to all
those who need these
solutions in a way which
is viable for patients,
society, and UCB

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Becoming more customer and
data-centric in our approach Developing digital platforms for
personalized patient care
Digital mindset Using data and technology
with purpose
Partnering externally for
greater impact
Our digital business transformation journey:
a strategic priority

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Digital
Transformation
Data and Real
World Evidence
Open
Innovation
We continuously innovate
References: 1. UCB 2021 Annual Report.
R&D
28%1
UCB invests about a
quarter of its revenue
in R&D annually
Continual Investment in
Research & Development

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Imagine the Year is 2033

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AI-Enabled Automation
● Automate ritualized communications to patients at
scale (e.g. visit follow ups, aftercare instructions, and
reminders)
● Automate staffing of visits by human or chatbot
● Automate record keeping
• summarizing visit notes, finding connections between
ideas within notes
• seamlessly generating record metadata and ensuring data
privacy and provenance (e.g. consent tracking)

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AI-Augmented Humans (Study Team)
● Patient identification and
matching for trial recruitment
● Personalized facilitation of
patient-staff interactions
• Communicating with patients
how they prefer (e.g. text,
email, phone), when they prefer
(e.g. after 3pm on weekdays)
● Clinical decision support
• Guiding investigators in handling
adverse events

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NextGen Computing
● Cloud computing - use of cloud
infrastructure for learning loops
● Distributed computing - multiple
software components are on
multiple computers in different
geographies, but run as a single
system
• users can give other scientists
additional computation power
at no cost to them

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NextGen Tech Stack
● Tech stack operates
programmatically
(self-orchestrated) with a chain of
trusted data (with each step
cryptographically signed)
● Web3 protocols - technologies that
enable the decentralized and
interoperable web
○ blockchain
○ peer-to-peer networking and
integrated user protocols

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Benefits of Computing and Tech Stack
● Enables a more secure enterprise which minimizes risk
○ utilizes hashes, signatures, proofs, key pairings, private
relays
● Enables data to be verifiable in real time, easy to credit,
privacy-preserving (no pseudo-anonymity with encryption
● Immutable, yet allows for erasure obligation known in
GDPR as “the right to be forgotten”

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Interoperability
● Standardization protocols enabling seamless data exchange
• Fast Healthcare Interoperability Resources (FHIR)
• Health Level Seven International (HL7)
● Reliance on reusable components like code libraries,
technical/operational specifications
● Integration with Health Information Exchange (HIEs) -
networks that allow for the secure and efficient exchange of
health information between healthcare providers
● Greater use of Application Programming Interfaces (APIs)
to allow software applications to communicate with one another

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Study Operations
● 3D printed tools, drones
● Wearables→Invisibles using
wall-mounted radio signaling
● Use of voice assistants
● Large language model
(LLM) capabilities for medical
questions (e.g. MedPalm)
● Biometric sampling and body
scans using computer vision
● Integration of omics data
*transcriptomics, genomics, proteomics, metabolomics

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Interaction and Patient Experience
● Enhanced patient and HCP experiences in the metaverse
○ no geographic boundaries to collaborate (sensory
integration, haptics, holograms with fully articulated direct
hand interactions)
Extended Reality (XR)
● Virtual Reality (VR) - a completely
computer generated world (e.g. simulation)
● Augmented Reality (AR) - digital world
overlays the real world
● Mixed Reality (MR) - digital world
interacts with the real world through 3d
manipulation (e.g. Hololens)

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Holographic User Interfaces

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Rather than discrete study sponsors or consortia (where
there is entity ownership) we will have Decentralized
Autonomous Organizations (DAOs) which have
distributed decision-making, management, and entity
ownership
DAOs will allow for even GREATER pre-competitive
collaboration, data sharing, and ownership among many
research entities
Decentralized Governance

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Decentralized Governance
Sharing of wisdom (collective
intelligence, not raw data)
○ Federated learning - an
average of localized AI
models
○ Split learning - participating
entities (stakeholder or
innovator networks) train
machine learning models
without sharing any raw data
(e.g. using curated github)

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New Data Ownership Paradigm
● Patients own their own data utilizing
tokenization
○ Non-fungible tokens (NFTs)
blockchain asset that allows holders to
prove ownership, can be bought/sold
○ Soulbound tokens (SBTs)
non-transferable digital tokens (NFTs)
that represent social identity in a
decentralized society
○ Businesses will own the insights
from the patient data

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Blockchain Enabled Business Models
● Data economy (both patients
and researchers are incentivized
to share data through
tokenomics [earning of rewards,
monetization])
● Maximization of data value
(intrinsic vs. extrinsic data
valuation) through data
aggregation/mining/exchange,
and smart contracts

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Differentiators in the NextGen Paradigm
● Incentivization - Giving people monetary or social credit for
contributing
● Data permanence - Keeps data available forever
● Data composability - Linking of data between databases
● Data ownership - Tokenization of data allows interoperability with
DeSci protocols
● Data privacy - Encryption of sensitive data
● Identity - On chain identity to decrypt, collaborate, reward
● Interoperability - Modularity with Web3 protocols

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Potential of These Platforms
● To fill gaps where there are lack of funds, resources, and
infrastructure within clinical research
● To increase accessibility, sustainability of research and care
● To focus on better disease prevention and diagnosis
● To enable user-centered, modular design where the patient
can better utilize digital tools
● To enable verifiable data lineage in transactions from the
deep web with metadata

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Enabling In Silico Medicine
The use of large synthetic datasets, representative of the patient
population, to
● Train computer-based models
● Conduct simulations
● Perform data analysis
…which can help us to better understand
● Disease mechanisms
● Drug interactions

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Needs and Required Upskilling
● To increase digital literacy
● To create a culture of innovation and ethics!
• Seeding a propensity for change (and
discomfort!) within every member of the research
and care ecosystems
● To employ systems thinking (we are stronger
together!)

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Thank You!