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“data is the new oil;”
for large Pharma and Bio-Pharma,
data is the new potential
blockbuster
2
Agenda
Co-create for a better future
Importance & Value of Data
in Pharma
Contextualizing Pharma Data
What Organizations need to do
Gold Standard of Evidence
and Drivers
Data and AI in Pharma
01.
02.
03.
04.
06.
07.
08.
09.
Data challenges in Clinical
The Data Strategy
05. 10.
Platform approach
2020 – STEFANINI GROUP | PRESENTATION
Q&A
Message for the Furture
3
• The McKinsey Global Institute estimates that applying
big-data strategies to better inform decision making
could generate up to $100 billion in value annually across
the US health-care system.
• The Smart Pill:
• Optimizing Functions.
• Increased collaborations- Pharma, Payers, Providers,
Physicians, Partners.
Value of Data
2020 – STEFANINI GROUP | PRESENTATION
Volume, Velocity, Variety
CONTEXTUALIZING DATA IN PHARMA
1 Trial including Genomic Data is 1 Petabyte of Data
Omics
Preclinical &
Drug Discovery
Clinical
SCM
Marketing & Patient
Genomics & Proteomics
HTS, Leads, Drug Target
Interactions
Trial Data
Supply Chain and
Manufacturing Systems, IoT,
Sensors
Marketing, Patient
engagement, sentiment,
social media, IoMT, Devices.
4
2020 – STEFANINI GROUP | PRESENTATION
GOLD STANDARD OF EVIDENCE & DRIVERS
Explosion of Data and Digital Technologies.
1
2
3
Generation ->
Clinical Trials
Generation ->
Digitization of
Healthcare- Claims,
EMR data- RWE
Generation->
Patient data from
wearables,
digital pills,
devices, IoMT.
4th Gen Post Covid19-
Smart & Virtual Trials,
Patient Outcomes
5
2020 – STEFANINI GROUP | PRESENTATION
WHAT ORGANIZATIONS NEED TO DO
Mindset & Culture Network CollaborateFunction CoE
Organization, Senior
Management and every
functions leadership to
be Digital and Data
mindset.
Create key functions
CoE around Data and AI
like: Omics, Preclinical
& Discovery, Clinical
Build a strong
ecosystem with
Partners, Startups,
Academia.
Eg: Merck with Inst of
Systems Biology, Takeda
& MIT, Novartis Biome
More with Customers-
Providers, Payers,
Physicians, Partners.
Value based contracting
with Payers, focused on
outcomes.
6
2020 – STEFANINI GROUP | PRESENTATION
DATA STRATEGY
Organization & Governance
Define ownership, accountability. Define
standards and policies.
Business Goals Alignment
Have alignment with business goals, functions
goals.
Risk & Compliance
Invest in GRC tools, technologies. Have
policies & procedures.
Proprietary Data
Identify propriety data, its value and have
processes policies to protect and gain value
from propriety data.
Data Quality
Ensure data quality, get rid of redundancies,
establish quality processes.
Architecture & Roadmap
Aligned to organization, business and
functions goals. Eg. Any function or TA
should be able to implement AI.
7
2020 – STEFANINI GROUP | PRESENTATION
DATA & AI IN PHARMA
In-silico preclinical testing
In-silico animal models for preclinical
testing. Automate manipulation,
analysis, cell selection.
In-silico, Digital Trials
In-silico clinical models, smart
trials, virtual trials.
Personalized Medicine
Trained AI models on
genotype, phenotype
information, behavior
patterns.
In-silico Drug Discovery
Computational, drug design and
discovery. AI on large data sets to
identify leads, targets.
Diagnosis
Automate medical image screening
with trained AI models.
Genotype–Phenotype
Identification
Smart SCM
Industry 4.0
Data from IoT, Factory Sensors,
SC. Mfg based on real time
consumption data. Robots.
Train AI for smart routes 8
2020 – STEFANINI GROUP | PRESENTATION
9DATA CHALLENGES IN CLINICAL
Multiple Systems,
Products, Vendors.
Many manual
processes resulting in
increased errors..
Increased time, cost
and efforts.
Complex environment
affecting the
collaboration and data
flow, data access,
analytics and reporting.
Disparate ComplexManual Low RoI
9
2020 – STEFANINI GROUP | PRESENTATION
10
Study Building Provisioning Smart Trials Decentralized Trials
A Digital Study Design &
Data Flow Solution
Above and beyond
traditional marketing by
promoting
environmental.
Device Provisioning with
an innovative Solution
with AI
Above and beyond
traditional marketing by
promoting
environmental.
Platform with eDC, eCOA,
eICF, Coder, IRT and CTMS
modules, in a unified
comprehensive platform
Above and beyond
traditional marketing by
promoting
environmental.
Above and beyond
traditional marketing by
promoting
environmental.
Platform Approach
Platform for Clinical Transformation
Integrates Automates Predicts Resolves Insights
Integrates with all
systems, devices and
applications. Provides
Support
Automates
Processes,
equipment's
Predicts issues &
alerts
Initiates solutions &
maintenance
Gives insights &
answers on all the
data
Virtual Trials: Patient data
can be collected anywhere,
site, home, remote.
Increased engagement,
retention & satisfaction
2020 – STEFANINI GROUP | PRESENTATION
10
11MESSAGE FOR THE FUTURE
DATA CULTURE
Organizations should have a data mindset and culture, it’s the
most valuable asset.
PATIENT FIRST
Should focus on outcomes, patient care and wellness.
DIGITAL
Should try to become digital, paper less with increased automation.
1
2
3
4P
Collaboration- Payers, Providers, Physicians, Partners.4
2020 – STEFANINI GROUP | PRESENTATION
12
12
2020 – STEFANINI GROUP | PRESENTATION
2020 – STEFANINI GROUP | PRESENTATION
Nagesh Jadhav
Director Digital Transformation &
Innovation, Life sciences
Nagesh.Jadhav@stefanini.com
Denis Rynders
Global Business Unit Leader,
Digital Health Services
Denis.Reynders@stefanini.com
Thank You!!

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Data and AI Transforming Pharma

  • 1. “data is the new oil;” for large Pharma and Bio-Pharma, data is the new potential blockbuster
  • 2. 2 Agenda Co-create for a better future Importance & Value of Data in Pharma Contextualizing Pharma Data What Organizations need to do Gold Standard of Evidence and Drivers Data and AI in Pharma 01. 02. 03. 04. 06. 07. 08. 09. Data challenges in Clinical The Data Strategy 05. 10. Platform approach 2020 – STEFANINI GROUP | PRESENTATION Q&A Message for the Furture
  • 3. 3 • The McKinsey Global Institute estimates that applying big-data strategies to better inform decision making could generate up to $100 billion in value annually across the US health-care system. • The Smart Pill: • Optimizing Functions. • Increased collaborations- Pharma, Payers, Providers, Physicians, Partners. Value of Data 2020 – STEFANINI GROUP | PRESENTATION
  • 4. Volume, Velocity, Variety CONTEXTUALIZING DATA IN PHARMA 1 Trial including Genomic Data is 1 Petabyte of Data Omics Preclinical & Drug Discovery Clinical SCM Marketing & Patient Genomics & Proteomics HTS, Leads, Drug Target Interactions Trial Data Supply Chain and Manufacturing Systems, IoT, Sensors Marketing, Patient engagement, sentiment, social media, IoMT, Devices. 4 2020 – STEFANINI GROUP | PRESENTATION
  • 5. GOLD STANDARD OF EVIDENCE & DRIVERS Explosion of Data and Digital Technologies. 1 2 3 Generation -> Clinical Trials Generation -> Digitization of Healthcare- Claims, EMR data- RWE Generation-> Patient data from wearables, digital pills, devices, IoMT. 4th Gen Post Covid19- Smart & Virtual Trials, Patient Outcomes 5 2020 – STEFANINI GROUP | PRESENTATION
  • 6. WHAT ORGANIZATIONS NEED TO DO Mindset & Culture Network CollaborateFunction CoE Organization, Senior Management and every functions leadership to be Digital and Data mindset. Create key functions CoE around Data and AI like: Omics, Preclinical & Discovery, Clinical Build a strong ecosystem with Partners, Startups, Academia. Eg: Merck with Inst of Systems Biology, Takeda & MIT, Novartis Biome More with Customers- Providers, Payers, Physicians, Partners. Value based contracting with Payers, focused on outcomes. 6 2020 – STEFANINI GROUP | PRESENTATION
  • 7. DATA STRATEGY Organization & Governance Define ownership, accountability. Define standards and policies. Business Goals Alignment Have alignment with business goals, functions goals. Risk & Compliance Invest in GRC tools, technologies. Have policies & procedures. Proprietary Data Identify propriety data, its value and have processes policies to protect and gain value from propriety data. Data Quality Ensure data quality, get rid of redundancies, establish quality processes. Architecture & Roadmap Aligned to organization, business and functions goals. Eg. Any function or TA should be able to implement AI. 7 2020 – STEFANINI GROUP | PRESENTATION
  • 8. DATA & AI IN PHARMA In-silico preclinical testing In-silico animal models for preclinical testing. Automate manipulation, analysis, cell selection. In-silico, Digital Trials In-silico clinical models, smart trials, virtual trials. Personalized Medicine Trained AI models on genotype, phenotype information, behavior patterns. In-silico Drug Discovery Computational, drug design and discovery. AI on large data sets to identify leads, targets. Diagnosis Automate medical image screening with trained AI models. Genotype–Phenotype Identification Smart SCM Industry 4.0 Data from IoT, Factory Sensors, SC. Mfg based on real time consumption data. Robots. Train AI for smart routes 8 2020 – STEFANINI GROUP | PRESENTATION
  • 9. 9DATA CHALLENGES IN CLINICAL Multiple Systems, Products, Vendors. Many manual processes resulting in increased errors.. Increased time, cost and efforts. Complex environment affecting the collaboration and data flow, data access, analytics and reporting. Disparate ComplexManual Low RoI 9 2020 – STEFANINI GROUP | PRESENTATION
  • 10. 10 Study Building Provisioning Smart Trials Decentralized Trials A Digital Study Design & Data Flow Solution Above and beyond traditional marketing by promoting environmental. Device Provisioning with an innovative Solution with AI Above and beyond traditional marketing by promoting environmental. Platform with eDC, eCOA, eICF, Coder, IRT and CTMS modules, in a unified comprehensive platform Above and beyond traditional marketing by promoting environmental. Above and beyond traditional marketing by promoting environmental. Platform Approach Platform for Clinical Transformation Integrates Automates Predicts Resolves Insights Integrates with all systems, devices and applications. Provides Support Automates Processes, equipment's Predicts issues & alerts Initiates solutions & maintenance Gives insights & answers on all the data Virtual Trials: Patient data can be collected anywhere, site, home, remote. Increased engagement, retention & satisfaction 2020 – STEFANINI GROUP | PRESENTATION 10
  • 11. 11MESSAGE FOR THE FUTURE DATA CULTURE Organizations should have a data mindset and culture, it’s the most valuable asset. PATIENT FIRST Should focus on outcomes, patient care and wellness. DIGITAL Should try to become digital, paper less with increased automation. 1 2 3 4P Collaboration- Payers, Providers, Physicians, Partners.4 2020 – STEFANINI GROUP | PRESENTATION
  • 12. 12 12 2020 – STEFANINI GROUP | PRESENTATION
  • 13. 2020 – STEFANINI GROUP | PRESENTATION Nagesh Jadhav Director Digital Transformation & Innovation, Life sciences Nagesh.Jadhav@stefanini.com Denis Rynders Global Business Unit Leader, Digital Health Services Denis.Reynders@stefanini.com Thank You!!