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Copyright © 2019 Centre for Process Innovation Limited trading as CPI. All rights reserved.
Through the looking glass:
A digital future for healthcare
Alfredo Ramos Plasencia
Managing Director CPI Enterprises
Healthcare today
3
Key healthcare market trends
SOCIETAL FACTORS
INNOVATIVE
TECHNOLOGIES
SHIFTS IN CARE AND
BUSINESS MODELS
4
OSD
Biologics
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
Therapy
Healthcare systems today – a model
5
OSD
Biologics
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
Therapy
Healthcare systems today – a model
6
OSD
Biologics
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
Therapy
Healthcare systems today – a model
7
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
Healthcare systems today – a model
The future
9
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
Healthcare systems today – a model
10
Healthcare systems today – a model
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
11
Healthcare systems today – a model
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
12
Healthcare systems today – a model
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
13
Healthcare systems today – a model
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
14
Healthcare systems today – a model
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
C&G
Therapies
Some of tomorrow’s opportunities
Machine-learning enables
large-scale processing of
individualised data
Advanced manufacturing
facilities supply personalised
treatments just-in-time
Machine-learning enables
assessment of effectiveness of
treatment for each patient
Enhanced quality of diagnosis
supporting earlier interventions
& individualised treatments
Enhanced quality of care
through earlier, individualised
interventions
Pharmaceutical and MedTech
companies reimbursed for
positive outcomes
Wearable diagnostic devices &
cloud computing providing
individualised medical data
Patient and treatment data
shared across the medicines/
medical device supply chain
Ubiquitous diagnostic devices
monitor patient’s response to
treatment
Data-driven,
Personalised Therapies
Smart & Connected
Diagnostics
Business & Reimbursement
Model Innovation
Does it all stack up?
17
Healthcare systems today – a model
ManufactureSupply
Clinical
Diagnosis
Diagnostics
Monitoring
Point of care /
Pharmacy
Clinical
Consultation
Clinical
Intervention
OSD
Biologics
Therapy
C&G
Therapies
18
Smart pharmaceutical packaging:
Condition Monitoring in the Supply of Medicines
• Condition monitoring using multiple sensors
• High volume, low cost solution using existing hardware
• High “resolution” (item-level tracking)
19
Smart blister packs – improving adherence
Information Mediary Corp.
med-IC
https://informationmediary.com/med-ic//
Schreiner-Medipharm / ECCT
https://www.schreiner-group.com/en/press/detail/schreiner-
medipharm-develops-smart-blister-pack-for-clinical-
trial.html
Jones Packaging Inc
Presented at AIPIA Congress and
Expo, Amsterdam. November 2018
20
Making personalised therapies a reality…
Current Art of
Drug Product
Manufacture
Digital Predictive
Design of Flexible,
Agile Manufacturing
from Mechanistic and
Data-driven Models
Digital Operation using
Predictive Models and
Autonomous Learning
• Manufacturability
• Operational efficiency
• Flexibility of operations
Digitally integrated
pharmaceutical supply
chain supporting Just-
In-Time manufacture &
Real-Time Release of
Clinical Material
Smart, demand-led
commercial supply
chain supporting
Stratified Medicines,
Regulatory and Pricing
Innovation
Medicines Manufacturing Innovation Centre
21
Data-driven, Personalised Therapies
Medicines Manufacturing Innovation Centre
Just-in-Time Clinical Pharmacy
22
Stranger things…
Healthcare Newsfeed
23
OMAR ISHRAK
CEO, Medtronic
VALUE-BASED HEALTHCARE”
“…part of a broader shift to
ADJUST PRICES based on
“…[signing supply contracts] that
how well the product works”
1,000 CONTRACTS”
“…Medtronic has signed nearly
Business & Reimbursement Innovation
Summary
25
Summary
▪ Innovative materials, novel manufacturing of electronics and digital
technologies are opening up significant opportunities to improve healthcare
delivery
▪ Uncertainties in business (e.g. establishing of digital ecosystems,
intermediation, new entrants) and reimbursement models, coupled with
regulatory and cultural hurdles will slow adoption
▪ Collaboration across the healthcare value and supply chains with joint
standards, strong cybersecurity protocols and clear data ownership models is
needed to exploit the benefits these technologies are poised to deliver
26
Barriers to adoption
▪ Regulatory hurdle to certify novel diagnostics & therapies
▪ Sophisticated supply chain requirements beyond current practice
• Managing patient data through the supply chain
• Challenging system infrastructure, process execution, quality assurance
• Traceability (right product → right patient for multiple products & multiple patients)
▪ Data ownership and data sharing model, particularly regarding patient data
• Who owns the data? Who decides how data is used? Who can see what in the healthcare
value chain? Individual’s privacy and business competitive advantage concerns
• Cybersecurity
▪ Emergence digital platforms & ecosystems (which ones will dominate?)
27
Some thoughts on addressing today’s and future
challenges (I)
▪ Pre-competitive collaboration through consortia built across the value chain
• Definition of standards, communication protocols, programming interfaces, etc.
• In the UK, the Medicines Manufacturing Innovation Centre (MMIC) will provide the
environment to test manufacturing technology innovation within a GMP environment, at
scale
▪ Allow exploration beyond regulatory framework, similar to other industries,
to de-risk technology and business model innovation
• In the financial sector, the UK’s Financial Conduct Authority (FCA) has set up a “regulatory
sandbox” to allow businesses to test products and services in a controlled environment
with real consumers (https://www.fca.org.uk/firms/regulatory-sandbox)
28
Some thoughts on addressing today’s and future
challenges (II)
▪ Solving the data ownership puzzle will require dialog and the
implementation of policy instruments to regulate the space
(rules of engagement)
▪ Regulated segments of the healthcare sector (pharma,
medtech) need to embrace digital technology
• Recruitment of new or cross-industry talent, retraining and further
development are essential
• Partnerships with technology companies may accelerate the process
Alfredo Ramos Plasencia
Managing Director CPI Enterprises
alfredo.ramos@uk-cpi.com

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Digital Transformation of Healthcare Through Data-Driven Personalized Therapies

  • 1. Copyright © 2019 Centre for Process Innovation Limited trading as CPI. All rights reserved. Through the looking glass: A digital future for healthcare Alfredo Ramos Plasencia Managing Director CPI Enterprises
  • 3. 3 Key healthcare market trends SOCIETAL FACTORS INNOVATIVE TECHNOLOGIES SHIFTS IN CARE AND BUSINESS MODELS
  • 4. 4 OSD Biologics ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention Therapy Healthcare systems today – a model
  • 5. 5 OSD Biologics ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention Therapy Healthcare systems today – a model
  • 6. 6 OSD Biologics ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention Therapy Healthcare systems today – a model
  • 7. 7 ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy Healthcare systems today – a model
  • 9. 9 ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy Healthcare systems today – a model
  • 10. 10 Healthcare systems today – a model ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy
  • 11. 11 Healthcare systems today – a model ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy
  • 12. 12 Healthcare systems today – a model ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy
  • 13. 13 Healthcare systems today – a model ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy
  • 14. 14 Healthcare systems today – a model ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy C&G Therapies
  • 15. Some of tomorrow’s opportunities Machine-learning enables large-scale processing of individualised data Advanced manufacturing facilities supply personalised treatments just-in-time Machine-learning enables assessment of effectiveness of treatment for each patient Enhanced quality of diagnosis supporting earlier interventions & individualised treatments Enhanced quality of care through earlier, individualised interventions Pharmaceutical and MedTech companies reimbursed for positive outcomes Wearable diagnostic devices & cloud computing providing individualised medical data Patient and treatment data shared across the medicines/ medical device supply chain Ubiquitous diagnostic devices monitor patient’s response to treatment Data-driven, Personalised Therapies Smart & Connected Diagnostics Business & Reimbursement Model Innovation
  • 16. Does it all stack up?
  • 17. 17 Healthcare systems today – a model ManufactureSupply Clinical Diagnosis Diagnostics Monitoring Point of care / Pharmacy Clinical Consultation Clinical Intervention OSD Biologics Therapy C&G Therapies
  • 18. 18 Smart pharmaceutical packaging: Condition Monitoring in the Supply of Medicines • Condition monitoring using multiple sensors • High volume, low cost solution using existing hardware • High “resolution” (item-level tracking)
  • 19. 19 Smart blister packs – improving adherence Information Mediary Corp. med-IC https://informationmediary.com/med-ic// Schreiner-Medipharm / ECCT https://www.schreiner-group.com/en/press/detail/schreiner- medipharm-develops-smart-blister-pack-for-clinical- trial.html Jones Packaging Inc Presented at AIPIA Congress and Expo, Amsterdam. November 2018
  • 20. 20 Making personalised therapies a reality… Current Art of Drug Product Manufacture Digital Predictive Design of Flexible, Agile Manufacturing from Mechanistic and Data-driven Models Digital Operation using Predictive Models and Autonomous Learning • Manufacturability • Operational efficiency • Flexibility of operations Digitally integrated pharmaceutical supply chain supporting Just- In-Time manufacture & Real-Time Release of Clinical Material Smart, demand-led commercial supply chain supporting Stratified Medicines, Regulatory and Pricing Innovation Medicines Manufacturing Innovation Centre
  • 21. 21 Data-driven, Personalised Therapies Medicines Manufacturing Innovation Centre Just-in-Time Clinical Pharmacy
  • 23. 23 OMAR ISHRAK CEO, Medtronic VALUE-BASED HEALTHCARE” “…part of a broader shift to ADJUST PRICES based on “…[signing supply contracts] that how well the product works” 1,000 CONTRACTS” “…Medtronic has signed nearly Business & Reimbursement Innovation
  • 25. 25 Summary ▪ Innovative materials, novel manufacturing of electronics and digital technologies are opening up significant opportunities to improve healthcare delivery ▪ Uncertainties in business (e.g. establishing of digital ecosystems, intermediation, new entrants) and reimbursement models, coupled with regulatory and cultural hurdles will slow adoption ▪ Collaboration across the healthcare value and supply chains with joint standards, strong cybersecurity protocols and clear data ownership models is needed to exploit the benefits these technologies are poised to deliver
  • 26. 26 Barriers to adoption ▪ Regulatory hurdle to certify novel diagnostics & therapies ▪ Sophisticated supply chain requirements beyond current practice • Managing patient data through the supply chain • Challenging system infrastructure, process execution, quality assurance • Traceability (right product → right patient for multiple products & multiple patients) ▪ Data ownership and data sharing model, particularly regarding patient data • Who owns the data? Who decides how data is used? Who can see what in the healthcare value chain? Individual’s privacy and business competitive advantage concerns • Cybersecurity ▪ Emergence digital platforms & ecosystems (which ones will dominate?)
  • 27. 27 Some thoughts on addressing today’s and future challenges (I) ▪ Pre-competitive collaboration through consortia built across the value chain • Definition of standards, communication protocols, programming interfaces, etc. • In the UK, the Medicines Manufacturing Innovation Centre (MMIC) will provide the environment to test manufacturing technology innovation within a GMP environment, at scale ▪ Allow exploration beyond regulatory framework, similar to other industries, to de-risk technology and business model innovation • In the financial sector, the UK’s Financial Conduct Authority (FCA) has set up a “regulatory sandbox” to allow businesses to test products and services in a controlled environment with real consumers (https://www.fca.org.uk/firms/regulatory-sandbox)
  • 28. 28 Some thoughts on addressing today’s and future challenges (II) ▪ Solving the data ownership puzzle will require dialog and the implementation of policy instruments to regulate the space (rules of engagement) ▪ Regulated segments of the healthcare sector (pharma, medtech) need to embrace digital technology • Recruitment of new or cross-industry talent, retraining and further development are essential • Partnerships with technology companies may accelerate the process
  • 29. Alfredo Ramos Plasencia Managing Director CPI Enterprises alfredo.ramos@uk-cpi.com