La relazione introduttiva di Luca Pani, Direttore Generale AIFA, per l'evento "K.O. allo spreco in sanità. Accesso alle cure e aderenza terapeutica", II Festa nazionale per la lotta agli sprechi, SPoleto, 6 giugno 2015

1. I Cittadini, i Pazienti e la Rivoluzione Digitale in
Farmacologia
Luca Pani, M.D.
Director General, Italian Medicines Agency (AIFA), Rome
CHMP and SAWP Member; EUMBT and ERMS Chair
European Medicines Agency (EMA), London
@Luca__Pani - dg@aifa.gov.it
Spoleto, 6 Giugno 2015

2. Public Declaration of transparency/interests*
Note: For this talk, I am not receiving any compensation
*Luca Pani, in accordance with the updated policy on Conflict of Interest Regulations approved by AIFA Board of Directors (25.03.2015) and published on the
Official Journal of 15.05.2015 according to 0044 EMA/513078/2010 on the handling of the conflicts of interest for scientific committee members and experts
Interests in pharmaceutical industry NO Currently Last 2 years
More than 2
years but less
than 5 years ago
Direct interests:
Employment with a company x
Consultancy for a company x
Strategic advisory role for a company x
Financial interests x
Ownership of a patent x
Indirect interests:
Principal investigator x
Investigator x
Individual’s Institution/Organisation receives a grant or other funding x

3. Disclaimer
The views expressed in this presentation are personal and may
not be understood or quoted as being made on behalf of or
reflecting the position of EMA, AIFA or any of their committees or
working parties.
They are not intended to be an official and/or binding regulatory
position.
These slides cannot be used without written permission.

4. We are really talking about Big Data !!
And all this is already old data...

5. Align business strategy to analytics
• Pharmaceutical organizations need to decide to focus on areas
which are core to them
Which area will deliver greatest value in shortest time
(Like: Patient safety, Study Design, Patient outcomes)
Pressing organizational operational challenge
Industry benchmarking
• Develop actionable plan to successfully implement analytics
Modified after D. Singh, DIA Paris 2015

6. How business should manage information and learn from it...
BusinessOptimization
Analytical Maturity
Unsystematic
Basic
Competitiv
e
Differentiating
Breakaway
• Spread sheet
and excel file
• Master data
Management
• Basic data
warehouse
• Data warehouse
appliances and
dashboards
• Structured and
Unstructured data
• Advanced
information
management
• Content analytics
• Predictive, Real
time analysis
• Basic
operational
needs
• Data
oriented
• Lack of analytical
skill set
• Manual data
manipulation
• Consistent and
trusted reporting
• Standard data
definition and
governance
• Business scenario
modelling
• Deep analytical skill
sets
• Information is
governed
• Actionable insights,
pre-emptive and
predictive business
management
• Information deemed
as strategic asset
Leverage Big Data

7. Big Data and Real World Evidence

8. Data sources in pharma from multiple functions...
• Plans
• Claims
• Member Populations
• Risk Models
• Open Data
• Influencers
• Publications
• Longitudinal Data
• Physician Survey
• LMI
• EMR, HER
• Quality of Care
• Outcomes
• Biomedical Sensors
• Blogs
• Health Websites
• Twitter/ Facebook
• Help websites
• Pharma Websites
• High Throughput Assay Data
• Clinical Trials
• Disease Management
• HEOR
• Sentiment
• Consumer Sensors
Clinical
Provider
Patient
Payer
Social Media
Real World
Pharma Co.

9. Personal Sensors are here!

10. Data Architecture for Big Data Analysis
Registries,
Cohort DBs,
Surveys
Unstructured
/ Semi
Structured
External
data source
Internal data source
Unstructured Application data
Data
Acquisition
ETL
Data
Virtualization
Data Analysis
Data
Integration
Cleaning
Semantic
Analysis
Semantic & Document
Repository
Internal data
source
Presentation
Layer
Semantic
Search
Self
Service
BI
Ad-hoc
Analytics
Insights for decision making
Clinical/Healthcare
Metadata Repository
Dashboards
Statistical
Computing
Environment
Modified after D. Singh, DIA Paris 2015

11. Critical Success Factors
• Develop a scalable infrastructure that leverages existing and
new information assets
• Align people, processes and information to sustain strategic
information over time
• Establish end-to-end information-driven strategies and
objectives that promote business priorities
• Plan and achieve short-term and long-term ROI

12. Challenges are not few but many…
Right data selection and aggregating widely dispersed data
Cost of data aggregation
Delivering data in a timely way to the systems and people that
need it
Providing decision makers with complete and accurate insights
Generate information that can have immediate impact on patient
treatment or patient safety issues
Ensure data quality, security and privacy standards
Ensuring that a proper architecture platform is established to
enable desired results
Modified after D. Singh, DIA Paris 2015

13. The real challenge...

14. #thankyou

15. Ask