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

Public Declaration of
transparency/interests*
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

Consultancy for a company

Strategic advisory role for a company

Financial interests

Ownership of a patent

Indirect interests:
Principal investigator

Investigator

Individuals Institution/Organisation receives a grant or other

funding

*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
Note: For this talk, I am not receiving any compensation

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.

We are really talking about Big Data !!

And all this is already old data...

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

Business Optimization

How business should manage information and learn from it...

Actionable
insights, preemptive and
predictive
business
management
Information
Breakaway
deemed as
Predictive,
strategic asset
Real time
analysis

Lack of
analytical skill
set
Manual data
manipulation

Business scenario
modelling
Deep analytical
skill sets
Consistent and Information is
trusted
governed
Differentiatin
reporting
Advanced
g
Standard data
information
definition and
management
governance Competiti
Content

Basic
Basic
Master data
operational
needs Unsystemati Management
Basic data
Data
Spread
c
warehouse
oriented
sheet and
excel file

Datave
warehouse
appliances and
dashboards
Structured and
Unstructured data

analytics

ata
D
Big
e
ag
r
e
Lev

Analytical Maturity

Big Data and Real World Evidence

Data sources in pharma from multiple functions...

Clinical

Blogs
Health Websites
Twitter/ Facebook
Help websites
Pharma Websites

High Throughput Assay Data

Clinical Trials
Disease Management
HEOR

Social Media

Open Data
Influencers
Publications
Longitudinal Data
Physician Survey
LMI
Real World

EMR, HER
Quality of Care
Outcomes
Biomedical Sensors

Provider
Pharma Co.

Sentiment
Consumer Sensors

Payer
Patient

Plans
Claims
Member Populations
Risk Models

Personal Sensors are here!

Data Architecture for Big Data Analysis

Internal data source

Unstructured Application data

Data Analysis

Data
Acquisition
External
data source
ETL
Unstructured
/ Semi
Structured

Registries,
Cohort DBs,
Surveys

Data
Integration
Cleaning

Data
Virtualization

Semantic
Analysis

Semantic & Document

Repository
Clinical/Healthcare
Metadata Repository

Modified after D. Singh, DIA Paris 2015

Presentation
Layer

Semantic
Search
Ad-hoc
Analytics
Self
Service
BI
Dashboards

Insights for decision making

Internal data
source
Statistical
Computing
Environment

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

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

The real challenge...

#thankyou

Ask