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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 - [email protected]
Spoleto, 6 Giugno 2015
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 CurrentlyLast 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
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
How business should manage information and learn from it...
Bu
sin
ess
Op
tim
izati
on
Analytical Maturity
Unsystematic
Basic
Competitive
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
Big Data and Real World Evidence
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.
Personal Sensors are here!
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
StatisticalComputing
Environment
Modified after D. Singh, DIA Paris 2015
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 dataCost of data aggregationDelivering 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 issuesEnsure data quality, security and privacy standardsEnsuring that a proper architecture platform is established to enable desired results
Modified after D. Singh, DIA Paris 2015
The real challenge...
#thankyou
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