Berlitz GlobalNET - Luton 30 Nov 2001. PILLS is a preparatory action European ... Explain how the PILLS system works

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PILLS: Patient Information
Language Localisation System
Evaluation Workshop
Berlitz GlobalNET - Luton 30 Nov 2001
PILLS is a preparatory action European
eContent project, ECD-3310-26904.

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The PILLS Consortium
Technical team:
 Information Technology Research Institute (ITRI), University of Brighton UKInformation Technology Research Institute (ITRI), University of Brighton UK
 Dr. Donia Scott, Professor of Computational Linguistics, Director of ITRI
 Dr. Richard Power, Reader in Computational Linguistics
 Medical Informatics Institute, University of Freiburg, GermanyMedical Informatics Institute, University of Freiburg, Germany
 Dr. Stefan Schulz, MD, PhD in Public Health
Market research team:
 Berlitz GlobalNET IrelandBerlitz GlobalNET Ireland
 Rose Lockwood, Director of Research
 Berlitz GlobalNET UKBerlitz GlobalNET UK
 Dawn Murphy - Consultant

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Objectives for the day
 What we want to doWhat we want to do
 Explain the rationale for the project
 Explain how the PILLS system works
 Show you the system working, and let you use it
 Get your advice and feedback on whether and how we undertake
further development of the system
 What we want you to doWhat we want you to do
 Advise us on whether we have correctly understood the publishing
requirements and challenges in the pharma industry
 Give feedback on regulation and localisation issues
 Experience PILLS for yourself
 Give feedback (and evaluation) on functionality, applicability of PILLS
 Collectively explore ideas for further development

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Agenda
 The pharmaceutical business environmentThe pharmaceutical business environment
 Challenges for pharmaceutical publishingChallenges for pharmaceutical publishing
 Regulation, harmonisation and localisationRegulation, harmonisation and localisation
 The PILLS solutionThe PILLS solution
 Demonstration and test driveDemonstration and test drive
 EvaluationEvaluation

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The business environment

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Pharma industry trends and challenges
 ConsolidationConsolidation
 quest for market share in highly competitive market
 product line integration, premium on comprehensive solutions,
efficiencies in distribution and service
 GlobalisationGlobalisation
 driven by changing policies (free trade), regulatory shifts
(harmonisation)
 leveraging sales & marketing for larger customers, exploiting global
opportunities
 Impact of technologyImpact of technology
 shorter product cycles, faster time-to-market
 Internet effect: new purchaser buying-power, shifts in the value chain
(new intermediaries), new market segmentations

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CONSOLIDATION - global market increasingly
concentrated in large companies
Company
global
market
share (%)
2000 location of HQ
Pfizer 7% US
GlaxoSmithKline 7% UK
Merck 5% US
AstraZeneca 5% UK
Bristol-Myers Squibb 4% US
Novartis 4% CH
J&J 4% US
Aventis 4% FR
Pharmacia 3% US
AHP 3% US
Lilly 3% US
Roche 3% CH
Total Top 12 52%
Source: IMS Health

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CONSOLIDATION - highly competitive market,
e.g. for psychiatric drugs...
Depression
• BMS
• Forest
• GlaxoSK
• Hoescht
• ICN
• Lederle
• Lilly
• Merck
• Novartis
• Organon
• Pfizer
• Schering
• Solvay
• Zeneca
Depression
• BMS
• Forest
• GlaxoSK
• Hoescht
• ICN
• Lederle
• Lilly
• Merck
• Novartis
• Organon
• Pfizer
• Schering
• Solvay
• Zeneca
Psychosis
• Boehringer
• Endo
• Janssen
• Lilly
• Novartis
• Ortho
• Pfizer
• Schering
• GlaxoSK
• Watson
• Zeneca
Psychosis
• Boehringer
• Endo
• Janssen
• Lilly
• Novartis
• Ortho
• Pfizer
• Schering
• GlaxoSK
• Watson
• Zeneca
Alcoholism
• Boehringer
• Dupont
• Wyeth-Ayerst
Alcoholism
• Boehringer
• Dupont
• Wyeth-Ayerst
Panic
• Pfizer
• P&U
• Roche
• GlaxoSK
Panic
• Pfizer
• P&U
• Roche
• GlaxoSK
Mania
• Abbott
• Roxane
• GlaxoSK
• Solvay
Mania
• Abbott
• Roxane
• GlaxoSK
• Solvay
ADHD
• Abbott
• Novartis
• Shire
• GlaxoSK
ADHD
• Abbott
• Novartis
• Shire
• GlaxoSK
Bulimia
• Lilly
Bulimia
• Lilly
Anxiety
• Abbott
• BMS
• ICN
• Pfizer
• P&U
• Roche
• Sanofi
Anxiety
• Abbott
• BMS
• ICN
• Pfizer
• P&U
• Roche
• Sanofi
Smoking
• GlaxoSK
Smoking
• GlaxoSK
Narcolepsy
• Shire
• GlaxoSK
Narcolepsy
• Shire
• GlaxoSK
OCD
• Lilly
• Novartis
• Pfizer
• GlaxoSK
• Solvay
OCD
• Lilly
• Novartis
• Pfizer
• GlaxoSK
• Solvay
Social Phobia
• GlaxoSK
• Pfizer
Social Phobia
• GlaxoSK
• Pfizer
Obesity
• Carnrick
• Gate/Teva
• Knoll
• Medeva
• Roche
• GlaxoSK
Obesity
• Carnrick
• Gate/Teva
• Knoll
• Medeva
• Roche
• GlaxoSK
Source: SAS

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GLOBALISATION - distribution of global
pharmaceutical sales in 2000 (US$ 318 billion)
48%
24%
16%
6%6%
North America
Europe
Japan
Latin America
ROW
52% of the industry is non-US
Source: IMS Health

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GLOBALISATION - proportion of non-US sales
for top suppliers
Merck US 47%
AstraZeneca UK 46%
GlaxoSmithKline UK 45%
Pharmacia US 42%
AHP US 40%
Eli Lilly US 40%
Bristol-Myers Squibb US 38%
Johnson & Johnson US 34%
Pfizer US 34%
Schering-Plough US 30%
Source: IMS Health

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Changes driven by the Internet
 Supply-chain relationshipsSupply-chain relationships
 Use of intranets for electronic exchange of research, compliance and
product info
 Integration with manufacturer, packaging supplier, sub-tier supplier
systems
 Customer relationshipsCustomer relationships
 Direct, transparent markets
 Pressure on cost and turnaround
 High visibility
 Relationships with doctors, pharmacists, patientsRelationships with doctors, pharmacists, patients
 Direct-to-consumer trends
 “e-Detailing”

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New channels to regional and global markets
 Fast growth in hospital e-procurement take-up in the USFast growth in hospital e-procurement take-up in the US
 currently $6.3 billion market
 grew by over $1.6 billion in 2000
 Integration of European procurement marketIntegration of European procurement market
 e.g. NHS Supplies (UK) linking with other European providers to
benchmark prices across Europe
 likely to catch up with the US as Web infrastructure solidifies
 Localisation becomes competitively significant in cross-Localisation becomes competitively significant in cross-
border marketsborder markets
 Flexible publishing solutions neededFlexible publishing solutions needed

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Challenges for
pharmaceutical publishing

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Impact of these trends on pharma publishing
 Technical publishing issuesTechnical publishing issues
 information design, Web architecture, multiple publishing formats
 Information ecology - leveraging content for multiple publishingInformation ecology - leveraging content for multiple publishing
requirements, e.g.requirements, e.g.
 marketing, labeling, instructions for use, operator manuals
 brochures, leaflets, manuals, support documentation (Print, CD, Web)
 Language and cultureLanguage and culture
 translation, adaptation to local conditions, symbology
 Legal & regulatoryLegal & regulatory
 local and regional conformance
 Industry-specific trendsIndustry-specific trends
 good practice, standards

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New levels of market exposure through Web
publishing
 Globally available product showcasesGlobally available product showcases
 In regional and global markets
 With diverse cultural and social norms, business cultures
 Increasing communication across language barriers
 Increasingly localised, withIncreasingly localised, with
 Content highly adapted to local conditions
 Combining local content with global product information
 With a mix of document and format types, stylistic formsWith a mix of document and format types, stylistic forms
and registers, variations in presentation of the same orand registers, variations in presentation of the same or
similar content.similar content.

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Info on Prozac, from the Eli Lilly site,
http://www.prozac.com/prescribing_info.jsp
Official
Package
Insert

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…and on WebMD, http://my.webmd.com/content/article/
“PIL-type”
info
provided
by Lilly

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…and from the VHN compendium site,
http://emc.vhn.net/public/
SPC

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…and the SPC for Fluoxetine (Prozac “generic”)
on the European Product Index site
License holder:
A/S GEA
Farmaceutisk Fabrik
(licensed in SE, DK,
FI, NE, UK)
SPC in English linked on
the Swedish regulator’s
site
http://www3.mpa.se/spc/

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“Monograph-type” info on the Mosby drug
information site, http://www.genrx.com/genrxfree/

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…and Mosby’s version of a PIL in English and
Spanish

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Patient Insert info on Trazodone on Thomson
Micromedex site, http://www.micromedex.com/products
(Prozac/Fluoxetine
not available in the
“free sample docs”
on this site!)

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Fluoxetine content on the BNF site (linked from
VHN), http://bnf.vhn.net/home/

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Info on Fluctin (Lilly brand name in Germany) from
the Netdoktor site, http://www.netdoktor.de
Patient
info in
German
This site is
published
in Danish,
Norwegian,
Swedish,
German
(2 versions
for AT &
DE) and
English

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Merck’s Fluoxetine on the Netherlands Medicine
Evaluation Board site, http://www.cbg-meb.nl/nl/prodinfo
SPC
in Dutch

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Information flow - pharmaceutical data
SPC
(EU)
USP
Monographs
Product “Label” (Official
Packet) Inserts (US)
BNF EP
Patient
Inserts
(US)PILs
(EU)
Web Delivery / Multi-Language
R&D
Clinical
Trials
Compliance
Dossiers
Patient
Info
Physician
Info
The goal:
common data sources
for multiple documents
in multiple languages
A question:
can this be done across
and between pharma
companies?
Health
Portals

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Regulation, harmonisation
and localisation

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The context for regulatory change
 ICHICH
 Changing European regulatory regime:Changing European regulatory regime:
 EMEA, EDQM
 Mutual Recognition Procedure
 Pharmacopoeia
 ...with similar content also published in less regulated...with similar content also published in less regulated
environments such as Web portalsenvironments such as Web portals
 Dramatic impact on use and re-use of pharma productDramatic impact on use and re-use of pharma product
info...info...

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EMEA: documents required in the regulatory
process
DERN /Pre-Qualification
QA Reporting: Trial
Methods Compliance
Submission Package
Assembly: QA & Report
Clinical Trial Study Plan:
Methods &
Measurements
Consultation Reports:
Preclinical
Submission Development
(Case, Refs, Tasking)
NDA: New Drug
Application
Risk Assessment on QA
& Reporting Protocols
Agency Meeting Reports
Submission Verification
Docs
Consultation Reports:
CM&C and Registrations
(e.g. DMFs)
Consultation/Expert
Reports: Clinical Data
QM: Quality Management
Reporting (CQI)
Adverse Event Coding
Case by Case
Adverse Events
Reporting: Spontaneous
& Mandatory Periodic
Other IND PSUR Docs/
Reporting
Adverse Event Medical
Evaluation Docs Report
Committee Answer Drafts
and Reporting
Agency Response Docs
SPC: Summary of
Product Characteristics
Drug Product Listing(s)
Submissions: Labeling,
PILs, Advertisements
Regulatory Process until
Approval or Withdrawal
(Average 100,000 pages)

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Prepares EP
monographs for
drugs with
marketing
approvals
Organisation of the EDQM
European Directorate for the Quality of Medicines
The European
Pharmacopoeia
was inaugurated in
1964 through a
convention under
the Council of
Europe

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Parties to the European Pharmacopeia Convention

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Language requirements for Pharmacopoeia
Languages:
EU13 (11+2 in European Economic
Area)
Danish, Dutch, English, Finnish,
French, German, Greek,
(Icelandic), Italian, (Norwegian),
Portuguese, Spanish, Swedish,
Total European languages = 29:
Bosnian, Bulgarian, Croatian, Cypriot Greek,
Czech, Danish, Dutch, English, Estonian,
Finnish, French, German, Greek, Hungarian,
Icelandic, Italian, Latvian, Lithuanian,
Macedonian, Maltese, Norwegian, Polish,
Portuguese, Romanian, Slovakian,
Slovenian, Spanish. Swedish, Turkish
Languages x12:
CEEC
Bulgarian, Cypriot Greek,
Czech, Estonian, Hungarian,
Latvian, Lithuanian, Maltese,
Polish, Romanian, Slovakian,
Slovenian
Languages x9:
Pharmacopeia
Bosnian, Croatian, Cypriot
Greek, Icelandic, Macedonian,
Norwegian, Slovakian,
Slovenian, Turkish

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Pharma localisation challenges
 13 EU languages – legal requirement for central13 EU languages – legal requirement for central
authorisationsauthorisations
 New countries joining EU (8 new languages anticipatedNew countries joining EU (8 new languages anticipated
in the near term)in the near term)
 20 days to produce translations20 days to produce translations
 1000s of documents1000s of documents
 Updates may be several times a yearUpdates may be several times a year
 Version control challengeVersion control challenge

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The PILLS approach

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How PILLS works
Feedback
text
Enter
information
WYSIWYM
Authoring
Create/Update
Master
Document
French
Germ
an
English
Other
Master
document
SPC
PIL
Label
SPC
PIL
Label
SPC
PIL
Label
Label
SPC
PIL
Generate Output Documents
Natural Language Generation Output format
Paper
Web
CD
XML

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PILLS concepts
 Domain modelDomain model
 Pharmaceutical/medical concepts, eg ingredients
 NOT just a dictionary
 WYSIWYM – Symbolic authoringWYSIWYM – Symbolic authoring
 Author selects concepts from domain model
 Menu-driven editor
 Author “writes” MASTER DOCUMENT
 Author = product specialist
 Natural Language GenerationNatural Language Generation
 Automatically creates text from concepts using linguistic rules
 Different style, terminology etc depending on doc type
 Generates document in any language for which linguistic rules are
available

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How does PILLS compare with other
technologies?
 Word processingWord processing
 Templates/old documents/previous versions
 New doc for each doc type
 Translation bottleneck
Translation
bureau 1
Translation
bureau 2
Local opco

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How does PILLS compare with other
technologies?
 Document management (XML)Document management (XML)
 Re-use at component level
 Less linguistic flexibility
 Translation reduced but still required for new text
<dose>The usual dose for
adults and children over 12 is
one to three tablets every 12
hours.</dose>
<side-effect>If you experience
any of the following, stop
taking the medicine
immediately and tell your
doctor: unexplained
wheezing, shortness of
breath, skin rash, itching,
bruising or facial
swelling.</side-effect>
How to take your medicine
The usual dose for
adults and children
over 12 is one to three
tablets every 12 hours.
Will I have any problems?
If you experience any
of the following, stop
taking the medicine
immediately …

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How does PILLS compare with other
technologies?
 Machine translationMachine translation
 Write source doc
 Quality issues – MT first has to understand the source language
MT System
Translations
Source
documents
Natural
language
understanding
Natural
language
generation

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Why take the PILLS approach?
 Save time by creating multiple documents fromSave time by creating multiple documents from
one master documentone master document
 Save time by avoiding translation stepSave time by avoiding translation step
 Automatically conform to regulatoryAutomatically conform to regulatory
requirements re contentrequirements re content
 Manage change by editing master documentManage change by editing master document
onlyonly

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PILLS demonstration

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Discussion and evaluation
 General impression and relevance of the PILLS systemGeneral impression and relevance of the PILLS system
 initial impression, relevance
 The PILLS authoring processThe PILLS authoring process
 acceptable? usable? the “master document” concept? the authoring
interface/method?
 Benefits and/or drawbacks of the PILLS approachBenefits and/or drawbacks of the PILLS approach
 benefits? problems? compatibility issues?
 Possible improvements to PILLSPossible improvements to PILLS
 changes? requirements/conformance? types of documents?
 Exploitation of PILLSExploitation of PILLS
 would/could you participate? other applications?

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Thank you!
Y NAME IS ABDUL AZIZ SHA
FROM; LARKANA