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PILLS: Patient Information Language Localisation System
Evaluation WorkshopBerlitz GlobalNET - Luton 30 Nov 2001
PILLS is a preparatory action European eContent project, ECD-3310-26904.
PILLS: Patient Information Language Localisation System
Evaluation WorkshopBerlitz GlobalNET - Luton 30 Nov 2001
PILLS is a preparatory action European eContent project, ECD-3310-26904.
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The PILLS ConsortiumThe 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 dayObjectives 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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AgendaAgenda
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 environmentThe business environment
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Pharma industry trends and challengesPharma 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
Globalisation Globalisation 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 companiesCONSOLIDATION - global market increasingly concentrated in large companies
Company
global market
share (%) 2000 location of HQ
Pfizer 7% USGlaxoSmithKline 7% UKMerck 5% USAstraZeneca 5% UKBristol-Myers Squibb 4% USNovartis 4% CHJ&J 4% USAventis 4% FRPharmacia 3% USAHP 3% USLilly 3% USRoche 3% CHTotal Top 12 52%
Source: IMS Health
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CONSOLIDATION - highly competitive market, e.g. for psychiatric drugs...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• LillyBulimia• Lilly
Anxiety• Abbott• BMS• ICN• Pfizer• P&U• Roche• Sanofi
Anxiety• Abbott• BMS• ICN• Pfizer• P&U• Roche• Sanofi
Smoking• GlaxoSKSmoking• 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)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 suppliersGLOBALISATION - 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 InternetChanges 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 marketsNew 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
Challenges for pharmaceutical publishing
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Impact of these trends on pharma publishingImpact of these trends on pharma publishing
Technical publishing issuesTechnical publishing issues information design, Web architecture, multiple publishing formats
Information ecology - leveraging content for multiple publishing Information 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 publishingNew 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 forms With a mix of document and format types, stylistic forms and registers, variations in presentation of the same or and 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.jspInfo on Prozac, from the Eli Lilly site, http://www.prozac.com/prescribing_info.jsp
OfficialPackage
Insert
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…and on WebMD, http://my.webmd.com/content/article/…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/…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…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
sitehttp://www3.mpa.se/spc/
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“Monograph-type” info on the Mosby drug information site, http://www.genrx.com/genrxfree/
“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…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
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/
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
Info on Fluctin (Lilly brand name in Germany) from the Netdoktor site, http://www.netdoktor.de
Patientinfo 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
Merck’s Fluoxetine on the Netherlands Medicine Evaluation Board site, http://www.cbg-meb.nl/nl/prodinfo
SPCin Dutch
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Information flow - pharmaceutical dataInformation flow - pharmaceutical data
SPC(EU)
USP
Monographs
Product “Label” (OfficialPacket) Inserts (US)
BNF EP
PatientInserts (US)PILs
(EU)
Web Delivery / Multi-Language
R&DClinicalTrials
ComplianceDossiers
PatientInfo
PhysicianInfo
The goal:common data sources for multiple documents in multiple languages
A question:can this be done across
and between pharma companies?
HealthPortals
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Regulation, harmonisation and localisation
Regulation, harmonisation and localisation
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The context for regulatory changeThe 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 product Dramatic impact on use and re-use of pharma product info...info...
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EMEA: documents required in the regulatory processEMEA: documents required in the regulatory process
DERN /Pre-Qualification
QA Reporting: TrialMethods Compliance
Submission PackageAssembly: QA & Report
Clinical Trial Study Plan:Methods &
Measurements
Consultation Reports:Preclinical
Submission Development(Case, Refs, Tasking)
NDA: New DrugApplication
Risk Assessment on QA& Reporting Protocols
Agency Meeting Reports
Submission VerificationDocs
Consultation Reports:CM&C and Registrations
(e.g. DMFs)
Consultation/ExpertReports: Clinical Data
QM: Quality ManagementReporting (CQI)
Adverse Event CodingCase by Case
Adverse EventsReporting: Spontaneous
& Mandatory Periodic
Other IND PSUR Docs/Reporting
Adverse Event MedicalEvaluation Docs Report
Committee Answer Draftsand Reporting
Agency Response Docs
SPC: Summary ofProduct Characteristics
Drug Product Listing(s)Submissions: Labeling,PILs, Advertisements
Regulatory Process untilApproval or Withdrawal
(Average 100,000 pages)
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Prepares EP monographs for
drugs with marketing approvals
Organisation of the EDQMEuropean Directorate for the Quality of MedicinesOrganisation of the EDQMEuropean 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 ConventionParties to the European Pharmacopeia Convention
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Language requirements for PharmacopoeiaLanguage 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, CypriotGreek, Icelandic, Macedonian,
Norwegian, Slovakian,Slovenian, Turkish
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Pharma localisation challengesPharma localisation challenges
13 EU languages – legal requirement for central 13 EU languages – legal requirement for central authorisationsauthorisations
New countries joining EU (8 new languages anticipated New 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 approachThe PILLS approach
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How PILLS worksHow PILLS works
Feedback text
Enter information
WYSIWYM Authoring
Create/Update Master
Document
French
GermanEnglis
h
Other
Master document
SPC
PILLabel
SPC
PIL
Label
SPC
PILLabel
Label
SPC
PIL
Generate Output Documents
Natural Language Generation Output format
Paper
Web
CD
XML
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PILLS conceptsPILLS 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?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?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?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?Why take the PILLS approach?
Save time by creating multiple documents from Save 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 regulatory Automatically conform to regulatory requirements re contentrequirements re content
Manage change by editing master document Manage change by editing master document onlyonly
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PILLS demonstrationPILLS demonstration
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Discussion and evaluationDiscussion 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!Thank you!
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