pills evaluation workshop
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PILLS: Patient InformationLanguage Localisation System
Evaluation WorkshopBerlitz GlobalNET - Luton 30 Nov 2001
PILLS is a preparatory action EuropeaneContent project, ECD-3310-26904.
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The PILLS Consortium
Technical team: Information 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, Germany Dr. Stefan Schulz, MD, PhD in Public Health
Market research team:
Berlitz GlobalNET Ireland Rose Lockwood, Director of Research
Berlitz GlobalNET UK
Dawn Murphy - Consultant
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Objectives for the day
What 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 do
Advise us on whether we have correctly understood the publishingrequirements 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 environment
Challenges for pharmaceutical publishing
Regulation, harmonisation and localisation
The PILLS solution
Demonstration and test drive
Evaluation
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The business environment
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Pharma industry trends and challenges
Consolidation
quest for market share in highly competitive market
product line integration, premium on comprehensive solutions,efficiencies in distribution and service
Globalisation
driven by changing policies (free trade), regulatory shifts(harmonisation)
leveraging sales & marketing for larger customers, exploiting globalopportunities
Impact 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 increasinglyconcentrated in large companies
Company
global
marketshare (%)
2000 location of HQ
Pfizer 7% US
GlaxoSmithKline 7% UK
Merck 5% US
AstraZeneca 5% UKBristol-Myers Squibb 4% US
Novartis 4% CH
J&J 4% US
Aventis 4% FR
Pharmacia 3% US
AHP 3% USLilly 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...
DepressionBMSForestGlaxoSKHoeschtICNLederleLillyMerckNovartisOrganonPfizerScheringSolvay
Zeneca
PsychosisBoehringerEndoJanssenLillyNovartisOrthoPfizerScheringGlaxoSKWatsonZeneca
AlcoholismBoehringerDupontWyeth-Ayerst
PanicPfizerP&URocheGlaxoSK
ManiaAbbottRoxaneGlaxoSKSolvay
ADHDAbbottNovartisShireGlaxoSK
BulimiaLilly
AnxietyAbbott
BMSICNPfizerP&URocheSanofi
SmokingGlaxoSK
NarcolepsyShireGlaxoSK
OCDLilly
NovartisPfizerGlaxoSKSolvay
Social PhobiaGlaxoSKPfizer
ObesityCarnrick
Gate/TevaKnollMedevaRocheGlaxoSK
Source: SAS
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GLOBALISATION - distribution of globalpharmaceutical 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 salesfor 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 relationships
Use of intranets for electronic exchange of research, compliance andproduct info
Integration with manufacturer, packaging supplier, sub-tier suppliersystems
Customer relationships Direct, transparent markets
Pressure on cost and turnaround
High visibility
Relationships 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 US
currently $6.3 billion market
grew by over $1.6 billion in 2000
Integration of European procurement market
e.g. NHS Supplies (UK) linking with other European providers tobenchmark prices across Europe
likely to catch up with the US as Web infrastructure solidifies
Localisation becomes competitively significant in cross-
border markets
Flexible publishing solutions needed
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Challenges forpharmaceutical publishing
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Impact of these trends on pharma publishing
Technical publishing issues
information design, Web architecture, multiple publishing formats
Information ecology - leveraging content for multiple publishingrequirements, e.g.
marketing, labeling, instructions for use, operator manuals
brochures, leaflets, manuals, support documentation (Print, CD, Web)
Language and culture
translation, adaptation to local conditions, symbology
Legal & regulatory
local and regional conformance
Industry-specific trends
good practice, standards
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New levels of market exposure through Webpublishing
Globally available product showcases In regional and global markets
With diverse cultural and social norms, business cultures
Increasing communication across language barriers
Increasingly localised, with
Content highly adapted to local conditions
Combining local content with global product information
With a mix of document and format types, stylistic formsand registers, variations in presentation of the same orsimilar content.
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Info on Prozac, from the Eli Lilly site,http://www.prozac.com/prescribing_info.jsp
Official
PackageInsert
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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 GEAFarmaceutisk Fabrik
(licensed in SE, DK,FI, NE, UK)
SPC in English linked on
the Swedish regulators
site
http://www3.mpa.se/spc/
M h t i f th M b d
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Monograph-type info on the Mosby druginformation site, http://www.genrx.com/genrxfree/
and Mosb s ersion of a PIL in English and
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and Mosbys version of a PIL in English andSpanish
Patient Insert info on Trazodone on Thomson
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Patient Insert info on Trazodone on ThomsonMicromedex site, http://www.micromedex.com/products
(Prozac/Fluoxetine
not available in the
free sample docs
on this site!)
Fluoxetine content on the BNF site (linked from
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Fluoxetine content on the BNF site (linked fromVHN), http://bnf.vhn.net/home/
Info on Fluctin (Lilly brand name in Germany) from
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Info on Fluctin (Lilly brand name in Germany) fromthe Netdoktor site, http://www.netdoktor.de
Patient
info in
German
This site is
publishedin Danish,
Norwegian,
Swedish,
German
(2 versions
for AT &
DE) andEnglish
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Mercks Fluoxetine on the Netherlands MedicineEvaluation Board site, http://www.cbg-meb.nl/nl/prodinfo
SPCin 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 ClinicalTrials
ComplianceDossiers
PatientInfo
PhysicianInfo
The goal:
common data sourcesfor multiple documents
in multiple languages
A question:
can this be done acrossand between pharma
companies?
Health
Portals
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Regulation, harmonisationand localisation
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The context for regulatory change
ICH
Changing European regulatory regime:
EMEA, EDQM
Mutual Recognition Procedure
Pharmacopoeia
...with similar content also published in less regulatedenvironments such as Web portals
Dramatic impact on use and re-use of pharma productinfo...
EMEA: documents required in the regulatory
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EMEA: documents required in the regulatoryprocess
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 ManagementReporting (CQI)
Adverse Event CodingCase by Case
Adverse Events
Reporting: Spontaneous& Mandatory Periodic
Other IND PSUR Docs/Reporting
Adverse Event MedicalEvaluation 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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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 central
authorisations
New countries joining EU (8 new languages anticipatedin the near term)
20 days to produce translations
1000s of documents
Updates may be several times a year
Version control challenge
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The PILLS approach
S
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How PILLS works
Feedback
text
Enter
information
WYSIWYM
Authoring
Create/UpdateMaster
Document
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
PILLS t
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PILLS concepts
Domain model Pharmaceutical/medical concepts, eg ingredients
NOT just a dictionary
WYSIWYM Symbolic authoring Author selects concepts from domain model
Menu-driven editor Author writes MASTER DOCUMENT
Author = product specialist
Natural 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 areavailable
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How does PILLS compare with othertechnologies?
Word processing
Templates/old documents/previous versions
New doc for each doc type
Translation bottleneckTranslation
bureau 1
Translation
bureau 2
Local opco
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How does PILLS compare with othertechnologies?
Document management (XML)
Re-use at component level
Less linguistic flexibility
Translation reduced but still required for new text
The usual dose for
adults and children over 12 isone to three tablets every 12hours.
If you experience
any of the following, stoptaking the medicineimmediately and tell yourdoctor: unexplainedwheezing, shortness ofbreath, skin rash, itching,bruising or facialswelling.
How to take your medicine
The usual dose foradults and childrenover 12 is one to threetablets every 12 hours.
Will I have any problems?
If you experience anyof the following, stoptaking the medicineimmediately
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How does PILLS compare with othertechnologies?
Machine translation
Write source doc
Quality issuesMT first has to understandthe source language
MT System
Translations
Source
documentsNatural
languageunderstanding
Natural
languagegenerat ion
Wh t k th PILLS h?
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Why take the PILLS approach?
Save time by creating multiple documents fromone master document
Save time by avoiding translation step
Automatically conform to regulatoryrequirements re content
Manage change by editing master documentonly
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PILLS demonstration
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Thank you!
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