1 PILLS: Patient Information Language Localisation System Evaluation Workshop Berlitz GlobalNET - Luton 30 Nov 2001 PILLS is a preparatory action European.

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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!