pills evaluation workshop

8/12/2019 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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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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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!