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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. The PILLS Consortium Technical team:

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The PILLS Consortium

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


The pills consortium l.jpg

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 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 environment

  • Challenges for pharmaceutical publishing

  • Regulation, harmonisation and localisation

  • The PILLS solution

  • Demonstration and test drive

  • Evaluation


The business environment l.jpg

The business environment


Pharma industry trends and challenges l.jpg

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 global opportunities

  • 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


Consolidation global market increasingly concentrated in large companies l.jpg

CONSOLIDATION - global market increasingly concentrated in large companies

Source: IMS Health


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  • Narcolepsy

  • Shire

  • GlaxoSK

  • Social Phobia

  • GlaxoSK

  • Pfizer

  • Mania

  • Abbott

  • Roxane

  • GlaxoSK

  • Solvay

  • Anxiety

  • Abbott

  • BMS

  • ICN

  • Pfizer

  • P&U

  • Roche

  • Sanofi

  • OCD

  • Lilly

  • Novartis

  • Pfizer

  • GlaxoSK

  • Solvay

  • ADHD

  • Abbott

  • Novartis

  • Shire

  • GlaxoSK

  • Obesity

  • Carnrick

  • Gate/Teva

  • Knoll

  • Medeva

  • Roche

  • GlaxoSK

  • Bulimia

  • Lilly

  • Panic

  • Pfizer

  • P&U

  • Roche

  • GlaxoSK

  • Smoking

  • GlaxoSK

CONSOLIDATION - highly competitive market, e.g. for psychiatric drugs...

  • 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

  • Alcoholism

  • Boehringer

  • Dupont

  • Wyeth-Ayerst

Source: SAS


Globalisation distribution of global pharmaceutical sales in 2000 us 318 billion l.jpg

GLOBALISATION - distribution of global pharmaceutical sales in 2000 (US$ 318 billion)

52% of the industry is non-US

Source: IMS Health


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GLOBALISATION - proportion of non-US sales for top suppliers

Source: IMS Health


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Changes driven by the Internet

  • Supply-chain relationships

    • Use of intranets for electronic exchange of research, compliance and product info

    • Integration with manufacturer, packaging supplier, sub-tier supplier systems

  • 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 to benchmark 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 for pharmaceutical 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 publishing requirements, 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 Web publishing

  • 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 forms and registers, variations in presentation of the same or similar content.


Info on prozac from the eli lilly site http www prozac com prescribing info jsp l.jpg

Official

Package

Insert

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


And on webmd http my webmd com content article l.jpg

…and on WebMD, http://my.webmd.com/content/article/

“PIL-type” info provided by Lilly


And from the vhn compendium site http emc vhn net public l.jpg

SPC

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


And the spc for fluoxetine prozac generic on the european product index site l.jpg

…and the SPC for Fluoxetine (Prozac “generic”) on the European Product Index site

SPC in English linked on the Swedish regulator’s site

http://www3.mpa.se/spc/

License holder:

A/S GEA Farmaceutisk Fabrik

(licensed in SE, DK, FI, NE, UK)


Monograph type info on the mosby drug information site http www genrx com genrxfree l.jpg

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


And mosby s version of a pil in english and spanish l.jpg

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


Patient insert info on trazodone on thomson micromedex site http www micromedex com products l.jpg

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!)


Fluoxetine content on the bnf site linked from vhn http bnf vhn net home l.jpg

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


Info on fluctin lilly brand name in germany from the netdoktor site http www netdoktor de l.jpg

Info on Fluctin (Lilly brand name in Germany) from the Netdoktor site, http://www.netdoktor.de

This site is published in Danish,

Norwegian,

Swedish,

German

(2 versions for AT & DE) and English

Patient

info in

German


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SPC

in Dutch

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


Information flow pharmaceutical data l.jpg

Clinical

Trials

Compliance

Dossiers

Physician

Info

Patient

Info

R&D

Information flow - pharmaceutical data

Web Delivery / Multi-Language

The goal:

common data sources for multiple documents in multiple languages

SPC

(EU)

Product “Label” (Official

Packet) Inserts (US)

Health

Portals

Patient

Inserts

(US)

A question:

can this be done across and between pharma companies?

Monographs

PILs

(EU)

USP

BNF

EP


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Regulation, harmonisation and localisation


The context for regulatory change l.jpg

The context for regulatory change

  • ICH

  • Changing European regulatory regime:

    • EMEA, EDQM

    • Mutual Recognition Procedure

    • Pharmacopoeia

  • ...with similar content also published in less regulated environments such as Web portals

  • Dramatic impact on use and re-use of pharma product info...


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EMEA: documents required in the regulatory process


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Organisation of the EDQMEuropean Directorate for the Quality of Medicines

Prepares EP monographs for drugs with marketing approvals

The European Pharmacopoeia was inaugurated in 1964 through a convention under the Council of Europe


Parties to the european pharmacopeia convention l.jpg

Parties to the European Pharmacopeia Convention


Language requirements for pharmacopoeia l.jpg

Language requirements for Pharmacopoeia


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Pharma localisation challenges

  • 13 EU languages – legal requirement for central authorisations

  • New countries joining EU (8 new languages anticipated in the near term)

  • 20 days to produce translations

  • 1000s of documents

  • Updates may be several times a year

  • Version control challenge


The pills approach l.jpg

The PILLS approach


How pills works l.jpg

WYSIWYM Authoring

Natural Language Generation

Output format

English

German

XML

Paper

Label

Label

Enter information

PIL

PIL

SPC

SPC

Master document

Label

Feedback text

Label

PIL

Web

PIL

SPC

SPC

Other

French

Create/Update Master Document

CD

Generate Output Documents

How PILLS works


Pills concepts l.jpg

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 are available


How does pills compare with other technologies l.jpg

Translation bureau 1

Translation bureau 2

Local opco

How does PILLS compare with other technologies?

  • Word processing

    • Templates/old documents/previous versions

    • New doc for each doc type

    • Translation bottleneck


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How does PILLS compare with other technologies?

  • Document management (XML)

    • Re-use at component level

    • Less linguistic flexibility

    • Translation reduced but still required for new text

<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>

<dose>The usual dose for adults and children over 12 is one to three tablets every 12 hours.</dose>

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 translation

    • Write source doc

    • Quality issues – MT first has to understand the source language

MT System

Source documents

Natural language understanding

Natural language generation

Translations


Why take the pills approach l.jpg

Why take the PILLS approach?

  • Save time by creating multiple documents from one master document

  • Save time by avoiding translation step

  • Automatically conform to regulatory requirements re content

  • Manage change by editing master document only


Pills demonstration l.jpg

PILLS demonstration


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Discussion and evaluation

  • General impression and relevance of the PILLS system

    • initial impression, relevance

  • The PILLS authoring process

    • acceptable? usable? the “master document” concept? the authoring interface/method?

  • Benefits and/or drawbacks of the PILLS approach

    • benefits? problems? compatibility issues?

  • Possible improvements to PILLS

    • changes? requirements/conformance? types of documents?

  • Exploitation of PILLS

    • would/could you participate? other applications?


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Thank you!


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