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The PILLS Consortium

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

  2. 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

  3. 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

  4. Agenda • The pharmaceutical business environment • Challenges for pharmaceutical publishing • Regulation, harmonisation and localisation • The PILLS solution • Demonstration and test drive • Evaluation

  5. The business environment

  6. 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

  7. CONSOLIDATION - global market increasingly concentrated in large companies Source: IMS Health

  8. 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

  9. GLOBALISATION - distribution of global pharmaceutical sales in 2000 (US$ 318 billion) 52% of the industry is non-US Source: IMS Health

  10. GLOBALISATION - proportion of non-US sales for top suppliers Source: IMS Health

  11. 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”

  12. 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

  13. Challenges for pharmaceutical publishing

  14. 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

  15. 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.

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

  17. …and on WebMD, http://my.webmd.com/content/article/ “PIL-type” info provided by Lilly

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

  19. …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)

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

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

  22. 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!)

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

  24. 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

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

  26. 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

  27. Regulation, harmonisation and localisation

  28. 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...

  29. EMEA: documents required in the regulatory process

  30. 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

  31. Parties to the European Pharmacopeia Convention

  32. Language requirements for Pharmacopoeia

  33. 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

  34. The PILLS approach

  35. 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

  36. 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

  37. 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

  38. 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 …

  39. 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

  40. 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

  41. PILLS demonstration

  42. 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?

  43. Thank you!

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