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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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Presentation on theme: "1 PILLS: Patient Information Language Localisation System Evaluation Workshop Berlitz GlobalNET - Luton 30 Nov 2001 PILLS is a preparatory action European."— Presentation transcript:

1 1 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.

2 2 The PILLS Consortium Technical team: Information Technology Research Institute (ITRI), University of Brighton UK 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 Medical Informatics Institute, University of Freiburg, Germany Dr. Stefan Schulz, MD, PhD in Public Health Market research team: Berlitz GlobalNET Ireland Berlitz GlobalNET Ireland Rose Lockwood, Director of Research Berlitz GlobalNET UK Berlitz GlobalNET UK Dawn Murphy - Consultant

3 3 Objectives for the day What we want to do 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 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 4 Agenda The pharmaceutical business environment The pharmaceutical business environment Challenges for pharmaceutical publishing Challenges for pharmaceutical publishing Regulation, harmonisation and localisation Regulation, harmonisation and localisation The PILLS solution The PILLS solution Demonstration and test drive Demonstration and test drive Evaluation Evaluation

5 5 The business environment

6 6 Pharma industry trends and challenges Consolidation Consolidation 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 technology 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 7 CONSOLIDATION - global market increasingly concentrated in large companies Source: IMS Health

8 8 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 Panic Pfizer P&U Roche GlaxoSK Mania Abbott Roxane GlaxoSK Solvay ADHD Abbott Novartis Shire GlaxoSK Bulimia Lilly Anxiety Abbott BMS ICN Pfizer P&U Roche Sanofi Smoking GlaxoSK Narcolepsy Shire GlaxoSK OCD Lilly Novartis Pfizer GlaxoSK Solvay Social Phobia GlaxoSK Pfizer Obesity Carnrick Gate/Teva Knoll Medeva Roche GlaxoSK Source: SAS

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

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

11 11 Changes driven by the Internet Supply-chain relationships 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 Customer relationships Direct, transparent markets Pressure on cost and turnaround High visibility Relationships with doctors, pharmacists, patients Relationships with doctors, pharmacists, patients Direct-to-consumer trends e-Detailing

12 12 New channels to regional and global markets Fast growth in hospital e-procurement take-up in the US 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 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 Localisation becomes competitively significant in cross- border markets Flexible publishing solutions needed Flexible publishing solutions needed

13 13 Challenges for pharmaceutical publishing

14 14 Impact of these trends on pharma publishing Technical publishing issues Technical publishing issues information design, Web architecture, multiple publishing formats Information ecology - leveraging content for multiple publishing requirements, e.g. 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 Language and culture translation, adaptation to local conditions, symbology Legal & regulatory Legal & regulatory local and regional conformance Industry-specific trends Industry-specific trends good practice, standards

15 15 New levels of market exposure through Web publishing Globally available product showcases 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 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. With a mix of document and format types, stylistic forms and registers, variations in presentation of the same or similar content.

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

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

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

19 19 …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 regulators site http://www3.mpa.se/spc/

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

21 21 …and Mosbys version of a PIL in English and Spanish

22 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 23 Fluoxetine content on the BNF site (linked from VHN), http://bnf.vhn.net/home/

24 24 Info on Fluctin (Lilly brand name in Germany) from the Netdoktor site, http://www.netdoktor.de Patient info in German This site is published in Danish, Norwegian, Swedish, German (2 versions for AT & DE) and English

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

26 26 Information flow - pharmaceutical data SPC (EU) USP Monographs Product Label (Official Packet) Inserts (US) BNFEP Patient Inserts (US) PILs (EU) Web Delivery / Multi-Language R&D Clinical Trials Compliance Dossiers Patient Info Physician Info The goal: common data sources for multiple documents in multiple languages A question: can this be done across and between pharma companies? Health Portals

27 27 Regulation, harmonisation and localisation

28 28 The context for regulatory change ICH ICH Changing European regulatory regime: Changing European regulatory regime: EMEA, EDQM Mutual Recognition Procedure Pharmacopoeia...with similar content also published in less regulated environments such as Web portals...with similar content also published in less regulated environments such as Web portals Dramatic impact on use and re-use of pharma product info... Dramatic impact on use and re-use of pharma product info...

29 29 EMEA: documents required in the regulatory process

30 30 Prepares EP monographs for drugs with marketing approvals Organisation of the EDQM European Directorate for the Quality of Medicines The European Pharmacopoeia was inaugurated in 1964 through a convention under the Council of Europe

31 31 Parties to the European Pharmacopeia Convention

32 32 Language requirements for Pharmacopoeia

33 33 Pharma localisation challenges 13 EU languages – legal requirement for central authorisations 13 EU languages – legal requirement for central authorisations New countries joining EU (8 new languages anticipated in the near term) New countries joining EU (8 new languages anticipated in the near term) 20 days to produce translations 20 days to produce translations 1000s of documents 1000s of documents Updates may be several times a year Updates may be several times a year Version control challenge Version control challenge

34 34 The PILLS approach

35 35 How PILLS works Feedback text Enter information WYSIWYM Authoring Create/Update Master Document French German English Other Master document SPC PIL Label SPC PIL Label SPC PIL Label SPC PIL Generate Output Documents Natural Language GenerationOutput format Paper Web CD XML

36 36 PILLS concepts Domain model Domain model Pharmaceutical/medical concepts, eg ingredients NOT just a dictionary WYSIWYM – Symbolic authoring WYSIWYM – Symbolic authoring Author selects concepts from domain model Menu-driven editor Author writes MASTER DOCUMENT Author = product specialist Natural Language Generation 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 37 How does PILLS compare with other technologies? Word processing Word processing Templates/old documents/previous versions New doc for each doc type Translation bottleneck Translation bureau 1 Translation bureau 2 Local opco

38 38 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 The usual dose for adults and children over 12 is one to three tablets every 12 hours. 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. 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 39 How does PILLS compare with other technologies? Machine translation Machine 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

40 40 Why take the PILLS approach? Save time by creating multiple documents from one master document Save time by creating multiple documents from one master document Save time by avoiding translation step Save time by avoiding translation step Automatically conform to regulatory requirements re content Automatically conform to regulatory requirements re content Manage change by editing master document only Manage change by editing master document only

41 41 PILLS demonstration

42 42 Discussion and evaluation General impression and relevance of the PILLS system General impression and relevance of the PILLS system initial impression, relevance The PILLS authoring process The PILLS authoring process acceptable? usable? the master document concept? the authoring interface/method? Benefits and/or drawbacks of the PILLS approach Benefits and/or drawbacks of the PILLS approach benefits? problems? compatibility issues? Possible improvements to PILLS Possible improvements to PILLS changes? requirements/conformance? types of documents? Exploitation of PILLS Exploitation of PILLS would/could you participate? other applications?

43 43 Thank you!


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