Andrew Williams (Head European Medical Operations)Britta Bohm(Director European Medical Information & Operations)

Is globalisation of Medical Information really possible ? A European perspective

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Agenda

• Global MI – what and why ?• GSK strategy & operating model• Critical enables• Challenges• Summary

What does Globalisation of Medical Information mean ?

GSK Standard: Ensure that all Medical Information responses to unsolicited enquiries from healthcare professionals are accurate, objective , specific to question and consistent across all GSK operating companies

• Scope : – All Pharma Medicines and Vaccines– Including in-licensed & co-marketed – Where GSK provides MI service for related companies (e.g. ViiV)– All (>100 LOCs)

Why apply a global standard ? GSK Value Proposition: In response to unsolicited enquiries, GSK Medical Information

will provide objective and consistent scientific information related to GSK products to enable HCPs to use the right GSK medicine with the right patient at the right time.

Risks :– Variable disclosure of data across jurisdictions– Lack of specificity

Value

RiskLow

High

High

Low

MI

MI is a key element of scientific engagement Scientific Engagement is defined as the interaction and exchange of information between GSK and external communities in order to advance scientific and medical understanding including the appropriate development and use of our medicines and vaccines; the management of disease; and patient care.

This is clearly distinct from promotion which is defined as the encouragement of the prescription, supply, sale or use sale or use of medicines or vaccines.

GSK Global MI Strategy

SOPS & Rules

Global Content

Management

Global MI

Operating Model Collaborative Global model

• Based on Pooled global resources and expertise

• Accountability for ensuring compliance to global SOP resides with the GM of each country– Responsibility delegated to country medical director– Overall governance accountability with CMO– Operating model developed through global

collaboration

Global Framework – Critical enablers• Single Global Medical Information system• Systematic and tightly controlled management of

MI content• Consistent Global Approach:

– Limited use of local language– No ‘customisation’ of MI Content– Business rules

• Quality assurance and Audit

GSK MI System• Medical Information Management System: WISDOM

(Worldwide Integrated System for Drug and Medical Information)• Paradigm Shift: from Document Management to Content

Management

Documents

Content Pieces

Systematic MI Content HierarchyWithin WISDOM

MASTER RESPONSE

(US English)

TRANSLATED RESPONSE(9 languages)

Local Response

Local Response

Local Response

Globally Valid content(Inc References)

Translated Global content

Translated Global contentplus local

• Brand name• Disclaimer• Guidelines • SPC (if needed)

Fulfilment – Limited to Two options

Designate/Major Markets Smaller Markets

MASTER RESPONSE(US English)

TRANSLATE RESPONSE

LOCAL RESPONSE

StandardCover

Letter+

or

orLocal LanguageDisclaimers

If the Global designate is the heart of the system, then the last component, the MI system is the circulatory system in distributing and enabling all LOCs to access content and fulfil SOP requirements

The a new medical information management systems called WISDOM (worldwide integrated system fro drug and medical information) marks a radical shift from managing medical information as individual letters to a content management approach

WISDOM developed for US market and has been in operation for 2 years.

Content is managed through a strict hierarchy :Master global content is created by the global designate - this is globally valid content including referencesMaster global content is then translated as required into one of 9 languages to create a translated global response. A local response can then be generated from the translated response. This enables localisation i.e.. addition of brand names, disclaimers, guidelines and inclusion of local SPC if required.

Two tier approach has been adopted to achieve this :Designates or major markets will have access to all components of WISDOM system enabling them to create local responses content according to needs

Small markets will only have access to fulfilment engine. They will search for relevant content and fulfil with a standard cover letter generated within the system which is written in local language and will contain disclaimers etc.Cover letter will provide a specific medical contact within LOC for further information/scientific discussion

Status European deployment

Local Company All MI users trained on WISDOM

Using WISDOM for MI fulfilment

Comments

France PII

Germany

Italy

Spain PII

UK

NW Area Majority

C&SE Area Ongoing

Challenges - Designate Model• Designate is a LOC that will take on world-wide responsibility for the development and

maintenance of Global Medical Information content for assigned product's

Issues Solutions

• Few MI scientists with required skills spread thinly over several European LOC designates

• Insufficient overall resource to support expanding portfolio

• LOC paid resource undertaking global roles

• Inconsistent communications between LOCs and designates

• Consolidate no or designates – create a single hub with critical mass of capabilities

• Increase overall resource level and increase proportion FTE funded regionally

• Communications : Contact Designate if the

information is not on WISDOM Acceptance that GSK does not

always have the information requested

Use of ‘No data responses’

Challenges - FulfilmentIssues Solutions• Personal identifiable information (PII)

challenges with some European countries• Linkage with Contact Centre software

• Levels of Resource/expertise in small markets

• Resource for creating translated response for the nine approved languages

• Limited capability for Small markets to answer SPC questions

• Inconsistent communications between LOCs and designates

• PII – system enhancements, model clause agreements

• Parallel project - New Contact centre solution which includes link to WISDOM

• Alternative ‘hub’ approach under consideration for some geographic areas

• Implementation of integrated semi-automated translation software

• Introduction of scripted answers in local language for on label responses that are a direct lift from SPC

• Accredited global training

Conclusion• Globalisation of Medical Information is mission

critical• Globalisation of MI can work with

– Solid operational framework– Continued system improvements– Continual endorsement of principles– Annual accredited training– Continued communication and education– Adequate resource

Questions

Back-up

Medical Information Responses

LRMGR (& TGR equivalent)

First Mention

Body Component

Disclaimers

Indications Statements

References

Global MI Response

Body Component

References

Bullet ComponentsBullet Components

Local MI Response

Bullet Component

Bullet Components

Bullet Component

Bullet Components

Standard MI letter