PRISME Forum Meeting Biogen Idec, Cambridge, MA, USA

1. PRISME Forum MeetingBiogen Idec, Cambridge, MA, USA Company Updates: Common Themes Wednesday 19-Oct-11

2. CSV • Top 3 unmet software needs • Top 3 standards • Increase disease understanding • In silico science • Leverage external innovation • Real World Evidence • Simplification • Patent-Cliff challenges • Help Desk re-organisation • Late-stage attrition is less • Investment in Oracle (Life Science Hub?) • SharePoint • Benchmarking is good – but what to benchmark?

3. Scientific & Health Care Data Deluge • Integration / Aggregation / Storage – data needs to be exposed to the user community • Data standards • Analytics and the need to find / recruit / retain appropriately qualified analytical medical / healthcare informaticians • Methodology and tools for managing and analysing RW data (is this a topic for review?)

4. A Possible SIG Presentation Topic • Biological System Representation • BEL (Biological Expression Language) http://selventa.com/technology/bel-framework http://belframework.org • BioPax (Biological Pathway Exchange Language) http://www.biopax.org/ • Compare and Contrast

5. A Possible SIG Presentation Topic • Patient-Centered Approaches to R&D • Referencing genetics and the environment • How to link NGS and the Patient-Centred Approach? • Exploiting NGS – from patient sample to drug discovery • NGS • Gene expression analysis • Data curation (including what data to throw away?) • How do we best share / analyse NGS data? • Data Analysis – visualisation • Sourcing Strategies • Understanding Patients • Translational Science • Question? Do different sequencing technologies produce different results

6. Provocation Session:“The Art of the Possible” • Co-chairs: Tom Flores & Bryn Roberts • Support: John Wise • Potential Contributors: • Media-X, Gartner, Forrester • IBM, Microsoft, Accenture • Google • Apple • MIT media lab • Leading Edge Forum • “Appi”fication (“hot topic”) • Visualization • ACTION: JW to draft a backgrounder – circulate the SC – then reach out to the companies above and see what might be done

7. SIGPatient Centred Approached • Co-Chairs: Olivier Gien and Jason Swift • Support: John Wise

8. Next PRISME Forum Meetings • Spring 2012 – AZ or Sanofi Aventis • Fall 2012 – Merck or Abbott • Decision: • Spring: AZ (Jason Swift) • Fall: Merck (Ingrid Akerblom)

9. CSV Working Party • Is there already a standard that provides a 90% solution? • IEC 62304 • is a standard which specifies life cycle requirements for the development of medical software and software within medical devices • Shared Assessments http://www.sharedassessments.org/ • Team to be drawn from: • Roche, Daiichi Sankyo, Merck, Pfizer, Novartis, Novo Nordisk, Sanofi Aventis • Leadership from Merck and Novo Nordisk • Team Consultants – UweTrinks, Sid Senroy, Ron Fitzmartin • Report back at next PRISME Forum • Objectives: Simplify and Reduce CSV costs and timelines - and improve quality - for both Sponsor and Vendor • Team to define scope and objectives – but to include optimizing vendor audit

10. Scoping Questions? • What areas would you company be interested in – in establishing pre-competitive standards for secure scientific data exchange? • This is also relevant in the clinical development domain e.g. Clinphone, Perceptive, Oracle, Inform <> Relsys • SWIFT for clinical data • Liaison • has done some of this work for a different industry • Real World Data Exchange • What pre-competitive assets would you be prepared to share including software and data? (e.g. baseline data – needs discussion with pharma internal data owners) • What value would you perceive in such activity? Can you quantify the value? • What standards-based services would you like to see established? • Would you be prepared to contribute a fee (to be determined) to establish such a standards-based service • Ingrid, Jim and Seth (if possible)