Pistoia alliance jan2010summary-0


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Pistoia alliance jan2010summary-0

  1. 1. Pistoia Alliance •http://pistoiaalliance.org Dec 2009
  2. 2. Agenda: Introduction to Pistoia • Origins of Pistoia – History – Industry Drivers – Technology Trends • Scope and Operations of Pistoia – Mission, Membership, Governance – Projects and Deliverables • Discussion: new Opportunities
  3. 3. Knowledge Management across R&D process Preclinical studies Clinical studies Discovery Development TARGET CHEMISTRY IND* PHASE I PHASE II PHASE III NDA** PHASE IV DISCOVERY / PHARMA- COLOGY Search for Search for Regulatory Safety Efficacy Comparative Regulatory Continued efficacious active review studies on studies on a studies on a review comparative intervention substances *Investigational healthy limited scale large number studies points for a New Drug volunteers of patients In vivo and in KNOWLEDGE & disease or Application for 50–150 vitro 100–200 symptom permission to COST Registration, toxicology & administer a new persons patients LEVEL market efficacy drug to humans 500–5,000 introduction studies patients KNOWLEDGE & **New Drug Application COST Application for LEVEL permission to market a new drug Approximately 10–15 years & $800m, from idea to marketable drug 3
  4. 4. Industry Drivers Commercial Pressures Cost, Time 25% of portfolio from collaborations Commoditisation of services Growing awareness of pre competitive, Open Collaboration and Open Innovation e.g. ‘Innocentive’, Innovation brokers Other industries have made these changes around collaboration: Insurance, Telcom, Car Mergers & Some problems are too big for one company Acquisitions What would Life Science Industry look like in 2 years? Customer Positioning Life Science groups to cope with larger Foundation Tools Sourcing/ changes. Its testing out the approach with alignment High-Performance Computing Platform for Calculated Properties Collaborations/ Virtual Screening/Comp Chem DMPK Models PC Flush ACES - Chemical Available AZProasis Clustering Chemicals/ Building fRGS Blocks R Group Stripping Design Library Design to mid term problems Tools CRO DiGS DMPK Database & IBIS Explore & Query Tools Test Service Test Make SCOUT Compound Reagent & Sample Management Registration AZ Compound Database Chemical ISAC & Query Tools Databases, HTS Data Capture & Query, Where is this heading? Exploitation Screening management ACMF Dispensary Management Management - HTS Plates Dispensary - Cherry Picking Management Virtual Pharma? Public Private Initiatives External B2B integration requires more information/interface standards Info
  5. 5. Example 3: Safety Front Loading Life Science Knowledge Services Hepatotox Knowledge Strategy Public Reports In vitro Screens In vivo Screens Clinical Trial Marts CRO Db Db Tox Study Db Db Amos & Services Content Db Db Amos Marts Adverse Event Reports Internal External Tox Reports Local Dbs Books & File Servers FDA Reports Literature User Focussed Knowledge Interfaces Local Environment Services Predictive (SAR+) models Species Why… in in • Rapid access to Safety data • Insight into chemical liability Observation Causes Mechanism • Insight into mechanisms driving • Assessment of screening cascade Causes Affects/has • Biomarkers discovery Chemistry/Therapy • Prototype approach for other decisions.
  6. 6. Pistoia Background – How it all started 2007 2008 2009 Now Informal Met in Create Pistoia as Not for Official 5 of top 10 Pharma as meeting Pistoia profit company Launch members Stanhope 20 members Gate Pistoia Curzon Domains Established Lhasa Collaboration/project Informal Collaborations meeting Initial Meeting with GSK, AZ, Pfizer and Novartis – outlined similar challenges and frustrations in the IT/Informatics sector of Discovery Pistoia Description The primary purpose of the (Pistoia) Alliance The advent of Web Services and Web2.0 allows for decoupling of Proprietary data from technology is to streamline non-competitive elements of the life science workflow by the Publicly available structural and biological DBS allow for a non-IP related analysis and as a scientific test specification of common standards, business suite. terms, relationships and processes Sponsorship from R&D IS heads within Life Science industry •Goal – to allow this framework to encompass/support most pre-competitive work between the organisations to support life science workflow prior to submission to work with other Standards organisations
  7. 7. Pistoia Collaborative Working e.g. 3 parties working together Past - Independence Emerging – Open Collaboration X Y X Y More X Y Z overlap We have all worked separately on our Z Agreeing the pre competitive space, allows for Z environments and with partners since we had collaboration on Standards budget and people and Services As Is - Sequence Services Vision - Sequence Services X Y X Y 3rd Party Service Develop Services that allow Companies replicate much of the same functionality decommissioning of internal and internally host external Sequences services at lower or Sequences content to ensure high equivalent costs. Also allows Z service levels and privacy Z for future enhancement costs to be shared
  8. 8. Open Collaboration - Process Solution Problem Demand Request Develop Delivery Collaborating Companies input Decide how to develop together Elaborate Share Decide to Decide how Prepare 3rd 3rd party Common beyond AZ collaborate to develop party hosting Needs Prepare tender/RFP Open Collaborations Open opens Traditional Collaboration opportunities Company Interface Interface earlier
  9. 9. Pistoia Standards Process Governance & Working Pistoia Operations Groups Community Board of Software and Directors submit Service Providers propose, Technical & comment Standards Pharma/ Operational Teams BioTech/Agro publish Team Not for coordinate Profit (e.g. IMI, EBI)
  10. 10. Pistoia Governance Tom Flores GlaxoSmithKline Ramesh Durvasula BMS • BoD Chris Waller Pfizer Alex Drijver ChemAxon Martyn Wilkins AstraZeneca Frank Brown Accelrys Patrick Warren Novartis Claus Stie Kallesøe Lundbeck Arun Kumar InfoSys Bryn Roberts F. Hoffmann-La Roche Jon McCarthy Symyx Michael Stapleton CambridgeSoft • Operational Team Ashley George GlaxoSmithKline Treasurer Kevin Hebbel Pfizer Programme Manager Nick Lynch AstraZeneca President Ramesh Durvasula BMS Communications Michael Braxenthaler Roche External Liaison • Technical Committee Chair Vacant Supported by Working Group Chairs and Operational Team • Pistoia Company Itself – Not for Profit Membership organisation (Incorporated in Delaware) – Bye laws and IPR policy defined – http://pistoiaalliance.org
  11. 11. Pistoia Membership updated: Jan 30, 2010
  12. 12. Pistoia Domains – help group areas of interest and deliver projects Pistoia Groups – Pistoia Domain – high level External as defined in byelaws grouping of WGs with common Groups themes outside of Domain Allows governance across a domain using Working Pistoia Board of Steering Group chairs and Directors Groups Technical Committee reps •Could join Pistoia •Influence Pistoia members The main project delivery Working Working mechanism in Pistoia. All •Influence through other standards Officers Groups Groups standards will be groups and activities (Operational delivered by WGs •Through Collaboration on Team) standards’ feasibility studies Provide experience into •Option for non Pistoia Workings groups and executive positions Technical Members running Pistoia. in Pistoia could be Define: formed Committee •Requirements •Technical Standards •Service Standards
  13. 13. Pistoia Domains – focused on business workflows/supply chains Enabling Knowledge and Information Services Vocabulary Visualisation Workflow Application Integration Others Biology Chemistry Translational Data Data Data Services Services Services
  14. 14. Pistoia Alignment Industry Standards Members Groups Board of Domain Industry & Directors Technical Science Domain Steering Challenges Committee Classification Groups Enabling Disease Knowledge and Information Services Vocabulary Pharmacology Visualisation Application Integration Standards DMPK Workflow Biology Chemistry Translational Safety Others Data Data Working Data Services Services Services Groups
  15. 15. Nature Reviews Drug Discovery 8, 701-708 (September 2009) | doi:10.1038/nrd2944 Opinion: Lowering industry firewalls: pre-competitive informatics initiatives in drug discovery Michael R. Barnes1, Lee Harland2, Steven M. Foord1, Matthew D. Hall1, Ian Dix3, Scott Thomas4, Bryn I. Williams-Jones5 & Cory R. Brouwer5
  16. 16. Discussion Points • How can industry groups like Pistoia be of benefit to groups in shaping your strategy? • Is there an opportunity to take a commom theme and work on it together? – What projects would align well? • What does it mean longer term for how these works with groups like Pistoia?
  17. 17. Pistoia Alliance: Emerging Biology Portfolio http://pistoiaalliance.org
  18. 18. Pistoia Domains – focused on business workflows/supply chains Enabling Knowledge and Information Services Vocabulary Visualisation Workflow Application Integration Others Biology Chemistry Translational Data Data Data Services Services Services
  19. 19. Pistoia Domains – focused on business workflows/supply chains Enabling Knowledge and Information Services Vocabulary Visualisation Workflow Application Integration Others Biology Chemistry Translational Data Data Data Services Services Services
  20. 20. A Cross Domain ‘Biology Portfolio’ No. Name Description Lead Status Sequence Service, data & technology stds for access Ashley George Project starting soon •2 Services to sequence services, including sequence, genome, genetic, RNAi etc data & assays (GSK) & TBD Vocabulary Semantic standards and associated Ian Dix (AZ) & Project scoping •3 Services* governance/change processes for biological/pharmacological vocabularies Lee Harland (Pfizer) Disease Proof of principle service evaluation for a I Dix (AZ), W Filsell Funding secured and Knowledge push model for access to disease knowledge (Unilever), M project kick off 15th Oct. •4 Services (SESL proposal) (gene-disease assertions) Braxenthaler (Roche), A George (GSK) & I Harrow (Pfizer) Open IMI KM round 2 call. Development of service Mike Barnes (GSK) & IMI call. P-C remit is to •5 Pharmacology Space and standards for access to publicly available SAR content and associated Bryn Williams-Jones (Pfizer) observe and ensure fit of standards with other analysis/summation tools P-C work packages. Translational Service, data & technology standards TBD & TBD Idea. Not developed. •6 Data Management required for cross pharma / academic / institute collaborations involving samples & ‘omic data analysis (common in IMI) Visualisation Service & application standards for pathway Lee Harland (Pfizer) & Idea. Not developed. •7 & network visualisation in biology. TBD •2 •4 •5 •6 •4 Target Lead Phase Hit ID Lead ID Phase I Phase II ID Opt III •3 •7
  21. 21. Sequence Services Industry agreed core services • Challenge: – Current internal platforms aging – expectation that refresh required in next 2-3 yrs – Current internal platform difficult to extend to Next Gen Seq, personalised genomes, tumour genome data mgmt, viz & analysis services. • Opportunity: – Adoption of public services & infrastructure • Problem: Historic service non-functional requirements unacceptable • Problem: Integration of internal content difficult • Problem: Current services incomplete & usability needs reviewing – Cross-pharma service specification for seq services – Do we need a commercial service wrapper over public services? • Current Situation in Pistoia: – GSK spearheading initiative (assigned PM). AZ supporting – Phase 1 proposal (Q409) • Develop full set of non-functional rqmts by end of Sept09 • Develop broad areas of sequence services by end of Sept • Contract 3rd party to host secure Ensembl, gene aliasing + example application hosting (Q4) • Develop full set of requirements (Jan10) (ensuring scope will mean we are able to decomission internal systems on completion (ie 2011)) – Phase 2 proposal (Q110 onwards, £?K, more companies involved • Contract 3rd party to provide common services to all pharma engaged?
  22. 22. SESL: Biomedical Knowledge Brokering • Challenge: – No single system for retrieving gene to disease relationships contained in both published & db content. – Need a ‘push model’ for biomedical knowledge access: the current model requires the consumer to search 1000s of content sources. • Opportunity: – Pilot the a ‘push model’ for biomedical knowledge brokering. – Engage multiple consumers, content providers and a single, public group to develop the necessary infrastructure to explore the stds required for the model to work in production • Current Situation in Pistoia: – SESL proposal: • Consumer companies: AZ, Pfizer, GSK, Roche, Unilever • Hosting group: EBI • Publishers: NPG (tbc), OUP, Elsevier & RSC. • 12 mth project, £200K direct funding ( + PM & Architecture support) • Deliverables: Stds required to make such a model production, Focused engagement with key content suppliers in moving to such a push model for content. – SESL timelines: • Funding agreed in Sept • Kick off meeting 15th Oct, EBI • Initiate in Oct09.
  23. 23. Open Pharmacology Space Screening Knowledge Services • Challenge: – No single system (or standards) for accessing target – compound relationships contained in both published & db content. • Opportunity: – Build open access public domain resources to support Drug Discovery – Use IMI as a vehicle to integrate public domain biology and chemistry data • Two Major Work Streams: – WS1: Development of an OPS service layer and resource integration – WS2: Development of exemplar work packages – Project Initiation for WS2 will be staggered to allow implementation of WS1 – Companies involved: – Lead by Pfizer & GSK – AZ, BI, Roche, Lundbeck, Esteve, Merck-Serono – 10M Euro EU + 10M Euro in-kind from Pharma – 3 years, Q2 2010. • Current Situation in Pistoia: • Pistoia – ensuring uniform standards with other Pistoia projects
  24. 24. Vocabularies A single language • Issue: Plethora of vocabulary ‘standards’ in biology/ pharmacology. • Goal: Agreeing a single open vocabulary standard for the Pharma information supply chain along with the infrastructure and processes required to keep it current. • Opportunity: OBO Foundry – a long standing public group of ontologists/scientists who have recognised the need for the controlled use of language to describe biology. – Coordinating extensive vocabulary assets as well as running/developing processes to ensure managed change. – Key issues: Funding, Focus, Quality, Coverage, Accreditation • Current Situation: – Pistoia reps have met 4 times with OBO board, including 1 day f-f. – AZ/Pfizer leading Pistoia WG, documenting v0.1 Pharma service rqmnts re vocabs. – OBO foundry documenting 5 yr plans & objectives – Nov/Dec 2009: Closed workshop involving OBO board, pharma & key information supply chain companies (KM, publishers & aggregators), key public groups to discuss sustainable business models for pre-competitive vocabulary services. – 2010: Expect to pilot model involving selected vocabularies, OBO & vocab suppliers. • Presuming pilot success, in 2010 will need to secure PPP funding for: – Pre-clinical vocabulary coordination – Pre-clinical vocabulary curation services – Vocabulary infrastructure services
  25. 25. Biomedical Knowledge Brokering •Multiple •Consumers •4 •5 •5 •4 •7 •Target •Compound •Disease •Network •Knowledge •‘Consumer’ •Dossier •Dossier •Dossier •Viz •Applications •Firewall •Service Layer •Std Public •Common •Open •Assertion & Meta Data Mgmt •3 •Vocabularies •Service •Stds •Transform / Translate •Business Broker •Integrator •Rules •Supplier •Content •Firewall •Suppliers •2 •Db 2 •6 •Db 4 •Effort required to fit DBs to service •Corpus 1 layer •Db 3 •Corpus 5