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•http://pistoiaalliance.org Pistoia Alliance Dec 2009
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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
Clinical studies
CHEMISTRY
/ PHARMA-COLOGY
IND* PHASE I PHASE II PHASE III NDA** PHASE IV
Search for active
substances
In vivo and in vitro
toxicology & efficacy studies
Regulatory review
Safety studies on
healthy volunteers
Efficacy
studies on a limited scale
Comparative studies on a
large number of patients
Regulatory review
Continued comparative
studies*Investigational
New Drug
Application for permission to
administer a new drug to humans
50–150persons
100–200patients
500–5,000patients
Registration, market
introduction
**New Drug Application
Application for permission to market a
new drug
KNOWLEDGE &
COST
LEVEL
KNOWLEDGE &
COST
LEVEL
Preclinical studies
DiscoveryDevelopment
Approximately 10–15 years & $800m, from idea to marketable drug
TARGET
DISCOVERY
Search for efficacious
intervention points for a disease or symptom
Knowledge Management across R&D process
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
Some problems are too big for one company
Customer
Mergers &Acquisitions
Sourcing/Collaborations/
CRO
External Info
Compound& Sample Registration
AZ Compound Database ISAC & Query Tools
Design
Test Make
ACMF DispensaryManagement - HTS Plates- Cherry Picking
ACES -Available Chemicals/Building Blocks
High-PerformanceComputing Platform forVirtual Screening/Comp Chem
Calculated PropertiesDMPK Models
DiGS DMPKDatabase & Query Tools
PC FlushChemical Clustering
Library Design Tools
Foundation Tools
ScreeningManagement
ChemicalDatabases,Query,Exploitation
IBIS Explore &Test Service
Reagent Management
SCOUT
HTS Data Capture &
management
DispensaryManagement
R Group Stripping
fRGS
AZProasis
What would Life Science Industry look like in 2 years?
Positioning Life Science groups to cope with larger changes. Its testing out the approach with alignment to mid term problems
Where is this heading?Virtual Pharma?
Public Private Initiatives
B2B integration requires more information/interface standards
Industry Drivers
Example 3: Safety Front LoadingHepatotox Knowledge Strategy
Marts
& Services
In vitro Screens
CRO
Content
Internal External
In vivo Screens
Local Dbs
& File Servers
DbDb
Db
DbDb
DbTox Study
Tox Reports
Clinical Trial
AmosAmos
Marts
Public Reports
Adverse Event Reports
Books
FDA Reports
Literature
Local EnvironmentFocussed Knowledge
Services
User Interfaces
Predictive (SAR+) models
Chemistry/Therapy
Observation
Species
MechanismCauses Affects/has
Causes
in in
Why…• Rapid access to Safety data• Insight into chemical liability• Insight into mechanisms driving• Assessment of screening cascade• Biomarkers discovery• Prototype approach for other decisions.
Life Science Knowledge Services
Pistoia Background – How it all started
Initial Meeting with GSK, AZ, Pfizer and Novartis –outlined similar challenges and frustrations in the IT/Informatics sector of Discovery
The advent of Web Services and Web2.0 allows for decoupling of Proprietary data from technology
Publicly available structural and biological DBS allow for a non-IP related analysis and as a scientific test suite. Sponsorship from R&D IS heads within Life Science industry
2008 2009 Now2007
Met in
PistoiaOfficial Launch
Create Pistoia as Not for profit company
Informal meeting Stanhope Gate
Informal CollaborationsLhasa Collaboration/project
Pistoia DescriptionThe primary purpose of the (Pistoia) Alliance is to streamline non-competitive elements of the life science workflow by the specification of common standards, business terms, relationships and processes•Goal –
to allow this framework to encompass/support most pre-competitive work between the organisations
to support life science workflow prior to submissionto work with other Standards organisations
5 of top 10 Pharma as members
20 members
Domains EstablishedPistoiaCurzonmeeting
Pistoia Collaborative Working e.g. 3 parties working together
X Y
Z
We have all worked separately on our environments and with partners since we had budget and people
X Y
Z Agreeing the pre competitive space, allows for collaboration on Standards and Services
Past - Independence Emerging – Open Collaboration
YX
Z
More
overlap
X Y
Z
As Is - Sequence Services
Companies replicate much of the same functionality and internally host external content to ensure high service levels and privacy
Vision - Sequence Services
Sequences
X Y
Z
Develop Services that allow decommissioning of internalservices at lower or equivalent costs. Also allowsfor future enhancement costs to be shared
3rd
Party Service
Sequences
Problem
Elaborate Common Needs
Demand Request Develop Solution Delivery
Decide to collaborate
Share beyond AZ
Collaborating Companies
input
Decide how to develop
Prepare 3rd
party
Prepare tender/RFP
Decide how to develop together
3rd party hosting
Traditional Company Interface
Open Collaboration
Interface
Open Collaborations opens opportunities earlier
Open Collaboration - Process
Technical & Standards Teams
Pistoia Standards Process
Board of Directors
Operational Team
Pistoia Community
Governance & Operations
Working Groups
Software and Service Providers
Pharma/BioTech/Agro
Not for Profit (e.g. IMI, EBI)
propose,comment
publish
coordinate
submit
Pistoia Governance
• BoD
• Operational Team
• Technical Committee Chair
• Pistoia Company Itself– Not for Profit Membership organisation (Incorporated in Delaware)– Bye laws and IPR policy defined– http://pistoiaalliance.org
Tom Flores GlaxoSmithKlineChris Waller PfizerMartyn Wilkins AstraZenecaPatrick Warren NovartisArun Kumar InfoSysMichael Stapleton CambridgeSoft
Ashley George GlaxoSmithKline TreasurerKevin Hebbel Pfizer Programme ManagerNick Lynch AstraZeneca PresidentRamesh Durvasula BMS CommunicationsMichael Braxenthaler Roche External Liaison
VacantSupported by Working Group Chairs and Operational Team
Ramesh Durvasula BMSAlex Drijver ChemAxonFrank Brown AccelrysClaus Stie Kallesøe LundbeckBryn Roberts F. Hoffmann-La RocheJon McCarthy Symyx
Pistoia Membershipupdated: Jan 30, 2010
Pistoia Domains – help group areas of interest and deliver projects
Officers (Operational
Team)
Domain Steering Groups
Board of Directors
Technical Committee
Working Groups
Pistoia Groups –as defined in byelaws
External Groups
outside of Pistoia
Pistoia Domain – high level grouping of WGs with common themes
The main project delivery mechanism in Pistoia. All standards will be delivered by WGs
Pistoia Members
Provide experience into Workings groups and running Pistoia.Define:•Requirements•Technical Standards•Service Standards
Allows governance across a domain using Working Group chairs and Technical Committee reps •Could join Pistoia
•Influence Pistoia members•Influence through other standards groups and activities•Through Collaboration on standards’ feasibility studies•Option for non executive positions in Pistoia could be formed
Working Groups
Pistoia Domains – focused on business workflows/supply chains
BiologyData
Services
Chemistry Data
Services
Translational Data
Services
Application Integration
Knowledge and Information ServicesVocabulary
Visualisation
Workflow
Enabling
Others
Pistoia Alignment
Biology Data
Services
Chemistry Data
Services
Translational Data
Services
Application Integration Standards
Knowledge and Information Services
Pharmacology
DMPK
Safety
Disease
Industry & Science
Challenges
Domain Classification
Vocabulary
Visualisation
Workflow
Enabling
Others
Members
Board of
Directors
Industry
Standards
GroupsDomain
Steering
Groups
Working
Groups
Technical
Committee
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
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?
Pistoia Domains –focused on business workflows/supply chains
BiologyData
Services
Chemistry Data
Services
Translational Data
Services
Application Integration
Knowledge and Information ServicesVocabulary
Visualisation
Workflow
Enabling
Others
Pistoia Domains –focused on business workflows/supply chains
BiologyData
Services
Chemistry Data
Services
Translational Data
Services
Application Integration
Knowledge and Information ServicesVocabulary
Visualisation
Workflow
Enabling
Others
Target ID Hit ID Lead ID Lead
Opt Phase I Phase II Phase III
No. Name Description Lead StatusSequence Services
Service, data & technology stds for access to sequence services, including sequence, genome, genetic, RNAi etc data & assays
Ashley George(GSK) & TBD
Project starting soon
Vocabulary Services*
Semantic standards and associated governance/change processes for biological/pharmacological vocabularies
Ian Dix (AZ) &Lee Harland(Pfizer)
Project scoping
Disease Knowledge Services (SESLproposal)
Proof of principle service evaluation for a push model for access to disease knowledge (gene-disease assertions)
I Dix (AZ), W Filsell(Unilever), M Braxenthaler (Roche), A George (GSK) & I Harrow (Pfizer)
Funding secured and project kick off 15th Oct.
Open Pharmacology Space
IMI KM round 2 call. Development of service and standards for access to publicly available SAR content and associated analysis/summation tools
Mike Barnes (GSK) & Bryn Williams-Jones (Pfizer)
IMI call. P-C remit is to observe and ensure fit of standards with other
P-C work packages.
Translational Data Management
Service, data & technology standards required for cross pharma / academic / institute collaborations involving samples & ‘omic data analysis (common in IMI)
TBD & TBD Idea. Not developed.
Visualisation Service & application standards for pathway & network visualisation in biology.
Lee Harland (Pfizer) & TBD
Idea. Not developed.
•2•3
•7
•4
•5
•6
•2 •6
•3
•4•5
•7
•4
A Cross Domain ‘Biology Portfolio’
• 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?
Sequence ServicesIndustry agreed core services
• 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.
SESL: Biomedical Knowledge Brokering
Open Pharmacology SpaceScreening 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
• 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
VocabulariesA single language
•Assertion & Meta Data Mgmt•Transform / Translate•Integrator
•Service Layer
•Corpus 1
•‘Consumer’
•Firewall
•Supplier
•Firewall
•Common
•Service Broker
•Multiple
•Consumers
•Db 2
•Db 3
•Db 4
•Corpus 5
•Std Public
•Vocabularies
•Knowledge
•Applications•Target
•Dossier•Compound
•Dossier
•Disease
•Dossier
•Content
•Suppliers
•Effort required to fit DBs to service layer
•Business
•Rules
•Network
•Viz
•2
•5 •4 •7•5
•6
•4
•3•Open
•Stds
Biomedical Knowledge Brokering
