Pre-competitive data submission by companies to public databases by cometjunkie56

VIEWS: 10 PAGES: 24

									   WORKPACKAGE 6:
   Data acquisition, curation and ownership




Pre-competitive data submission by
  companies to public databases

                  Dr. Tom Weaver
                Commercial Director
                Medical Solutions, plc

                    CASIMIR Meeting
                          Corfu
                    Friday Oct 5 2007
             WORKPACKAGE 6:
             Data acquisition, curation and ownership




Table of Contents

Vision For Resources

Sustainability Models: Observations and Case Studies
    – Geneservice
    – RZPD

IPR Issues on Data Submission: Observations & Some Case Studies
     – Incyte Genomics
     – Exelixis
     – Wyeth/Scotland NHS “Translational Medicine Collaboration”

Bioinformatics: UK SME Perspective
     – BIA Survey
             WORKPACKAGE 6:
             Data acquisition, curation and ownership




Table of Contents

Vision For Resources

Sustainability Models: Observations and Case Studies
    – Geneservice
    – RZPD

IPR Issues on Data Submission: Observations & Some Case Studies
     – Incyte Genomics
     – Exelixis
     – Wyeth/Scotland NHS “Translational Medicine Collaboration”

Bioinformatics: UK SME Perspective
     – BIA Survey
              WORKPACKAGE 6:
              Data acquisition, curation and ownership




Vision for Genomics

Francis Collins Roadmap

Comprehensive Biological Reference Sets
   – Model Organisms: mammals, vertebrates, chordates, invertebrates
   – DNA & RNA: Clone libraries, ORFs, primers, microarrays
   – Proteins: Expression vectors, protein chips, affinity reagents
   – Mutation Analysis: Mapping, Mutant Animals, Cell lines, RNAi

Databases
    – Integrate Sequences with curated information and other large datasets
    – Tolls for effective data mining
Biobanks
    – DNA, RNA, plasma, urine, ….

Small molecules for drug discovery
   – Libraries, assays, screening, chemistry
         WORKPACKAGE 6:
         Data acquisition, curation and ownership




Challenges

Open Access

“gold standard” Quality

Sustainability

Data Integration
            WORKPACKAGE 6:
            Data acquisition, curation and ownership




Solutions

Open Access
   – Web-based Portal to Reagents
   – Super Core Lab for Services

“gold standard” Quality
    – Community Standards
    – QMS

Data Integration
    – Resource Database
    – Links with PDBs

Sustainability
   – Commercialization (vs subsidy or “cost recovery”)
WORKPACKAGE 6:
Data acquisition, curation and ownership



                         UK Government Funding Body
                         £450M/Year Medical Research
                         22 Nobel Laureates
                         Human Genome Mapping Project (1994)

2001                     Biological Archive
                         Core Technology Lab In MRC
                         “Cost Recovery” Model

2005                     Spun Out from MRC
                         Products & Contract Research
                         Private Company

2007                     Acquird by Medical Solutions
                         Diganostics, Healthcare, Life Science
                         Nottingham, Cambridge, Oxford, UK
                         Public Limited Company (LSE: MLS)
           WORKPACKAGE 6:
           Data acquisition, curation and ownership



Human Genome Mapping Project –
Resource Center
Formed in 1994
Contribution to HGP
   – Bioinformatics, Clones
R&D Introduced in 1998
Funding Crisis in 2000



                     HGMP Structure: 2001



    Bioinformatics         Research & Dev         MRC geneservice
             WORKPACKAGE 6:
             Data acquisition, curation and ownership




Sustainability: MRC geneservice Business Model

Non-Profit Revenue Generating Enterprise (Oct 01)
    – Underwritten by MRC for 5 years
    – Revenue => Cost neutral by end of grant

Organization
    – Ops/tech dev/IT/Admin/Bus Dev
    – Babraham & Hinxton Genome Campus
    – Bioinformatics & R/D => Provided by HGMP

Benefits to “Community”
    – Access to technology & resources
    – Efficiency of service provision
    – Lowered Costs to MRC
                   WORKPACKAGE 6:
                   Data acquisition, curation and ownership



                                         Core Products
                                                &             Research
                                        Service Offerings
MRC HGMP Assets
                                         Genomic Reagents
                                                              Customers
                                                              •University
Historic Collections                        DNA Services      •Government
    Technology                                                •Pharma
     Knowhow
                                            RNA Services      •Biotech
  Bioinformatics
                                                              •UK/Europe
                                          Custom Services
                                                              •US/Asia

                       Opportunities
                       •HGMP R&D
                       •Grants/Collabotrations
                       •In-Licensing
              WORKPACKAGE 6:
              Data acquisition, curation and ownership




Major Issues
Bioinformatics & R/D Units
     – Caulcott review/recommendation of Bioinformatics
         => Fee-for-service wouldn’t work, commercialization not an option
     – Poor External Science Review
     – MRC Shut Down Both Units => Implications for MRC geneservice

“Cost Recovery” Model Not Profitable For Certain Activities
    – REAL FEC: Always bits that require funding
    – “Not funded here” => WHO PAYS?

Schizophrenia of purpose
    – High expectations without investment backup
    – Are you a company or an academic lab?
    – Academics demand for subsidy not backed by funders
               WORKPACKAGE 6:
               Data acquisition, curation and ownership




Commercialization Drivers

Autonomy for key decisions
    – Board Level Accountability
    – Rapid Response

Support for Entrepreneurial Environment
    – Financial Freedom
    – Risk Management
    – Staff Incentives

Intellectual Property Management

External Investment Opportunities

Since Feb2005….
    –   Profitable
    –   Expanding
    –   Acquired
              WORKPACKAGE 6:
              Data acquisition, curation and ownership




RZPD Case-Study

Set up in 1995; Not-for-profit company in 2000
     – Shareholders: MPI; DKFZ; MDC
     – Three Divisions (similar to HGMP)
     – National Genome Research Network (NGFN)
     – EU Programs:
          • EUCOMM; EUREXPRESS; Proteome Binders; TEMBLOR

Cost-Recovery Model (70:30)
    – Bioinformatics & Research/Development Programs EXTREMELY expensive
    – Not viable via business model: Same Issues As HGMP-RC
    – Shut Down Aug 2007

Two Companies Have Spun-out
    – Imagenes (Clones/Services)
    – Atlas Biolabs (Microarray/Diagnostics)
            WORKPACKAGE 6:
            Data acquisition, curation and ownership




Better Model: Academic – Commercial Partnership
Focus on Core Competencies

Academic Labs
    –   Develop New Applications/Tools
    –   Develop Analysis Systems
    –   Define Communal Needs
    –   Define Quality Standards
    –   Sustainability via INSTITUTIONAL FUNDING

Commercial Organization
   – Provide Standard Technology & Quality Systems (Service Providers)
   – Sales & Marketing (Distributors)
   – Collaborative Research & Licensing (Pharma/Biotech)
   – Sustainability via COMMERCIAL ACTIVITY
             WORKPACKAGE 6:
             Data acquisition, curation and ownership




Table of Contents

Vision For Resources

Sustainability Models: Observations and Case Studies
    – Geneservice
    – RZPD

IPR Issues on Data Submission: Observations & Some Case Studies
     – Incyte Genomics
     – Exelixis
     – Wyeth/Scotland NHS “Translational Medicine Collaboration”

Bioinformatics: UK SME Perspective
     – BIA Survey
               WORKPACKAGE 6:
               Data acquisition, curation and ownership




General Observations

Companies do not share data as a matter of course.

Companies will share data only if….

•   They get paid
     – eg subscription fee, pay-for-view
     – Incyte

•   Marketing/Public Relations
     – eg helps them sell product or demonstrate utility of product/technology
     – Exelixis

•   Research Collaboration
     – eg they can’t do in-house
     – Wyeth
              WORKPACKAGE 6:
              Data acquisition, curation and ownership




Incyte Genomics Case Study
Founded in 1991 by Randy Scott & Roy Whitfield

First Genomics Company to go public (1993)
     – First profitable Genomics Company
     – $5M/year to >20 Big Pharma

Developed first “Database Product” in Genomics (HTP cDNA sequencing)
    – “LifeSeq Gold” Product
    – Non-exclusive yearly subscriptions: Included license to use in drug
       development
         • INCY retained IPR rights for biological products
    – >500 Issued Patents
    – Celera developed similar model: filed patents for 10K genes in 2000

Pressure from public domain effort
    – Incyte Offered “Life Seq Public” in 2000
    – Only partial sequence information. Incyte pulled the website, not sure what
       happened to the data.
    – We have the FL clones and data, but never launched due to IPR
       restrictions!
              WORKPACKAGE 6:
              Data acquisition, curation and ownership




Exelixis Case Study

Founded in 1994
    – Model Organisms in Drug Development
    – P element knock-outs in every fly gene: Focus on Signal Transduction
    – Hugely protective of technology and information
    – Acquired Artemis (zebrafish equivalent) in 2001

Transition to “classic” drug development 2002-03
    – Built up Chemistry & HTP screening
    – Model Organisms less important

2004 Donated Fly Stocks & Sequence Information to Fly Community
    – Presented at Fly Meeting => Rebellion, although resolved and complimentay
       programs with public efforts (eg EU dros del)
    – Major Publication: Included flanking sequence data => Published on flybase
    – Distribution of stocks => MTA or Commercial Use License
             WORKPACKAGE 6:
             Data acquisition, curation and ownership



Translational Medicine Research Collaboration:
New Paradigm in Drug Development
April 2006 Wyeth, NHS Scotland and Universities of Edinburgh, Dundee,
   Aberdeen and Glasgow announce $100m collaboration.

Wyeth commit to:
    – Fund [30] translational programmes through a specialist translational
       research institute
    – “single and seamless” research infrastructure
         • Tissue and patient data bioinformatics.
         • Small scale volunteer patient studies.
         • Biomarker Development

Output:
    – Wyeth Exclusive rights to certain therapeutic targets
    – Joint venture company (exclusive rights to all information and IPR)
    – High Impact Publications. HOWEVER, ONLY AFTER PATENTS HAVE
        BEEN FILED
            WORKPACKAGE 6:
            Data acquisition, curation and ownership




Issues
Legal Complexities
   – Major Business Development Effort
   – MTAs, Licenses, Due-diligence,…
   – Tech Transfer Groups generally add to the complexity
   – Liability if all goes pear shaped

Key Question: Why do you want to engage with commercials?
    – Access their data?
       • Barriers as described

    – Funding?
       • Good, but requires business development/management
       • But realistically there will be strings attached….
       • Risk companies may fold/change bus plan

    – Support their efforts?
       • Major Need and should be supported by EU funders.
             WORKPACKAGE 6:
             Data acquisition, curation and ownership




Table of Contents

Vision For Resources

Sustainability Models: Observations and Case Studies
    – Geneservice
    – RZPD

IPR Issues on Data Submission: Observations & Some Case Studies
     – Incyte Genomics
     – Exelixis
     – Wyeth/Scotland NHS “Translational Medicine Collaboration”

Bioinformatics: UK SME Perspective
     – BIA Survey
                   WORKPACKAGE 6:
                   Data acquisition, curation and ownership



    BioIndustry Association: Insight into Bioinformtics
Discovery Informatics Advisory Committee (DIAC) set up in 2003
    – Primary objectives were to determine
        • Key individuals and organisations working in Bioinformatics
        • Areas of activity and future aspirations

Survey of Best Practice and Needs (2004)
    – 812 Bioscience Companies Identified in UK
         • Service Providers; Healthcare; Diagnostics; Environmental and AgBio
    – 235 Expressed Interest in Bioinformatics / 74 Replied To Survey
    – All but 2 companies had <20 staff working with bioinformatics

Biggest Need: Data Integration & Software Development
    – Standardization of datasets
    – Integration of datasets and projects
    – Implementation of patient management systems
    – More universal access to high quality large-scale clinical patient data
    – Greater awareness of new developments
WORKPACKAGE 6:
Data acquisition, curation and ownership
            WORKPACKAGE 6:
            Data acquisition, curation and ownership




Goals of WorkPackage

•   Assessment and recommendations for data quality control

•   Financial and scientific assessment of curation practices in
    existing databases

•   Effect of IPR issues on database submissions

•   Recommendations to overcome problems

								
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