Enterprise Lab Notebook Improves Collaboration

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          Enterprise Lab Notebook
          Improves Collaboration
          Flexibility to partner can shorten path to more robust, promising pipeline

               John McCarthy

                                  ith key patents

          W                       worth a projected
                                  $30 billion in
                                  revenue pegged
                                  to expire between
          2010 and 2013, pharmaceutical com-
          panies are looking for ways to improve
          the effectiveness and efficiency of
          their drug discovery and develop-
          ment programs. Many are turning to
          partnering and outsourcing as key
          strategies to boost R&D productiv-
          ity, enhance operational agility, lower
          costs and accelerate product pipelines.
          Partnering can mean many things
          — from sponsoring basic research                                    F I G U R E 1 : An enterprise electronic lab notebook fosters improved collaboration
          at a university lab, to collaborating
          with a biotech to speed the discovery                               ciently in order for the relationship to         day, it is the place where design, execu-
          of early-stage compounds, or out-                                   result in productivity gains.                    tion, analysis, reporting and sharing of
          sourcing R&D projects to a contract                                                                                  experiments takes place. However, with
          research organization (CRO).                                        Enterprise ELNs                                  today’s challenging R&D landscape,
             Today’s rapidly proliferating CROs                                   Although traditional paper note-             discipline-specific ELNs devoted to the
          offer specialized knowledge and know-                               books may be tried-and-true, they                ad hoc requirements of different chem-
          how in target biology, synthesis, screen-                           are difficult to share across global             istry and biology domains present their
          ing, pharmacokinetics, pharmacody-                                  boundaries, and one illegible entry              own challenges, since they contribute
          namics and analytical characterization                              can stop an experiment in its tracks.            to the proliferation of knowledge silos,
          projects, to name just a few capabilities.                          More importantly, they tend to create            information sharing obstacles, mul-
          As such, they provide an excellent                                  knowledge silos that are difficult to            tiple user interfaces, inconsistent or
          opportunity for R&D organizations to                                manage, access, contrast and compare.            inaccurate data, inconsistent processes
          improve operational efficiency and pro-                             With individual scientists often fol-            and skyrocketing costs of ownership.
          ductivity. However, communication and                               lowing their own inclinations in docu-           Challenges such as these have led
          information sharing across geographical                             menting experiments and capturing                companies to turn to single, enterprise
          and corporate boundaries are critical to                            results, paper notebooks can provide             ELNs that foster collaboration, drive
          successful partnering and CRO collabo-                              problematic support of regulatory                efficiencies and lower costs.
          ration. The challenge is that numerous                              requirements, especially for organiza-              Free flow of electronic informa-
          scientific disciplines working in differ-                           tions working in both regulated and              tion within and across organizations
          ent geographic locations and time zones                             non-regulated environments.                      moves products efficiently from lab
          (and often guided by dissimilar business                                The new center for workflow coor-            to plant. An enterprise ELN helps to
          rules) need to work together in design-                             dination and information exchange                accomplish this by offering a central-
          ing and executing experiments — and                                 is the electronic laboratory notebook            ized data repository and infrastructure
          they need to do this seamlessly and effi-                           (ELN). The focal point of the work               for capturing, accessing and sharing

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     experimental data, while also support-                 leverages an enterprise ELN into the           better results next time?
     ing the diverse needs of different disci-              CRO, with work requests and tasks              What is the history of a set of
     plines without extensive customization.                that are built and managed using a             experiments?
     Customizable workflows, complimented                   shared ELN infrastructure. However,            How can I improve my work based
     with fine-grained security, enable sci-                it is important to keep in mind that           on other scientists’ research?
     entists in different organizations to take             deploying an enterprise ELN across
     responsibility for individual parts of an              global organizations and CROs places        Centralized storage and security
     experiment. At the same time, central-                 added infrastructure requirements.             Deploying an enterprise ELN
     ized document management, work-                        For example, the system must support:       minimizes IT setup time, facilitates
     flow focus and secure infrastructure                        coordinated workflows across           system management and enhances
     significantly enhance an outsourcing                        geographic and business boundaries     integration across partnering teams.
     organization’s ability to adjust resources                  experiment authoring by multiple       The outsourcing organization defines
     dynamically, to collaborate effectively                     authors (and sometimes, authors        consistent business rules for manag-
     with global partners and CROs, and to                       working within different companies)    ing experimental protocols and data
     accomplish more with less.                                  experiment capture and access          capture and deploys the resulting
                                                                 across the globe and between           experiment templates to the CRO via
     Building virtual research teams                             business networks                      a central server. The organization then
        Since virtual research teams work best                   secure control of read and write       has the freedom to push additional
     when there is operational transparency                      access at experiment and experi-       projects to the CRO with the assur-
     between the outsourcing organization                        ment section levels                    ance that they will be carried out in a
     and the CRO site, it makes sense for out-                   regulated and unregulated lab docu-    consistent manner. On the other side
     sourcing organizations to engage CROs                       mentation procedures, as appropriate   of the virtual divide, the CRO always
     in long-term partnerships, getting them                    A flexible, configurable and exten-     has instant access to the latest tem-
     involved early in the R&D process, and                 sible enterprise ELN should be able         plates without having to waste time
     establishing clear protocols for exchang-              to meet these technical requirements        with costly, software reinstallations.
     ing information and materials. Such                    while also addressing the workflow             Cost and maintenance are critical
     engagement and partnership streamlines                 information challenges faced by             issues for most CROs, which typi-
     the exchange of information, activities                scientists every day on both sides          cally function with reduced operating
     and materials, since they are sharing                  of the virtual research continuum.          margins and lean IT resources. CRO
     consistent experimental procedures,                    Thus equipped, scientists can quickly       desktop installations utilizing a virtual
     processes and results in real time. This               advance their common projects by            desktop emulation environment, such
     means that scientists at each location can             answering such questions as:                as Citrix server, can minimize deploy-
     respond with agility to changing experi-                    What experiments do I run next?        ment and ongoing support costs for
     mental conditions and requirements.                         What are the latest results from       both CROs and their outsourcing
        The challenges involved in success-                      our experiments?                       partners. A virtual desktop emulation
     fully integrating CRO scientists into                       What experiments have been car-        environment also facilitates remote
     a virtual global research team can be                       ried out before?                       access where bandwidth is limited, as
     significantly lessened when the out-                        What experiments were successful?      the emulation environment transmits
     sourcing organization extends and                           What could we fine-tune to get         screens/keystrokes instead of data files.
                                                                                                        More importantly, this configuration
               R&D                                                                     CRO              enables outsourcing organizations to
                                     Publish plan/               Receive plan/
             Scientist                 design                       design           Scientist          maintain their intellectual property at
                                                                                                        the corporate location and provide as-
             Notebook                                                               Notebook
                                                                                                        needed access to CROs.
             Design/Plan                                                                Plan               Effective CRO enablement requires
          Materials request                          Communication                Materials request
                                                                                                        an informatics infrastructure that can
                                 Agent                  Cloud                                           be “turned on” to enable CRO collabo-
          Materials received     (RSS)                                            Materials made        ration and then shut down at the end
           Characterization                                                       Characterization      of the engagement, ideally requiring a
                  Report              Load results              Publish results        Report           minimal footprint within the CRO. This
                                                                                                        approach helps the CRO, which gains
                                                                                                        advanced scientific informatics technol-
     F I G U R E 2 : When operating over a global network, the enterprise ELN supports rapid
                                                                                                        ogy without the burden of added infra-
     experimental design, execution, analysis and reporting, as well as real-time data access.
                                                                                                        structure costs, and also benefits the

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          outsourcing organization, which gains
          the ability to select different CRO part-
          ners depending on its research needs.
              The ELN security model also must
          be capable of restricting CRO scien-
          tists to only appropriate repositories
          and folders. For example, outsourcing
          scientists may have permission to view
          all corporate repositories including the
          CRO repository, while CRO scientists
          can only access repositories associated
          with specific contract research projects.
          Such fine-grained security restricts
          projects, experiments and field-level
          data to appropriate eyes, once again
          protecting critical intellectual property.
          Another essential security requirement
          is the implementation of appropriate
                                                                               F I G U R E 3 : A multidisciplinary, enterprise ELN, such as Symyx Notebook 6, streamlines the
          security details to enable operation in a
                                                                               capture of chemical and biological information in regulated and non-regulated environments.
          21 CFR Part 11 compliant environment
          that supports electronic signatures, good                            enabling the CRO scientists to access the          intellectual property. The outsourcing
          laboratory practices and audit trails with                           experiment directly from their inbox.              scientists can then take advantage of
          secure document versioning.                                          They then check out the experiment,                configurable reporting templates to
                                                                               execute the reaction and record the                create and distribute required reports
          Integrated workflows and access                                      procedure. They can access any section             supporting project team collaboration.
             The following simple example illus-                               of the experiment and add new sec-
          trates how the enterprise ELN enables                                tions during editing to capture relevant           Conclusion
          secure, authorized workflows while                                   analytical data as needed; meanwhile,                 As R&D organizations accelerate
          also minimizing information exchange                                 scientists at the requesting organization          the pace and extent to which they
          delays from data capture through                                     can monitor progress at the CRO.                   outsource R&D operations to CROs,
          analysis and reporting.                                                 When the experiment is complete,                their primary strategic issue is how
             In this scenario, scientists at the out-                          the CRO scientists check it back into              to increase productivity. A multi-
          sourcing organization initiate an experi-                            the CRO repository and route it back               disciplinary, enterprise ELN can be
          ment and clone it into the CRO reposi-                               to the requesters. The experimental                used internally across the enterprise,
          tory after clearing out any proprietary                              protocol enables the scientists at the             as well as worldwide across business
          information that is not appropriate for                              outsourcing organization to mark the               ventures, making it possible for sci-
          the CRO scientists to see. A synthesis                               CRO experiment as complete and to                  entists to collaborate effectively on
          request can be created using ELN                                     remove the CRO scientists’ permissions             multistage projects while concurrently
          messaging or a document workflow,                                    to the experiment, thereby protecting              building upon the successful meth-
                                                                                                                                  odologies and collective results of
                            Outsourcing in the Pharmaceutical Industry                                                            others. Deployment across partnering
                                                                                                                                  organizations offers the opportunity
             With the cost of discovering and developing new drugs rising and the number of approved new molecular
                                                                                                                                  to reinvent outsourcing relationships
             entities declining, life sciences organizations are increasingly turning to contract research organizations (CROs)
                                                                                                                                  and to make global partnerships more
             to improve R&D productivity, streamline workflows and restore drug pipelines.
                                                                                                                                  productive by ensuring that virtual
             • CRO market size estimated at $14 billion in 20061
                                                                                                                                  research teams are sharing informa-
             • Annual growth rate of 14 to 16 percent to reach $24 billion through 20101
                                                                                                                                  tion efficiently, communicating effec-
             • Over 1,100 CROs worldwide,1 large growth in China and India
                                                                                                                                  tively and, most importantly, working
             • Outsourcing estimated to reach $168 billion in 20092
                                                                                                                                  off the same virtual page.
             • Contract manufacturing of prescription drugs expected to rise to $43.9 billion by end of 20092
             • Contract manufacturing of over-the-counter and nutritional products is the largest and fastest grow-
                                                                                                                                    John McCarthy is VP, Product
               ing segment with an average annual growth rate of 11.3 percent to $102 billion by 2009.2
                                                                                                                                  Management Strategy, at Symyx
             1. “The CRO Market Outlook: Emerging Markets, Leading Players and Future Trends” Business Insights, May 2007         Software. He may be reached at
             2. BCC Research, Report ID:PHM043A, Published: May 2005, Analyst: Shalini Shahani

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