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Strategic Partnerships with
Service Providers
Bonnie Mangold
Vice President, Head of Strategic Sourcing
November 2009
Novartis Pharmaceuticals Corporation
Agenda

Introduction Strategic Sourcing
Introduction Strategic Sourcing

Why to bring in new capabilities and strategic opportunities?
Why to bring in new capabilities and strategic opportunities?

New model of partnerships
New model of partnerships

Active Benchmarking - what you measure is what you get
Active Benchmarking - what you measure is what you get




 2 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Integrated Development Sourcing Strategy


                                              Capacity                         Reactive                             Strategic
                          From                 Driven                         Outsourcing                           Sourcing




                   Alignment of core/non-core activities

                   Strategic involvement in demand planning

                   Implementing an outcomes-based approach with strategic partnerships

                   Innovative sourcing models

                   Maximum cross-Novartis spend transparency & volume leverage


3 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Benefits Strategic Sourcing

                                                                                                                                             Expected benefit: Competitive
                                                                                                                                                      advantage




                                       Executive time/focus on the core activities
                                       Executive time/focus on the core activities

                                       Access to innovation and expertise
                                       Access to innovation and expertise

                                       Shorten development times, and accelerate patient recruitment
                                       Shorten development times, and accelerate patient recruitment

                                       Reduced costs, faster decision making
                                       Reduced costs, faster decision making
                                       Access to additional capital to fund more projects
                                       Access to additional capital to fund more projects




4 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
What are the reasons to change now?




5 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Changing Face of Pharma
                                                                     Focusing on biologics and high-potency Oncology
                                                                     Re-establish position in generics (biosimilars)
                Big Pharma
                                                                     Targeting emerging markets
                                                                     Acquisitions/mergers



             Emergence of
                                                                     Japanese, Indian, Chinese companies expanding globally
              New Players



                                                                     Early development pipeline nearly doubled from 1998 to 2008
                Smaller
                                                                     However, major pharma making radical cuts in portfolios to improve R&D
              Development                                            efficiency
                Pipeline
                                                                     Increasing trial costs and complexity


                                                                     Critical element of every biopharm and pharmaceutical company
                  More                                               Handing off functions previously considered core competencies including
               Outsourcing                                           toxicology, clinical data management, manufacturing
                                                                     Trend to favor CROs with greatest capabilities and financial strength

    Source: PharmTech.com April 8, 2009

6 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
CRO Evolution: The world is changing

                                                                                                                                                             2006-Today

                                                                                               2000/2005                                         Partnership models
                                                                                                                                                 emerge with big pharma
                                1980/90s                                             Biotech/specialty pharma                                         Big pharma moves
                                                                                     use CRO’s strategically                                          towards strategic
                                                                                                                                                      outsourcing
            Tactical outsourcing by big                                                  Well-funded biotechs
            pharma                                                                       lacking internal                                             Growth rate for CRO
                                                                                         capabilities rely on CROs                                    industry increases
                CROs are spill-over capacity,
                used tactically                                                          CRO demand stabilizes,                                       Recent large deals:
                Volatility in CRO growth rates                                           performance improves,
                and profitability                                                        investments add scale




    Source: Covance; Literature searches



7 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Agenda

Introduction Strategic Sourcing
Introduction Strategic Sourcing

Why to bring in new capabilities and strategic opportunities?
Why to bring in new capabilities and strategic opportunities?

New model of partnerships
New model of partnerships

Active Benchmarking - what you measure is what you get
Active Benchmarking - what you measure is what you get




 8 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Why to bring in new capabilities and strategic
    opportunities?
     “Active Benchmarking”
     “Active Benchmarking”
 to bring in new capabilities, improvement and strategic opportunities through
 expanded partnership with CROs



                                           Provide alternative resources and approaches to drug development
                                           Provide alternative resources and approaches to drug development

                                                         Define process and roles & responsibilities for extended CRO
                                                         Define process and roles & responsibilities for extended CRO
                                                         partnership on program level rather common trial operational level
                                                         partnership on program level rather common trial operational level

         Benefits                                       Provide external development expertise to Novartis
                                                        Provide external development expertise to Novartis
                                                        (i.e. integrated model-based approach, real-time data analysis,
                                                        (i.e. integrated model-based approach, real-time data analysis,
                                                        faster decision making with less patients)
                                                        faster decision making with less patients)

                                              Provide alternative solution to manage portfolio risk, i.e. CROs to
                                              Provide alternative solution to manage portfolio risk, i.e. CROs to
                                              provide at-risk capital or services (risk-sharing model)
                                              provide at-risk capital or services (risk-sharing model)


9 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Agenda

Introduction Strategic Sourcing
Introduction Strategic Sourcing

Why to bring in new capabilities and strategic opportunities?
Why to bring in new capabilities and strategic opportunities?

New model of partnerships
New model of partnerships

Active Benchmarking - what you measure is what you get
Active Benchmarking - what you measure is what you get




 10 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Strategic approach via Active Benchmarking

          Program Team CRO                                                                                                                  Program Team Sponsor

         External team integrated into                                                                                                           Company line functions
         Program Teams via Sourcing                                                                                                              generate learning about
         relationship                                                                                                                            insufficient internal processes
         Involved in strategic                                                                                                                   Results in reviewing own
         development activities rather                                                                                                           productivity and adapt as
         than trial operations only                                                       New model                                              needed
                                                                                            of CRO
         Providing scientific                                                                                                                    Gain scientific learning from
         opportunities and expertise                                                      partnership                                            external partner
         Uses a model-based                                                                                                                      Gain understanding about
         approach including real-time                                                                                                            integrated program team
         data analysis                                                                                                                           sourcing model




11 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Develop key principles of partnership…

        Communication driven                                              Establishing mutual trust
                                                                                                                                            Monthly Progress Report of
        through single-point of                                                 and partnership
                                                                                                                                               performance metrics
               contacts                                                   (fully integrate CRO team
                                                                                                                                             (agreed upon the project
        (fewest touch-points as                                            members to the project
                                                                                                                                                      start)
               possible)                                                             team)




                                                                        Clearly define sponsor and                                           Quarterly Review Meetings
   Gain stakeholder support to
                                                                              CRO roles and                                                  (F2F) with Program Team
   overcome internal barriers
                                                                              responsibilities                                                   and Clinical Team




12 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Develop key principles of partnership…(cont.)

            Face-to-Face Kick-off
              Meeting essential
                                                                             An understanding that not                                                 Willingness to allow
         (define objectives, roles &
                                                                             all partnership processes                                                 empowerment to the
           responsibilities across
                                                                               will be defined upfront                                                  strategic partner
           departments and both
               organizations)




                                                                             Keep it simple and remain
              Overcoming well-                                                                                                                   Establish infrastructure at
                                                                              focused on key program
            established cultures to                                                                                                              the beginning of a project
                                                                                     questions
               allow innovative                                                                                                                 (incl. legal, contracting and
                                                                             (do not address too many
                  approaches                                                                                                                         quality assurance)
                                                                                 questions at once)




13 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Extended responsibilities included…
        Design and finalization of assigned trial protocols (one compound), including
         Design and finalization of assigned trial protocols (one compound), including
        data analysis and clinical study report
         data analysis and clinical study report


       Clinical lead of the studies, including medical and statistical consultancy
        Clinical lead of the studies, including medical and statistical consultancy


       Utilizing integrated, model-based development strategies focused on key
        Utilizing integrated, model-based development strategies focused on key
       decision points
        decision points

       Overall Program Lead (incl. regulatory, drug supply management, trial
        Overall Program Lead (incl. regulatory, drug supply management, trial
       operations, contract management etc.)
        operations, contract management etc.)

       Budget Management and support of invoice handling and negotiations with
        Budget Management and support of invoice handling and negotiations with
       other service providers
        other service providers

       Provide aacompletely transparent status of study progress through aasecure
        Provide completely transparent status of study progress through secure
       web portal
        web portal

14 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Were there any bottlenecks?
         Novartis remained the lead for key
        regulatory, drug supply release and
          financial responsibilities due to                                                       New internal processes need to be developed to
          established internal processes                                                          integrate external partner successfully




    Difficulty to overcome internal barriers                                                                                Benefits of change in complex
    to give-up “core” activities & to deviate                                                                            organization not always immediately
          from established processes.                                                                                                understood




                                                            Open communication essential to
                                                                 overcome bottlenecks



15 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Feedback – Measurement of success

               Monthly Traffic Light Reports on agreed metrics

               CRO Feedback to Novartis

               Novartis Survey Feedback to CRO




16 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Established Governance Model
          Monthly Program Meeting Updates with metrics in place




          Quarterly Review Meetings with CRO and Novartis

          Quarterly Surveys to assess overall collaboration

17 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Clinical metrics: key milestones for reporting and
    relevant performance benchmarks monitored
      Milestones/
                                         Description / Details                                                                                   Performance benchmarks
      measurements
                                                                                                                                                 Time from assignment of CTH to
      FP                                 Final protocol signed (plan vs. actual)
                                                                                                                                                 FP
      FPFV                               First patient first visit (plan vs. actual)                                                           Time from FPFV to LPFV
      LPFV                     Study milestonesvisit (plan vs. actual)
                                  Last patient first and progress reported on                                                                 a(recruitment time)
                                                                                                                                                 Monthly
      LPLV                     Basis topatient last visit (plan vs. actual)
                                  Last core Novartis Lead                                                                                        None
      FIR
                               Close collaboration between CRO Ops Lead None
                                  First interpretable results
                                                                            &
      LDG                      Novartis Dirgenerated (Program and Sourcing) Time from LDG to DBL
                                  Last data of Ops
      DBL                                Database locked (plan vs. actual)
                 CRO joins Global Program Team meetings on monthly to CSR
                                                                       Time from DBL
      CSR            Clinical study report available (plan vs. actual)
                 basis for project update and scientific input to
                        Expected cost (FTEs and external cost); total
                 developmentpatient
      Budget & Cost     and per                                        Cost per patient (?)
                                               Actual vs. expected cost
                                               Number of patients
      Other                                    Number of sites                                                                                   None (?)
                                               Total study duration




18 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Actual versus Planned Milestones

                                                                            Time Actual Milestone versus Planned



                                    30


                                    20


                                    10


                                      0
             Working Days
                                   -10


                                   -20


                                   -30


                                   -40
                                                  FP               FPFV –               LPLV –               FPFV –              LPFV –                  LP               LPLV –
                                                                   Cohort A             Cohort A            Cohort B-1          Cohort B-1           Randomized          Cohort B-1

                                                                                                           Milestones




19 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
CRO Feedback – areas that worked well


                     Sponsor educated CRO partner to learn internal processes quickly
                           Project standards were kept (CRF’s, vendors) ensuring integration into program
     CRO Feedback




                              Willingness and openness to integrate CRO partner into NVS Program Team

                                 Investigator contracts: Inclusion of CRO into the approval process

                                  CRO successfully managed vendor negotiations and contract execution

                                 Open to working with new vendors at the CRO’s recommendation
                              Coordinated QA audits of new vendors

                           Leveraging expertise and relationships with KOLs

                     Safety reporting – process integrated with CRO




20 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Survey Results 2009
          66% satisfied/very satisfied in Q3 compared to 37% in Q1 Survey:
          30% increase in overall satisfaction within 4 months


                                                                             Overall Satisfaction Rate




                  Overall Satisfied




                                                0%                         20%                        40%                         60%                        80%         100%


                                                                                   Survey Q1 2009                   Survey Q3 2009


     Response rate ~70%
21 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Survey Results 2009
          92% agreed that the Active Benchmarking                                                                     67% (21% increase from Q1) agreed that
          Project provided useful insights/lessons that                                                               Active Benchmarking Project provided
          may apply to future collaborations with                                                                     effective external resources to the Novartis
          external resources                                                                                          Development Team
          42% increase in “strongly agree”                                                                            Dissatisfaction rate decreased over time


  100%                                                                                                      100%


    80%                                                                                                       80%


    60%                                                                                                       60%


    40%                                                                                                       40%


    20%                                                                                                       20%


      0%                                                                                                        0%
                Strongly           Agree             Neither         Disagree          Strongly                           Strongly          Agree            Neither        Disagree   Strongly
                 Agree                                                                 Disagree                            Agree                                                       Disagree

                            Survey Q3 2009                  Survey Q1 2009                                                             Survey Q3 2009                    Survey Q1 2009




22 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Outlook: Main Questions to be answered

       Costs: How efficient was resource utilization?

            Speed: What was the speed to decision point?

                               Quality: Did the data produced enable confident and
                                        informed decision-making?

                                          Concept: What were risks of the specific approach?
                                                                       What did we learn that could be brought into
                                                                       our organization?




23 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Agenda

Introduction Strategic Sourcing
Introduction Strategic Sourcing

Why to bring in new capabilities and strategic opportunities?
Why to bring in new capabilities and strategic opportunities?

New model of partnerships
New model of partnerships

Active Benchmarking - what you measure is what you get
Active Benchmarking - what you measure is what you get




 24 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Why Use Metrics?
                            Increase focus in a complex environment
                                  Focus on what needs to be done to reach goals



                            Move down the “learning curve”




                            Work smarter, not faster




                            Reduce “ineffective” work



    Source: David Zuckerman (2006), “Pharmaceutical Metrics” from Gower Press

25 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Three Principles of Metrics


                                     1                                                               2                                                               3


                   Metrics measure                                                   Metrics help us                                             Metrics get us out
                   progress toward                                                   prevent failure                                              of ruts/routine
                      our goals




    Source: David Zuckerman (2006), “Pharmaceutical Metrics” from Gower Press

26 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Metrics need to be defined and agreed upon…




                                                                       Metrics for outsourcing

                                        To provide information for evaluating our project
                                        success, ultimately driving decision making for future
                                        collaboration with CRO
                                        Allow for consistent measurement and comparison of
                                        internal vs. external/ outsourcing option




27 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Summary – Productivity improvement needed

              Constructive Change needed to make clinical trials affordable


              Pilot innovative collaborations with less complexity


              Reduce Bureaucracy and number of contracts


              Implement sensible benchmarking


              Increase mutual trust with external partners


              Communicate success broadly to gain wide stakeholder support


              Adapt risk-shared approaches


28 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
Thank you

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Outsourcing

  • 1. Strategic Partnerships with Service Providers Bonnie Mangold Vice President, Head of Strategic Sourcing November 2009 Novartis Pharmaceuticals Corporation
  • 2. Agenda Introduction Strategic Sourcing Introduction Strategic Sourcing Why to bring in new capabilities and strategic opportunities? Why to bring in new capabilities and strategic opportunities? New model of partnerships New model of partnerships Active Benchmarking - what you measure is what you get Active Benchmarking - what you measure is what you get 2 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 3. Integrated Development Sourcing Strategy Capacity Reactive Strategic From Driven Outsourcing Sourcing Alignment of core/non-core activities Strategic involvement in demand planning Implementing an outcomes-based approach with strategic partnerships Innovative sourcing models Maximum cross-Novartis spend transparency & volume leverage 3 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 4. Benefits Strategic Sourcing Expected benefit: Competitive advantage Executive time/focus on the core activities Executive time/focus on the core activities Access to innovation and expertise Access to innovation and expertise Shorten development times, and accelerate patient recruitment Shorten development times, and accelerate patient recruitment Reduced costs, faster decision making Reduced costs, faster decision making Access to additional capital to fund more projects Access to additional capital to fund more projects 4 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 5. What are the reasons to change now? 5 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 6. Changing Face of Pharma Focusing on biologics and high-potency Oncology Re-establish position in generics (biosimilars) Big Pharma Targeting emerging markets Acquisitions/mergers Emergence of Japanese, Indian, Chinese companies expanding globally New Players Early development pipeline nearly doubled from 1998 to 2008 Smaller However, major pharma making radical cuts in portfolios to improve R&D Development efficiency Pipeline Increasing trial costs and complexity Critical element of every biopharm and pharmaceutical company More Handing off functions previously considered core competencies including Outsourcing toxicology, clinical data management, manufacturing Trend to favor CROs with greatest capabilities and financial strength Source: PharmTech.com April 8, 2009 6 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 7. CRO Evolution: The world is changing 2006-Today 2000/2005 Partnership models emerge with big pharma 1980/90s Biotech/specialty pharma Big pharma moves use CRO’s strategically towards strategic outsourcing Tactical outsourcing by big Well-funded biotechs pharma lacking internal Growth rate for CRO capabilities rely on CROs industry increases CROs are spill-over capacity, used tactically CRO demand stabilizes, Recent large deals: Volatility in CRO growth rates performance improves, and profitability investments add scale Source: Covance; Literature searches 7 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 8. Agenda Introduction Strategic Sourcing Introduction Strategic Sourcing Why to bring in new capabilities and strategic opportunities? Why to bring in new capabilities and strategic opportunities? New model of partnerships New model of partnerships Active Benchmarking - what you measure is what you get Active Benchmarking - what you measure is what you get 8 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 9. Why to bring in new capabilities and strategic opportunities? “Active Benchmarking” “Active Benchmarking” to bring in new capabilities, improvement and strategic opportunities through expanded partnership with CROs Provide alternative resources and approaches to drug development Provide alternative resources and approaches to drug development Define process and roles & responsibilities for extended CRO Define process and roles & responsibilities for extended CRO partnership on program level rather common trial operational level partnership on program level rather common trial operational level Benefits Provide external development expertise to Novartis Provide external development expertise to Novartis (i.e. integrated model-based approach, real-time data analysis, (i.e. integrated model-based approach, real-time data analysis, faster decision making with less patients) faster decision making with less patients) Provide alternative solution to manage portfolio risk, i.e. CROs to Provide alternative solution to manage portfolio risk, i.e. CROs to provide at-risk capital or services (risk-sharing model) provide at-risk capital or services (risk-sharing model) 9 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 10. Agenda Introduction Strategic Sourcing Introduction Strategic Sourcing Why to bring in new capabilities and strategic opportunities? Why to bring in new capabilities and strategic opportunities? New model of partnerships New model of partnerships Active Benchmarking - what you measure is what you get Active Benchmarking - what you measure is what you get 10 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 11. Strategic approach via Active Benchmarking Program Team CRO Program Team Sponsor External team integrated into Company line functions Program Teams via Sourcing generate learning about relationship insufficient internal processes Involved in strategic Results in reviewing own development activities rather productivity and adapt as than trial operations only New model needed of CRO Providing scientific Gain scientific learning from opportunities and expertise partnership external partner Uses a model-based Gain understanding about approach including real-time integrated program team data analysis sourcing model 11 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 12. Develop key principles of partnership… Communication driven Establishing mutual trust Monthly Progress Report of through single-point of and partnership performance metrics contacts (fully integrate CRO team (agreed upon the project (fewest touch-points as members to the project start) possible) team) Clearly define sponsor and Quarterly Review Meetings Gain stakeholder support to CRO roles and (F2F) with Program Team overcome internal barriers responsibilities and Clinical Team 12 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 13. Develop key principles of partnership…(cont.) Face-to-Face Kick-off Meeting essential An understanding that not Willingness to allow (define objectives, roles & all partnership processes empowerment to the responsibilities across will be defined upfront strategic partner departments and both organizations) Keep it simple and remain Overcoming well- Establish infrastructure at focused on key program established cultures to the beginning of a project questions allow innovative (incl. legal, contracting and (do not address too many approaches quality assurance) questions at once) 13 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 14. Extended responsibilities included… Design and finalization of assigned trial protocols (one compound), including Design and finalization of assigned trial protocols (one compound), including data analysis and clinical study report data analysis and clinical study report Clinical lead of the studies, including medical and statistical consultancy Clinical lead of the studies, including medical and statistical consultancy Utilizing integrated, model-based development strategies focused on key Utilizing integrated, model-based development strategies focused on key decision points decision points Overall Program Lead (incl. regulatory, drug supply management, trial Overall Program Lead (incl. regulatory, drug supply management, trial operations, contract management etc.) operations, contract management etc.) Budget Management and support of invoice handling and negotiations with Budget Management and support of invoice handling and negotiations with other service providers other service providers Provide aacompletely transparent status of study progress through aasecure Provide completely transparent status of study progress through secure web portal web portal 14 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 15. Were there any bottlenecks? Novartis remained the lead for key regulatory, drug supply release and financial responsibilities due to New internal processes need to be developed to established internal processes integrate external partner successfully Difficulty to overcome internal barriers Benefits of change in complex to give-up “core” activities & to deviate organization not always immediately from established processes. understood Open communication essential to overcome bottlenecks 15 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 16. Feedback – Measurement of success Monthly Traffic Light Reports on agreed metrics CRO Feedback to Novartis Novartis Survey Feedback to CRO 16 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 17. Established Governance Model Monthly Program Meeting Updates with metrics in place Quarterly Review Meetings with CRO and Novartis Quarterly Surveys to assess overall collaboration 17 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 18. Clinical metrics: key milestones for reporting and relevant performance benchmarks monitored Milestones/ Description / Details Performance benchmarks measurements Time from assignment of CTH to FP Final protocol signed (plan vs. actual) FP FPFV First patient first visit (plan vs. actual) Time from FPFV to LPFV LPFV Study milestonesvisit (plan vs. actual) Last patient first and progress reported on a(recruitment time) Monthly LPLV Basis topatient last visit (plan vs. actual) Last core Novartis Lead None FIR Close collaboration between CRO Ops Lead None First interpretable results & LDG Novartis Dirgenerated (Program and Sourcing) Time from LDG to DBL Last data of Ops DBL Database locked (plan vs. actual) CRO joins Global Program Team meetings on monthly to CSR Time from DBL CSR Clinical study report available (plan vs. actual) basis for project update and scientific input to Expected cost (FTEs and external cost); total developmentpatient Budget & Cost and per Cost per patient (?) Actual vs. expected cost Number of patients Other Number of sites None (?) Total study duration 18 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 19. Actual versus Planned Milestones Time Actual Milestone versus Planned 30 20 10 0 Working Days -10 -20 -30 -40 FP FPFV – LPLV – FPFV – LPFV – LP LPLV – Cohort A Cohort A Cohort B-1 Cohort B-1 Randomized Cohort B-1 Milestones 19 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 20. CRO Feedback – areas that worked well Sponsor educated CRO partner to learn internal processes quickly Project standards were kept (CRF’s, vendors) ensuring integration into program CRO Feedback Willingness and openness to integrate CRO partner into NVS Program Team Investigator contracts: Inclusion of CRO into the approval process CRO successfully managed vendor negotiations and contract execution Open to working with new vendors at the CRO’s recommendation Coordinated QA audits of new vendors Leveraging expertise and relationships with KOLs Safety reporting – process integrated with CRO 20 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 21. Survey Results 2009 66% satisfied/very satisfied in Q3 compared to 37% in Q1 Survey: 30% increase in overall satisfaction within 4 months Overall Satisfaction Rate Overall Satisfied 0% 20% 40% 60% 80% 100% Survey Q1 2009 Survey Q3 2009 Response rate ~70% 21 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 22. Survey Results 2009 92% agreed that the Active Benchmarking 67% (21% increase from Q1) agreed that Project provided useful insights/lessons that Active Benchmarking Project provided may apply to future collaborations with effective external resources to the Novartis external resources Development Team 42% increase in “strongly agree” Dissatisfaction rate decreased over time 100% 100% 80% 80% 60% 60% 40% 40% 20% 20% 0% 0% Strongly Agree Neither Disagree Strongly Strongly Agree Neither Disagree Strongly Agree Disagree Agree Disagree Survey Q3 2009 Survey Q1 2009 Survey Q3 2009 Survey Q1 2009 22 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 23. Outlook: Main Questions to be answered Costs: How efficient was resource utilization? Speed: What was the speed to decision point? Quality: Did the data produced enable confident and informed decision-making? Concept: What were risks of the specific approach? What did we learn that could be brought into our organization? 23 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 24. Agenda Introduction Strategic Sourcing Introduction Strategic Sourcing Why to bring in new capabilities and strategic opportunities? Why to bring in new capabilities and strategic opportunities? New model of partnerships New model of partnerships Active Benchmarking - what you measure is what you get Active Benchmarking - what you measure is what you get 24 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 25. Why Use Metrics? Increase focus in a complex environment Focus on what needs to be done to reach goals Move down the “learning curve” Work smarter, not faster Reduce “ineffective” work Source: David Zuckerman (2006), “Pharmaceutical Metrics” from Gower Press 25 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 26. Three Principles of Metrics 1 2 3 Metrics measure Metrics help us Metrics get us out progress toward prevent failure of ruts/routine our goals Source: David Zuckerman (2006), “Pharmaceutical Metrics” from Gower Press 26 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 27. Metrics need to be defined and agreed upon… Metrics for outsourcing To provide information for evaluating our project success, ultimately driving decision making for future collaboration with CRO Allow for consistent measurement and comparison of internal vs. external/ outsourcing option 27 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only
  • 28. Summary – Productivity improvement needed Constructive Change needed to make clinical trials affordable Pilot innovative collaborations with less complexity Reduce Bureaucracy and number of contracts Implement sensible benchmarking Increase mutual trust with external partners Communicate success broadly to gain wide stakeholder support Adapt risk-shared approaches 28 | 8th Annual Partnerships in Clinical Trial Conference | Rotterdam Nov 4-6 2009 | Strategic Sourcing | Bonnie Mangold, Novartis Pharmaceuticals | Business Use Only