Impact of licensing on portfolio management - Getting you more

							The Impact of Licensing on Portfolio Management




       Rob Hockney Ph.D.
       Director Global Discovery Alliances
       AstraZeneca



       SMI
       Pharmaceutical Portfolio and
       Product Life-Cycle Management Conference
       19th &20th June, 2006
       Millennium Gloucester Hotel,
       London
Outline




          Why this is important


          Late stage vs. Early stage licensing


          Opportunities


          Determining impact and managing risk


          Benefits and ongoing challenges
Big Pharma – Meeting Future Unmet Need


 Living longer   Obesity epidemic   Smoking addiction            Stress




                               • From symptomatic control to disease
                                 modification and prevention
                               • From ‘one size fits all’ to Personalised
                                 Medicine
                               • Biopharmaceuticals
AZ R&D investment, $m




                    3,500
                                            3,451
                    3,000
                                    3,069
                    2,500   2,687
                    2,000
                    1,500
                    1,000
                     500
                       0
                            2001    2002    2003
    Investment as
                            16.6%   17.2%   18.3%
    % of sales
High Attrition – A Constant Challenge




       Toxicology
          23%

                            Efficacy   Only 7% of candidate drugs
      Other                   22%           become products!!
    (incl. DMPK)
       20%
                    Portfolio
                      23%
Big Pharma – A View of the Future




   External            DEVELOPMENT   Unmet
   Alliances             PIPELINE    Medical
                                      Need
Big Pharma – Today
and An Alternative View of the Future



Internal Discovery         DEVELOPMENT   Unmet
      Engine                 PIPELINE    Medical
                                          Need



               External
               Alliances
Late vs. Early Stage Licensing


  Internal Discovery             DEVELOPMENT
        Engine                     PIPELINE
Improving Portfolio Productivity: The 4Rs



                                             Strategic Actions
       Toxicology                      • Right disease mechanism
          23%                            (Discovery Medicine)
                            Efficacy   • Right patient
                              22%        (Disease stratification and
      Other
    (incl. DMPK)                         personalised medicine)
       20%                             • Right compound
                    Portfolio            (Front-loading/Lead
                      23%                generation/optimisation)
                                       • Right strategic fit
                                         (Portfolio management)

      Only 7% of candidate drugs become products!!
AstraZeneca – Today and Tomorrow


Internal Discovery         DEVELOPMENT   Unmet
      Engine                 PIPELINE    Medical
                                          Need


  Discovery                Development
 Technology                Compounds

               Research
               Alliances
Understanding disease mechanisms via high resolution
phenotyping




      Unprecedented opportunities to characterise the
      disease state
Discovery Medicine - 3Ms
Integrating patient and pre-clinical information


  Mechanism: New targets from human tissues
             validation – early data in man


  Model: Translational disease models
         animals -> man



  Marker: Predictive response: Efficacy, safety,
          appropriate patient populations



         clinical benefits > side effects
Disease re-classification via pharmacogenomics -
proteomics

     Gene expression                    Protein expression

                                erbB2                   VEGF




                                  S100P                  crk


                  diagnosis: responder/non-responder
Front-loading DMPK & toxicology


• Earlier DMPK & toxicity studies, development of bio-markers
  including efficient hERG screen

• Predictive modelling of DMPK & toxicity




   Compound design         Modelling PK       Modelling whole-body
                             & dose           kinetics

                             Beyond             Essen
        Cytokinetics
                            Genomics
AstraZeneca – Today and Tomorrow


Internal Discovery         DEVELOPMENT   Unmet
      Engine                 PIPELINE    Medical
                                          Need


  Discovery                Development
 Technology                Compounds

               Research
               Alliances
AstraZeneca – The Importance of Alliances

              Conaris
             Procardis
                                    Cytokinetics
             Shanghai                                Schering
                               Beyond Genomics
                 Oxford                                CAT
  Kudos      Perlegen                  Essen         Abgenix

 Right disease      Right Patient        Right Compound
 mechanism
  Array    Curie                    Neogenesis     AtheroGenics

  Astex                              Biosignal
                                                    Protherics
   NPS                                 NPS
                                                      Abraxis
                                       Astex

                                       Array
                                     Dainippon
Mapping Alliances to the Portfolio


  Discovery Alliances


 MS    1    2              3    4    5    FTIM   5.5           6        7       8              9




      Discovery Pipeline                 Development Pipeline

 TG                        1   1.5   2             2.5              3       4        5


           DISCOVERY LED                          DEVELOPMENT LED                   GMBD LED




                                         Compound Licensing
Assessing Alliance Impact on the Discovery Portfolio


 • How, by how much, where (which MS
   transitions) and when is the Alliance
   expected to impact Discovery Pipeline
   KPIs?
   (Volume, Capacity, Time, Cost, Quality, Value)


 • What is the probability
   that these benefits will be
   realized?

    A set of KPI-based,
    probability adjusted impact
    and value statements for
    each alliance in the context
    of the AZ R&D portfolio
    model.
Portfolio Modelling




•   Portfolio impacts –
    changes to capacity;
    and operational costs
    and effect on number
    and timing of milestone       3   Results



    transitions from MS1
    through to FTIM           2
    (potentially MS7)
                                  1   Assumptions
Alliance Impact Shape



         Describing key attributes of Investments
  'Six Parameter' Key Performance Indicator Framework




                                 Risk adjusted volume/
                                 quality/time/cost/
                                 capacity/value
Benefits
 Clear description of investment impacts on portfolio

 Comparison of dissimilar investments

 Inter-conversion of pipeline impacts and $ value

 Decision making is better informed

 Impacts negotiation and price to pay

 Enables and improves scenario planning at all stages

 Clear linkage to business planning

 Transparency of benefits accruing from external investments

    Facilitates and empowers alliance management
Ongoing Challenges




    Cultural systematics in an entrepreneurial industry
The Impact of Licensing on Portfolio Management




                Thank You


       SMI
       Pharmaceutical Portfolio and
       Product Life-Cycle Management Conference
       19th &20th June, 2006
       Millennium Gloucester Hotel,
       London