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Elias Zerhouni - January 22, BioForward Breakfast Event Presentation

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Elias Zerhouni - January 22, BioForward Breakfast Event Presentation

  1. 1. BioForward Leadership Breakfast series Elias Zerhouni Wisconsin, January 22, 2013
  2. 2. THE CORE ISSUEA spectacular drop in productivity Clinical timelines Clinical timelines NME11approvals by NME approvals by increasing increasing FDA decreasing FDA decreasing Rising R&D costs Rising R&D costsMean clinical Number of NCEs2 and R&D expendituredevelopment time (years) NBEs3 approved per drug ($M)12 400 2000 177810 9.2 1.500 +11% 300 +20% Approval 1318 8 7.7 1250 241 6.7 -26% 210 54 6 5.6 200 1.000 880 84 162 4.5 42 133 4 Clinical 608 24 NBE 100 187 500 359 400 2 230 126 120 109 NCE 125 54 0 0 0 82-89 90-94 95-99 00-04 05-06 90-94 95-99 00-04 05-10 76 82 87 90 94 96 01 03 07 1041. NME: New molecular entity 2. NCE: New chemical entity 3. NBE: New biological entity 4. 2010 data is from Paul et al Nature Feb-10, rest of data from TuftsSource: FDA; EvaluatePharma; Tufts CSDD 2007; Parexel; CMR; Paul et al, 2010, BCG analysis | 2
  3. 3. Why?Major drivers of change● Patient needs ● Regulation ● Acute to chronic ● Regulatory burden ● Personalized ● Safety thresholds ● Generics ● Postmarketing requirement ● Longer R&D cycles● Payer driven market ● Science ● Differential medical value ● Low predictability in Humans ● Rise of formularies ● Too concentrated on a few targets ● Payment restrictions ● Low success rates ● Price controls ● Low overall efficiency | 3
  4. 4. What went wrong?● The INNOVATION model ● Belief that advances in basic sciences could be easily translated to human disease ● A linear process from discovery to development to market with little interactions throughout the innovation cycle ● Concentration of research on « ME-TOO » drugs ● Too many novel but not validated targets in humans ● A strategy of « MANY SHOTS ON GOAL »● The ORGANIZATIONAL model ● Large complex organizations inherited from successive mergers ● All research focused on internal research without much interactions with larger world of external innovation ● Resource allocations driven by functions rather than specific projects and programs ● A disconnect between R&D strategies and the rapid changes in the Scientific, Medical and Market environments | 4
  5. 5. Future of Healthcare is Dramatically Changing 5
  6. 6. Unsustainable growth in Healthcare CostsIndex Index Index(2000 = 100) (2000 = 100) (2000 = 100)300 Historic Forecast 300 Historic Forecast 300 Historic Forecast HC cost HC cost HC cost200 GDP 200 200 GDP GDP100 100 100 2000 2005 2010 2015 2020 2000 2010 2020 2000 2010 2020Index Index Index(2000 = 100) (2000 = 100) (2000 = 100) HC cost HC cost300 Historic Forecast HC cost 300 Historic Forecast 300 Historic Forecast GDP GDP GDP200 200 200100 100 100 2000 2010 2020 2000 2010 2020 2000 2010 2020 6 Note: Index GDP on basis of local currency. GDP forecast by EIU while HC cost forecast by EIU (2010-2015) and BCG / OECD (2015-2020) Source: EIU forecast (2011), OECD, Espicom, WHO, BCG estimates (2011)
  7. 7. We Need to Rethink Innovation 7
  8. 8. What Will it Take to Be?Translational Medicine Open InnovationBecause strengthening cooperation Because we recognize that insidebetween laboratory researchers, and outside our walls, there isclinical trial directors and clinical astounding scientific discoveryresearchers whose work focuses going on and that it is throughon patients and populations, is of collaboration that we will deliver theparamount importance to make our best, the most innovative and thescience available to those who most awaited solutions patients areneed it hoping for 8
  9. 9. Our FocusWe Are Where Diseases & Needs ArePriority Areas of Research | 9
  10. 10. Sanofi R&D Profile | 10
  11. 11. Our Way of WorkingLeveraging Local Innovative EcosystemsOur ambition is to create integrated R&D Hubs To make the best of the opportunities, science, talents and resources available in local innovative ecosystems | 11
  12. 12. Flexible, responsive, adapted toolbox toextend the reach of R&D making the OpenInnovation a reality Maximize Synergies in Everything We Do Maximize Synergies in Everything We Do 12

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