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PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
PMRG 2008 Presentation
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PMRG 2008 Presentation


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Presentation of the challenges and opportunities for the pharmaceutical industry

Presentation of the challenges and opportunities for the pharmaceutical industry

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  • 1. DAVID S. LESTER, PH.D. SENIOR VP GENE EXPRESS INC. The Pharmaceutical Industry in Transition -- Pharma 2020 March 10, 2008, Phoenix, AZ
  • 2. Good things about the pharmaceutical industry today: -
    • Still making a lot of money!
    • Still earning good margins on products.
    • Still providing a significant role in healthcare with existing and emerging product lines, particularly for acute care.
    • Still in the spotlight of politics and the media.
    • Process still turns out successful products in terms of NDAs.
  • 3. Bad things about the pharmaceutical industry today
    • Number of NDAs approved continues to decline on a yearly basis.
    • Big vs. medium vs. small Pharma.
    • The rising challenge of generics.
    • Entering the world of generics.
    • US vs. non-US pricing.
    • Increased regulatory scrutiny.
    • The “threat” of Personalized Medicine.
    • Demonstrating improved efficacy.
    • The broken Pharma R & D process.
    • The disconnect between R & D and commercialization.
    • The broken healthcare system.
    • And so on, and so on, and so on………..
  • 4. Improving R & D productivity (a)
    • Changes in R & D have been identified as different fashions, e.g. High Throughput Screening, Combinatorial Chemistry, Genomics, Biomarkers, Adaptive Clinical Trials, etc……………….NONE HAVE WORKED!
    • All are incremental. Need disruptive changes.
    • May only be possible in small –mid Pharma or biotechs, e.g. Vertex Pharmaceuticals, Genzyme.
  • 5. Improving R & D productivity (b)
    • Extensive growth and investment in biologics by large Pharma.
      • Problems
        • Different R & D model required.
        • Different and unclear regulatory demands.
        • Limited expertise for development.
        • Higher risk as unknown arena.
        • Amgen went the other way (from biologics to small molecules) and look what is happening to them!
  • 6. Improving R & D productivity (c)
    • A solution to the R & D process?
      • Outsource/license all products (both small molecule and biologics) from biotech type model.
      • Development outsourced to CROs (more overseas activity, e.g. India, China, Eastern Europe).
      • Pharma focuses on Commercialization of products.
      • Develop more of a private equity business model focusing on product lines that are most successful for that company.
  • 8. “ Three Things You Can’t Say About Healthcare”
    • The U.S. has the best healthcare system in the world
    • New is better
    • Healthcare is special
    J.Grossman, WHIT Congress, Dec. 2007
  • 9. The Personalization of Healthcare
    • Personalized Medicine – the focus is moving towards diagnosis.
    • Movement from acute to chronic care to prevention.
    • From population to individual.
      • Molecular Diagnostics –genomics, proteomics.
      • Multiplex panels.
      • Diagnostic algorithms.
    • Not just about therapeutics!
  • 10. The Consumerization of Healthcare
    • The internet is creating the “proactive consumer” in healthcare.
    • “ Life science meets lifestyle” (W.Rosenzweig, Physic Ventures)
    • Moving from products to “the science of service delivery” (J. Grossman, Harvard Business School).
  • 11. The Healthcare System of Today: Which iPod do I trust? Regulators Pharmaceutical Companies Payers Providers Suppliers Caregivers Device Manufacturers Employers
  • 12. The Patient of Today – The iPod: What accessory do I choose? Eastern Medicines/Treatments Generics Pharmaceuticals Supplements Regulated Devices Non-Regulated Devices Nutraceuticals Physical Activities
  • 13. Factors influencing the patient consumer decision making Internet sites TV Music Food preferences Newspapers/ journals Pharmacist Pharma DTC Health/nutrition stores
  • 14. Disruptions to Pharma and Healthcare
    • Minute clinics
    • Social networking
    • Patient Health Records
    • Wireless Devices
  • 15. Conclusions for Pharmaceutical Industry
    • Healthcare begins with diagnosis – diagnosis will provide strategy for pharmaceuticals (not the other way around as it is today). This means personalized medicine, even individual therapies.
    • “ Personalized Medicine” improves “value” of compounds on the market, including generics.
    • The move from treating sickness to keeping people health or well is very challenging (needs lots of data!).
    • Pharmaceuticals will be viewed as one of the “accessories” that will be used in both health and healthcare.
    • The pharmaceutical industry will have to create new business models that will integrate with different “silos” in health and healthcare.
  • 16. DAVID LESTER, PH.D. EMAIL: [email_address] TEL: 973786-1066 THANK YOU!