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Getman Apr29 F I N A L

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  • 1. Globalization of Innovation: Opportunities, Enablers and Challenges Daniel Getman, Ph.D. Vice-President, Pfizer Global Research and Development Director, St Louis Laboratories
  • 2. Globalization of Innovation: Opportunities, Enablers and Challenges  Background on Pharmaceutical Industry  Trends and Opportunities  Drivers and Enablers  Accessing Innovation Globally  Threats to Innovation
  • 3. New Medicines: Innovation-Driven High Risk and Very Expensive What’s behind the little white pill? Typical Net Cost: $1.3 Billion* Invested Over 10 - 15 years * A. DiMasi and H.G. Grabowski: Managerial and Decision Economics 28 (2007), 469-479.
  • 4. The Long Road to a New Medicine 1) Ensure Safety 2) Does it work? File New Drug 1) Ensure Safety Application Phase 3 3) Select dose 2) Does it work? With FDA Patients (1000s) 1) Ensure Safety 1) Seek FDA OK 2) Dosing Frequency 2) Go to Humans Phase 2 Phase 1 Make sure Patients (100s) Healthy Volunteers (10s) it’s safe Understand 1) Identify Lead Biology and 2) Optimize Lead Disease 3) File patents
  • 5. Does it work in humans? Mechanism Disease Selective COX-2 Inhibition Pain and Inflammation PDE5 Inhibition Erectile Dysfunction, Pulmonary Hypertension Alpha 2 Delta Epilepsy, Neuropathic Pain, Anxiety, Sleep Disorders Our Work Nicotine Partial Agonist Smoking Cessation Validates or Disproves Tyrosine Kinase Inhibition Cancer Medical CCR5 Antagonism HIV - AIDS Hypotheses
  • 6. Sutent Gastrointestinal Stromal Tumor and Renal Cell Carcinoma Strong Efficacy in Refractory GIST 7 Days 50 mg/d Sutent Source: Demetri, ASCO Virtual Meeting, 2003 Approved in US: Jan 2006
  • 7. United States Life Expectancy  1900 - 47 yrs  2003 - 77.6 yrs  Factors Affecting Life Expectancy:  Improved Sanitation  Improved Nutrition Our Work  Medical Innovation Impacts People’s Lives
  • 8. Examples of Medical Innovation Vaccines Cardiovascular Drugs Penicillin HIV/AIDS and Antibiotics Cancer
  • 9. Current Worldwide Life Expectancy Factors Affecting Life Expectancy Sanitation Nutrition Medical Innovation
  • 10. Recommended Reading
  • 11. Globalization of Innovation: Opportunities, Enablers and Challenges  Background on Pharmaceutical Industry  Trends and Opportunities  Drivers and Enablers  Accessing Innovation Globally  Threats to Innovation
  • 12. Trends and Opportunities “The U.S. remains the world leader in scientific and technological innovation, but its dominance is threatened by economic development elsewhere, particularly in Asia.” January 16, 2008 Citing a NSF report http://www.nsf.gov/statistics/seind08/ National Science Board: Science and Engineering Indicators 2008
  • 13. First university natural sciences degrees, by selected country: 1985–2005 United States China SOURCE: National Science Board, Science and Engineering Indicators 2008
  • 14. Math and Science scores, grades 4 and 8, and 15-yr-old students: 2003 SOURCE: National Science Board, Science and Engineering Indicators 2008
  • 15. Estimated R&D expenditures and share of world total, by region: 2002 37% 29% 30% SOURCE: National Science Board, Science and Engineering Indicators 2008
  • 16. Globalization of Innovation “We intend to make our internal capability even more effective by tapping into the best scientific capability outside of our walls - wherever it exists. That’s why we are reaching out to scientists around the world.” - Jeff Kindler Pfizer Chairman & CEO
  • 17. Globalization of Innovation: Opportunities, Enablers and Challenges  Background on Pharmaceutical Industry  Trends and Opportunities  Drivers and Enablers  Accessing Innovation Globally  Threats to Innovation
  • 18. Drivers and Enablers  Increasingly skilled workforce  Return of experienced scientists  Emerging capabilities  Strong government support and investment  State-of-the-art facilities and equipment  Increasing intellectual property rights  Participate in growing markets  Brazil, Russia, Korea, India, China  Internet and communications  Increased bandwidth and lower costs  Lower cost – but will likely increase over time
  • 19. Globalization of Innovation: Opportunities, Enablers and Challenges  Background on Pharmaceutical Industry  Trends and Opportunities  Drivers and Enablers  Accessing Innovation Globally  Threats to Innovation
  • 20. Our Global Organization Major Research Sites Worldwide RTC Rinat, SF Cambridge, MA Sandwich, UK Tokyo, Japan LaJolla, CA Groton, CT Shanghai, China CA St Louis, MO Incubator Singapore > 11,000 Researchers Worldwide > $7.5B Annual R&D Investment
  • 21. Biotherapeutics & Bioinnovation Center A new model for drug discovery San Francisco Research Unit Collaborations TBD Incubator Portfolio Company Cell Biology RGo Rinat RNAi Fabrus San Diego Scripps CovX BBC RTC TBD Boston Stem Cells Wintherex MIT Coley TBD Stem Cells Current TBD TBD Planned Asia Europe
  • 22. The Pfizer Incubator www.thepfizerincubator.com/index.html Founder(s) TPI acquires IP, know-how NewCo exclusive rights Executes Research TPI Plan Funding, facilities, Spin out operational support Entity Creation Incubation Exit Scenarios
  • 23. Drug Pfinder® An Innovative Partnership A Partnership with academia to internalize novel targets Pfizer gets … The collaborator gets … University • Jump-start Discovery projects •Access to Pfizer’s screening expertise and chemical collection • Access to attractive targets • Chemical tools for basic science • Intellectual property • Research funding • Expertise, reagents, tools • Involvement in drug discovery • Relationships • Relationships www.drugpfinder.com
  • 24. Bend Research Inc. – Pfizer Licensing Opportunity Spray-Dried Dispersion (SDD) www.bendres.com This initiative provides an opportunity for companies to advance problematic low-solubility compounds that otherwise stall in development, or require medicinal chemistry intervention. 3 Stages  Stage 1: Non-Confidential Technical Evaluation  Stage 2: Feasibility Study  Stage 3: Pfizer License & Option Negotiation
  • 25. Translational Medicine Call for Proposals www.pfizer.com/translationalmedicine 1 Pfizer identifies problem to address and completes Request For Proposal (RFP) Template 2 RFP on public website and distributed to known potential partners 3 Proposals received, reviewed Pfizer and winner selected. manages Agreements completed with alliance through a center(s). milestone- 4 driven Center completes required collaboration studies to solve the problem any research plan modifications jointly agreed Oncology Measures of Anti-Tumor Efficacy and Apoptosis Inflammation Biomarkers for Disease-Modifying Anti-Rheumatic Drugs Ophthalmology Ocular Blood Flow and Glaucoma Neurosciences Exposure/EEG Response Data (Schizophrenia and Alzheimer's)
  • 26. Strategic Investments in China  4 Wholly-Owned factories  Pfizer R&D China  Pfizer Foundation- at Dalian, Wuxi and Suzhou Established R&D hospital management program with Peking Dalian factory is the first center in Shanghai university to pass GMP in China with nearly 200 employees in 2008 Established in 2004, have trained hundreds of hospital directors in 4 years Pfizer is one of the biggest Multi-National Companies in China with total investments exceeding US$ 500M
  • 27. Pfizer Clinical Research Units (CRUs) (Phase 1 Units) Brussels New Haven Singapore
  • 28. Pfizer Clinical Research Units (CRUs) 1 Unit with 3 sites Innovation through Standardization!!!  Operate identically (systems, SOPs, medical practice, etc.)  Highly standardized & technologically most advanced:  On-line, real time data capture  Data lock 24 hrs after Last Subject Last Visit  Speed to quality decisions
  • 29. Globalization of Innovation: Opportunities, Enablers and Challenges  Background on Pharmaceutical Industry  Trends and Opportunities  Drivers and Enablers  Accessing Innovation Globally  Threats to Innovation
  • 30. Some Challenges we face as an industry Threats to Biomedical Innovation  Life Sciences is a innovation – driven industry  Create and maintain a supportive environment Intellectual Price Property Controls Issues Increasing Restricted Litigation Government Access to Regulation Medicines
  • 31. The Long Road to a New Medicine 1) Ensure Safety 2) Does it work? File New Drug 1) Ensure Safety Application Phase 3 3) Select dose 2) Does it work? With FDA Patients (1000s) 1) Ensure Safety 1) Seek FDA OK 2) Dosing Frequency 2) Go to Humans Phase 2 Phase 1 Make sure Patients (100s) Healthy Volunteers (10s) it’s safe 1) Identify Lead Understand 2) Optimize Lead Biology and 3) File patents Disease
  • 32. Intellectual Property - Globally Some challenges we face  2008:  Potential changes to U.S. Patent Law  2007:  U.S. Supreme Court ruling on KSR International Co. v. Teleflex Inc.  2006:  Compulsory licenses declared in medium income countries (Thailand and Brazil)  2006:  India rejects Novartis Glivec patent  1994:  Agreement on TRIPS (Trade Related Aspects of Intellectual Property Rights) – international agreement administered by WTO (World Trade Organization)  Contains requirements that nations’ laws must meet for Intellectual Property
  • 33. Globalization of Innovation: Opportunities, Enablers and Challenges Happy to take questions!