Lustrumlezing paul stoffels de rol van innovatie voor de gezondheidszorg van de toekomst

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Ter gelegenheid van het 40 jarig bestaan van de Universiteit werd een reeks lustrumlezingen georganiseerd. Voor de faculteit Gezondheid en Levenswetenschappen hadden we de eer Dr. Paul Stoffels - Worldwide Chairman , Janssen Pharmaceutical Chief Scientific Officer, Johnson & Johnson - te mogen ontvangen.

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Lustrumlezing paul stoffels de rol van innovatie voor de gezondheidszorg van de toekomst

  1. 1. Scientific and Medical Innovation making a difference for patients. The foundation of a global business. Dr. Paul STOFFELS Worldwide Chairman , Janssen Pharmaceutical Chief Scientific Officer, Johnson & Johnson
  2. 2. Important choices in life… What to study ? Music or Science Medicine – direct impact on people. Where to study ?
  3. 3. 3 Important Choices : where to live and work…
  4. 4. 4
  5. 5. Life expectancy at birth (years) Source: United Nations Population Division (2004). World Population Prospects: The 2004 Revision, database. Botswana South Africa Swaziland Zambia Zimbabwe 1970–1975 1975–1980 1980–1985 1985–1990 1990–1995 1995–2000 2000–2005 2005–2010 70 65 60 55 50 45 40 35 30 25 20 4.1 Life changing events…
  6. 6. Play Stills (Passion for Patients) (1 minute) Critical people in my life
  7. 7. Potent and selective inhibition of HIV-1 replication in vitro by a novel series of TIBO derivatives Rudi Pauwels*, Koen Andries†, Jan Desmyter*, Dominique Schols*, Michael J. Kukla‡, Henry J. Breslin‡, Alfons Raeymaeckers†, Jozef Van Gelder†, Robert Woestenborghs†, Jozef Heykants†, Karel Schellekens†, Marcel A. C. Janssen†, Erik De Clercq* & Paul A. J. Janssen† *Rega Institute for Medical Research, Katholieke Universiteit Leuven, Minderbroedersstraat 10, B-3000 Leuven, Belgium †Janssen Research Foundation, Turnhoutseweg 30, B-2340 Beerse, Belgium ‡Janssen Research Foundation, Bethlehem Pike, Spring House, Pennsylvania 19477, USA IN the search for compounds active against human immunodeficiency virus (HIV), we have found that members of a novel series of tetrahydro-imidazo[4,5,1-jk][l,4]-benzodiazepin-2(1H)-one and -thione (TIBO) derivatives inhibit the replication of HIV-1, the main aetiological agent of AIDS, but not of HIV-2, or of any other DNA or RNA viruses. In five cell systems, HIV-1 is inhibited by TIBO derivatives in nanomolar amounts, which are 104−105 times lower than the cytotoxic concentration. The unprecedented specificity of these compounds may be due to an interaction with a reverse transcriptase-associated process. By contrast, AZT (3'-azido-2',3'- dideoxythymidine), which is used for the treatment of AIDS, and DDC (2',3'-dideoxycytidine) and DDI (2',3'-dideoxyinosine), whose clinical application is being assessed, inhibit both HIV-1 and HIV-2 at concentrations that, depending on the cell systems, are 2 to 4 orders of magnitude below their cytotoxic concentration. TIBO-derivatives are new chemicals unrelated to any other antiviral agents. We believe that they are the most specific and potent inhibitors of HIV-1 replication studied so far. Nature, 1990: the first NNRTI : a new drug for HIV ?
  8. 8. Tibotec, the big jump… First P3 Lab
  9. 9. Inside P3 Laboratory
  10. 10. HIV protease gene diversity matrix 1 10 20 30 40 50 60 70 80 90 Amino-acid position Viral isolates 0.05 0.1 0.5 1 5 10 50 0.05 0.1 0.5 1 5 10 50 % Asp25 sc COOH Asp29 mc NH Asp30 mc NH Asp30 mc NH Gly27 mc O NH-H2O mc Ile50
  11. 11. Phase II results: activity in multi-drug resistant patients (POWER 1&2, week 48)
  12. 12. Improving on drug formulation during development: etravirine Phase IIa – 900mg 18 capsules bid Phase IIb – 800mg 4 large tablets bid Phase III – 200mg 2 tablets bid Solution: spraydrying
  13. 13. 25
  14. 14. Janssen Pharmaceutica in Belgium Beerse I Beerse II Olen Geel Merksem
  15. 15. Creating Value Through Innovation End-to-End Strategy Focused on Five Therapeutic Areas NEUROSCIENCE • Alzheimer’s Disease • Mood disorders • Schizophrenia • Chronic pain CARDIOVASCULAR & METABOLISM • Cardiovascular disease • Diabetes IMMUNOLOGY • Inflammatory bowel disease • Rheumatoid arthritis • Psoriasis • Pulmonary ONCOLOGY • Prostate • Lung • B-cell malignancies INFECTIOUS DISEASES & VACCINES • HIV • HCV • Respiratory • Vaccines 27
  16. 16. * Companies with 5 New Drugs: Amgen, Bayer, Genzyme. ** Companies with 4 New Drugs: AstraZeneca, Boehringer Ingelheim, CSL Behring, Eisai, Forest Labs, Genentech, Eli Lilly, Shire, Takeda. *** Companies with 3 New Drugs: Astellas, Baxter. Innothink Janssen Pharmaceutica The Most Productive Company in the Past 10 Years FDA NME Approvals 28 # of New Drugs 9 Companies** 2 Companies*** 3 Companies*
  17. 17. Fastest Growing Top 10 Pharmaceutical Company1 WW Pharmaceuticals: Operational Sales Change vs. Prior Year Respective Quarter* Q1’09 Q3’09 Q1’10 Q3’10 Q1’11 Q3’11 Q1’12 Q3’12 11.4% Q1’13 Source: 1. IMS MIDAS as of 1Q 2013 vs. prior year respective quarter (based on available data May 20, 2013). * Q4 2009 and Q4 2010 operational sales change adjusted for the dynamics of the 53rd week in Q4 2009. 29
  18. 18. 30 Years of life saved Years of quality of life generated = the basis for our business.
  19. 19. Health Care Makes a Significant Difference in Society • Increase in life expectancy from new medicines • Significant progress in quality of life • Broadening access to medicine in emerging markets Source: World Health Organization
  20. 20. Today’s Dynamic Global Landscape Poses Challenges • Complex medical challenges • Innovation threshold • Challenging economic environment • Regulatory and payer demands Our Solution: Transformational Innovation
  21. 21. Science and Technology Offer Tremendous Opportunities to Innovate • Next generation biotechnology – Novel scaffolds – Stem cells – Vaccines • New frontiers in personalized medicine – Genomics – Biomarkers – Companion diagnostics • Advances in imaging • Powerful bioinformatics
  22. 22. Total Focus on Innovation • Medical need and differentiation • Therapeutic areas and disease areas • Attracting best talent • Increased probability of success • Outcome and value #1
  23. 23. Level of Innovation Needed for Success has Dramatically Increased 35 Levelofinnovation 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Time/year The innovation threshold Differentiated product Value Me too Market expectations HIGHLY CONFIDENTIAL – NOT FOR DISTRIBUTION
  24. 24. Our Approach to Sourcing Innovation • Astellas – JAK Inhibitor • Corimmun – Targeting Beta 1- Adrenergic Receptor Auto- Antibodies • Genmab – Daratumumab • Pharmacyclics – Ibrutinib • Shionogi – BACE Inhibitor • Index Ventures • Polaris Ventures • MPM Capital • Boston • California • London • Shanghai Discovery/ Concept Early Development Late Development Regulatory Review Early Exploration Post- Launch Approval # 2 Internal Discovery and Early Research Biomarkers, Research Capabilities Global Development Early Stage Innovation via Innovation Centers Leveraging Venture Capital Licensing and Acquisitions
  25. 25. HIV CancerRA Diabetes Alzheimer’s Biotech PharmaAcademia The Value Creation Chain Marketplace Reward Government funding Research Grants VC Funding Public Capital Markets Public Capital Markets Payors Governments
  26. 26. Sourcing External Innovation through Johnson & Johnson Innovation Centers California London Boston Shanghai San Diego Minneapolis Israel Innovation Center Satellite # 2 Tokyo Sydney
  27. 27. Collaborations Licensing Incubators Ventures Partnerships Johnson & Johnson Scientific Expertise | Local Transactional Capabilities | Business Expertise Access Innovation Wherever Best Science Happens Johnson & Johnson Innovation Centers # 2 Johnson & Johnson Pharmaceuticals | Medical Devices & Diagnostics | Consumer
  28. 28. Excellence in Execution • World-class development capabilities • Accelerating pipelines in Japan and China • Optimizing output, time, and cost with the highest degree of quality • With flexibility in deploying resources • Speed to market • Making us a partner of choice • Industry leading success rates* * Third Party Proprietary Research #3
  29. 29. Accelerating Cycle Time Industry Median 5.7 months XARELTO® (Atrial Fibrillation) ZYTIGA® (Prostate Cancer) INCIVO® (Hepatitis C) EDURANT® (HIV) INVOKANA™ (Diabetes) Industry Median 5.7 Months Janssen Average 3.8 Months ~2 Months Better Than Industry Median Today: Average Cycle Time from Database Lock to Submission #4 * Third Party Proprietary Research
  30. 30. IMMUNOLOGY NEUROSCIENCE INFECTIOUS DISEASES & VACCINES CARDIOVASCULAR & METABOLISM ONCOLOGY SIMPONI® STELARA® INVEGA® INVEGA® SUSTENNA® NUCYNTA® NUCYNTA® ER PREZISTA® INTELENCE® EDURANT® INCIVO® SIRTURO® XARELTO® INVOKANA® VELCADE® ZYTEGA® DACOGEN® 15 New Differentiated Medicines in 10 Years Eleven New Products Since 2009Four New Products from 2004 – 2008 Transforming Our Portfolio
  31. 31. Janssen Heritage in Schizophrenia 1958: Janssen lab notebook, first synthesis of R1625, haloperidol 1958: first clinical publication
  32. 32. Janssen Heritage in Schizophrenia Haloperidol Haloperidol Decanoas Risperidone Risperidone Consta HERITAGE FUTURE Point-of-Care Compliance Diagnostic Paliperidone 3 MonthPaliperidone Paliperidone Palmitate (1 month) PRESENT 44
  33. 33. HCV: Major Public Health Challenge 150 Million Infected Worldwide 45 World Health Organization. Hepatitis C. Weekly Epidemiological Record, 1997; 72:65-69. Gastroenterology 2010; 138(2): 513-521. 1 Million Cases of Liver Cirrhosis in US by 2020 Anti-HCV Seroprevalence by GBD Region, 2005 1. If HCC risk in HCV-infected individuals with fibrosis does not change. Gastroenterology. 2010;138(2):513-521. Peak Incidence: >145,000 Cases/Year in ~2020 Peak Incidence: >14,000 Cases/Year in 20191 Cases, n Hepatocellular Carcinoma (HCC)
  34. 34. WHO 2012 Global TB Report
  35. 35. Building a business with a purpose • Passionate people • The best science • Solving global medical problems
  36. 36. Our Medicines Serving Global Health • Leveraging our science to address neglected diseases • SIRTURO® – New drug for MDR-TB • Product development partnerships – TB Alliance, IPM, Gates Foundation • Innovative access models – PREZISTA ® IP – Partnerships with generic companies – #2 in ATMI • Significant contributions to UN Millennium Development Goals • Vaccines (Polio and HIV in development)
  37. 37. The critical role of education
  38. 38. The critical role of academic basic research
  39. 39. Creating the environment for innovation
  40. 40. Creating an environment for entrepreneurs & risk taking
  41. 41. Play Stills (Passion for Patients) (1 minute)

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