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.

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. Important choices in life…
What to study ?
Music or Science
Medicine – direct impact on people.
Where to study ?

3. 3
Important Choices : where to live and work…

4. 4

6. 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…

8. Play Stills
(Passion for Patients)
(1 minute)
Critical people in my life

9. 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 ?

10. Tibotec, the big jump…
First P3 Lab

11. Inside P3 Laboratory

20. 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

21. Phase II results: activity in multi-drug resistant patients
(POWER 1&2, week 48)

22. 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

25. 25

26. Janssen Pharmaceutica in Belgium
Beerse I
Beerse II
Olen
Geel
Merksem

27. 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

28. * 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*

29. 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

30. 30
Years of life saved
Years of quality of life generated
= the basis for our business.

31. 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

32. Today’s Dynamic Global Landscape
Poses Challenges
• Complex medical challenges
• Innovation threshold
• Challenging economic environment
• Regulatory and payer demands
Our Solution: Transformational Innovation

33. 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

34. Total Focus on Innovation
• Medical need and differentiation
• Therapeutic areas and disease areas
• Attracting best talent
• Increased probability of success
• Outcome and value
#1

35. 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

36. 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

37. 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

38. Sourcing External Innovation through
Johnson & Johnson Innovation Centers
California
London
Boston
Shanghai
San Diego
Minneapolis
Israel
Innovation
Center
Satellite
#
2
Tokyo
Sydney

39. 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

40. 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

41. 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

42. 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

43. Janssen Heritage in Schizophrenia
1958: Janssen lab notebook, first synthesis of R1625,
haloperidol
1958: first clinical publication

44. 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

45. 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)

46. WHO 2012 Global TB Report

47. Building a business with a purpose
• Passionate people
• The best science
• Solving global medical problems

48. 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)

49. The critical role of education

50. The critical role of
academic basic research

51. Creating the environment for
innovation

52. Creating an environment for
entrepreneurs & risk taking

53. Play Stills
(Passion for Patients)
(1 minute)