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!