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Globalization of Innovation: Opportunities, Enablers and
Challenges
Daniel Getman, Ph.D.
Vice-President, Pfizer Global Research and Development
Director, St Louis Laboratories
Globalization of Innovation: Opportunities, Enablers and Challenges
Background on Pharmaceutical Industry
Trends and Opportunities
Drivers and Enablers
Accessing Innovation Globally
Threats to Innovation
New Medicines: Innovation-DrivenHigh Risk and Very Expensive
* A. DiMasi and H.G. Grabowski: Managerial and Decision Economics 28 (2007), 469-479.
Typical Net Cost: $1.3 Billion*
Invested Over 10 - 15 years
What’s behind the little white pill?
The Long Road to a New Medicine
Understand Biology and
Disease
1) Identify Lead
2) Optimize Lead
3) File patents
Make sure
it’s safe
1) Seek FDA OK
2) Go to Humans
Phase 1
Healthy Volunteers (10s)
Phase 2
Patients (100s)
1) Ensure Safety
2) Does it work? Phase 3
Patients (1000s)
File New Drug
Application
With FDA
1) Ensure Safety
2) Does it work?
3) Select dose
1) Ensure Safety
2) Dosing Frequency
Mechanism Disease
Selective COX-2 Inhibition Pain and Inflammation
PDE5 Inhibition Erectile Dysfunction, Pulmonary Hypertension
Alpha 2 Delta Epilepsy, Neuropathic Pain, Anxiety, Sleep Disorders
Nicotine Partial Agonist Smoking Cessation
Tyrosine Kinase Inhibition Cancer
CCR5 Antagonism HIV - AIDS
Does it work in humans?
Our Work
Validates or
Disproves
Medical
Hypotheses
SutentGastrointestinal Stromal Tumor and
Renal Cell Carcinoma
7 Days
50 mg/d
Sutent
Strong Efficacy in Refractory GIST
Source: Demetri, ASCO Virtual Meeting, 2003
Approved in US: Jan 2006
United States Life Expectancy
1900 - 47 yrs
2003 - 77.6 yrs
Factors Affecting Life Expectancy:
Improved Sanitation
Improved Nutrition
Medical InnovationOur Work
Impacts
People’s
Lives
Examples of Medical Innovation
Vaccines
Penicillin and
Antibiotics
Cardiovascular Drugs
HIV/AIDS
Cancer
Current Worldwide Life Expectancy
Factors Affecting Life Expectancy
Sanitation
Nutrition
Medical Innovation
Recommended Reading
Globalization of Innovation: Opportunities, Enablers and Challenges
Background on Pharmaceutical Industry
Trends and Opportunities
Drivers and Enablers
Accessing Innovation Globally
Threats to Innovation
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
First university natural sciences degrees, by selected country:
1985–2005
SOURCE: National Science Board,
Science and Engineering Indicators 2008
China
United States
Math and Science scores,grades 4 and 8, and
15-yr-old students: 2003
SOURCE: National Science Board,
Science and Engineering Indicators
2008
Estimated R&D expenditures and share of world total, by region: 2002
SOURCE: National Science Board, Science and Engineering Indicators 2008
37% 29%
30%
“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
Globalization of Innovation
Globalization of Innovation: Opportunities, Enablers and Challenges
Background on Pharmaceutical Industry
Trends and Opportunities
Drivers and Enablers
Accessing Innovation Globally
Threats to Innovation
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
Globalization of Innovation: Opportunities, Enablers and Challenges
Background on Pharmaceutical Industry
Trends and Opportunities
Drivers and Enablers
Accessing Innovation Globally
Threats to Innovation
St Louis, MO
Groton, CTLaJolla, CA
Sandwich, UK
Our Global OrganizationMajor Research Sites Worldwide
> 11,000 Researchers Worldwide
> $7.5B Annual R&D Investment
Rinat, SFRTC
Cambridge, MA
CA Incubator
Shanghai, China
Tokyo, Japan
Singapore
Biotherapeutics & Bioinnovation CenterA new model for drug discovery
Research Unit
Collaborations
Incubator Portfolio Company
Current
Planned
BBC
San Francisco
BostonSan Diego
EuropeAsia
Cell Biology
Scripps
MIT
Fabrus
Stem Cells
Rinat
RTCCovX
RGo
Wintherex
TBD
TBD
Coley
RNAi
TBD TBD
TBD Stem Cells
The Pfizer Incubatorwww.thepfizerincubator.com/index.html
Founder(s)
IP, know-how NewCoExecutes
Research
PlanTPI
Funding, facilities,
operational support
TPI acquires
exclusive rights
Spin out
Entity Creation Incubation Exit Scenarios
A Partnership with academia to internalize novel targets
University
• Access to Pfizer’s screening
expertise and chemical collection
• Chemical tools for basic science
• Research funding
• Involvement in drug discovery
• Relationships
• Jump-start Discovery projects
• Access to attractive targets
• Intellectual property
• Expertise, reagents, tools
• Relationships
The collaborator gets …Pfizer gets …
Drug Pfinder®
An Innovative Partnership
www.drugpfinder.com
Bend Research Inc. – Pfizer Licensing Opportunity
Spray-Dried Dispersion (SDD)
3 Stages
Stage 1: Non-Confidential Technical Evaluation
Stage 2: Feasibility Study
Stage 3: Pfizer License & Option Negotiation
This initiative provides an opportunity for companies
to advance problematic low-solubility compounds
that otherwise stall in development, or require
medicinal chemistry intervention.
www.bendres.com
Translational Medicine Call for Proposals
www.pfizer.com/translationalmedicine
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)
Pfizer identifies problem to
address and completes Request
For Proposal (RFP) Template
Center completes required
studies to solve the problem any
research plan modifications
jointly agreed
RFP on public website and
distributed to known potential
partners
Proposals received, reviewed
and winner selected.
Agreements completed with
center(s).
1
2
3
4
Pfizer
manages
alliance
through a
milestone-
driven
collaboration
4 Wholly-Owned factoriesat Dalian, Wuxi and Suzhou
Dalian factory is the first to pass GMP in China
Pfizer R&D China
Established R&D center in Shanghai with nearly 200 employees in 2008
Pfizer Foundation-hospital management program with Peking university
Established in 2004, have trained hundreds of hospital directors in 4 years
Strategic Investments in China
Pfizer is one of the biggest Multi-National Companies in China
with total investments exceeding US$ 500M
Pfizer Clinical Research Units (CRUs)(Phase 1 Units)
Brussels
New Haven
Singapore
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
Pfizer Clinical Research Units (CRUs)1 Unit with 3 sites
Innovation through Standardization!!!
Globalization of Innovation: Opportunities, Enablers and Challenges
Background on Pharmaceutical Industry
Trends and Opportunities
Drivers and Enablers
Accessing Innovation Globally
Threats to Innovation
Some Challenges we face as an industryThreats to Biomedical Innovation
Life Sciences is a innovation – driven industry
Create and maintain a supportive environment
Intellectual Property Issues
Increasing Government Regulation
Price Controls
Restricted Access to Medicines
Litigation
The Long Road to a New Medicine
Understand Biology and
Disease
1) Identify Lead
2) Optimize Lead
3) File patents
Make sure
it’s safe
1) Seek FDA OK
2) Go to Humans
Phase 1
Healthy Volunteers (10s)
Phase 2
Patients (100s)
1) Ensure Safety
2) Does it work? Phase 3
Patients (1000s)
File New Drug
Application
With FDA
1) Ensure Safety
2) Does it work?
3) Select dose
1) Ensure Safety
2) Dosing Frequency
Intellectual Property - GloballySome 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
Globalization of Innovation: Opportunities, Enablers and Challenges
Happy to take questions!