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!