Pfizer’s Centers for Therapeutic Innovation

December 16, 2011

Today’s Agenda

Share rationale/context for creation of CTI

Provide an overview of the CTI model and progress to-date

Discuss unique attributes of the academic-industry collaborative model

For External Presentation Purposes Only; Not for Distribution•2

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A bit of background on me…

Chief Operating Officer, Centers for Therapeutic Innovation

Responsible for business affairs of CTI, including alliance management

Background on the commercial side of the biotech industry–R&D strategy and commercial development – MedImmune–Product management and marketing - Genentech

Context for Creation of CTI

For External Presentation Purposes Only; Not for Distribution•4

Background Context for CTI:Challenges to Pharmaceutical Industry and Academic Centers

CTI New partnership to deliver on the promise of innovative discoveries to treat diseases of high unmet medical need

with differentiated new medicines

InvestorsPhysicians

Patients

Payors

Regulators Legislators

Pressure from:Slow progression of pipeline

Cost of drug discoveryCost of drug development

Productivity

Academia

PIs challenged to translate discoveries to the clinic while maintaining "control"

Public funding pressures

Focused on Translational MedicineVC funding retreat

•Industry

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Pharma R&D Productivity

For External Presentation Purposes Only; Not for Distribution•6

Allocation of the 252 drugs approved by the FDA from 1998 - 2007

Kneller, Nature Reviews DD, 2010

Academia/Biotech

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Past Approaches to External Partnerships

Standard licenses and sponsored research agreements

Pharma concern re: controlling all aspects of products, especially intellectual property– Attempts to limit publication/presentation of results

– Loss of patent rights due to premature disclosure

Less emphasis on understanding disease biology & mechanisms of action

– Not Invented Here syndrome– Perception that non-pharma research less reliable– Led to “Valley of Death” for many academic discoveries

For External Presentation Purposes Only; Not for Distribution•8

CTI – How It Works

For External Presentation Purposes Only; Not for Distribution•9

Centers for Therapeutic Innovation

CTI STRATEGYOPEN INNOVATION model that deploys Pfizer R&D

resources where breakthrough science is happening

CTI APPROACHA new entrepreneurial partnerships at Academic

Medical centers focused on translational medicine

CTI VISIONAccelerate the translation of innovative discoveries from

bench to the clinic

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Core Elements of the CTI Model

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CTI: Scientific Approach

Scientific

Approach

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Partnership Model Encourages Collaboration

Joint Decision-MakingJoint Steering Committee

Global Resource AccessHeadquarters

Collaborative decision makingGo / No-go decision points and timelinesPursue alternative funding sourcesDeclaration of POM achievement

Boston, MALeadership and drug discovery expertiseResource allocation

CTI Head

Antibody Engineering

Phage Generation

Humanization

Affinity Maturation

Protein Group

Protein Purification

Protein Bioanalytics

CTI Biology

Assay Development

Cell Signaling

Clinical

Translational Medicine

Bioinformatics

Partnerlines

Toxicology

PK / PD

Pharmaceutical Sciences

Academic PI #1

Post Doc Post Doc

Academic PI #2

Post Doc Post Doc

Sem

i-Aut

onom

ous

Labs

In c

olla

bora

tion

Processes

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Governance of the Open Innovation ModelAM

C New targets and associated IPPI identifies post-docs

PI recruits clinical collaboratorEarly clinical studies conducted at AMC

Pfize

r $$$Partner lines supportRegulatory Support

$$$Program support including clinical and translational sciences

Go / No-godecision to

exercise license option

Evaluate program for continued inclusion $$$$$$

Projects selectedDiscovery Research at CTI Center

Go / No-go for IND submission and clinical study design

Candidate Drug Selection •2–3 years

POC•Project Selected•Co-development

IND Endorsement•3–4 years

•POM (+/-)•4 years

Shar

ed

•Decision Point

•Milestone Investment

•Milestone Payment

•JSC •Flexible Fund

Processes

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Incentives for Collaboration with CTI

Access to proprietary Pfizer librariesEnable PI to translate the mechanism from discovery into the clinicBroad IP and publishing rightsSignificant financial awards

•Incentives

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Assets Returned

Diversified Monetization Scenarios

POM

CTI Value Creation for Pfizer and Academic Partners

Academic Partner CTI Pfizer

Assets Exclusively Developed by Pfizer

to POC

Assets Out-licensed

Assets Developed in Partnership with

Third Parties

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Centers for Therapeutic Innovation – CTI Network

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The Next Evolution of Model?

Motion Picture Industry

A TimeWarner Co. filmproduced by

New Line Cinemain association with

Castle Rock Entertainment

Pharmaceutical IndustryA CTI moleculedeveloped by Pfizer

[funded by JDRF/Pfizer]Discovered by

Children’s Boston and CTI

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Attributes of the Collaborative Model

For External Presentation Purposes Only; Not for Distribution•19

Key Attributes

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How CTI Solicits & Selects ProposalsScientifically Rigorous, but Light on Bureacracy

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1 •CTI Conducts a Call for Proposals – Annually on Each Campus

2 •PIs Submit a 3-page, Non-confidential Pre-proposal for Consideration

3 •CTI Convenes a Local Joint Steering Committee to Select Finalists

4 •Finalist PIs Author a Full Proposal, Working Together with a CTI Scientist

5 •Joint Steering Committee Reviews Full Proposal and Selects Projects for Funding

Drill Down: The Proposal Process

Key elements increase chances of success for academic project concepts to become future pipeline candidates:

– Managing contamination risk – pre/full proposals

– Building trust – confidentiality and limited review audience

– Combining areas of expertise – co-authorship of full proposals

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What We Look for: Key Attributes of Successful Programs

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Project Team Structure

CTI Head

Antibody Engineering

Phage Generation

Humanization

Affinity Maturation

Protein Group

Protein Purification

Protein Bioanalytics

CTI Biology

Assay Development

Cell Signaling

Clinical

Translational Medicine

Bioinformatics

Partner Lines

Toxicology

PK / PD

Pharmaceutical Sciences

Academic PI #1

Post Doc Post Doc

Core Team

Academic PI

Pfizer Project Leader

Pfizer Project

Manager

Enabling Function

RepsTox, PKPD

CTI: A New Partnership Model with Leading AMCs

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