Pfizer ’ s Centers for Therapeutic Innovation

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

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 Cost of drug development Cost of drug discovery Productivity Slow progression of pipeline Pressure from: Investors Payors Physicians Legislators Industry Regulators Patients PIs challenged to translate discoveries to the clinic while maintaining "control" Focused on Translational Medicine VC funding retreat Academia Public funding pressures CTI New partnership to deliver on the promise of innovative discoveries to treat diseases of high unmet medical need with differentiated new medicines

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 • 7

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

CTI VISION Accelerate the translation of innovative discoveries from bench to the clinic Centers for Therapeutic Innovation CTI STRATEGY OPEN INNOVATION model that deploys Pfizer R&D resources where breakthrough science is happening CTI APPROACH A new entrepreneurial partnerships at Academic Medical centers focused on translational medicine

Core Elements of the CTI Model New type of partnership Focused on biologics From discovery to end of Clinical Phase I Focus on mechanisms across all disease areas Enable translational medicine Deploying people and technology Access to IND-enabling activities Equal and fair IP Financial incentives

Scientific Approach CTI: Scientific Approach • Partner with PIs to enable development of preclinical discovery into the clinic (Phase I) • Focus on protein therapeutics • Parallel development of Translational Medicine approach – understanding patient heterogeneity and patient stratification • Focus on Mechanisms - across all disease areas • Oncology, Infectious Disease, CV, Metabolic diseases, Neuroscience, Autoimmune and Respiratory Disease

Partnership Model Encourages Collaboration Processes CTI Head Academic PI #1 Academic PI #2 Antibody Engineering Protein Group CTI Biology Clinical Partnerlines Post Doc Post Doc Post Doc Post Doc Semi-Autonomous Labs In collaboration Phage Generation Protein Purification Assay Development Translational Medicine Toxicology Humanization Protein Bioanalytics Cell Signaling Bioinformatics PK / PD Affinity Maturation Pharmaceutical Sciences Joint Decision-Making Joint Steering Committee Global Resource Access Headquarters • Collaborative decision making • Go / No-go decision points and timelines • Pursue alternative funding sources • Declaration of POM achievement • Boston, MA • Leadership and drug discovery expertise • Resource allocation

Governance of the Open Innovation Model Processes • New targets and associated IP • PI identifies post-docs • PI recruits clinical collaborator • Early clinical studies conducted at AMC AMC Projects selected Discovery Research at CTI Center Evaluate program for continued inclusion Go / No-go for IND submission and clinical study design $$ $$$$ Shared Project Selected Co-development Candidate Drug Selection • 2–3 years IND Endorsement • 3–4 years POM (+/-) 4 years POC $$$ $$$ Go / No-godecision to exercise license option • Partner lines support • Regulatory Support • Program support including clinical and translational sciences Pfizer Decision Point Milestone Investment Milestone Payment JSC Flexible Fund

Incentives for Collaboration with CTI • Incentives • Access to proprietary Pfizer libraries • Enable PI to translate the mechanism from discovery into the clinic • Broad IP and publishing rights • Significant financial awards

CTI Value Creation for Pfizer and Academic Partners Diversified Monetization Scenarios Academic Partner CTI Pfizer Assets Returned Assets Exclusively Developed by Pfizer to POC POM Assets Developed in Partnership with Third Parties Assets Out-licensed

Centers for Therapeutic Innovation – CTI Network

The Next Evolution of Model? Pharmaceutical Industry A CTI molecule developed by Pfizer [funded by JDRF/Pfizer] Discovered by Children’s Boston and CTI Motion Picture Industry A TimeWarner Co. film produced by New Line Cinema in association with Castle Rock Entertainment • 18

Attributes of the Collaborative Model For External Presentation Purposes Only; Not for Distribution • 19

Key Attributes • Project Selection Process • Project Team Structure • Funding Approach

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

What We Look for: Key Attributes of Successful Programs • Essentials • Targetable with a biologic • Principally monoclonal antibodies, peptides, proteins • Novel mechanism addressing key areas of unmet medical need • Strong link of pathway to disease • Differentiators • Ability to elucidate path to proof-of-mechanism in humans • Focus on translating basic biological research into the clinic • Connection of basic scientific researcher and clinical investigator • Understanding of the Clinical Differentiation opportunity via Patient Stratification, Molecular Signatures, Genetic associations, Biomarkers • Range of projects stages from ideas/validated pathways to pre existing mAbs

Project Team Structure Academic PI #1 Academic PI Pfizer Project Leader Post Doc Post Doc Core Team CTI Head Antibody Engineering Protein Group CTI Biology Clinical Partner Lines Phage Generation Protein Purification Assay Development Translational Medicine Toxicology Pfizer Project Manager Enabling Function Reps Tox, PKPD Humanization Protein Bioanalytics Cell Signaling Bioinformatics PK / PD Affinity Maturation Pharmaceutical Sciences

CTI: A New Partnership Model with Leading AMCs • True integration and partnership • Joint governance • Combining the best of capabilities within both academia and industry • Aiming to translate novel discoveries into the clinic • Focused on developing important medications for patients

This webinar is sponsored by Merrill DataSite – The Secure Virtual Data Room Solution for the Life Sciences Industry

Pfizer ’ s Centers for Therapeutic Innovation