Centers for Therapeutic Innovation – CTI September 16, 2011 Disclaimer: This document was prepared by pfizerWorks per your request. This document provides an outline of a presentation and is incomplete without the accompanying oral commentary and discussion. Conclusions and/or potential strategies contained herein are NOT necessarily endorsed by Pfizer management. Any implied strategy and use of this data should be compliant with, and adhere to, all applicable sales promotion policies, procedures and would be subject to management, regulatory and legal review and approval before implementation. For example, this report or any portion herein should not be used for any detailing or targeting activities of excluded specialties per the Company’s policy on Sales Credit Exclusions. Anthony Coyle, Ph.D. Vice President / CSO, Global Centers for Therapeutic Innovation Background: – Ph.D. Pharmacology / Immunology 1989: Kings College, London UK – Post Doc • Institute Pasteur, Paris; France • National Jewish Centre for Immunology, Denver, Colorado Industry: – Glaxo Institute of Molecular Biology, Geneva, Switzerland – Director of Inflammation and Immunology Millennium Pharmaceuticals – VP Respiratory, Inflammation and Autoimmune (RIA) diseases, MedImmune – biological division of Astra Zeneca Academic Position: – Professor – McMaster University, 2002–present; Dept of Gene Therapeutics and Pathology – Published over 180 papers Achievements: – Transitioned 10 programs into PoM over last 5 years 2 Challenges to Pharmaceutical Industry and Academic Centers Slow progression of pipeline Cost of drug development Cost of drug discovery •Industry Productivity Pressure from: Stakeholders investors Payors Physicians Legislators Regulators Patients Focused on Translational Medicine PIs challenged to translate discoveries VC funding mechanism to the clinic while Academia maintaining Funding pressures “control” CTI New partnership to deliver on the promise of innovative discoveries to treat diseases of high unmet medical need with differentiated new medicines 3 Problem The promise of genomics: not yet fulfilled. Complexity of disease: Target/pathway biology is complex. Disease definition is imprecise. A disease often has multiple causes. Drugs work with multiple mechanisms. Patients with the same disease are different. Patients and clinical samples define relevance. Translation science and medicine: key roles. For External Presentation Purposes Only; Not for Distribution •4 Origin of the 252 drugs approved by the FDA from 1998 - 2007 Kneller, Nature Reviews DD, 2010 Academia/Biotech •5 Past Approaches to External Partnerships Standard licenses and sponsored research agreements Pharma concern re controlling all aspects of products – Emphasis on owning as much IP as possible, and – Directing prosecution of related IP Attempts to limit publication/presentation of results – Loss of patent rights due to premature disclosure Less emphasis on understanding disease biology & mechanisms of action – Belief that explosion in genomics info would lead to increased NMEs Not Invented Here syndrome – Perception that non-pharma research less reliable – Led to “Valley of Death” for many academic discoveries •6 Pharma R&D Productivity •7 Centers for Therapeutic Innovation CTI VISION Accelerate the translation of innovative discoveries from bench to the clinic CTI STRATEGY OPEN INNOVATION model that deploys Pfizer R&D resources where breakthrough science is happening CTI APPROACH New entrepreneurial partnerships at Academic Medical Centers focused on translational medicine 8 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 9 CTI: A New Partnership Model Work with leading PIs in specific mechanisms Scientific Approach Leverage expertise in translational medicine Establish proof-of-mechanism in the clinic using protein therapeutics Explore across multiple disease states Access to proprietary Pfizer libraries Incentives Enable PI to translate the mechanism from discovery into the clinic Broad IP and publishing rights Significant financial awards Flexible operating model Processes Semi-autonomous Accelerated decision-making through early clinical evaluation Shared expertise and assets in one location 10 CTI: Scientific Approach Work with leading PIs in specific mechanisms Scientific Approach Leverage expertise in translational medicine Establish proof-of-mechanism in the clinic using protein therapeutics Explore across multiple disease states Partner with PIs to enable development of preclinical discovery into the clinic (Phase I) 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 11 CTI: Governance & Processes Flexible operating model Processes Semi-autonomous Accelerated decision-making through early clinical evaluation Shared expertise and assets in one location Gary Firestein, Jerry Olefsky, David Brenner, Catriona Jamieson, Michael Jackson Anthony Coyle, Rick Lindberg, Charles Baum, Scott Glaser, Gary Woodnutt 12 CTI Head In collaboration Semi-Autonomous Labs Partnership Model Encourages Collaboration Antibody Engineering Protein Group CTI Biology Processes Academic PI #1 Clinical Phage Generation Protein Purification Assay Development Translational Medicine Humanization Protein Bioanalytics Cell Signaling Bioinformatics Affinity Maturation Partnerlines Post Doc Post Doc Academic PI #2 Post Doc Toxicology Academic PI #1 Academic PI #2 PK / PD Post Doc Post Doc Post Doc Post Doc Pharmaceutical Sciences Joint Decision-Making Global Resource Access Joint Steering Committee Headquarters Collaborative decision making Go / No-go decision points and timelines Pursue alternative funding sources Declaration of POM achievement Post Doc Cambridge, MA Leadership and drug discovery expertise Resource allocation 13 CTI- San Francisco: Located on the Mission Bay campus Occupancy for ~45 Scientists >40 programs submitted 5 funded Jeff Bluestone, Lewis Lanier, Clay Johnston, Keith Yamamoto Anthony Coyle, Rodney Lappe, Joe Dal Porto 14 CTI – New York City: Located in the East River Science Park Occupancy for ~40 Scientists >100 programs submitted 10 funded 15 CTI- Boston •Center for Life Sciences 16 What We Look for: Key Attributes of Successful Programs Processes Range of project stages from ideas/validated pathways to pre-existing mAbs: • 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 17 Proposals have been submitted across all therapeutic areas and research stages •Note: Numbers above are reflective of CTI-SF and CTI-NY proposals only 18 Shared AMC Governance of the Open Innovation Model New targets and associated IP PI identifies post-docs Projects selected Discovery Research at CTI Center •Project Selected •Co-development Processes PI recruits clinical collaborator Early clinical studies conducted at AMC Evaluate program for continued inclusion Candidate Drug Selection Go / No-go for IND submission and clinical study design IND Endorsement •3–4 years $2M $12M •POM (+/-) POC •4 years •2–3 years Pfizer $3M $3M Partner lines support Regulatory Support •Decision Point •Milestone Investment Program support including clinical and translational sciences •Milestone Payment •JSC Go / No-go decision to exercise license option •Flexible Fund 19 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 20 Access to Proprietary Pfizer Libraries Incentives Monoclonal antibody therapeutics •Human •Antibodies •Humanized •Antibodies • Human monoclonal antibody via phage display technology • Human monoclonal antibody from human IgG transgenic mice •Fc Fusion •Proteins •Therapeutic Proteins • Humanized rodent monoclonal antibody Non-antibody biotherapeutics • Fc fusion protein • Secreted protein •Peptides •Bispecific Abs Peptide therapeutics Novel biotherapeutic modalities • Bispecific antibodies • Antibody drug conjugates (ADCs) •ADCs •CovX Bodies • CovX bodies 21 Enable Translation from Discovery to the Clinic Incentives Systems biology • Transcriptional profiling • Proteomic studies •Transcriptional Profiling • Computational analysis of biological networks and pathways Genetic and genomic analysis • Deep sequencing •454 Deep Sequencing Biological models • Genetically modified animals • Stem cell models • Human clinical samples State-of-the-art imaging technologies Protein structural studies and molecular modeling 22 Enable Translation from Discovery to the Clinic Incentives Large-scale expression and purification of biotherapeutic candidates • Proprietary expression vector system • Mammalian expression system for the generation of hundreds of milligrams to grams of proteins • Sophisticated purification methods to obtain high-quality purified proteins Robust analytic methods • Biochemical analysis • Enable Translation from discovery to the clinic PK / PD • Rodents and non-human primates • PK / PD modeling • Immunogenicity prediction Toxicology • Rodents and non-human primates • Tissue bank analysis of target expression 23 CTI Value Creation for Pfizer and UCSD/SBMI Diversified Monetization Scenarios UCSD/SBMI Assets Returned Assets Reinvested in CTI Partnership CTI POM Pfizer Assets Exclusively Developed by Pfizer to POC Assets Developed in Partnership with Third Parties Assets Out-licensed 24 Processes Next steps 25 CTI Processes 26 CTI Web Portal •27 Process Flow and Timelines in CTI Stage I Proposal Submission: Non Confidential Review 2–3 page proposal submitted via e-mail Reviewed by JSC and finalists selected Stage II Proposal Submission: Confidential Review 8–10 page programs will be coauthored by academic PI and CTI scientist Preclinical experiments, IND enabling work, patient stratification Proof of Mechanism study in humans Stage III – Work Plan and Budget Funding level and milestones agreed by JSC 28 Advantages of collaborating with CTI Therapy area and disease area agnostic Comparable attrition and funding success rate to NIH R01 grant Streamlined but scientifically rigorous submission and awarding process of 3 months Milestone-based financial support with focus on translation of basic biological research into a clinical POM study Co-location near academic laboratory with access to Pfizer’s phage display library and drug development expertise 29 CTI – Working with UCSD & SBMI Building long-term relationships through truly collaborative partnerships: Breaking boundaries of traditional therapeutic area constraints Developing novel science and establishing new mechanisms in the clinic in the right patient population Innovative science and entrepreneurial business model Seamless transition from discovery to clinic 30 The Next Evolution of Model? Motion Picture Industry A TimeWarner Co. film produced by New Line Cinema in association with Castle Rock Entertainment Pharmaceutical Industry A CTI compound developed by Pfizer [funded by Foundation/Pfizer] Discovered by UCSD/SBMI and CTI •31 Acknowledgements Belen Carillo-Rivas Margi McLoughlin Justin McCarthy Louisa Daniels Director Biotherapeutics Research Sr. Director WW Bus Dev & Innovation SVP Associate General Counsel VP and Assistant General Counsel Alex Fayne Jose Carlos Gutierrez-Ramos Director Strategy & Operations CTI SVP Biotherapeutics Research 32 Centers for Therapeutic Innovation – CTI Network CTI-Boston CTI-New York CTI-California 33 Jennifer J. Ford Office of Contract and Grant Administration Anticipated Timeline Stages of the CTI Proposal Process CTI anticipated Timeline RFA anticipated to be released November 2011 Pre-proposal deadline anticipated to be December 2011 Full proposal deadline anticipated to be Jan/Feb 2012 Selection by JSC anticipated to be March 2012 Funding Awards anticipated to be April 2012 Key Dates Event Date Town Hall at UCSD September 16, 2011 Town Hall at SBMI October 13, 2011 Call for proposals October 17, 2011 Pre-proposals submitted to UCSD/SMBI OCGA Office November 10, 2011 Pfizer internal pre-proposal review meeting December 16, 2011 Pre-Proposal JSC meeting December 19, 2011 Decision Letters Distributed UCSD Informed Participation Meetings Full-proposals submitted to UCSD/SMBI OCGA Office January 6, 2012 January 10 or 13, 2012 February 10, 2012 Pfizer internal full-proposal review meeting March 7, 2012 Full-proposal JSC meeting March 9, 2012 Stages of the CTI Proposal Process Pre-Proposal application submitted to the Joint Steering Committee includes: Two-page synopsis with clear objectives and deliverables, abstract and internal questionnaire Synopsis and abstract cannot include Confidential Information Consultation with Dr. Andrew Wiseman (Director, UCSD HS Corporate Development) to discuss applicability of the project Informational Interview at Pfizer’s option Non-confidential interview to discuss Pre-Proposal Stages of the CTI Proposal Process Full Proposal upon invitation of Joint Steering Committee Four to six-page detailed research program which describes scope and includes timelines, abstract and suggested deliverables including a Proof-of-Mechanism clinical trial. The full proposal may contain Confidential Information if clearly marked as such. A description of any required Pfizer resources/materials shall be included. UCSD informational discussion and informed participation document. Stages of the CTI Proposal Process Approved Research Program Award Pfizer and UCSD researchers jointly prepare the Statement of Work. Both Pre-Proposals and Full Proposals must be reviewed by OCGA prior to submission to Pfizer Contacts Jennifer J. Ford Principal Contract and Grant Officer, OCGA 858-534-3335 [email protected] Andrew Wiseman Director of Business Development [email protected] Gary S. Firestein
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