CTI: A New Model for Accelerating Translation of Basic Academic Science to the Clinic

Transcription

1 CTI: A New Model for Accelerating Translation of Basic Academic Science to the Clinic AAMC November, 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.

2 Overview Reinventing Academic/Pharma Partnership Evolution towards a new R&D ecosystem Centers for Therapeutic Innovation overview Key attributes of the collaborative model Early results 2

3 Pharma R&D Productivity 3

4 From Peter Corr

5 -From Peter Corr

6 A Perfect Storm Threatens R&D in Pharma and Academia Industry Pipeline dilemmas Cost of R&D Premium on innovation Productivity NCEs & NBEs Pressure from: Investors Payers Physicians Government Patients Academia Focus on translational medicine VC funding Govt funding PIs challenged to translate discoveries to the clinic while maintaining "control" CTI New partnership to deliver on the promise of innovative discoveries to treat diseases of high unmet medical need with differentiated new medicines 6

7 Origin of the 252 drugs approved by the FDA from , Where do we look? Kneller, Nature Reviews DD, 2010 Academia/Biotech 7

8 Increasingly, major biomedical institutions and industry share common objectives Basic research Applied research Patient access Novel targets Innovative drugs Precision medicine Patient impact Therapeutic technologies Clinical material Enabling functions 8

9 CTI Network - October 2012 CTI-Boston CTI-New York CTI-California 9

10 Centers For Therapeutic Innovation Creating greater focus to strengthen our scientific core Build a new entrepreneurial Research Unit to provide additional early opportunities by partnering with the leading experts in targets/pathways/mechanisms Driving competitive advantage through strategic externalization Create a network of leading AMCs, opening access to thousands of physician scientists and opportunities to collaborate in a pre-agreed structure Positioning ourselves for differentiated innovation Collaborate with selected PIs employing precision medicine approaches to stratify patients, delivering meaningful clinical data with differentiated potential therapeutics 10

11 Centers for Therapeutic Innovation CTI VISION Accelerate the Translation of Academic Innovative Discoveries into Early Stage Proof-of-Mechanism in the Clinic CTI STRATEGY Co-localization, Joint Teams for Rapid Translation into the Clinic Leveraging Complimentary Expertise Capital Light, Efficient and Flexible Funding CTI APPROACH Biotech-like Approach Close Collaboration with Scientific Partners Pre-Negotiated Terms Goal and Strategy Alignment 11

12 CTI: A New Partnership Model Scientific Approach Work with leading PIs in specific mechanisms Leverage expertise in translational medicine Establish proof-of-mechanism in the clinic using protein therapeutics Explore across multiple disease areas Incentives Access to proprietary Pfizer libraries and technology Enable PI to translate the mechanism from discovery into the clinic Broad IP and publishing rights Significant financial awards Processes Flexible operating model Semi-autonomous Accelerated decision-making through early clinical evaluation Shared expertise and assets in one location 12

13 Access to Proprietary Pfizer Libraries Incentives Human Antibodies Fc Fusion Proteins Peptides ADCs Humanized Antibodies Therapeutic Proteins Bispecific Abs CovX Bodies Monoclonal antibody therapeutics Human monoclonal antibody via phage display technology Human monoclonal antibody from human IgG transgenic rodents Humanized rodent monoclonal antibody Non-antibody biotherapeutics Fc fusion protein Secreted protein Peptide therapeutics Novel biotherapeutic modalities Bispecific antibodies Antibody drug conjugates (ADCs) CovX bodies 13

14 Enable Translation from Discovery to the Clinic Incentives Transcriptional Profiling 454 Deep Sequencing Systems biology Transcriptional profiling Proteomic studies Computational analysis of biological networks and pathways Genetic and genomic analysis 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 14

15 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 15

16 CTI- San Francisco: Located on the Mission Bay campus Occupancy for ~45 Scientists >50 programs submitted 8 selected for funding Jonathan Weissman, Lewis Lanier, June Lee, Keith Yamamoto Anthony Coyle, Rick Lindberg, Gary Woodnut, Joe Dal Porto 16

17 Partnership Model Encourages New Type of Collaboration Processes Semi-Autonomous Labs In collaboration Antibody Engineering Phage Generation Humanization Affinity Maturation Protein Group Protein Purification Protein Bioanalytics CTI Head CTI Biology Assay Development Cell Signaling Clinical Translational Medicine Bioinformatics Partner lines Toxicology PK / PD Pharmaceutical Sciences Post Doc Academic PI #1 Post Doc Post Doc Academic PI #2 Post Doc Joint Decision-Making Joint Steering Committee Collaborative decision making Go / No-go decision points and timelines Pursue alternative funding sources Declaration of POM achievement Boston, MA Global Resource Access Headquarters Leadership and drug discovery expertise Resource allocation 17

18 Advantages of Co-localization of CTI and AMC Close proximity allows regular face-to-face dialogue and collaborative problem-solving in an efficient manner Regular meetings allow ongoing discussion beyond formal agenda Post docs working in CTI facilities (and CTI scientists in academic facilities) ensures transfer of knowledge in both directions and ability to work where appropriate (e.g. where available equipment or reagents are) Easy exchange of reagents and tools Access beyond formal boundaries of collaboration, e.g. access to additional academic experts including JSC members, seminars.. 18

19 CTI Value Creation for Pfizer and AMC Diversified Monetization Scenarios AMC CTI Pfizer Assets Returned POM Assets Exclusively Developed by Pfizer to POC Assets Reinvested in CTI Partnership Assets Developed in Partnership with Third Parties Assets Out-licensed 19

20 Proposals Have Been Submitted Across Many Therapeutic Areas As of 2012 Q2 Preproposals > 300 Full proposals > 50 Funded proposals > 20 CTI received over 300 proposals across our network ranging from ideas/validated pathways to pre existing mabs 20

21 CTI: A New Partnering Model with Academic Medical Centers True integration and partnership Common goals Joint governance Combines the best of capabilities from academia and industry Aim is translation of novel discoveries into the clinic Focused on developing important new medicines for patients with unmet needs 21