pfizer ’ s centers for therapeutic innovation
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
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
3
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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