Download CTI - Tech Transfer Central

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
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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
3
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
Slow progression of pipeline
Cost of drug development
Cost of drug discovery
•Industry
Productivity
Pressure from:
Investors
Payors Physicians
Legislators
Regulators
Patients
Focused on Translational Medicine PIs challenged to
translate discoveries
VC funding retreat
to the clinic while
Academia
maintaining
Public 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
5
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 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
A new entrepreneurial partnerships at Academic Medical
centers focused on translational medicine
10
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
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CTI: Scientific Approach
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
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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
PK / PD
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
Boston, MA
Leadership and drug discovery expertise
Resource allocation
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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
$$
$$$$
•POM (+/-) POC
•4 years
•2–3 years
Pfizer
$$$
$$$
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
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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
15
CTI Value Creation for Pfizer and Academic Partners
Diversified Monetization Scenarios
Academic Partner
Assets
Returned
CTI
POM
Pfizer
Assets Exclusively
Developed by Pfizer
to POC
Assets Developed in
Partnership with
Third Parties
Assets Out-licensed
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Centers for Therapeutic Innovation – CTI Network
CTI-Boston
CTI-New York
CTI-California
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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 molecule
developed 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
•1
Key Attributes
Project Selection Process
Project Team Structure
Funding Approach
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How CTI Solicits & Selects Proposals
Scientifically 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
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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
• 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
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Project Team Structure
Academic PI #1
Post Doc
CTI Head
Antibody
Engineering
Phage
Generation
Humanization
Affinity
Maturation
Protein Group
Protein
Purification
Protein
Bioanalytics
CTI Biology
Assay
Development
Cell Signaling
Pfizer
Project
Leader
Academic
PI
Post Doc
Core
Team
Clinical
Translational
Medicine
Bioinformatics
Partner Lines
Toxicology
PK / PD
Pharmaceutical
Sciences
Pfizer
Project
Manager
Enabling
Function
Reps
Tox, PKPD
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
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This webinar is sponsored by Merrill DataSite – The
Secure Virtual Data Room Solution for the Life Sciences
Industry