01- PRISTIQ Strategic and Tactical IE Presentation ppt

Report
Centers for Therapeutic Innovation – CTI
September 16, 2011
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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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