Transcript State of the Cancer Center Address 2008

An Academic Model to
Bridge the Valley of Death
April 17, 2009
Scott Weir, PharmD, PhD
Institute for Advancing Medical Innovation
University of Kansas
Aligning The Stars in Kansas
Key Success Factors
• Reducing Cancer Burden in Kansas
• Ewing Kauffman Foundation
• Drug Discovery, Delivery and Development
• State Economic Impact
• Academic, Industry and Disease Philanthropy Partnerships
• Pharmaceutical industry expertise and best practices
Reducing Cancer Burden in Kansas
Regional Problem: Cancer
•25,700 citizens in Kansas
and western Missouri
diagnosed in 2008*
•11,028 deaths in 2008*
•Cancer mortality rate
reductions in KS (-0.5%) and
MO (-0.7%) lags national
trend (-2.1%)
•$4.3 Billion annually in
medical expenses and lost
productivity
*Cancer patients must travel 200 to
700 miles to reach an NCIdesignated Comprehensive Cancer
Center
*American Cancer Society. Statistics for 2008.
Reducing Cancer Burden in Kansas
NCI Designation Differentiators
Drug Discovery,
Delivery &
Development
Institute for
Advancing
Medical
Innovation
Community-based
Approach
Clinical
Trials
Office
Prevention & Control
Research
Rural Primary
Care
Outreach
Breast Cancer
Prevention &
Survivorship
Centers
Results
More advanced cancer prevention,
early detection, treatment, and survivorship
Ewing Kauffman Foundation
Entrepreneurship
• Largest foundation devoted to innovation and
entrepreneurship
• $16.2M over five years
• Proof of Concept funding
• Industry adjunct faculty
• Project managers
• Fellowships
Ewing Kauffman Foundation
Institute for Advancing Medical Innovation
Novel Drugs &
Drug Targets
Drug Products &
Delivery
Platforms
Drug
Discovery
Research
Drug
Delivery
Research
Biomaterials
& Medical
Devices
BioEngineering
Research
Drug-Device
Combination
Products
Integrated
Bio-Engineering
& Drug Research
Training the Next Generation
Of Medical Innovators
Advance Medical Innovations To Commercialization
Drug Discovery, Delivery and Development
Capitalizing on Pharmacy Strengths
• NIH Funding History
• Medicinal Chemistry
» Chemical Methodologies and Library Development Center
» Specialized Chemistry Center
» Faculty
• Pharmaceutical Chemistry
»
»
»
»
Dr. Higuchi, The Father of Physical Pharmacy
Alza Corporation founded at KU
NCI formulation contract (Taxol®, Velcade®)
Dr. Val Stella
Drug Discovery, Delivery and Development
Reengineered Discovery Process
10 – 18 months
Target -> Chemical Hit
~ 18 months
Chemical Hit -> Lead
•1
•3
•4
•5
•6
•7
•Target
•Target
•High
•Chemical
•Define Lead •Prediction of •In vitro
•Selection •Production •Throughput
•Hit
•Selection
•Physio- •Potency &
•&
•Screening •Identification
•Criteria
•Chemical •Selectivity
•Validation
•Properties •In vivo
•Proof
•2
•of Concept
Novel
Drug Target
•8
•Early
•ADMET
Lead ->
Development
Candidate
•9
•10
•11
•Pre –
•In vivo and •Prepare for
•Formulation •In vitro
•IND
•Screening •ADMET
•Enabling
•Profiling •Activities
Development
Candidate
Our Drug Pipeline
62 Projects
36 Cancer Projects
State Economic Impact
Investors in Our Program
• Faculty recruitment
• Facilities
• Facilitating collaborative research
• R&D Infrastructure
• Innovation centers
• Federal grant matching
• Heartland BioVentures
• Drug Delivery Center of Excellence
• Entrepreneurship training
State Economic Impact
Kansas Centric Big Picture
Target
Selection
&
Validation
3 Years
1 Year
6-8 Years
1.5 Yr
Drug Discovery
Early Stage
Drug Development
Late Stage
Drug Development
Product
Registration
HTS
Identified
Chemical
Hits
Optimized
Development
Chemical
Candidate
Lead
Selected
Candidates
Within Universities
GLP
Drug
Safety
GMP Drug
Substance
& Product
Mfg
IND
Prep
Submission
Filing
Kansas Start-Up
Phase I
Clinical
Trial
Phase II
Clinical
Trials
Phase III
Clinical
Trials
NDA
Preparation
Submission
And
Approval
Commercialization Entity
National Drug Development Accelerator
Partnerships
Assembling the Bridge
Disease
Philanthropy
Partners
NIH
NCI
KU Researchers,
Cores and
Centers
Advancing
Innovations to
Clinical Proof
of Concept
Investors
Pharma
Partners
Academic
Partners
Partnerships
• “LLS, University of Kansas Cancer Center Announce
Innovative Partnership to Accelerate Drug
Development”
• January 7, 2009 Press Release
• Currently $1.5M in funding supporting two projects
• Counts toward cancer-related research funding
• April 22 Health Canada Pre-CTA Meeting
Partnerships
“Institute for Pediatric Innovation Awarded Funding by University of
Kansas to Analyze the Use of Extemporaneously Prepared
Medicines in Children’s Hospitals”
June 30, 2008 Press Release
KU is the drug development partner with Beckloff Associates Inc.
First pediatric product developed and ready for GMP manufacturing
Kauffman Foundation grant funding development of two products
annually
Pharmaceutical Industry Best Practices
• Pharma “profiling”
• Go/no go decisions
• Pre-determined criteria
• Industry experienced leadership and project management
• High performance project teams
• Cores and centers
• Partnerships
• Portfolio review and prioritization
• Drug targets
• Continuous pipeline review
• Leveraging industry partners (e.g., GLP, GMP)
• Integration of intellectual property management activities
Pharmaceutical Industry Best Practices
Offering Our Platform to Collaborators
Within the
University
Industry
Measurable Outcomes
In the Clinic in 2009!
Nanotax®
Repurposed
Agent for
Blood Cancers
Academia/Philanthropy/
Industry Collaboration
SR-13668 Phase 0
Academia/Academia/NCI
Collaboration
Industry/Academia
Collaboration
Advancing
Innovations to
Clinical Proof
of Concept
Reformulated
Chemotherapy
Agent
Industry/Academia
Collaboration