Advancing T1 Translational Research with PublicPrivate Partnerships

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Advancing T1 Translational Research with
Public-Private Partnerships

• National Advisory Research Resources Council
  Meeting
• May 28, 2009
• Presented by Ken Holroyd, MD, MBA
• Vanderbilt Institute for Clinical and
  Translational Research (VICTR)
• Co-Chair, CTSA Public-Private Partnerships Key
  Function Committee
• Assistant Vice Chancellor for Research
• Vanderbilt University Medical Center (VUMC)
• Kenneth.Holroyd_at_Vanderbilt.Edu

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Its
Build, Buy, or Partner?
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Whats in A Word?
The Word Is.
Partnership Alliance Collaboration Teaming Strateg
ic Relationship Joint Venture Outsourcing
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Whats In a Word?

• SCIENCE ALLIANCE
• SCIENTIST ALLIANTIST

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Where are the Alliantists?

• Industry Physicians and Scientists
• Industry Alliance Management Professionals

• Academic Physicians and Scientists
• Academic Alliance Management Professionals?

Private-Public Partnership
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Relationships Drive Partnerships
Strategic Relationship
Master Agreement
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It can help to have lived with the dolphins if
youre going to partner with them.
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Vanderbilt
Corporate Research Alliances group begun in
November, 2005
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484 Projects with 180 Companies Pharma Dominates
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125 Million of Corporate Sponsored
ResearchIndustry Mirror?
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Increase in Corporate Sponsored Research Why?
CTSA Award for Vanderbilt Sept 07
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Unified Leadership for Clinical Research
Processes Improvement
IRB
VICTR
GRANTS AND CONTRACTS
RESEARCH SUPPORT SERVICES
CLINICAL TRIALS OFFICE
Gordon Bernard, MD CTSA PI and VICTR Leader
RESEARCH OPTIMIZATION COMMITTEE
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(No Transcript)
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• Linked Patent Licensing and Research

T1 PPP Drug Discovery Partnership
Three-Peat The Wall Street Journal JANUARY 8,
2009, 1017 P.M. ET JJ, Vanderbilt Team Up on
Schizophrenia Drugs By Shirley S. Wang JJ,
Michael J. Fox Foundation, Seaside Therapeutics
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• Like a Biotech Company With Financial Stability

Jeff Conn
Dave Weaver
Craig Lindsley
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Drug Development Partnerships
Target Identification
Many Areas for Public-Private
Partnerships Leave Process Chemistry and
Preclinical Development for Industry Partners
Lead Identification
Lead Optimization
Target Validation
Process Chemistry
Preclinical Development
Clinical Development
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Other T1 Partners of Note
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How Our Most Innovative and Multifaceted T1
Partnership Developed
Carlos Arteaga of Vanderbilt-Ingram Cancer Center
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Transforming Collaborations

• Traditional Approach
• Separate individual transaction
• Different individuals /teams
• Target / compound specific
• Silo
• No integration
• Reinventing the wheel

• Integrated Approach
• Coordinated teams
• Clear points of contact
• Integrated communication
• Institutional relationship
• Shared learning
• Increased performance

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AZ Oncology Alliance Strategy
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Coordinating a Global RD Organization
7 sites in Europe
4 in North America
2 sites in Asia
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How Does the Partnership Keep Moving Forward?
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What Has Been Accomplished?

• Basic Research
• Basic Research Related to Compounds
• Clinical Trials Expansion of Studies in all
  Phases
• Wide Scientific Exchanges in All Day Programs
• Post-doctoral Project Support
• PhD Program Support

• Core Team for Alliance Management
• Master Agreements for Preclinical and Clinical
  Research
• Material Transfer Master Agreement
• Cross-Alliance Scientific Exchange
• Initial International Exchanges

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Whats Planned Next?

• Improve Speed for Project Planning and Execution
• Compound Catalog Access
• Compound Clinical Partnership
• Support Cross-Alliance Collaborations

• Increase Use of Technology Platforms
• Additional Input to Company Science Strategy
• Improve Project Tracking
• Define Performance Measures

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Development Candidate AccessSmall Molecule
Compound Catalog
Vascular Modulation
Endocrine Manipulation
DNA Repair
Cell Cycle
GFSS
Anti-Invasion
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What Are The Barriers for Doing More of These
Partnerships?
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Legal Harmonization

• Like ICH Process for Drug Regulatory Affairs?
• Variations in Legal Contract LanguageLike
  Variations in Medical Practice for Standard
  Procedures?
• Evidence and Outcome Based Contract Law?
• NCI and CEO Roundtable on Cancer--Contract
  Project
• Academic and Industry Barriers to Harmonization

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Three Wishes Alliantist Professionals More
Career Exchange Between Industry and
Academia Legal Harmonization
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Consortium-Wide CTSA Opportunities for Advancing
Partnerships

• Business Development and Dialogue with Industry
• Consortium-Wide CTSA T1 Projects
• Pre-Competitive Projects with Industry
• Legal Harmonization Across the Consortium
• Education Related to Partnership Activities
• Drug Repositioning

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Music City