Translational Research - New Innovation Model

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A model for translating and validating discoveries within a University Environment.

A model for translating and validating discoveries within a University Environment.

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  • 1. New Innovation ModelDiscovery through Validation
  • 2. Innovator’s DNA 5 Skills that result in Innovation Experiment Network Question Observe AssociateDyer, H., Gregersen, H. & Christensen, C. (2009) TheInnovator’s DNA,. Harvard Business Review, 87 (12):60-7, 128.
  • 3. Question: Is the “Business Model” of the research University meeting theneeds of its stakeholders in today’s environment?
  • 4. Observation:Federal Funding Flattening or Decreasing
  • 5. Observation:Tuition Growth NOT Sustainable
  • 6. Observation: The University EnvironmentFocused on academic excellenceResearch labs focused on basic researchand discoverySystems in place to reward publishingIntellectual property policies consistentwith Bayh-Dole Act
  • 7. Observation: Economic Development Mission Purdue University: Promoting discovery with delivery by conducting field-defining research with breakthrough outcomes and catalyzing research-based economic development and entrepreneurship. Indiana University: Indiana University is a partner in helping to transform the Hoosier economy, and a key result of the [Strategic Plan] will be new innovations and transferableresearch that together will help create the basis for economic transformation and growth in Indiana. The Ohio State University: Become a catalyst for the development of Ohio’s technology-based economy. Increase collaborations with the private sector to enhance research, successfully transfer University technology, and provide experiential learning opportunities for students.
  • 8. Observation: Emerging Industry Support Purdue GIT MIT U of M CMUIndustry Expend/Total 13% 8% 7% 4% 8%License/FTE 8.5 7.2 2.8 2.7 3.1Startups 10 9 18 10 8Startups/Licenses 12% 14% 20% 53% 10%
  • 9. Observation: The U.S. Corporate EnvironmentPressure to focus limited resources oncore strengthsDesire and pressure to outsource asmuch as possible, including research,discovery, and development activitiesDesire to keep R & D in U.S.
  • 10. Observation: Outsourcing of “Discovery” Growing Drug Discovery Outsourcing Market ($B)$16.0 $13.8$14.0 $11.8$12.0 $10.0$10.0 $8.4 $7.3 $8.0 $6.3 $5.4 $6.0 $4.7 $4.1 $4.0 $2.0 $0.0 2005 2006 2007 2008 2009 2010 2011 2012 2013
  • 11. Observation:Academic - Focus on Basic Research Product Dev. Translational Research Basic Research
  • 12. Observation:Industry - Focus on Product Development Product Development Translational Research Basic Research
  • 13. ObservationAssociation:Emerging Model – Focus on Translational Research Product Dev. “Valley of Death” Translational Research Basic Research
  • 14. Association: Need for PublicPrivate Strategic Partnerships with focus on Translational Research•University’s need to explore and expandresearch funding sources•Industry needs to add more “R” to its “D”•Translational Research is common focus
  • 15. Experiment: Manage multi-disciplinary team to defined “deliverable”Major Challenges to resolve:• Contracting and IP transfer verycomplicated• Individual Faculty utilize $$ for ownindividual objectives• Focus on publication not translation• No project management or coordination• Unfamiliarity with industry expectations• Academic culture and industry cultureare very different
  • 16. Experiment: A test model for collaboration Kylin Therapeutics• Purdue Invention: pRNA – Self-assembling RNAnanoparticle• Goal: Develop therapeutic pRNA nanoparticlefor ovarian cancer• Deliverable: Proof of principle data package andclinical candidate• Partnership: Kylin sponsors research effort inthe Bindley Bioscience center & Kylin scientistsand Purdue scientists work cooperatively tocommon goal.
  • 17. Experiment: A test model for collaboration Kylin Therapeutics Concept Concept Publish FundingPublish Funding Discovery Discovery Delivery Current Basic Research Model New Innovation Research Model
  • 18. Experiment: A test model for collaboration Kylin Therapeutics Experimental Observations since 2007 University Mission• Average of 6 full-time staff (avg. $69k per year)• $574K in sponsored research since 2007• 3 publications• 2 manuscripts in production• Diverse research opportunities• 1 post-doc• 2 research internships• 1 business internship• Opportunity to Network with Industry experts
  • 19. Experiment: A test model for collaboration Kylin Therapeutics Experimental Observations since 2007 Industry Mission• 3 patent applications• 3 publications• 2 Manuscripts in production• Pharmacological characterization of pRNAcompleted• Novel pRNA chemical synthesis methodsdeveloped• Opportunity to Network with Academic experts• $145K* per FTE* Average - Includes general lab and reagent supplies
  • 20. Experiment: A test model for collaboration • Focus on “Delivery”Academic Industry Discovery • “Agile” projectExpertise management Joint Research Team • Multi-disciplinary Academic/Industry research teams Delivery • Culture of Entrepreneurship •Diverse Networking
  • 21. Experiment: A test model for collaboration •Tech Transfer, Sponsored Research, Tech Transfer Research Team and Business Offices needBusiness to be aligned to a Office common mission Sponsored Program Services • Common metrics • “Service” oriented • Business Friendly
  • 22. New Innovation ModelDiscovery through Validation Large Pharma and Biotech Animal Clinical Testing Trials Facility Translational Management – a virtual CRO GMP Mfg. Research Facility Staff Multi- disciplinary Academic Team
  • 23. New Innovation ModelDiscovery through Validation Large Pharma Academic TeamUniv. Virtual CRO • ProblemIP • ExpertiseIP • Project • $ • Facilities Management • Expertise • Multi-disciplinary • Manage to approach “Deliverable” • Contract Support Negotiation GMP Mfg. Research Staff Animal Testing Clinical Trials• Outsourced • The “Hands” • Vivarium • Affiliated Mfg (if • Animal Hospitals required) Testing and • Clinical Trial Analysis Management
  • 24. New Innovation ModelDiscovery through Validation Large Pharma and Biotech Animal Clinical Testing Trials Facility Translational Management GMP Mfg. Research Facility Staff Multi- disciplinary Academic Team Clinical Pipeline
  • 25. New Innovation Model Recent Examples• Pfizer/UCSF: $85Million to fund biotherapeuticdiscovery and development•Johnson & Johnson/Vanderbilt: up to $100 Millionfor Schizophrenia drug development• AstraZeneca/Univ. College of London: Major stemcell collaboration•GenentechUCSF: $13 Million to fund discovery anddevelopment of neurodegenerative diseases
  • 26. Discovery through Validation J. Eric Davis edavis@in-vivoventures.com 650-260-8923Value Proposition• Identify and assemble world-class research teamsIP• Negotiate and manage complex contracting process• Manage IP protection and transfer - Licensing• Manage research and development projects to Deliverable • Proof of principle data package • Problem resolution • Clinical Candidate• Average fully-loaded FTE cost $155K•Provide contract research staff Focus Areas Cancer HIV Infectious Disease Inflammation DiabetesObesity Neurological Disorders