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

1. New Innovation Model
Discovery through Validation

2. Innovator’s DNA
5 Skills that result in Innovation
Experiment
Network Question Observe
Associate
Dyer, H., Gregersen, H. & Christensen, C. (2009) The
Innovator’s DNA,. Harvard Business Review, 87 (12):
60-7, 128.

3. Question:
Is the “Business Model” of the
research University meeting the
needs of its stakeholders in today’s
environment?

4. Observation:
Federal Funding Flattening or Decreasing

5. Observation:
Tuition Growth NOT Sustainable

6. Observation:
The University Environment
Focused on academic excellence
Research labs focused on basic research
and discovery
Systems in place to reward publishing
Intellectual property policies consistent
with 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 transferable
research 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 CMU
Industry Expend/Total 13% 8% 7% 4% 8%
License/FTE 8.5 7.2 2.8 2.7 3.1
Startups 10 9 18 10 8
Startups/Licenses 12% 14% 20% 53% 10%

9. Observation:
The U.S. Corporate Environment
Pressure to focus limited resources on
core strengths
Desire and pressure to outsource as
much as possible, including research,
discovery, and development activities
Desire 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 expand
research 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 very
complicated
• Individual Faculty utilize $$ for own
individual objectives
• Focus on publication not translation
• No project management or coordination
• Unfamiliarity with industry expectations
• Academic culture and industry culture
are very different

16. Experiment:
A test model for collaboration
Kylin Therapeutics
• Purdue Invention: pRNA – Self-assembling RNA
nanoparticle
• Goal: Develop therapeutic pRNA nanoparticle
for ovarian cancer
• Deliverable: Proof of principle data package and
clinical candidate
• Partnership: Kylin sponsors research effort in
the Bindley Bioscience center & Kylin scientists
and Purdue scientists work cooperatively to
common goal.

17. Experiment:
A test model for collaboration
Kylin Therapeutics
Concept Concept
Publish Funding
Publish 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 pRNA
completed
• Novel pRNA chemical synthesis methods
developed
• 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” project
Expertise
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 need
Business
to be aligned to a
Office common mission
Sponsored
Program
Services • Common metrics
• “Service” oriented
• Business Friendly

22. New Innovation Model
Discovery 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 Model
Discovery 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 Model
Discovery 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 biotherapeutic
discovery and development
•Johnson & Johnson/Vanderbilt: up to $100 Million
for Schizophrenia drug development
• AstraZeneca/Univ. College of London: Major stem
cell collaboration
•GenentechUCSF: $13 Million to fund discovery and
development of neurodegenerative diseases

26. Discovery through Validation
J. Eric Davis
edavis@in-vivoventures.com
650-260-8923
Value 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