translational research - new innovation model

New Innovation ModelDiscovery through Validation

Innovator’s DNA5 Skills that result in Innovation

Question

Experiment

Observe

Associate

Network

Dyer, H., Gregersen, H. & Christensen, C. (2009) The Innovator’s DNA,. Harvard Business Review, 87 (12): 60-7, 128.

Question:

Is the “Business Model” of the research University meeting the

needs of its stakeholders in today’s environment?

Observation:Federal Funding Flattening or Decreasing

Observation: Tuition Growth NOT Sustainable

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

Observation:The University Environment

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.

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%

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.

Observation:The U.S. Corporate Environment

Observation:Outsourcing of “Discovery” Growing

$4.1$4.7

$5.4$6.3

$7.3$8.4

$10.0

$11.8

$13.8

$0.0

$2.0

$4.0

$6.0

$8.0

$10.0

$12.0

$14.0

$16.0

2005 2006 2007 2008 2009 2010 2011 2012 2013

Drug Discovery Outsourcing Market ($B)

Observation:Academic - Focus on Basic Research

ProductDev.

Translational Research

Basic Research

Observation:Industry - Focus on Product Development

ProductDevelopment


Basic Research

Observation\Association:Emerging Model – Focus on Translational Research

ProductDev.


Basic Research

“Valley of Death”

Association:Need for Public\Private 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

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

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.


Kylin Therapeutics

Concept

Funding

Discovery

Publish

Concept

Funding

DiscoveryDelivery

Publish

Current Basic Research Model New Innovation Research Model


Kylin TherapeuticsExperimental 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


Kylin TherapeuticsExperimental 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


Delivery

Joint Research

Team

Academic Expertise

IndustryDiscovery

• Focus on “Delivery”

• “Agile” project management

• Multi-disciplinary Academic/Industry research teams

• Culture of Entrepreneurship

•Diverse Networking


Sponsored Program Services

Business Office

Tech Transfer

•Tech Transfer, Sponsored Research, Research Team and Business Offices need to be aligned to a common mission

• Common metrics

• “Service” oriented

• Business Friendly


Translational Management – a virtual

CRO

Large Pharma and

Biotech

Animal Testing Facility

Research Staff

Multi-disciplinary Academic

Team

GMP Mfg. Facility

Clinical Trials


Large Pharma

• Problem\IP• $• Expertise

Academic Team\Univ.

• Expertise\IP• Facilities• Multi-disciplinary

approach

Virtual CRO

• Project Management

• Manage to “Deliverable”

• Contract Support\Negotiation

GMP Mfg.

• Outsourced Mfg (if required)

Research Staff

• The “Hands”

Animal Testing

• Vivarium• Animal

Testing and Analysis

Clinical Trials

• Affiliated Hospitals

• Clinical Trial Management


TranslationalManagement

Large Pharma

and Biotech

Animal Testing Facility

Research Staff

Multi-disciplinary Academic

Team

GMP Mfg. Facility

Clinical Trials

Clinical Pipeline

New Innovation ModelRecent Examples

• Pfizer/UCSF: $85Million to fund biotherapeuticdiscovery and development

•Johnson & Johnson/Vanderbilt: up to $100 Million for Schizophrenia drug development

• AstraZeneca/Univ. College of London: Major stem cell collaboration

•Genentech\UCSF: $13 Million to fund discovery and development of neurodegenerative diseases

Discovery through ValidationJ. Eric Davis

[email protected]

Value Proposition• Identify and assemble world-class research teams\IP• 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 AreasCancer HIVInfectious Disease InflammationDiabetes\Obesity Neurological Disorders

mailto:[email protected]

translational research - new innovation model

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