© 2007 by the Ewing Marion Kauffman Foundation. All rights reserved. “Every individual that we can inspire, that we can guide, that we can help to start

© 2007 by the Ewing Marion Kauffman Foundation. All rights reserved.

“Every individual that we can inspire, that we can guide, that we can help to start a new company, is vital to the future of our economic welfare.” — Ewing Kauffman

Mid-America Healthcare Mid-America Healthcare Investors NetworkInvestors Network- A Call to Action- A Call to Action

Stanford Biodesign Program

needs inventmed tech patentlicense collaboratecost effectivesurgical innovationlicense StanfordFDA discoverytechnology transfer

ethics & policy prototype reimbursement specialty innovation teamwork outcomes

biodesign

To develop leaders in biomedical technology innovation

Mission

Educate. Collaborate. Innovate.

Program in Biodesign

invention &discovery

ethics &policy

technology transfer

education

depth

innovation knowledge and skills

A repeatable training process…

Biodesign Innovation FellowshipsBiodesign Innovation Fellowship

‘07-08 White Team: Anesthesia

Nandan Lad, MD, PhD

Chicago Medical

Fogarty Fellow

Grube Fellow

David BoudreaultMD

St. Louis U

Beverly Tang, PhD

Stanford

Marie Johnson, PhD

U of Minnesota

Lucile PackardFellow

Lucile PackardFellow

3 months clinical immersion…Clinical Immersion/ Partnering with Departments

biodesign

Identify at least 200 needs…

Select the top needs to pursue…Select the top needs to pursue…

biodesign

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

NEED

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

CONCEPT

Go for quantity of ideas…

J. Abele, C. Alferness, P. Arensdorf, P. Auerbach, D. Auth, M. Baker, J. Bakker, L. Barish, A. Belson, M. Berman, A. Bianchi, N. Blevins, L. Bottorff, K. Bowsher, R. Buyan, B. Byers, J. Capek, M. Carusi, T. Chou, K. Connors, B. Constantz, R. Croce, R. Curtis, M. Cutkosky, M. Dake, A. de Bord, M. Deem, J. Delagardelle, D. Donohoe, D. Echt, D. Feigal, R. Ferrari, F. Fischer, R. Fisher, T. Fogarty, G. Foster, J. Garfinkle, M. Garrison, J. Geriak, G. Gershony, H. Gifford, J. Gill, J. Gold, J. Gordon, G. Graham, J. Green, J. Grossman, E. Grube, D. Gruenfeld, L. Guterman, S. Hamade, W. Hawkins, M. Hendricksen, J. Hickey, T. Hinohara, R. Hirsch, E. Hlavka, D. Hoffmeister, L. Hogle, H. Holstein, M. Horsewski, S. Hossainy, K. Im, M. Imran, F. Ingle, P. Jackson, J. Jacobs, W. Jaeger, R. Jaffe, J. Joye, S. Jwanouskos, A. Kaganov, D. Kelley, T. Kelley, K. Kelley, F. Khosravi, G. Kilman, T. Kohler, E. Koskinas, M. Lachman, J. Lacob, G. Lambrecht, T. Lamson, J. Lasersohn, S. Latterman, T. Lefteroff, M. Lesh, A. Macfarlane, W. Maloney, J. Mandato, J. Maroney, D. Mauney, A. May, M. Mayer, C. McGlynn, L. Michael, T. Mills, N. Mourlas, D. Murphy-Chutorian, J. Nehra, C. Nelson, W. New, S. Oesterle, J. Onopchenko, M. Paganini, J. Palmaz, O. Palmer, T. Kim Parnell, R. Perkins, T. Petersen, D. Piacquad, H. Plain, M. Raab, G. Rao, A. Rasdal, R. Reiss, G. Robertson, D. Roeder, E. Rogers, S. Rowinski, G. Rubin, S. Salmon, W. Samson, J. Schox, M. Selmon, J. Shapiro, J. Shay, T. Simons, J. Simpson, Y. So, F. St. Goar, B. Starling, B. Stern, M. Sugarman, R. Sutton, J. Swick, R. Tabibiazar, K. Talmadge, L. Tannenbaum, R. Thomas, S. Toyloy, S. Turnbull, J.S. Uy, B. Vale, S. Van Bladel, C. Vidal, M. Wan, K. Wasserstein, K. Widder, A. Will, J. Wilson, S. Wolf, T. Wollaeger, P. Young, R. Zider…& others

Real-World Mentors

biodesign

Biodesign Year

OUS, US

Clinical Status Business Status

Acquired

Biodesign Fellow, Student & Alumni Start-Ups

SPIRACOR

1

2

1

1

4

6

4

7

7

7

OUS, US

OUS, US

OUS, US

Pre-Trial

Pre-Trial

Pre-Trial

Pre-Trial

Pre-Trial

Pre-Trial

Series C

Series B

Acquired

Series A

Series A

Series A

SBIR Ph. 1

SBIR Ph. 1

Series A

Nick Mourlas Chris Eversull‘01 Fellows:

Our real product

biodesign

biodesign OTL

technology transferTech Transfer

biodesign

Stanford Medical Device Invention Disclosures & Licenses2000 to 2006

Disclosures and licensing

Preliminary and confidentialErik Pineiro, PhDKarolinska Institute

- The great increase in number of disclosures with the OTL almost exactly coincides with the start of the Medical Device Network (later to become Biodesign)

- As the number of “active participants: (i.e., speakers, directors, teachers…) increases, the number of disclosures increase.

Preliminary and confidentialErik Pineiro, PhDKarolinska Institute

Potential contribution of Biodesign

biodesign

Biodesign Corporate Sponsors

biodesign

Biodesign Venture Sponsors

Advanced Technology VenturesAlloy VenturesCytyc CorporationDelphi VenturesDeNovo VenturesFrazier Healthcare VenturesInterwest PartnersKleiner, Perkins, Caufield & ByersKearny VenturesMohr Davidow Ventures

Montreux Equity PartnersNew Enterprise AssociatesNew Leaf Venture Partners

ONSET VenturesProspect Venture Partners

Sanderling VenturesSplit Rock Partners

Three Arch PartnersUS Venture Partners

Versant Ventures

Innovative Excellence: Innovative Excellence: An Academic Model to An Academic Model to

Bridge the Valley of Bridge the Valley of Death Death

February 26, 2009February 26, 2009

Scott Weir, PharmD, PhDScott Weir, PharmD, PhDDirector, Director,

Institute for Advancing Medical InnovationInstitute for Advancing Medical Innovation


• Partnership with Ewing Marion Kauffman Foundation» $8.1 million grant from Kauffman Foundation

» $8.1 million matching grant from University of Kansas Endowment Association

• Mission» Support commercialization through the discovery and

advancement of medical innovations and foster the development of drug discovery, drug delivery, and bioengineering entrepreneurs who can contribute to economic growth

Why KU?Why KU?• University of Kansas School of Pharmacy ranked No. 1

» NCI formulation contract: 7 of 19 drugs from NCI’s Developmental Therapeutics pipeline formulated by KU

» “Father of Physical Pharmacy”, Dr. Higuchi

• Medicinal Chemistry Program Strengths» Chemical Methodologies and Library Development Center» Specialized Chemistry Center *» Center for Cancer Experimental Therapeutics COBRE

• Drug Delivery» Pharmaceutical Chemistry Distinguished Professors

• Dr. Stella, Dr. Borchardt, Dr. Middaugh• Biotechnology Innovation and Optimization Center

• KU Center for Technology Commercialization

* NIH Roadmap Initiative

Why KU?Why KU?

• University of Kansas Cancer Center» #1 priority for KU

» Vision to become number one academic generator of drugs for treatment, prevention and control of cancer

• Office of Therapeutics, Discovery & Development » Implements best practices from industry into academia to

foster commercialization in a quicker timeframe

• Established National and Regional Partnerships» Stowers Institute for Medical Research; Leukemia &

Lymphoma Society; Institute for Pediatric Innovation; Children’s Mercy Hospital; Kansas State University; Mayo Clinic Comprehensive Cancer Center; Kansas Bioscience Authority; Kansas Technology Enterprise Corporation

Advance Medical Innovations To Commercialization

Novel Drugs & Drug Targets

Drug Products & Delivery

Platforms

Drug Discovery Research

Training the Next GenerationOf Medical Innovators

Drug DeliveryResearch

Institute for Advancing Medical Innovation

Drug-DeviceCombination

Products

IntegratedBio-Engineering& Drug Research

Bio-Engineering

Research

Biomaterials & Medical

Devices

IAMI: Collaborative ModelsIAMI: Collaborative Models

PartnershipsPartnerships• Goal: assist academic, industry and philanthropic collaborators

to advance medical innovations• Philanthropic Partnerships

» Leukemia & Lymphoma Society• $1.5 million in current funded projects

• Industry Partnerships» Institute for Pediatric Innovation

• Partnership with Beckloff Associates, Pediatric Hospital Consortium

• POC funding for 2 projects with IPI

• Academic Partnerships» Scripps Research Institute» The Cancer Prevention Program at the Mayo Clinic

Comprehensive Cancer Center

IAMI: OpportunitiesIAMI: Opportunities

Innovation Fellow Training and Education Innovation Fellow Training and Education ProgramProgram

• Prepare graduate and postdoctoral students for careers in development and commercialization of medical innovations

• Fellows develop skills to successfully work in multi-disciplinary environments and commercialize medical innovations

• Curriculum includes academic and experimental focus• Opportunities to participate in Kauffman Fellows program

activities• Fellowships for 10 graduate students and 4 post-docs


Proof of Concept FundsProof of Concept Funds

• Funding to support proof of concept for outstanding projects; focus on balanced portfolio

• Project Eligibility» Clinical applications including: disease diagnosis, treatment

prevention and control

» Novel drug target, drug, product, drug delivery platform technology, biomaterial, medical device, and drug-device

» KU intellectual property, sole inventors or co-inventors

• Funding Mechanisms» RFP process annually

» Ad hoc funding mechanism throughout the year


Proof of Concept FundsProof of Concept Funds

• Funding typically ranges from $50K-$100K per project• Funding is milestone driven, i.e., to advance project from

one decision point to the next• Funding Process

» Application template

» Project plan including overall objectives, go no/go decision points, specific studies or experiments, cost and timing

» Principal Scientist and Project Director required to make joint presentation to Board

» Proposals vetted through IAMI Leadership Team prior to submission to IAMI Advisory Board for consideration

» IAMI Industry Advisory Board reviews and approves funding

• Quarterly progress reports required

Final PointsFinal Points


• Completely integrated institute to foster advancement of novel drug and drug targets, drug products, drug delivery platform technologies, biomaterials, medical devices, and drug-device combination products

• Includes program that incorporates training of graduate and post-doc fellows in project management with real-world applications

• Unique program unlike anywhere else in the world


Mission

To help individuals attain economic independence by advancing educational achievement and entrepreneurial success.


New Firms and U.S. Economic GrowthNew Firms and U.S. Economic Growth

600,000 new firms per year

Of which 1,000 are high-growth

$$

Equaling 1/3 of total economic growth

Or 1% growtheach year



Focus on Founders Focus on Founders & Firm Creation& Firm Creation


New Kauffman Programs

Kauffman Postdoc Fellows…the Kauffman 12

Kauffman Entrepreneur Fellows (incubators) ExploraMed

The Foundry

PureTech Ventures

Kauffman Pediatric Innovation Fellows

Kauffman Singapore Scholars


Why is Kauffman Focusing on Postdocs?

“The critical role that scientists play in our economy is compromised because faculty, graduate students and postdocs do not have a base level understanding of commercialization to empower them to recognize and advance their own innovations.”

Lesa Mitchell, VP, Kauffman Advancing Innovation


Postdoctoral Researchers – a Quandary

Postdocs are vital to the

scientific and clinical research

engine

They are 1st authors on 43% of

research papers (Science)

Many grants to PI’s are based

on postdoc research, postdocs

do bulk of research grant

writing

Postdocs are tied to the lab bench, rarely get exposure to entrepreneurship and translational research education on campus

Their PI often can’t evaluate their own research for commercial/translational potential

1 of 10 postdocs seeking an academic career get a faculty position, yet many postdocs struggle with making the transition to industry (NPA)

The Promise The Challenge


Innovation Ecosystem

Faculty-Firm-Not for Profit Consulting/Sponsored Research

Open Collaborations


Kauffman Postdoctoral Entrepreneur FellowshipKauffman Postdoctoral Entrepreneur Fellowship

One year full support PI agrees to <20 hours/week release time from bench Evaluate and develop commercialization plan for

postdoc/lab’s research Dedicated business mentor Customized industry internship (venture firm, startup) Entrepreneurship immersion workshops at Kauffman Access to broader Kauffman network (investors, etc.)

Objective: train tomorrow’s scientific/clinical founders


A unique time for midwest life sciences

KU Alignment of university leadership with talent & funding A shift in approach to licensing, sponsored research

Other regional efforts U Minn medical device center Northwestern Univ “translational” bioengineering Coulter Foundation translational research seed grant programs

at U Mich and Wisconsin


A Call to Action

We need you! Teaching in courses, seminars Mentoring & Coaching (students and faculty) Advising

Policy (IP, consulting, conflict of interest) Tech transfer

Why get involved? Relationships Increased & higher quality deal flow over long term


Documents

© 2007 by the Ewing Marion Kauffman Foundation. All rights reserved. “Every individual that we can inspire, that we can guide, that we can help to start