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Discussion Document: July 6, 2009

The Avon Founda-on, Na-onal Cancer Ins-tute and Center for Advancing Innova-on Business Plan and Startup Challenge University Presenta-on By: Rosemarie Truman, Founder and CEO, The Center for Advancing Innova-on October 16, 2013

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What is the Challenge: Develop a business plan and launch a startup using 10 near-‐term, commercially viable inven-ons Challenge Overview •  Business Plan (BP) and Startup Contest using 10 near-‐term, commercially viable inven8ons conceived

and developed by inventors from the NCI and an Avon Founda8on (AF) grantee •  Challenge teams will par8cipate in three phases: LeFer of Intent, Business Plan and Start-‐up

Goals: •  Breast Cancer (BC): Increase survivability and improve the standard of care in areas of unmet need •  Technology Transfer (TT) Memorandum: “Accelerate and increase the volume of Federally funded

technology transfer in support of high growth businesses” •  Economic Growth: Spur economic growth across the na8on through new startups and jobs •  Entrepreneurship Learning: Provide a plaLorm for Universi8es to expand their entrepreneurial

programs •  Business Model: Create new business models in TT, transla8onal research and R&D funding

Phases: Three phases -‐ Challenge Teams’ Opportunity: •  Business Plan Prize: Up to 100 teams will par8cipate, 10 teams per inven8on. There will be one $5K

prize per inven8on ($50k in total awards) •  Start-‐up Phase Seed Funding: Up to 30 successful start-‐ups will apply and poten8ally be awarded

funding which could range from $100K to over $1MM •  Funding will come from venture capital, economic development corpora8ons, Avon Founda8on or

other private sources. Funding will not be provided from the NIH


Who are the key players?

BIO SoPE CoFoundersLab Universi8es

•  Students gain: real-‐world, cross-‐discipline, entrepreneurship experience; gain exposure to experts

•  Universi/es gain publicity for providing entrepreneurial student opportuni8es and new way to create jobs

•  Economic Development organiza8ons

•  Venture capital •  Private equity •  Angel investors

•  Breast Cancer Survivors •  Venture Capitalists •  Successful Serial Entrepreneurs •  Industry Execu8ves and Experts •  Founda8on, NCI and CAI Core Team

Judges/Mentors

Supporters

Core Partners: •  The Avon Founda8on •  Na8onal Cancer Ins8tute •  The Center for Advancing Innova8on

Seed Funders


Challenge Topics: Novel, Commercially Viable Breast Cancer Inven-ons

#1 -‐ Diagnos-c from Biopsies with SoYware Analysis Title: Breast Cancer Diagnos-c Based on Spa-al Organiza-on of Genes in the Cell Nucleus Execu-ve Summary Category: Diagnos8cs/Health IT Disease Focus: Breast Cancer using tumor biopsies Basis of Inven-on: Gene (DNA) How it works: Uses the 3D placement of genes to detect breast cancer in 8ssue Patent Status: Patent issued in Europe (validated in Germany, UK, France), pending in US, Canada Lead Inventor: Tom Misteli, PhD Development Stage: In vitro and retrospec8ve in vivo

Therapeu8cs: 5 Diagnos8cs: 5 Prognos8cs: 1 Vaccine: 1 Health IT: 1 Device: 1 Delivery Method: 1 Note: some inven8ons have more than one use and cover 2 or more of the above

Breast Cancer Challenge Topics

NCI Inven-on Example


Who can par-cipate?

Team Design: Mandatory Requirements*

Challenge TEAM

Business

Legal

Medical/Scien8fic

Seasoned Entrepreneur

Other Key Notes on Who May Par-cipate

Students: •  Graduate and undergraduate

Students •  Post-‐docs, those in residency Anyone else beyond the three mandatory students Others Areas of Recommended Knowledge Sources: •  Business development •  Payers •  Key Opinion Leader •  FDA/Regulatory •  Venture Capital •  Clinical Research Outsourcer

•  Over 18 years old •  At least three students on the team

*Note: two inven8ons require addi8onal disciplines Inven8on #1: computer science; inven8on #3: engineering


Overview of Phases: 100 teams enter; a poten-al of 30 startups

10 Inven-ons

10 Teams for Each Inven-on

Planning Phase 1:

Letter of Intent Phase 2:

Business Plan Post-Contest Phase 3: Startup

Inven-on 1

3 Teams per Inven-on Go to Ph3

Inven-on 1

3 Startups for Each Inven-on

“Startup Winner” Has Licensing Agreement and Seed Funding

•  Select an inven8on

•  Form a team

•  Business Plan •  Pitch •  Elevator Speech

•  Revise Business Plan

•  Launch Startup •  Apply for seed funding

•  Apply for a license

•  Enter your core team, mentors, advisors and collaborators

•  Collaborate with the NCI or AF grantee University, Clemson

•  Launch a Product


Lecer of Intent: Guidelines, Deliverables and Key Dates

Letter of Intent

Deliverables: •  LeFer of Intent form (it contains a CDA click through) •  Prize Alloca8on Form •  Resumes (one package containing all resumes of core team members,

mentors, and advisors) •  Join Wiggio; create group and invite CAI to your group •  OPTIONAL: Stakeholder Analysis and Collaborators Guidelines: •  Augment your team with Venture Capitalists who may provide funding •  Iden8fy collaborators that can provide seed funding and/or services to

your start-‐up (e.g., legal, accoun8ng, valua8on, etc.) •  Include team members that have relevant inven8on experience •  Prepare a strong LOI with all disciplines required, mentors and advisors.

We are accep8ng strong teams on a rolling basis Key Dates: October 1st, 2013 to November 29, 2013 •  Start accep8ng LOIs: October 1st; Stop accep8ng LOIs, December 1st, 2013 •  Receive final LOI communica8on by December 4th , 2013

10 Teams for Each Inven-on

Inven-on 1

Phase 1:


Challenge Team Member Defini-ons

Challenge Team Defini-on: The “Challenge Team” is made up of the Team Leader, Core Team Members, Advisors, Mentors A Team Leader is our single point of contact for the Challenge and accountable for deliverables A Core Team Member is accountable for deliverables

A Mentor has domain experience and will ac8vely work with the team on a daily/weekly basis to review/complete deliverables

An Advisor has domain exper8se and the team uses for Q&A sessions, e.g., KOL

A Collaborator is an organiza8on that can improve your probability of success; they will include seed funders, services firms, etc.


Business Plan: Guidelines, Deliverables and Key Dates

Business Plan Deliverables: •  10 page business plan or a business model canvas •  1 minute elevator pitch posted on YouTube •  5 minute live pitch via Skype or video conferencing to judges •  10 page pitch deck (maximum 10 pages Powerpoint or Prezio) Guidelines: •  Begin with the end in mind. Make sure you understand

•  Seed funders criteria for investment •  NIH or Clemson’s license agreement requirements

•  Leverage CAI’s templates/guidelines for your business plan, regulatory strategy, development plan, and commercializa8on plan, etc.

•  Check the criteria we are using to assess deliverables

Key Dates: •  Deliverables due: February 3rd (can be submiFed early) •  Pitches: February 3rd to February 13th •  Award Announced: February 19th

Prize: $5K for each of 10 winning teams– one award per inven8on

Phase 2:

3 Teams per Inven-on Go to Ph3


Start-‐up: Guidelines, Deliverables and Key Dates

Start-up

Deliverables: •  Revised regulatory strategy, commercializa8on plan and development plan •  Start-‐up incorpora8on •  Seed funding applica8on(s) •  NIH or Clemson licensing applica8on

Guidelines: •  Incorporate your start-‐up as soon as possible •  Revise your deliverables by gaining addi8onal input from KOLs, payers, the

FDA, VCs, poten8al collaborators, CROs, CMOs, service providers, etc. •  Parallel process your deliverable crea8on – especially seed funding and

licensing applica8on; there could be a “chicken or the egg” scenario

Key Dates: •  Start date: February 20, 2014 •  Deliverables due: June 17, 2014 •  Awards announced: June 27, 2014 (or later)

Defini-on of Success: Start-‐ups launched a company; raised capital and in-‐licensed an inven8on. Successful start-‐ups are honored with a “Start-‐up Medal of Honor” in an awards ceremony

Phase 3:

Inven-on 1

3 Startups for Each Inven-on


Post-‐Challenge Expecta-ons

Avon Founda-on: Ongoing partnering to ensure success NCI/Clemson University Research Founda-on: Ongoing Collabora8on The Center for Advancing Innova-on: Ongoing coaching/mentoring

EVENTUALLY: NEW BREAST CANCER PRODUCTS/SOLUTIONS ON THE MARKET


More on the inven-ons, page 1 of 2

#1 – Health IT Inven8on – Detects Breast Cancer based on Spa8al 3D Gene Placement Tom Misteli, Patents issued in Europe (validated in Germany, UK and France) pending in US/Canada In vivo and in vitro data

#2 – Therapy/Vaccine– Slows tumor growth, preven8ng metastasis post surgery Dennis Klinman, Patent pending in the US, pre-‐clinical in mice

#3 – Device/Therapeu8c/Vaccine– Collagen composite 8ssue replacement material as a reconstruc8on plaLorm with an8-‐tumor capabili8es Karen Burg, Patent issued in the US, human breast 8ssue tested in pre-‐clinical

#4 – Therapeu8c/Diagnos8c – Binds specifically to a cancer cell target and inhibits the tumor growth Mitchell Ho, US patent pending, in-‐vitro data also mouse xenograph models

#5 – Therapeu8c/Vaccine– S8mulates immune response for tumor inhibi8on Alan Krensky, Patent Pending in US, Canada, Australia, and Europe, pre-‐clinical in mice


More on the inven-ons, page 2 of 2

#6 – Therapeu8c– Small molecule that works with current drugs to enhance their effec8veness Nayda Tarasova, US patent issued; Europe, patent pending; pre-‐clinical in-‐vitro

#7 – Two Inven8ons Vaccine and/or Drug Delivery – PlaLorm to deliver proteins to cancer cells – much less toxic and more specific than current models Deb Chatterjee, Patents issued in US; another pending, in vitro and in vivo data

#8 – Diagnos8c– Uses genes to detect Cancer and associated stage Steven Libus, US patent pending, retrospec8ve human data from clinical trials

#9 – Diagnos8c– Predict pa8ents survival rate and guides treatment Stephen HewiF, Pending in U.S., Canada, Europe, Australia, Japan, Israel, and New Zealand, more than a thousand samples of human data

#10 – Diagnos8c– Determines the effec8veness of chemotherapy for a pa8ent Sherry Yang, US patent granted; Pending in Europe, Canada, Australia, and Japan, data from >1500 human 8ssue samples


LeFer of Intent

Oct 1-‐Nov 29 2013

• 8/30/13 – 10/1/13: Form team

• 10/1/13: Submit LOI • 11/29/13: LOIs due • 12/4/13: Communicate to teams

Business Plan

Dec 2 2013 – Feb 19 2014

• 12/2/13: Launch BP effort • 2/3/14: Deliverables due • 2/3/14 – 2/13/14: Virtual pitches with teams

• 2/19/14: Award top teams for each inven8on

Start-‐up

Feb 20, 2014-‐ June 27, 2014

• 2/20/14: Launch SU effort • Ongoing: Revise BP; create SU; apply for funding and license

• 6/17/14: Deliverables due • 6/27/14: Announce successful start-‐ups

An8cipated Post-‐Contest Ac8vi8es

• Conduct discussions regarding collabora8ve R&D agreement

• Con8nue R&D on inven8on

• Con8nue raising capital

Key Dates

•  Provide mentoring / guidance to teams •  Receive ques8ons and filter to SMEs as necessary •  Review rolling BP and SU deliverables

Ongoing

SUMMARY: Key Dates Under the “Overview” Sec-on on hcp://www.breastcancerstartupchallenge.com

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Key Links

hFp://www.breastcancerstartupchallenge.com

Challenge Website

LeFer of Intent Forms – For Teams Team Leader Core Team Members, Mentors, Advisors and Collaborators:

Wiggio Links – For Teams

hFps://www.surveymonkey.com/s/TeamLeadLOISurvey

hFps://www.surveymonkey.com/s/BCSChallengeCDAForm

Main Group hFp://wiggio.com/group_open_join.php?groupid=1838019&password=CAI1234&ref=1787839 Team Collabora8on hFp://wiggio.com/group_open_join.php?groupid=1848688&password=CAITEAM&ref=1787839

16 Proprietary and Confiden8al to The Center for Advancing Innova8on. Do not distribute outside The Center for Advancing Innova8on

Connect with us!

Ques-ons: Contact Rosemarie Truman, [email protected]

Facebook -‐ Breast Cancer Start-‐up Challenge TwiFer -‐ @BCSChallenge

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