BCS Challenge: Faster Cures Presentation- Nov. 4, 2013

Discussion Document: July 6, 2009Breast Cancer Startup Challenge

Partnering for Cures

Date: November 4th 2013Time: 1:45-2:10pm

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What is the Challenge: Develop a business plan and launch a startup using 10 near-term, commercially viable inventions

Challenge Overview• Business Plan (BP) and Startup Contest using 10 near-term, commercially viable inventions conceived

and developed by inventors from the NCI and an Avon Foundation (AF) grantee• Challenge teams will participate in three phases: Letter 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 nation through new startups and jobs• Entrepreneurship Learning: Provide a platform for Universities to expand their entrepreneurial

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

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

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

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

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

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Who are the key players?

BIO

SoPE

CoFoundersLabUniversities

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

• Universities gain publicity for providing entrepreneurial student opportunities and new way to create jobs

• Economic Development organizations

• Venture capital• Private equity• Angel investors

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

Judges/Mentors

Supporters

Core Partners: • The Avon Foundation• National Cancer Institute• The Center for Advancing Innovation

Seed Funders

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Challenge Topics: Novel, Commercially Viable Breast Cancer Inventions

#1 - Diagnostic from Biopsies with Software AnalysisTitle: Breast Cancer Diagnostic Based on Spatial Organization of Genes in the Cell Nucleus

Executive Summary

Category: Diagnostics/Health ITDisease Focus: Breast Cancer using tumor biopsies Basis of Invention: Gene (DNA) How it works: Uses the 3D placement of genes to detect breast cancer in tissuePatent Status: Patent issued in Europe (validated in Germany, UK, France), pending in US, CanadaLead Inventor: Tom Misteli, PhDDevelopment Stage: In vitro and retrospective in vivo

Therapeutics: 5Diagnostics: 5Prognostics: 1 Vaccine: 1Health IT: 1Device: 1Delivery Method: 1Note: some inventions have more than one use and cover 2 or more of the above

Breast Cancer Challenge Topics

NCI Invention Example

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Who can participate?

Team Design: Mandatory Requirements*

Cha

lleng

e TE

AM Business

Legal

Medical/Scientific

Seasoned Entrepreneur

Other Key Notes on Who May Participate

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 inventions require additional disciplinesInvention #1: computer science; invention #3: engineering

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Overview of Phases: 100 teams enter; a potential of 30 startups

10 Inventions

10 Teams for Each Invention

PlanningPhase 1:

Letter of IntentPhase 2:Business

Plan

Post-ContestPhase 3: Startup

Invention 1

3 Teams per Invention Go to Ph3

Invention 1

3 Startups for Each Invention

“Startup Winner”Has Licensing

Agreement andSeed Funding

• Select an invention

• 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

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Letter of Intent: Guidelines, Deliverables and Key Dates

Letter of Intent

Deliverables:• Letter of Intent form (it contains a CDA click through)• Prize Allocation 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• Identify collaborators that can provide seed funding and/or services to

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

We are accepting strong teams on a rolling basis

Key Dates: October 1st, 2013 to November 29, 2013• Start accepting LOIs: October 1st; Stop accepting LOIs, December 1st, 2013• Receive final LOI communication by December 4th , 2013

10 Teams for Each Invention

Invention 1

Phase 1:

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Challenge Team Member Definitions

Challenge Team Definition: 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 actively work with the team on a daily/weekly basis to review/complete deliverables

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

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

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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 commercialization plan, etc.

• Check the criteria we are using to assess deliverables

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

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

Phase 2:

3 Teams per Invention Go to Ph3

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Start-up: Guidelines, Deliverables and Key Dates

Start-up

Deliverables:• Revised regulatory strategy, commercialization plan and development plan• Start-up incorporation• Seed funding application(s)• NIH or Clemson licensing application

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

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

licensing application; 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)

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

Phase 3:

Invention 1

3 Startups for Each Invention

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Post-Challenge Expectations

Avon Foundation: Ongoing partnering to ensure success

NCI/Clemson University Research Foundation: Ongoing Collaboration

The Center for Advancing Innovation: Ongoing coaching/mentoring

EVENTUALLY: NEW BREAST CANCER PRODUCTS/SOLUTIONS ON THE MARKET

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More on the inventions, page 1 of 2

#1 – Health IT Invention – Detects Breast Cancer based on Spatial 3D Gene PlacementTom Misteli, Patents issued in Europe (validated in Germany, UK and France) pending in US/CanadaIn vivo and in vitro data

#2 – Therapy/Vaccine– Slows tumor growth, preventing metastasis post surgeryDennis Klinman, Patent pending in the US, pre-clinical in mice

#3 – Device/Therapeutic/Vaccine– Collagen composite tissue replacement material as a reconstruction platform with anti-tumor capabilitiesKaren Burg, Patent issued in the US, human breast tissue tested in pre-clinical

#4 – Therapeutic/Diagnostic – Binds specifically to a cancer cell target and inhibits the tumor growthMitchell Ho, US patent pending, in-vitro data also mouse xenograph models

#5 – Therapeutic/Vaccine– Stimulates immune response for tumor inhibitionAlan Krensky, Patent Pending in US, Canada, Australia, and Europe, pre-clinical in mice

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More on the inventions, page 2 of 2

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

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

#8 – Diagnostic– Uses genes to detect Cancer and associated stageSteven Libutti, US patent pending, retrospective human data from clinical trials

#9 – Diagnostic– Predict patients survival rate and guides treatmentStephen Hewitt, Pending in U.S., Canada, Europe, Australia, Japan, Israel, and New Zealand, more than a thousand samples of human data

#10 – Diagnostic– Determines the effectiveness of chemotherapy for a patientSherry Yang, US patent granted; Pending in Europe, Canada, Australia, and Japan, data from >1500 human tissue samples

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Letter 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 invention

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

Anticipated Post-Contest

Activities

• Conduct discussions regarding collaborative R&D agreement

• Continue R&D on invention

• Continue raising capital

Key Dates

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

Ongoing

SUMMARY: Key DatesUnder the “Overview” Section on http://www.breastcancerstartupchallenge.com

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Key Links

http://www.breastcancerstartupchallenge.comChallenge Website

Letter of Intent Forms – For TeamsTeam Leader Core Team Members, Mentors, Advisors and Collaborators:

Wiggio Links – For Teams

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

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

Main Grouphttp://wiggio.com/group_open_join.php?groupid=1838019&password=CAI1234&ref=1787839

Team Collaborationhttp://wiggio.com/group_open_join.php?groupid=1848688&password=CAITEAM&ref=1787839

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Questions: Contact Rosemarie Truman, rt@thecenterforadvancinginnovation.org

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