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

2 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation

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

3Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation

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


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


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


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


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:


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.


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


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


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


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


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


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


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

http://www.breastcancerstartupchallenge.com/

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

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


Connect with us!

Questions: Contact Rosemarie Truman, [email protected]

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Twitter - @BCSChallenge

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https://www.facebook.com/thebreastcancerstartupchallenge



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bcs challenge: faster cures presentation- nov. 4, 2013

Business

core team

breast cancer

business plan

commercialization

team leader

patent issued

patents issued

february 3rd