the center for advancing innovation

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1 the center for advancing innovation BREAST CANCER STARTUP CHALLENGE OVERVIEW Discussion Document: July 6, 2009 Partnership between the National Cancer Institute, the Office of Technology Transfer, the Avon Foundation for Women and The Center for Advancing Innovation Rosemarie Truman, Founder and CEO, The Center for Advancing Innovation April 21, 2014

2 Contents Introduction to NCI, Avon Foundation and CAI Background of the Breast Cancer Startup Challenge High Level Overview of Challenge Results and Benefits Moving Forward 2

Partners Involved in Startup Challenge Marc

Center for Advancing Innovation Tom Stackhouse, Ph.

3 Partners Involved in Startup Challenge Marc Hurlbert, Ph.D., Executive Director Avon Foundation Breast Cancer Crusade Rosemarie Truman, Founder and CEO The Center for Advancing Innovation Tom Stackhouse, Ph.D., Associate Director for the Technology Transfer Center at the NIH National Cancer Institute 3

4 NIH- National Cancer Institute National Institutes of Health consists of 27 Institutes and Centers NCI is largest Institute within NIH 85 % of NCI s budget supports extramural programs for grants and contracts 15% of budget supports an intramural research program 4

Avon Foundation: Largest corporate supporter of breast

Crusade: Research Understanding the causes of breast

detection, recurrence, and metastasis Developing new

5 Avon Foundation: Largest corporate supporter of breast cancer research: $780 million Avon Breast Cancer Crusade: Research Understanding the causes of breast cancer and primary prevention Diagnostics for detection, recurrence, and metastasis Developing new treatments for metastatic breast cancer, inflammatory BC and other unmet needs 5

6 CAI is a global, public-private, nonprofit innovation intermediary that provides technology transfer, commercialization, growth and transformation services Overview Mission: Accelerate and increase the volume of research commercialization in order to ignite entrepreneurship and economic impact Team Capability: RHT: 20 years experience in due diligence, growth strategy and subsequent transformation Capability: End-to-end, from due diligence to realizing results Team: ~20 people. 90% PhDs and MBAs from life sciences companies or medical/scientific backgrounds Key Focus Areas: Due Diligence Portfolio, Market and Growth Strategy Operational Transformation Team Qualifications and Experience: Over 110 strategy projects Track record of working with investment firms and life sciences organizations to identify the right investments to realize value quickly Intellectual Property Three trade secrets in growth strategy One additional trade secret on due diligence, operational optimization and maximizing commercial launch in the life sciences industry 6 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute

7 Current CAI Partnerships portfolio assessment; commercialization:11 organizations 7 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute

8 Background of the Breast Cancer Startup Challenge 8

CAI used a rigorous framework to evaluate NCI and Avon Foundation grantee inventions 130-154 dimensions Medical Scientific Attractiveness Operational Feasibility Risk/Return Approvability Ability to

9 CAI used a rigorous framework to evaluate NCI and Avon Foundation grantee inventions dimensions Medical Scientific Attractiveness Operational Feasibility Risk/Return Approvability Ability to Attract Funding and Collaborators Market Viability Unmet Need of Current Drugs Development Complexity Comparative Effectiveness Deal Trends (Upfront Payments and Realization) Addressable Market Size/ Growth Rate Safety, Efficacy and Efficiency Versus Peers Ability to Access Patients Government Priority, e.g., NIH, Military, etc. Sustainability of Adequate Funding Incidence and Prevalence Standard of Care Versus Peers Management Experience and Capability Tropical Disease Subpart H In-licensing Opportunities Market Sustainability 9 Current Resistant Rates Novelty / Unique Mechanism of Action Indications Time to Develop/ Commercialize Risk and Barriers to Entry Ease of Manufacturing, Enrolling Priority Review List Regulatory Strategy Clarity of End Points R&D Collaborative Agreements IP Attractiveness Value Proposition for Collaboration Upfront Payment Versus Time to Maturity Competitive Intensity/ Differentiation Profitability - Payers Pay a Premium Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation

portfolio Evaluated potential match between great inventions and biotech/pharma demand 10 Proprietary and

10 Evaluation Results From Portfolio Review Evaluated > 4500 NCI patents 10 years of Avon Foundation grantee inventions Found 50 commercially viable inventions from NCI and 6 from the Avon Foundation grantee portfolio Evaluated potential match between great inventions and biotech/pharma demand 10 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation

11 Challenges created an opportunity Challenges 1. Categories of commercially viable inventions will not be licensed by pharma because they do not align with large pharma s business model/commercial practices 2. Federal labs and foundations are prevented from launching startups. New models are needed to create start-ups from federal inventions and for venture philanthropy Opportunity Launch the first-ever business plan and start-up challenge with a sole purpose of creating viable start-ups to impact public health 11 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation

12 Breast Cancer Startup Challenge Overview 12

13 The Breast Cancer Startup Challenge is LAUNCHED! International Business Plan and Startup Contest using 10 near-term, commercially viableinventions conceived and developed by inventors from NCI and an Avon Foundation (AF) grantee Participants: University students; seasoned entrepreneurs; team members with legal, business, medical/scientific disciplines; and anyone else Phases: Letter of Intent, Business Plan and Start-up 13 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation *Current companies excluded; most provide guidelines but discourage retail, consulting and franchises

14 Challenge Goals Breast Cancer: Increase survivability and improve the standard of care Economic Growth: Spur economic growth through new startups and jobs Entrepreneurship Learning: Provide entrepreneurial education programs for scientists Business Model: Create new business models in translational research and R&D funding Technology Transfer Memorandum: Accelerate and increase the volume of Federally funded technology transfer in support of high growth businesses 14 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation *Current companies excluded; most provide guidelines but discourage retail, consulting and franchises

Challenge Phases: Very high bars in each phase Planning Phase 1: Letter of Intent Phase 2: Business Plan

3 Startups for Each Invention Startup Winner Has Licensing Agreement and Seed Funding Invention 1

Confidential to The Center for Advancing Innovation.

15 Challenge Phases: Very high bars in each phase Planning Phase 1: Letter of Intent Phase 2: Business Plan Phase 3: Startup Post-Contest 10 Inventions 10 Teams for Each Invention 3 Teams per Invention Go to Ph3 3 Startups for Each Invention Startup Winner Has Licensing Agreement and Seed Funding Invention 1 Invention 1 CAI Start-up Mentoring/Curriculum and Brainstorming/Q&A with Inventors 15 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation *Current companies excluded; most provide guidelines but discourage retail, consulting and franchises

16 Breast Cancer Start-up Challenge Differentiators: Not an Academic Exercise 1. Challenge Structure: 1. Mandatory cross-disciplinary teams, including legal, medical/scientific, seasoned entrepreneur and business to have the highest probability of success. The #1 reason start-ups fail is due to their team 2. Includes BOTH a business plan and start-up phase in which teams can compete 3. High-touch model with curriculum and mentoring 2. End Result: We re launching start-ups versus start-ups that have already formed coming into the challenge 3. Opportunity: 10% or more chance of winning as soon as teams enter the business plan phase $100 thousand to $3 million in seed funding 4. Business Model: A therapeutically oriented foundation has sponsored a contest to launch start-ups A federal lab has put its inventions in an international, university-based contest 5. Invention Selection: The inventions were selected as a result of a SYSTEMATIC assessment of over patents in a federal lab and across 30+ universities 16 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute outside The Center for Advancing Innovation

17 Breast Cancer Start-up Results 17

18 BCSC is now the largest in the world based on participation and team size Status Rice Our Challenge Quote Super Bowl and World Series Combined the World s Richest and Largest Business Plan Competition, CNN and Fortune We are looking forward to start-ups launching around these inventions to accelerate research and break the mold of how research is funded, Marc Hurlbert, Ph.D. executive director, Avon Foundation for Women # of Years 13 Lessthan 1 year Running Teams In Team Members 126, ~3 per team 478, ~10 per team Scope Business Plan Business Plan and Start-up SeedFunding $1.5 million $850thousand (SO FAR) start-upsmay earn up to $10mm from seed funders # of Sponsors monetary; 1 non-monetary; others Most Inventions Technology-oriented selected by student Deliverables Business Plan, Pitch, and Elevator Speech Breast Cancer Business Plan, Pitch andelevator Speech, as well as Launch Startup, Licensing Agreement and Seed Funding Applications 18 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute

19 Other Statistics for the Breast Cancer Startup Challenge Entries: Out of 200 teams interested, 46 teams made it in (10 people per team) Team Strength: 4,356 years of experience ~100 years per team University Diversity: 83 universities participated on teams Geographic diversity: 20% of the people participating were from outside the US Winners: 30% of the winners were from outside the US 19 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute

20 What could happen if 10% of startups are successful? Potential Yearly Product Launches and NIH Royalty Income Yearly Patent and Maintenance Cost Savings from Startup Challenges $ $45, $40,000 Royalty Income (Millions) $200 $150 $100 $ # Launched Products Cost Savings (000s) $35,000 $30,000 $25,000 $20,000 $15,000 $10,000 5 $5,000 $- 0 $0 Fiscal Year of Product Launch Cumulative 5-Year Income $175.5 Million Cumulative 5-Year GDP Impact $11.7 Billion Cumulative 10-Year Income $955.5 Million Cumulative 10-Year GDP Impact $63.7 Billion Consecutive Years of Startup Challenge Cumulative 5-Year Cost Savings $113 Million Cumulative 10-Year Cost Savings $302 Million 20

21 What s Next? The Heritage Provider Network is Partnering with NIH and CAI to launch: The Brain Challenge Design changes: 1. public voting 2. tiered elevator speech/executive summary process versus business plan 3. lower bar to enter 21 Proprietary and Confidential to The Center for Advancing Innovation. Do not distribute

If there are any unanswered (Required) questions by the deadline, your LOI will be disqualified and rejected from the Challenge.

If there are any unanswered (Required) questions by the deadline, your LOI will be disqualified and rejected from the Challenge. Nano Startup Challenge in Cancer (NSC): Letter of Intent Form This is the Letter of Intent Form (LOI) for Phase 0 of the Nano Startup Challenge in Cancer. The Team Leader of each team should fill out and