The document summarizes a seminar on commercializing biotech products. It discusses the stages of developing a new venture from an initial idea through profitability. It also outlines the typical phases of developing a biotech product from research through FDA approval and marketing. Finally, it provides an example market analysis for a potential new drug for AIDS, including unmet needs, existing treatment options, market size, and considerations around pricing and reimbursement.

1. 2012 TAMHSC Commercialization Seminar
Business Plan
Ping Zhou
Research Valley Innovation Center
The Research Valley Partnership, Inc.
Feb 15, 2012
v0
February 28, 2012 ©2008 The Research Valley Innovation Center

2. Agenda
1. Stages of New Venture
2. Biotech Product Life Cycle
3. Business Plan
4. Market Analysis
5. An Example of Market Analysis
February 28, 2012 ©2008 The Research Valley Innovation Center

3. Stages of New Venture
0
February 28, 2012 ©2008 The Research Valley Innovation Center

4. Stages of New Venture
• Idea
• Pre-formation – Business Plan Gets
Started
• Formation
• 1st Dollar Revenue
• Breakeven
0
• Profitability
• Exit
February 28, 2012 ©2008 The Research Valley Innovation Center

5. Biotech Product Life Cycle
Research Development Commercialization
Drug Animal FDA
Phase I Phase II Phase III Phase IV
Candidates Trials Approval
IND submitted NDA submitted Drug launched
2-5 yrs 6-7 yrs 0.4-2 yrs
February 28, 2012 ©2008 The Research Valley Innovation Center

6. An Outline of A Business Plan
1. Executive Summary
2. The Business Model and Financial Goals
3. Market Analysis
4. Solutions
5. Go-to-Market
6. Operations, Production, and Supply
7. Organization
8. Major Milestones with Funding
9. Financial Projections
(Entrepreneurship 2011)
February 28, 2012 ©2008 The Research Valley Innovation Center

7. Market Analysis
Unmet clinical needs
Market size/growth rate/segmentation
Existing treatment options
Pricing/reimbursement
February 28, 2012 ©2008 The Research Valley Innovation Center

8. An Example – a new drug
for AIDS
Unmet clinical needs: “In 2007, HIV was the 6th leading
cause of death for those ages 25–44, down from #1 in 1994 and
1995”
Market size:
40 million globally
1.1 million at US, 50,000 new infections every year
Has been stable for a decade
$14.1B federal funding for care in 2011
( Kaiser Family Foundation Fact Sheet: The HIV/AIDS Epidemic in the United States, Dec 2011.)
February 28, 2012 ©2008 The Research Valley Innovation Center

9. An Example – a new drug for
AIDS (continued)
Existing treatment options:
About 30 Anti-retroviral drugs, $9.2B sales in 2010
• Nucleoside analogues: GSK’s AZT
• Protease inhibitors: Abbott’s Ritonavir
• Fusion inhibitor: Roche’s Fuzion
• Entry inhibitors: Pfizer’s Selzentry
• Integrase inhibitors: Merck’s Isentress
(IMS Health, National Sales Perspectives, Dec 2010)
February 28, 2012 ©2008 The Research Valley Innovation Center

10. An Example – a new drug for
AIDS (continued)
Who will pay for the drug?
What is the price of the drug?
February 28, 2012 ©2008 The Research Valley Innovation Center

11. Thank You!
Questions?
pzhou@researchvalley.org
(979) 260-1755
February 28, 2012 ©2008 The Research Valley Innovation Center