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  • Title: C__DOCUME~1_JARADR~1_LOCALS~1_Temp_plugtmp-83_AEM_122_slides_2.4.08
  • Type: Notes
  • School: Cornell
  • Course: AEM 1220
  • Term: Spring

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122 AEM Spring, 2008 Entrepreneurship in the Life Sciences: An Overview Professor Bruce Ganem Department of Chem & Chem Biol/Baker Lab Johnson Graduate School of Management Cornell University Ithaca, NY 14853 bg18@cornell.edu Experience Launching Life Sciences Companies NovaSterilis, Inc Bridging the Pipeline Gap: From Research Idea to Product Academia Hypothesis/Idea Research Discoveries Challenges of Early Stage Life Sciences Startups Research Development ly ear anies ) (too comp e stag Industry Inventions Products Commercialization $$$ Knowledge Proceeds from Stock R&D Sales Products Marketing/Sales Manufacturing Bridging the Funding Gap: Venture Capital? (Maybe) IPOs Disclose the Many Risks in Life Sciences Companies Inventor/ Entrepreneur RISK! Researcher ?? Financial Capital RISK AVERSE! Some of the Risks in Life Sciences Companies Financial Intellectual Property Scientific Operational Market Regulatory Risk in Life Sciences Companies: FINANCIAL RISK Usually significant losses since inception... and for the foreseeable future May never achieve or maintain profitability Failure to raise capital when needed, forcing delays, reduction, elimination of product development or commercialization efforts ArQule's Financial Performance 1996-2008 Risk in Life Sciences Companies: INTELLECTUAL PROPERTY RISK Failure to protect proprietary information Failure to secure IP protection Infringement risks -1.32 0.02 -0.54 -0.90 -0.24 -2.35 -4.00 -1.28 -0.77 -0.65 -1.33 -1.36 Failure to comply with third party licenses Earnings/Loss Per Share Risk in Life Sciences Companies: RISK SCIENTIFIC Heavy dependence on most advanced product May be early clinical or preclinical Preclinical problems may delay clinical entry, adding costs and commercialization risks Adverse effects of reliance on collaborations Inability to enroll patients in clinical trials Risk in Life Sciences Companies: OPERATIONAL RISK Use of hazardous materials may require environmental, governmental compliance Cost/availability of materials necessary to manufacture product candidates may be compromised Third-party risks: costs, timing, supplies Risk in Life Sciences Companies: MARKET RISK Market opportunities: smaller than expected Market acceptance: difficult to predict Physicians, medical community Patients Third party payors Risk in Life Sciences Companies: REGULATORY RISK FDA approval International regulatory approval Orphan drug approval Reimbursement approvals Third-party payor approvals Pricing approvals Third party liability risks NovaSterilis, Inc Loss of sales/marketing channels Failure to expand capabilities when necessary Risk in Life Sciences Companies: ALL THE OTHER RISKS... Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel. Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop. We face substantial competition which may result in others discovering, developing or commercializing products before or more successfully than we do. QUESTIONS? ...from Idea to Business Bruce Ganem, Scott Allen February 11th, 2008

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Path: USC >> BME >> 402 Spring, 2007
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Path: USC >> ECON >> 203 Fall, 2007
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Path: Colorado >> THTR >> 1009 Spring, 2007
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