Starting, Surviving and Enjoying a Life Sciences Business

Starting, Surviving, and Enjoying a Life Sciences Business A Personal Story Shira Kramer, Ph.D. President Sterilex Corporation Biosciences Business Interest Group National Institutes of Health November 10, 2004 1 The Journey   Background    Education Employment RidgeCom, Inc. Sterilex Corporation     Mentors Path to Entrepreneurship Motivating Factors False Assumptions 2 RidgeCom, Inc.   Business Focus Epidemiologic Research and Analysis    Clients Petroleum Industry Pharmaceutical Companies Universities Professional Trade Organizations Law Firms (Toxic Tort Litigation)        Advantages Professional Service – Small Start-Up Costs Immediate Customer Base No Regulatory Barriers 3 Sterilex Corporation      History Military Contract – BW/CW Decontamination Technology Transfer to Non-Military Applications Founders Funding Regulatory Barriers   Sterilex Mission Antimicrobial Products Designed to Overcome Factors Related to Antimicrobial Resistance    Initial Technology Platform Targets Biofilm Hard Surface Applications 4 Biofilm is a Major Cause of Antimicrobial Resistance  Antimicrobial resistance: A worldwide public health threat  Biofilm-related resistance factors underlie failure of hard-surface antimicrobials and anti-infective agents Biofilm: Natural habitat for microorganisms Confers resistance to antimicrobial agents and virulence  5 Biofilm is a Major Cause of Antimicrobial Resistance  Biofilm: Highly structured, matrixencased cooperative communities of microorganisms  80% of all human infections caused by biofilm 6 Imperative For Biofilm Control In Many Settings  Medical  Nosocomial infections and deaths from reusable and indwelling medical and dental devices  > 100,000 deaths due to nosocomial infections  Resistance to antibiotics is escalating 7 Imperative For Biofilm Control In Many Settings (continued)  Food Processing     Foodborne pathogens cause 76 million illnesses/year High case fatality rate from E. coli and L. monocytogenes contamination New USDA regulations: Zero tolerance for Listeria in ready-to-eat meat and poultry plants > 20 million pounds of meat recalled per year  Industrial and Water Treatment    Legionella Product contamination and corrosion of equipment Fouling of processing systems 8 Control Of Biofilm Requires Targeted Technology  Polysaccharide matrix strongly adheres to surfaces and serves as a barrier to penetration and removal Microorganisms in biofilms express resistance (1000 times the dose of antimicrobials required) Conventional antimicrobials are not designed to penetrate biofilm    Not sufficient to kill the organisms – must remove the reservoir 9 Sterilex Anti-Biofilm Products Core technology platform rapidly attacks and removes biofilm from hard surfaces  Kills target microorganisms  Retards regrowth by completely removing the reservoir  10 Current Sterilex Markets Dental Care  Food Processing  Water Treatment  Industrial Biodecontamination  11 Current Status  Product status  Sterilex  Ultra products for dental infection control    Dental unit water lines Evacuation systems Enzymatic products for evacuation systems & ultrasonic cleaning Hard surface disinfection 12 The Sterilex Corporation ROCKVILLE, Md., April 27 /PR Newswire/ -- At a sold-out dinner last evening, The Technology Council of Maryland (TCM) announced the winners of the Annual Dinner and Tech Awards Celebration. Sterilex Ultra for Dental Unit Waterlines was awarded “Bio Product of the Year” for 2004 13 Current Status (continued)  Product status  Sterilex UltraKleen products in food/wine processing   Meat and poultry processing equipment and environmental surfaces Wineries and retail beer  Sterilex    UltraKleen products in water treatment and textile manufacturing Recirculating water cooling towers Wet processing systems Air washers 14 Major Barriers to Growth    Regulatory No biofilm claims ever allowed by EPA No standard tests for registering biofilm claims Test methods very early stage Current regulatory testing requirements for antimicrobial agents do not simulate natural conditions      Customer/Public Awareness What are biofilms? Conventional products are EPA registered 15 Current Funding Sources      Revenues Personal Resources Other Businesses (Personal; Family) Loans (Personally Guaranteed) Grants 16 Growth Strategy      Expand Sales and Marketing – Current Markets and Products New Technology Development Anti-Biofilm Disinfectants Preservatives Pharmaceutical Products  Penetrate New Markets 17 Personal Reflections    Why Do I Do This? Control Creative Challenging Always Learning – Never Boring Diverse and Fascinating People; Technologies, and Occupational Settings ?? Financial Rewards     18 Personal Reflections  The Challenges  Lack of Business Development and Management Training  Breaking Out of the R & D Comfort Zone  Building a Sales and Marketing Team  Personnel and Management Issues  Uncertainty – High Risk of Failure  Regulatory Risks  Funding  Dealing with Setbacks and Barriers  Isolation 19 Personal Reflections  Considerations and Advice      Understand your motivations, expectations, and risk tolerance Make sure there is a market Huge difference between a patent and producing a product that customers will buy Don’t become a grant mill Most valuable assets are products and customers 20 Personal Reflections  Considerations and Advice        Surround yourself with talented people Know your limitations Learn from your mistakes The journey can lead you to unexpected opportunities Be realistic about funding needs Do your homework about VC’s and potential investors Network 21 Organizations for Networking and Professional Support          Department of Business and Economic Development Technology Council of Maryland MD Bio Greater Baltimore Technology Council (CEO Roundtables) TEDCO Biomedical Management Institute Women in Bio Women’s High Tech Coalition MIT Forum 22