# Presentation: 184926

## 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**

## The Journey 

- Background
- Education
- Employment
- RidgeCom, Inc.
- Sterilex Corporation
- Mentors
- Path to Entrepreneurship
- Motivating Factors
- False Assumptions

## 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

## 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

## 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

## Biofilm is a Major Cause of Antimicrobial Resistance

- Biofilm: Highly structured, matrix-encased cooperative communities of microorganisms
- 80% of all human infections caused by biofilm

## 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

**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**

## 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

**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**

## 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

- 	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

**Control Of Biofilm Requires Targeted Technology**

## 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

## Dental Care
Food Processing
Water Treatment
Industrial Biodecontamination

- Food Processing
- Water Treatment
- Industrial Biodecontamination

**Current Sterilex Markets**

## 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

**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**

## The Sterilex Corporation

**Sterilex Ultra for Dental Unit Waterlines was awarded “Bio Product of the Year” for 2004**

**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. **

## 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

**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**

## 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

## Current Funding Sources 

- Revenues
- Personal Resources
- Other Businesses (Personal; Family)
- Loans (Personally Guaranteed)
- Grants

## Growth Strategy 

- Expand Sales and Marketing – Current Markets and Products
- New Technology Development
- Anti-Biofilm Disinfectants
- Preservatives
- Pharmaceutical Products
- Penetrate New Markets

## Personal Reflections 

- Why Do I Do This?
- Control
- Creative
- Challenging
- Always Learning – Never Boring
- Diverse and Fascinating People;  Technologies, and Occupational Settings
- ?? Financial Rewards

## 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

## 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

## 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

## 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