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Sustainability & Green Chemistry in Pharma


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One approach to developing a modest sustainability program, including green chemistry initiatives.

One approach to developing a modest sustainability program, including green chemistry initiatives.

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    • 1. Gilead’s Sustainability and Green Chemistry Efforts Phylmar Regulatory Roundtable Lockheed Martin Missles & Space Sunnyvale CA October 22 2008 Laura D. McHugh, PE, MBA Director, Environmental Health & Safety Gilead Sciences, Inc. – Foster City CA
    • 2. About Gilead Sciences, Inc.
      • Mission
        • Discover, develop and commercialize medications to advance the care of patients suffering from life-threatening diseases in areas of unmet medical need.
      • Primary Areas of Focus
        • Antivirals for HIV/AIDS and chronic hepatitis.
        • Cardiovascular conditions such as pulmonary arterial hypertension and resistant hypertension.
        • Respiratory diseases including influenza and cystic fibrosis.
    • 3. Gilead Sciences, Inc.
      • Headquartered in Foster City, California.
      • Established in 1987.
      • 2007 annual revenues exceeded $4 billion.
      • Eleven FDA-approved drugs.
      • Operations spanning three continents (North America, Europe and Australia) and a staff of more than 3,000 employees.
        • Corporate Offices in Foster City, California
        • R&D Labs in CA, WA, CO and NC (5 sites)
        • Manufacturing sites in CA, AB and IRE (4 sites)
        • Sales Offices Throughout World
    • 4. The Still-Maturing Bio-Pharma Sector
      • Not Big and Yet, Not Small
        • Many of The Potential Issues of Big Pharma, Without The Bureaucracy and/or Resources
      • Fast-Paced and Dynamic Environment
        • Financial Pressure/Focus on Pipeline, Not Safety!
      • High Growth Rate/Turnover in Research Staff
        • Medium to Low Awareness of Safety and Compliance; Mixed Bag of Safety Programs from “Where I Got My PhD”
      • Scientific Company/Many PhDs on Staff
        • Excellent Knowledge of Chemistry and Technology
        • Can Be Somewhat Prone to Pushback on Safety
    • 5. Environmental Health & Safety
      • ISO 14001 Framework for Environmental Management Implemented in 2002
        • EH&S Policy signed by CEO
        • Global policies and procedures written for core elements in consultation with EH&S Steering Committee
        • Perform annual audits and implement corrective actions
        • Integrate EMS into routine Safety Committee meetings
        • Publish monthly performance reports on forward-looking metrics to senior management
    • 6. What’s Working Well?
      • Safety Goals Well Established; Experience Modification Rate (XMod) of 0.58
      • EMS in Place with Key Elements Implemented:
        • EH&S Performance Metrics Reporting
        • Incident Reporting and Investigation System
        • Learning Management System
        • Lab Safety Inspections Program
        • EH&S Audits Corrective Action Tracking Database
        • Chemical Management System
      • EH&S Best Practices Council Governs EH&S Programs
    • 7. “ Accidental” Successes
      • Pilot Plant Design/Construction in 2006
        • Zero Air Emissions – KOPs
        • Zero Wastewater Discharge; Water Cleaning Substitutes for Solvents Where Possible
        • Acid Scrubber System Further Reduces Emissions
        • Careful Monitoring of Solid Wastes for Characterization Prior to Disposal
        • Safety Summary Review Drives Substitution of Less Toxic Chemicals When Possible
      • Environmental Benefits
        • Shift from air and water emissions from direct to waste incineration
        • More awareness of environmental impacts of operations; improvement over smaller pilot plant (ca 1990)
    • 8. “ Accidental” Successes
      • Chemical Management System
        • Help researchers shop “in house”
        • 6,000 chemicals on-site
        • Many expire and must be disposed at 8-10x original purchase cost
      • Environmental Benefits
        • Use raw materials more efficiently; reduce purchasing costs
        • Avoid waste disposal through use
        • Improve safety through reduction of inventory and more timely clean-outs
        • Lessen permitting-associated burdens on EH&S staff
      Chemical Management System Brought to you by EH&S and Lab Services
    • 9. Why Sustainability Now?
      • More Visibility To Green Issues in Media
        • Shareholder and Institutional Investor Inquiries to the Board of Directors
        • Employee Concerns
        • Some Employee Grass Roots Efforts
      • Concerns Advanced to Senior Management
        • Public Affairs
        • Investor Relations
        • HR Employee Communications
      • EH&S Selected to Lead 2008 Initiative
    • 10. EH&S Poised To Take Action
      • Four Years of Voluntary Responses to the Carbon Disclosure Project
      • Baseline Data on GHG Collected in 2007 EH&S Audits
    • 11. Key Factors for Success
      • Top management commitment and support
      • Business and facility access to implementation tools and resources to implement recommendations
      • Measurement and recognition of progress
      • Effective communications to internal and external stakeholders and other interested parties
    • 12. Aspects/Impacts - Examples Air emissions (exhaust) Water consumption Fuel release (accidental spills) Fuel release (accidental spills) Noise generation Energy consumption (hoods/lights) Paper use Air quality degraded Water resource depleted Storm water contaminated Soil contaminated Area nuisance Increased CO 2 Landfill space conserved, raw materials conserved Aspect Impact
    • 13. Backcasting to Identify Alternatives
      • Method for Identifying Priorities and Developing Recommended Alternatives
        • Key Impacts Easily Identified Using GHG Footprint Data
        • Forced Ranking Identified Four Key Aspects and Impacts
          • Transportation/Employee Travel – Commute and Work-related
          • Water Use
          • Waste – Hazardous and Solid
          • Energy Use
        • Core Team Brainstorming in Small Groups
        • Where should we be in 5, 10, 25 years?
        • If we want to be at “x” in 10 years, what do we have to be doing differently today?
    • 14. Key Proposed Initiatives - 2009
      • Energy Saving Measures
        • Years 1 & 2: insulation of buildings, daytime sensors for lights, dual-pane windows, tinting, window covers, conservation education
        • Use up to 80% renewable energy sources by Years 5 to 15
      • Transportation Planning/Trip Reductions
        • Increase participation on Employee commuter programs by 50% in 2009
        • Increase sales fleet increase fuel efficiency (overall) by 60% by Year 5
        • Conduct 1 of 5 meetings currently requiring travel by webinar/virtually by Year 5
        • Reduce employee commutes by 20% from current levels in Year 5 – consider: adjusted work schedules (4X10), allow telecommuting, encourage walk to work, technology to monitor, promote chemical-less research, increase car/vanpooling, allow non-peak commutes by changing work hours
    • 15. Key Proposed Initiatives - 2009
      • Water Use
        • Gradually replace landscaped elements with xeriscape (no watering required) plants by Year 5; total xeriscaping by Year 15
        • Install water efficient appliances in restrooms, break rooms and labs by Year 5 to reduce water usage by 20% (low flow urinals, dual flush toilets, motion activated faucets)
      • Solid/Hazardous Waste
        • Continue to improve hazardous waste minimization – decrease hazardous waste generated per researcher by 3% per year
        • Ensure all new breakrooms and cafes are equipped with recycle program bins and communications information
      • Other
        • Create disincentives for departments that continue to use paper – internal premium (tax) on paper use
        • Create employee and shareholder communications plan
    • 16. Green Chemistry – 12 Principles*
      • Prevent waste rather than treat it.
      • Incorporate all raw materials into final product.
      • Use synthetic methods.
      • Design chemical products to reduce toxicity.
      • Phase out solvents/other intermediates.
      • Use energy efficient processes.
      • Use renewable raw materials.
      • Reuse chemical intermediates to reduce waste.
      • Select catalysts to carry out single reaction many times.
      • Use chemicals that break down.
      • Develop better analytical techniques for real-time monitoring.
      • Use chemicals with low risk for accidents, fires and explosions.
      *PT Anastas and JC Warner. Green Chemistry: Theory and Practice. Oxford Science Publications, Oxford (1998).
    • 17. Combinatorial Chemistry – aka “Drug Synthesis”
      • What is Combinatorial Chemistry?
      • Technique to synthesize, in parallel, more than one compound.
      • Combinatorial chemistry techniques premiered in the 1980s.
      • Technologies Used
        • Hardware (automated dispensing robots, parallel reaction devices and analytical equipment)
        • Software tools (experimental design, well tracking and data analysis and archival, etc.).
      • ‘ Combinatorial design principles’ are defined as parallel synthesis guided by statistical design of experiments.
    • 18. The Drug Discovery and Development Process Family/Class of Compounds 1-2 Lead Compounds Small Scale Synthesis Scale Up/Pre- Manufacturing Fill/Finish Manufacturing Distribution/Sales
    • 19. Synthetic Methods
      • Replace OVAT with simultaneous process design and optimization.
      • Replace bench-top reactions with software modeling.
      • Goal: Speed process optimization and decrease costs and iterations of wet chemistry.
    • 20. Design Chemical Products to Reduce Toxicity/Phase Out Solvents
      • Pre-manufacturing phase refines the process chemistry to be as safe and environmentally-friendly as possible for large scale manufacturing.
      • Cost reductions realized by replacing exotic chemicals with routinely available ones.
      Use Chemicals with Low Risk for Accidents, Fires and Explosions
    • 21. Use Energy and Materials-Efficient Processes x
      • Miniaturize the chemical screening process through use of microplate well-plate technologies and robotics.
      • Decreases sample sizes from 50-100 milliliters to 5-10 micro-liters thus using less energy and creating less waste.
    • 22. Conclusion
      • Late entry into Sustainability Planning has saved time and effort – many benchmarking examples.
      • Green Chemistry is a challenge in a chemical synthesis business, and several principles are “baked in” to our processes, but it has it’s limits.
    • 23.
      • Laura D. McHugh – PE, MBA
      • Director, Global Environmental Health & Safety
      • Gilead Sciences, Inc .
      • 333 Lakeside Drive
      • Foster City CA 94404
      • (650) 574-3000
      • [email_address]