Sustainability & Green Chemistry in Pharma


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

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  • Sustainability & Green Chemistry in Pharma

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