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09 September 2008

Continuously Improving CI Lisa Cozza , Sr. Director, Mfg Alliances Mark Stacey, Director, Strategic Sourcing & Procurement Jon Conary , Sr. Director, Mfg Ops Donna Dimke , Sr. Director, Project Management Human Genome Sciences. 09 September 2008. Agenda. Company Background

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09 September 2008

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  1. Continuously Improving CI Lisa Cozza, Sr. Director, Mfg AlliancesMark Stacey, Director, Strategic Sourcing & ProcurementJon Conary, Sr. Director, Mfg OpsDonna Dimke, Sr. Director, Project ManagementHuman Genome Sciences 09 September 2008

  2. Agenda • Company Background • History of CI at HGS (2004-2008) • Successes • Lessons Learned • CI as we head into 2009 • Maneuvering the Inevitable CI Roadblocks

  3. HGS – Company Overview • Founded in 1992 • Rockville, Maryland and Düsseldorf, Germany • Almost 900 employees, with ~ 500 in Ops • State of the art manufacturing facilities designed multiple products and high quality • Publicly traded on NASDAQ • Over 600 patents to date • Pipeline of products in late stage clinical development • Immunology • Infectious Disease • Oncology • 3 clinical phase III processes validation programs underway

  4. HGS Belward Manufacturing Campus LSM 2x 20K Microbial CC 2x 1.6K CC

  5. Continuous Improvement at HGS HGS has been putting CI ideas into practice since 2005 Employees now believe that CI can be applied to almost everything that is done at HGS

  6. HGS Prior to CI – Late 2004 • Shifted focus to late-stage Process Development, Manufacturing, and Commercialization • Hired senior management from biopharm and large pharma with commercial and CI experience • Emerging business case for CI • Six manufacturing sites of various scales, several administrative buildings and decentralized functions • Redundancy and waste was evident • Significant efforts went in to reorganize and consolidate our facilities

  7. CI’s Evolution at HGS 2008: Involvement of Mgt Change in CI Leadership Inclusion of Finance & IT Goal of $3M in savings 2007 – CI is contagious Change in CI Leadership 2 FT CI staff & PR campaign 249 trained; 43+ projects 2006 – Keep it up Change in CI Leadership Steering Committee & Metrics 215 trained; 22 kaizens 2005 - Introduction of LEAN Outside consultant & trainer 169 trained; 17 kaizens HGS Champion

  8. Introduction of Lean - 2005

  9. Introduction of Lean - 2005Program Roles & Responsibilities CI Champion: Lisa Cozza •  Arrange external training  Establish kaizen projectsSet up kaizen teams • CI as side project from MFG duties • Begin buy in process for key stake holders Trained Employees  Some participate on kaizens

  10. Introduction of Lean – 2005Training Program

  11. Introduction of Lean - 20052005 Success and Lessons Learned • Groundbreaking at HGS • Most staff were not from other industries, new concepts • Groundswell of excitement with most • Started kanbans • Built inventory excess awareness • Key stakeholders were not entirely convinced • New concept; unproven • Flavor of the month – will this really last? • Measuring success was weak at best • Culture was not entirely ready to embrace – seen as an operations only program

  12. QC Laboratories - Use of Kanbans • QC Inventory and organization problems - Solved

  13. CI’s Evolution at HGS 2008: Involvement of Mgt Change in CI Leadership Inclusion of Finance & IT Goal of $3M in savings 2007 – CI is contagious Change in CI Leadership 2 FT CI staff & logo 249 trained; 43+ projects 2006 – Keep it up Change in CI Leadership Steering Committee created 215 trained; 22 kaizens 2005: Introduction of LEAN Outside consultant & trainer 169 trained; 17 kaizens HGS Champion

  14. 2006 – Keep it Up!

  15. 2006 – Keep it Up! Program Roles & Responsibilities CI Champion – Mark Stacey  Chair Steering Committee  Establish kaizen projects  Set up kaizen teams  CI as side project from MFG duties CI Steering Committee • Select kaizen projects  View kaizen presentation & improvements Sustain and grow program • Company metrics published Kaizen Team Members  Participate on kaizens

  16. 2006 – Keep it Up! Training Program

  17. 2006 – Keep it Up! Successes and Lessons Learned • Created a cross functional, senior leadership, steering committee: • Increased visibility • Helped overcome roadblocks • Committed resources • Formalized program elements beyond training and projects (mission, vision, roles) • Development of corporate metrics – now on the front page of intranet • Tracked projects until completion encouraged measurements • Don’t try and hit the homerun • Don’t overextend the scope of the program. Stay focused • Overestimated the value of cross functional teams • Underestimated the value of using the tools

  18. HGS Metrics • Provides graphic “dashboard” on intranet home page that easily relays overall company health to employees • Indicator allows navigation to the metrics home page that provides more detailed information on each metric • Tracking Program Milestones • Mfg Success Rate • Quality Performance • HGS Retention • Financial Performance

  19. CI’s Evolution at HGS 2008: Involvement of Mgt Change in CI Leadership Inclusion of Finance & IT Goal of $3M in savings 2007 – CI is contagious Change in CI Leadership 2 FT CI staff & PR Campaign 249 trained; 43+ projects 2006 – Keep it up Change in CI Leadership Steering Committee & Metrics 215 trained; 22 kaizens 2005: Introduction of LEAN Outside consultant & trainer 169 trained; 17 kaizens HGS Champion

  20. 2007 – CI is Contagious!

  21. 2007 – CI is Contagious! Program Roles & Responsibilities CI Champion - Jon Conary  Supervise full time CI employees  CI ExpertSubmit project ideas  Provide program guidance Full Time CI Employees (n = 2)  Program strategy & implementation  Generate & deliver training  Communicate program updates  Serve on kaizen teams CI Steering Committee • Select kaizen projects  View kaizen presentation & improvements CI PR Campaign Yellow Belts, Kaizen Team Members, All HGS Employees  Participate on kaizens  Apply CI within own work groups

  22. 2007 – CI is Contagious! Training Program

  23. 2007 – CI is Contagious! Successes and Lessons Learned • Program transitioned to more integrated program focused on closing operational gaps and inefficiencies • Impact of two FTE’s dedicate to CI • CI no longer an afterthought • PR Blitz raised visibility • Build it and they will come • Choose your projects wisely • We need Sr. Management buy-in • You can not over advertise

  24. Logo Development and Significance

  25. Recognition and Rewards CI projects that fall below the limited scope/moderate value reward threshold are eligible for non-cash rewards, such as items from the Company Collection or Amex gift certificates.

  26. 2007 – CI is Contagious! Examples of Success Corporate Goal: Complete conformance lots for two programs by 31 Dec 07 • Issue 1: Two batches lost due to contamination • $1.4 million in lost time, materials • Issue 2: Deviation closure • Inefficient, detracts from implementing corrective actions

  27. Identification: Contamination enters manufacturing suites in 5 ways People Equipment Material Resolution: Kaizen to address Material/Equipment flow SOPs aligned for all areas Changes to cleaning strategy appropriate to room classification Cleaning equipment added to airlocks to facilitate cleaning of material/equipment brought into the suite Air Water Issue #1: Lost batch due to contamination

  28. Continuous Improvement in Action

  29. Issue #2: Deviation closure rates • Identification: Improve deviation closure process • QR closure rate below what is expected for commercial production • 65% in January vs. goal of 85% • Resolution: Held Kaizen event to foster new business processes for deviation closure • Revision of SOPs and Work Instructions • Routine forum for Ops Managers • Improved CAPA to reduce the number of deviations • Creation of Manufacturing Specialist role

  30. Business Impact: Deviation Closure Kaizen • Increased QR Closure rate from 65% to >90% • Decreased number of batches lost due to contamination – enabling conformance lot production for ABthrax • Fostered collaborative process review

  31. Old Methodology Departmental focused solution – “I will handle it, leave me alone” Unclear accountability “Let’s just make more” New Methodology Kaizen Cross-functional teams People on the floor Remove things that get in the way FMEA – prevent issues before they occur Changes in Behavior Fostered By CI

  32. CI’s Evolution at HGS 2008: Integration of Sr. Mgt Change in CI Leadership Inclusion of Finance & IT Goal of $3M in savings 2007 – CI is contagious Change in CI Leadership 2 FT CI staff & PR Campaign 249 trained; 43+ projects 2006 – Keep it up Change in CI Leadership Steering Committee & Metrics 215 trained; 22 kaizens 2005: Introduction of LEAN Outside consultant & trainer 169 trained; 17 kaizens HGS Champion

  33. Late 2008….CI Strengths • Basic structure established with mission, goals, metrics and CI website • Developed good processes to support program • CI mindset is growing within Ops functions; more generation of ideas from the floor • Having FT CI has driven CI program farther than anticipated • Three out of 5 of the senior Ops mgt have involvement/fully back program

  34. Late 2008….CI Strengths • Project selection • Successfully launched multiple smaller CI projects • Improving project vetting process • Project accountability • FT CI role has been a key driver in pushing teams • CISC implemented sponsor roles • CI Public Relations • Communication via Sr. Ops Mgt meetings has raised awareness and impact • Happy Hours, Company meetings, CI website, café table tents and posters have helped drive visibility

  35. Late 2008….CI Challenges • CI resource buy-in while headcount is tight • Increase high impact CI projects • Increasing the cross functionality of CI participation • Increase ability to financially quantify output from kaizens • Increase communication of business results from completed kaizens • Continuously improve CI program

  36. 2008 – Integration of Senior Management to the Program – or – “If you can’t beat ’em, join ’em”

  37. 2008 - Integration of Senior Management Ops Senior Management (VP’s) Advisory Board  Approve project selection  View kaizen presentationsAccountable for kaizen completion  Serve as project sponsors • Senior and functional management • Most are CI experts • Review kaizen results and impact  Feedback on program  How & when to expand beyond Ops Full Time CI staff (n = 1)  Program strategy & implementation  Facilitate CI Team Generate & deliver training  Communicate program updates  Solicit project approval at DRM  Serve on kaizen teams CI Team (25% of time dedicated to CI)  CI Functional Experts  Drive CI into respective dept  Generate project ideas  Provide training  Remove roadblocks  Quantify kaizen outcomes Yellow Belts, Kaizen Team Members, All HGS Employees  Participate on kaizens  Apply CI within own work groups Raise CI project ideas from the floor

  38. 2008: Training Program

  39. Project Selection Flow Chart • Sr. Mgt Approves CI projects • Sr. Ops Mgt reviews, ranked by CI • May add own ideas to the mix • Decides on those most critical to the business • Assign Sr. Mgt Sponsor • Review and agree to resources and timeline for output • CI Filters the CI ideas • Does some initial data digging • Is this a CI issue or mgt issue? • Complexity? • Potential Impact on business? • Who can lead this project? • Gives it a rating to review at DRM • CI Project Idea Generation • On the Floor: White belts participants, venting, Suggestion Cmte, random conversations • Management: Supervisors, Mgrs, DH and Sr. Ops • CI and functions outside of Ops

  40. Sample CI Project Filter

  41. Maneuvering the Roadblocks: Resistance • Not in my backyard; broadening the impact • Added non Ops to CI Steering Committee • Executed cross functional projects • 5 S in PD, Manufacturing and Quality Labs • HR Hiring Process • Freezer Kaizen • Move to GPM and inclusion of finance and IT in all projects • Not my resources • Voluntary sign-up for training – when people are free • Flexibility in kaizen project implementation • Involved mgt in commitment to projects & people involved • Increased accountability of CI outcomes • All major functional Ops areas have a 25% resource for CI

  42. Maneuvering the Roadblocks: Balancing Top Down & Bottom Up • Most ideas should be generated on the floor • Dept or functional white belt sessions • HGS Suggestion Committee • 50% come from random conversations with CI folks (“venting”) • But management controls the resources and can prioritize based on business impact • Vet projects and resources to prioritize • Sr. Mgt take on sponsor role • Accountability for results and implementation

  43. Maneuvering the Roadblocks: Lack of Visibility • 2007 – The LISC PR campaign • Rewards program • Goal achievement • Logo contest • All Company Meeting /Happy Hours • Regular updates at management mtgs • 2008 • Built into many individual goals • Finance and IT involvement at project level • Presenting results to Sr. Ops Management • Move CI to Project Management • Future: HGS’ Sr. Mgt / CI Advisory Board

  44. Build it and they will come • Build your business case • Start with outside help then develop an internal program, own it – make it unique to your culture • Demonstrate results – then publish • Involve as many stakeholders as possible • Provide rewards or incentives for CI • Realize that the program will need to evolve—and embrace the changes

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