Bill Clark Manager , Seattle Facilities & Engineering Space Planning, BMRAM System Owner

            84-90 90-91 91-92 92-95 95-98 98-99 99-02 02-05 05-07 07-09 09-10 10-Pres Reactor Operator Instrument Technician Validation Technician Supervisor, Validation – U.S. Navy – Immunex – Immunex – Immunex Manager, Eng. Services – Immunex Manager, GMP/R&D Maintenance – Immunex Manager, Maintenance & Utilities – Immunex Area Manager, Maint. & Cal’n Maint. & Utilities Specialist Maint. Mgmt. Sys. Lead Facilities Manager – Amgen – Amgen – Snohomish Co PW – Acucela Manager, Facilities & Engineering – Dendreon

      Edgar Engleman and Samuel Strober Founded Activated Cell Therapy in 1992 in Mountain View, CA 1995 Name changed to Dendreon and moved to Seattle 2000 Started up R2 BMRAM in Seattle Provenge data presented April 2009 April 29, 2010, PROVENGE® received FDA approval Oct. 2012 R3 for non GMP

 Driven by Validation Dept. 2000  F&E created in 2006-7  Priority given to having a regulated compliant location of documents  Focus was on the GMP equipment.

 Enrollment (Induction)  Validation  Calibration  Maintenance

    Seattle, WA Morris Plains, NJ One team  Travel from site to site  All paper process  All hands effort at the site level to record on paper  Corporate team entered the data ▪ Calibration ▪ Maintenance ▪ Validation With the burden of a manual process and the timeframe given only critical information was entered

  SOP’s  Written to have flexibility WO’s  Paper   Electronic Work request  Use BMRAM  Use email and create WO

 Post approval of Provenge  Rapid growth to meet high expectations ▪ From 200 to 1200+ employees in ~12 months  Facilities & Engineering joins Dendreon in 2006-7 ▪ 4 sites by the end of 2011 ▪ Seattle HQ and R&D  Facilities Management ▪ Morris Plains, NJ Manufacturing Plant  Facilities & Engineering ▪ Seal Beach, CA Manufacturing Plant  Engineering & Metrology ▪ Union City, GA Manufacturing Plant  Engineering & Metrology  Similar processes, but not identical

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Multi sites

 Individual flavors ▪ Similar processes are not consistent ▪ Sharing of best practices cannot be implemented  Efficiencies not realized across all sites  Central oversight/mandate  Bringing all our experience together

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GMP Calibrations and Maintenance

 Calibration and Maintenance of QC equipment  Calibration and Maintenance of Manufacturing  Maintenance of Utilities  UC has started parts inventory and is mostly paperless  Validation ▪ CSV ▪ IOQ ▪ Requalification 

30 users license

  Manual data entry is not the way to go Leverage technology   Hardware Keep current with your software  Work arounds are often addressed with the next HF, SR, or Revision. R3

 Objective: One time data entry  Eliminates duplicate effort  Reduces errors by transcription  Promotes sharing of information  Increases data integrity

Without recognition  No release management from IT   Part time support from IT Upgrades compete with Enterprise Systems ▪ Payroll ▪ Quality Systems ▪ ▪ ▪ ▪ Document management Training Change Control ER’s, CAPA tracking and approval

   Driven by the business Standardize ▪ Calibrations ▪ Maintenance ▪ ▪ Like for Like spare parts Site specific ▪ Global service contracts Vendors ▪ Regional driven maintenance ▪ Weather

 Good Engineering/Maintenance practices  Scheduled PM’s and Cals  Documentation ▪ Work plans ▪ Calibration (MDT’s)  Second check work out of the ordinary  Established roles and approvals  QA oversight (an added process for GMP)  Validation  QA review and approval (Quality by Design) ▪ Review where it adds value

   Foundation are the work rules  Reviewed and approved up front  Auditable by Quality Assurance 24/7 Focused on value added review of daily work  If a work plan or calibration is completed as planned, no QA post review of the work is required.

 All On-Demand WO’s are reviewed ▪ Except – restock it’s such as light bulb replacements A base level of competency in our staff is required

  Budget constraints Competing priorities  Business Case ▪ Dependent on historic data to show improvement  A major benefit  Everyone in F&E wants an easier way to track Calibration and Maintenance

    Approved in earlier 2012 for non GMP work Demonstrate improvements based on lessons learned Gain experience without the constraints of a GMP environment Test how our future GMP configuration would look.

     All work (Calibration & Maintenance) performed by F&E documented One time data capture (document of record) Parts tracked SOP’s for who and why Work plans/Events for what and when  Thank you again for this opportunity