Dendreon: Fast Growth Biotech

1. Bill Clark Manager , Seattle Facilities & Engineering Space Planning, BMRAM System Owner Dendreon: Fast Growth Biotech

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

3. Dendreon Milestones • 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

4. Getting started with 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

5. Rolling out R2 • 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

6. Growing pains • SOP’s • Written to have flexibility • WO’s • Paper • Electronic • Work request • Use BMRAM • Use email and create WO

7. Challenges with rapid growth • 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

8. Dendreon: Our challenge today • 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

9. How we use R2 today • 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

10. Lessons Learned • 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

11. Solution for paper manual entry • Objective: One time data entry • Eliminates duplicate effort • Reduces errors by transcription • Promotes sharing of information • Increases data integrity

12. Major lesson learned - Foundation 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

13. Configuration Standardized • Driven by the business • Standardize • Calibrations • Maintenance • Global service contracts • Like for Like spare parts • Site specific • Vendors • Regional driven maintenance • Weather

14. R2-R3 in a GMP environment • 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

15. Quality by Design • 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

16. New product = new challenges • 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

17. R3 shows the way to the future • 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.

18. My vision • 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

19. Questions?