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A Decade of Data

A Decade of Data. Scott Billman, Biogen Larry Kranking, Commissioning Agents, Inc. Jim McGlade, AIA, BHDP Architecture ISPE CASA Technology Conference March 31, 2016. Agenda. Welcome Overview of FOYA Program Submittal Data Review 2005-2015 Industry Trends 2005-2015 Future Trends.

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A Decade of Data

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  1. A Decade of Data Scott Billman, Biogen Larry Kranking, Commissioning Agents, Inc. Jim McGlade, AIA, BHDP Architecture ISPE CASA Technology Conference March 31, 2016

  2. Agenda Welcome Overview of FOYA Program Submittal Data Review 2005-2015 Industry Trends 2005-2015 Future Trends

  3. FOYA Overall Winners

  4. FOYA Program Overview • Purpose • Annual program that recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, to reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery • Categories • Equipment Innovation • Facility Integration • Operational Excellence • Process Innovation • Project Execution • Sustainability • Facility of the Future (beginning 2016) • Submittals to date >150

  5. Project Delivery Methods

  6. Types of Facilities

  7. Submissions by Regions

  8. Facility Types - Asia

  9. Facility Types - Australia

  10. Facility Types – Europe

  11. Facility Types – North America

  12. Facility Types – South America

  13. Submittal Data Review 2005-2015 ALL PROJECTS

  14. Submittal Data Review 2005-2015 PARENTERAL • Over 60% delivered by Design/Bid/Build method (highest) • 25% submitted in 2011 • 1% under budget • 11.5% Out-of-House Engineering fees • 8.8% Construction Management fees

  15. Submittal Data Review 2005-2015 BIOLOGICS • 98% of submissions from North America and Europe • 31% delivered by GMP method (highest %) • 7% under budget • 17.9% Out-of-House Engineering fees • 12.7% Construction Management fees

  16. Submittal Data Review 2005-2015 API • 98% of submissions from North America and Europe • 0% delivered by GMP method • 7% under budget • 7.3% Out-of-House Engineering fees • 4.8% Construction Management fees

  17. Submittal Data Review 2005-2015 LABORATORIES • 63% of submissions from North America • All delivery methods used • 19% under budget • 10.0% Out-of-House Engineering fees • 6.2% Construction Management fees

  18. Submittal Data Review 2005-2015 Oral Solid Dosage • 67% of submissions from Europe • All delivery methods used • 5% under budget • 14.2% Out-of-House Engineering fees (12% w/out largest project) • 14.9% Construction Management fees (8% w/out largest project)

  19. Industry Trends 2005-2015 • Endless repositioning – mergers, acquisitions, & partnerships • Average time to develop a drug > 10 years • Clinical trial approval % rate • R&D spending increased 28% • Revenue increased 63%

  20. Industry Future Trends • Endless Repositioning will continue • Projected growth – 5% annually • Maturing Market Opportunities • Biologics Growth • Gene Therapy • Disposables

  21. Facility of the Future • Constants • Still the last piece of the pill puzzle • Premium for speed • Changes • Flexibility • Sustainability • Continuous manufacturing & quality verification • Real-time release testing • Technology

  22. Discussion, Questions, Comments

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