A DECADE OF DATA Scott Billman Biogen Larry

A DECADE OF DATA Scott Billman, Biogen Larry Kranking, Commissioning Agents, Inc. Jim Mc. Glade, 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

FOYA Overall Winners Connecting Pharmaceutical Knowledge ispe. org

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 Connecting Pharmaceutical Knowledge ispe. org

Project Delivery Methods Other 6% Design/Build 33% Design/Bid/Build 48% GMP 12% Connecting Pharmaceutical Knowledge ispe. org

Types of Facilities Other 7% Parenteral 32% OSD 20% Laboratory 9% Biologics 20% API 13% Connecting Pharmaceutical Knowledge ispe. org

Submissions by Regions South America 2% Asia 21% North America 37% Australia 1% Europe 39% Connecting Pharmaceutical Knowledge ispe. org

Facility Types - Asia Other 4% API 22% Parenteral 35% Lab 9% OSD 30% Connecting Pharmaceutical Knowledge ispe. org

Facility Types - Australia Lab 50% Biologics 50% Connecting Pharmaceutical Knowledge ispe. org

Facility Types – Europe Other 5% API 9% Parenteral 33% Biologics 23% Lab 7% OSD 23% Connecting Pharmaceutical Knowledge ispe. org

Facility Types – North America Other 10% API 12% Biologics 24% Parenteral 34% OSD 7% Connecting Pharmaceutical Lab 12% Knowledge ispe. org

Facility Types – South America Biologics 33% OSD 67% Connecting Pharmaceutical Knowledge ispe. org

Submittal Data Review 2005 -2015 ALL PROJECTS Average Project Area • 109, 279 sf • 10, 156 sm Total Direct Costs • $604/sf • $6, 459/sm Connecting Pharmaceutical Total Installed Costs • $780/sf • $8, 359/sm Knowledge Total Project Costs • $843/sf • $9, 068/sm ispe. org

Submittal Data Review 2005 -2015 PARENTERAL Average Project Area • 128, 667 sf • 11, 958 sm Total Direct Costs • $767/sf • $8, 255/sm Total Installed Costs • $948/sf • $10, 197/sm Total Project Costs • $1, 034/sf • $11, 121/sm • 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 Connecting Pharmaceutical Knowledge ispe. org

Submittal Data Review 2005 -2015 BIOLOGICS Average Project Area • 100, 917 sf • 9, 379 sm Total Direct Costs • $937/sf • $10, 082/sm Total Installed Costs • $1, 318/sf • $14, 180/sm Total Project Costs • $1, 571/sf • $16, 902/sm • 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 Connecting Pharmaceutical Knowledge ispe. org

Submittal Data Review 2005 -2015 API Average Project Area • 53, 472 sf • 4, 969 sm Total Direct Costs • $451/sf • $4, 855/sm Total Installed Costs • $487/sf • $5, 237/sm Total Project Costs • $504/sf • $5, 421/sm • 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 Connecting Pharmaceutical Knowledge ispe. org

Submittal Data Review 2005 -2015 LABORATORIES Average Project Area • 89, 255 sf • 8, 295 sm • • • Total Direct Costs • $292/sf • $3, 142/sm Total Installed Costs • $329/sf • $3, 537/sm Total Project Costs • $330/sf • $3, 550/sm 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 Connecting Pharmaceutical Knowledge ispe. org

Submittal Data Review 2005 -2015 Oral Solid Dosage Average Project Area • 139, 096 sf • 12, 927 sm Total Direct Costs • $281/sf • $3, 025/sm Total Installed Costs • $340/sf • $3, 661/sm Total Project Costs • $382/sf • $4, 113/sm 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) • • Connecting Pharmaceutical Knowledge ispe. org

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% Connecting Pharmaceutical Knowledge ispe. org

Industry Future Trends • Endless Repositioning will continue • Projected growth – 5% annually • Maturing Market Opportunities • Biologics Growth • Gene Therapy • Disposables Connecting Pharmaceutical Knowledge ispe. org

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 Connecting Pharmaceutical Knowledge ispe. org

Discussion, Questions, Comments Connecting Pharmaceutical Knowledge ispe. org