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
Industry Trends
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
Average Project Area
109,279 sf
10,156 sm
Total Direct Costs
$604/sf
$6,459/sm
Total Installed Costs
$780/sf
$8,359/sm
Total Project Costs
$843/sf
$9,068/sm
Submittal Data Review
ALL PROJECTS

14. Submittal Data Review 2005-2015
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
Submittal Data Review
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
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
Submittal Data Review
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
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
Submittal Data Review
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
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
Submittal Data Review
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
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
Submittal Data Review
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
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 Changes
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