Transcript Slide 1

March 22, 2012
The Massachusetts BioReadyTM Community Campaign
Presented to
South Shore/Canal Regional Economic Development District
About MassBio
To foster a
positive
environment
that enables
each
biotechnology
company to
achieve its full
potential
Advocacy for
industry on
Beacon Hill
and Capitol Hill
MBC Member Benefits
Savings from 20-80% on
everything from lab gases,
lab equipment, supplies,
office equipment, energy
and much more.
110+ member meetings,
4,000 attendees
State & Federal
Policy
Economic
Development
Purchasing
Consortium
Networking &
Visibility
MassBio
Membership
Annual Events
MassBioEd
Foundation
Professional
Development
MassBioEd Courses,
MassBio Committee Meetings
About Biotechnology
The use of biological processes to solve problems or make useful products.
Biotechnology is a collection of technologies that capitalize on the attributes
of cells, such as their manufacturing capabilities, and put biological
molecules, such as DNA and proteins, to work for us.
Pharmaceuticals
are
chemical-based
medicines
Biologic-based
Medicines
Biologic-based
Medical Devices
Biological Research
Tools
Biofuels, AgBio,
Bio Industrials
Massachusetts Biotech Timeline
1953
Double helix of DNA explained by Watson & Crick
Biogen founded
1978
1980
1981
1985
U.S. Supreme Court approves patenting of recombinant life forms,
Passage of Bayh-Dole Act
Genzyme founded
MassBio becomes the 1st biotechnology
industry association
Map of the human genome is completed
Novartis locates Global Research HQ in Cambridge, MA
2000
2002
2003
MassBio issues Biotech 2010 Report
BMS chooses to build $1b facility in Devens, MA
2006
2008
$1 B Massachusetts Life Sciences Initiative enacted
The Difficult Path to Bring a Drug to Market
• For every
5,000
investigational
drugs that begin
down the path,
only 1 is
successfully
commercialized.
1250
1000
750
Annual Net
Cash Flow
• Average
research and
development
cost of is $1
billion.
Patent Filing
500
Launch
Discovery
(2–10 Years)
Phase I
Preclinical
20–80
Testing
Healthy
Laboratory and Volunteers
Animal Testing
Phase II
100–300
Patient
Volunteers
Phase III
1,000–5,000
Patient
Volunteers
FDA
Review
Approval
250
Market
0
5
10
-250
-500
Valley of Death
15
Massachusetts BioPharma Employment Growth
2011
49,825
2002
32,571
53%
Growth
Since
2002
Source: U.S. Census, County Business Patterns and MassBio formula and analysis.
*2010 figure is a final estimate based on review of Massachusetts ES-202 data for 2010. 2011 figure is a preliminary estimate.
Biotechnology R&D Employment
According to
the Bureau of
Labor Statistics’
Quarterly
Census of
Employment &
Wage (QCEW)
data,
Massachusetts
leads the
nation in
biotechnology
research &
development
employment.
CA
CT
MA
MD
MI
MO
NJ
NY
NC
PA
WA
2007
19,134
2,452
24,565
10,154
4,670
4,262
8,567
2,679
7,042
15,902
2,499
2010
21,616
1,582
26,807
9,469
2,759
3,874
9,224
3,553
6,275
12,776
3,730
Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)
Biotech R&D Employment, 2007-2010
WA
Massachusetts
grew
biotechnology
research
employment
between 20072010.
Massachusetts
was outpaced
only by
California.
1231
PA
-3126
-767
NC
NY
874
NJ
-388
657
MO
MI
-1911
MD
-685
MA
CA
2242
2482
Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)
Biotechnology Research Concentration
Massachusetts
holds a dominant
position in terms
of industry
concentration in
“Biotechnology
Research and
Development” –
almost twice the
concentration of
jobs as the next
closest state.
The
Massachusetts
concentration
did, however,
decline slightly
from 2009.
What is a Location
Quotient?
8
Location Quotients measure
the concentration and
strength of an industry in a
region versus the nation as a
whole. Location Quotients of
more that 1.0 mean that the
industry enjoys a greater
concentration in a region
versus the nation as a whole.
7
6
5
2007
4
2009
2010
3
2
1
0
CA
MD
MA
MO
NJ
NC
PA
WA
CA
MD
MA
MO
NJ
NC
PA
WA
2007
1.22
4.1
7.32
1.56
2.15
1.75
2.71
0.87
2009
1.34
3.77
7.58
1.55
2.20
1.68
2.19
0.90
2010
1.39
3.74
7.42
1.4
2.29
1.57
2.09
1.27
Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)
Biotech R&D Employment: U.S. Counties
Among
leading U.S.
counties in
biotech R&D
employment,
Middlesex
County in
Massachusett
s continues to
stand out.
18,000
16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
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Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)
BioPharma Manufacturing Employment
2010
Only
Massachusetts,
Maryland, and
North Carolina
have grown
biopharma
manufacturing
jobs since 2006.
9,514
2006
7,944
Massachusetts
was one of only 3
states to grow
biopharma
manufacturing
jobs between 2006
and 2010.
Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)
Drug Development Pipeline August 2011
Massachusettsheadquartered
companies*
account for
about 10% of
the U.S. drug
development
pipeline and
5% of the
global pipeline.
Candidate medicines of Massachusetts-headquartered* companies, by clinical trials stage
Pre-Clinical
316
Phase I
216
Phase II
275
Phase III
76
Pending Approval
14
Massachusetts-headquartered companies’ share of U.S. and Global drug development
pipeline
% of US
% of Global
Total Trials
9.41%
4.91%
PC
11.00%
5.88%
I
11.99%
6.43%
II
8.26%
4.56%
III
8.46%
3.52%
PA
3.89%
1.44%
* There are many drugs in development in Massachusetts by companies with
headquarters located outside of Massachusetts. These candidate drugs are not
included in any Massachusetts pipeline estimates found in this report.
Source: MedTrack Online, Life Sciences Analytics, Inc.
Massachusetts Drug Pipeline Movement:
May 2010-April 2011
Between May 2010
and April 2011, 217
candidate drugs
advanced in the
development
pipeline – from
entering into preclinical trials through
advancing to
approval by the
FDA.
Preclinical
Studies
Phase I
Pending
Approval
Phase III
Phase II
Approvals
79
57
46
20
27
PC
candidates
acquired by
by
out-of-state
acquisition
16
Discontinued
PC studies
12
3
16 clinical candidates
acquired by out-of-state acquisition
40 terminated trials
3
Non-approvals
Source: MedTrack Online, Life Sciences Analytics, Inc.
Why Massachusetts?
500+
430+
Biopharma
Biotech
Companies
Top 5
Top
5
122
NIH funded
NIH funded
Research
Research
Hospitals
Hospitals
Colleges &
Universities
1st in
1st in
Education
Level of
workforce (US)
Workforce
Venture Capital
& federal
SBIR funds
research
per worker
funds
per worker
Supportive
Local, State Government
Life Sciences Initiative
Biotech Caucus
Top 5 NIH Funded Hospitals in U.S., FY 2011
1. Massachusetts General Hospital ($324,620,848)
2. Brigham and Women's Hospital ($288,436,449)
3. Beth Israel Deaconess Medical Center ($131,304,171)
4. Dana-Farber Cancer Institute ($130,136,550)
5. Children's Hospital Boston ($118,512,044)
Source: National Institute of Health; 2009
15
Top 5 Massachusetts NIH-funded Universities, FY 2010*
1. Harvard University
$393 M
2. University of Massachusetts
$196M
3. Boston University
$163 M
4. Massachusetts Institute of Technology $158 M
5. Tufts University
$136 M
*includes ARRA funds.
16
National Institutes of Health Funding, 2010
On a NIH-funding
per capita basis,
Massachusetts far
exceeded other
leading NIHrecipient states.
CALIFORNIA
MASSACHUSETTS
NEW YORK
PENNSYLVANIA
TEXAS
MARYLAND
NORTH CAROLINA
WASHINGTON
ILLINOIS
OHIO
$374
$3,332,378,004
$2,447,323,040
$2,001,047,954
$1,405,917,085
$1,078,078,997
$1,018,825,272
$931,973,222
$846,526,930
$732,681,496
$662,354,991
$176
$158
$139
$103
$98
$89
$56
CA
MA
NY
PA
TX
MD
NC
WA
$57
$57
IL
OH
Sources: National Institutes of Health, U.S. Census Bureau.
Venture Capital Investment
$1.071
billion
invested in MA
biotechs in
2011 is an
historic high.
$8.054
billion
since 2002
Source Data: 2011 PricewaterhouseCoopers, National Venture Capital Association, MoneyTree TM Report, Historical Trend Data, and
MassBio analysis.
MA Share of the Biotech VC Dollar
MA biotechs
received
22.6% of all
VC biotech
financing, just
below the
2010 all-time
high.
Source: 2011 PricewaterhouseCoopers, National Venture Capital Association,
MoneyTreeTM Report, Historical Trend Data, MassBio analysis.
BioPharma Industry Impact in MA
The estimated
average salary
in the
biopharma
industry is 77%
higher than the
estimated state
average salary
of $53,834.
$4,615,364,513 in payroll (2010)
$95,628 in average salary (2010)
Source: U.S. Census, County Business Patterns, MassBio estimate using 2009 base data, MassExport Center.
Leading BioPharma Employers (MA), 2011
MA has
benefited from
the pharma
industry’s
embrace of
biotechnology.
1. Genzyme (Sanofi)
2. Pfizer
3. Biogen Idec
4. Novartis
5. Thermo Fisher Scientific
6. Shire
7. Vertex
8. EMD Millipore
9. Parexel International
10. Millenium: Takeda Oncology
11. Charles River Laboratories
12. AstraZeneca
13. EMD Serono
14. Hologic
15. Abbott Laboratories
16. Sunovion Pharmaceuticals (DSP)
17. Nova Biomedical
18. Cubist
19. Lantheus
19. Merck
20. Bristol-Myers Squibb
4,356
2,600
2,300
2,100
1,700
1,500
1,310
1,237
1,200
1,050
970
900
850
800
750
690
631
626
550
330
320
Sources: MassBio, membership reports, survey, Boston Business Journal Book of Lists, 2011.
The $1 Billion Massachusetts Life Sciences Initiative
Over time, the
industry
demonstrated its
value,
commitment to
the region, and
promise for the
future . . . and
state government
responded.
• 10
years
• $1 billion
Investment
Top 20 job listing categories on MassBio.org in 2011
6,223 total jobs listed in 2011
Job Listings by desired education level, 2011
HS/Vocational/Certification, 283
Associate’s Degree, 200
Master’s Degree, 717
Bachelors Degree
3,416
PhD, 797
HS/Vocational/Certificate
Associate's Degree
4.5%
3.2%
Master's Degree
11.5%
PhD
12.8%
Unspecified
Bachelor's Degree
13.0%
54.9%
Unspecified
810
6,223 jobs listed in 2011
Projected Job Growth by Industry and Selected Occupations
Industry & Occupations
“Middle skill”
occupations
2008
Projected
Increase
Projected 2018
% increase
Scientific Research
43,700
59,000
15,300
35.0
Medical Scientists, not Epidemiologists
4,400
6,970
2,570
58.4
Biological Technicians
1,920
2,530
610
31.9
Biochemists and Biophysicists
1,530
2,440
910
59.0
Computer Software engineers
1,540
2,240
700
45.5
Biomedical Engineers
470
940
470
100.6
BioPharma Manufacturing
9,590
12,100
2,510
26.2
Biochemists and Biophysicists
780
1,130
350
45.0
Biological Technicians
520
630
110
20.8
Medical Scientists, not Epidemiologists
350
510
160
44.9
Machine operators and tenders
530
640
110
20.9
Separating, Filtering, Clarifying, etc.
200
280
80
44.9
Hospitals
183,600
205,860
22,260
12.1
Medical Scientists, not Epidemiologists
1,580
2,150
570
35.9
Registered Nurses
48,860
58,190
9,330
19.1
Colleges & Universities
146,580
155,680
9,100
6.2
Medical Scientists, not Epidemiologists
910
1,160
250
27.6
Biological Sciences Teachers, postsecondary
3,110
3,400
290
9.3
Source: Massachusetts Industry-Occupation Employment Matrix, 2008-2018, MA DLWD.
Biotech/Pharma Buildings
EMD Serono, Rockland, MA
Abbott Bioresearch, Worcester, MA
AstraZeneca R&D Boston, Waltham, MA
Biotech/Pharma Buildings
Biotechnology Laboratory Facilities
Biotechnology Manufacturing Facilities
Laboratory Safety
BioSafety Level 1
BioSafety Level 2
BioSafety Level 3
Suitable for work involving well
characterized agents not
known to cause disease in
healthy adult humans and of
minimal potential hazard to
laboratory personnel and the
environment.
Suitable for work involving
agents of moderate potential
hazard to personnel and the
environment.
Suitable for work with
infectious agents which may
cause serious or potentially
lethal disease as a result
of exposure by the inhalation
route.
Source: Centers for Disease Control
Manufacturing Safety
Good Manufacturing Practice regulations (GMPs) are used by pharmaceutical and medical device
manufacturers as they produce and test products that people use. In the United States, the U.S. Food
and Drug Administration (FDA) has issued these regulations as the minimum requirements.
• Human pharmaceutical products and veterinary products (21 CFR 210-211)
• Biologically derived products (21 CFR 600 and 21 CFR 620)
• Medical devices (21 CFR 820)
The manufacturing or "production" area is where the drug products are actually made with the
active pharmaceutical ingredients and other materials such as high-purity water or sugars and
other binding/lubricating agents. Depending on the final product, the manufacturing process can be
very simple or extremely complicated.
Labeling in Laboratory
Laboratory Instrumentation
Quality assurance
Quality Control
Facilities
Control Room
Source: Learning Plus, Inc.
Validation
Snapshot of Lab & Plant Physical Requirements
Hours of Operation
Floor to Floor
heights
Electrical
Water
Sewer
Gas
Basic Research Facility
Typical business
hours
14-18'
12 KV
8-20,000 GPD
Some pretreatment,
use of neutralization
tanks
Required
Process Development Facility
Typical business
hours
14-18'
12 KV
20,000 GDP
Pretreatment using
neutralization tanks
Required
Adequate public
Pilot Manufacturing
24 hours a day, 7
days a week
18-25'
15 KV
Higher volume
2,400 GPH per
sewer capacity.
1,000 s.f. (approx.
than research or
Discharges require kill
60,000 GPD for 30
process
syetems and pH
K s.f. facility)
facilities.
pretreatment
Manufacturing
Fill and Finish Facility
24 hours a day, 7
days a week
20-40'
5 days of operation,
24/7 on utilities
25' minimum
Varies, greater than
Adequate public
Pilot facility,
sewer capacity.
redundent supply
25 KV with
often required. (1.5 Discharges require kill
redundant supply M GPD for 100 k
syetems and pH
mfg space an
pretreatment
example)
12.5 KV
Varies, but
significantly less
than mfg. facility
High volume
Required
30
BioReadyTM Ratings Criteria
Bronze - A municipality at this level features municipal water and sewer in
commercial and industrial areas, zoning allowing for biotech laboratory and
manufacturing uses by special permit, and has identified a local point of contact in to
assist biotech projects.
Silver - A municipality meets all Bronze criteria AND allows biotech uses by right,
convene Site Plan Review meetings to expedite development projects, and has
identified sites for biotech uses in municipal plans or has land sites and/or buildings
included in BioSites inventory at www.massachusettssitefinder.com, or is a Growth
District, or has identified Priority Development Sites per Chapter 43D.
Gold - A municipality meets Silver criteria plus has sites or buildings pre-permitted for
biotechnology use, OR has existing buildings in which biotech laboratory or
manufacturing activities are taking place.
Platinum - A municipality meets Gold criteria plus has adopted the National Institutes of
Health guidelines on rDNA activity as part of its Board of Health regulations, has a building
or buildings that are already permitted for biotech uses and which have 20,000+ square feet
available space for biotech uses OR has a shovel-ready pre-permitted land site with
completed MEPA review and municipal water and sewer capacity to meet additional
demand.
www.massbio.org
BioReadyTM Communities Map
Community Guide for Biotechnology
Available for
download at
MassBio
BioReady
web pages.
Next Steps
•
•
•
•
See BioReadyTM guidance at www.massbio.org
Download Biotechnology Community Guide
Take a look at the BioReadyTM survey
Call with any questions:
Pete Abair, 617-674-5130
[email protected]
• We travel! Happy to visit your town to discuss.
• When you are ready, submit a BioReadyTM Survey for
your municipality
• Get you BioReadyTM buildings and sites onto
MassBio.org’s real estate web pages