Slide 1 - Massachusetts Biotechnology Council

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Dec 5, 2012 (4 years and 9 months ago)

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The Massachusetts BioReady
TM

Community Campaign

Presented to


South Shore/Canal Regional Economic Development District

March 22, 2012

MBC Member Benefits
Purchasing
Consortium
Networking &
Visibility
Annual Events
Professional
Development
MassBioEd
Foundation
Economic
Development
State & Federal
Policy
MassBio
Membership
Purchasing
Consortium
Networking &
Visibility
Annual Events
Professional
Development
MassBioEd
Foundation
Economic
Development
State & Federal
Policy
MassBio
Membership
110+ member meetings,

4,000 attendees

Savings from 20
-
80% on
everything from lab gases,
lab equipment, supplies,
office equipment, energy
and much more.

Advocacy for
industry on
Beacon Hill
and Capitol Hill

MassBioEd Courses,

MassBio Committee Meetings

To foster a
positive
environment
that enables
each
biotechnology
company to
achieve its full
potential

About MassBio

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.

Biologic
-
based

Medicines

Biologic
-
based

Medical Devices

Biofuels,
AgBio
,

Bio Industrials

Biological Research
Tools

Pharmaceuticals

are

chemical
-
based

medicines

Massachusetts Biotech Timeline

1980
1985
2006
Double helix of DNA explained by Watson & Crick
1978
1953
Biogen
founded
U.S. Supreme Court approves patenting of recombinant life forms,
Passage of
Bayh
-
Dole Act
2000
Map of the human genome is completed
2002
Novartis locates Global Research HQ in Cambridge, MA
2008
$1 B Massachusetts Life Sciences Initiative enacted
BMS chooses to build $1b facility in
Devens
, MA
Genzyme
founded
1981
MassBio
becomes the
1
st
biotechnology
industry association
2003
MassBio
issues Biotech 2010 Report
1980
1985
2006
Double helix of DNA explained by Watson & Crick
1978
1953
Biogen
founded
U.S. Supreme Court approves patenting of recombinant life forms,
Passage of
Bayh
-
Dole Act
2000
Map of the human genome is completed
2002
Novartis locates Global Research HQ in Cambridge, MA
2008
$1 B Massachusetts Life Sciences Initiative enacted
BMS chooses to build $1b facility in
Devens
, MA
Genzyme
founded
1981
MassBio
becomes the
1
st
biotechnology
industry association
2003
MassBio
issues Biotech 2010 Report
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.




Average
research and
development
cost of is
$1
billion.

Market
250
500
750
1000
1250
Patent Filing
Launch
5
10
15
0
-
250
-
500
Discovery
(2

10 Years)
Preclinical
Testing
Laboratory and
Animal Testing
Phase I
20

80
Healthy
Volunteers
Phase II
100

300
Patient
Volunteers
Phase III
1,000

5,000
Patient
Volunteers
FDA
Review
Approval
Annual Net
Cash Flow
Valley of Death
Massachusetts BioPharma Employment Growth

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.

32,571

49,825

2002

2011

53%

Growth

Since

2002

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.

Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)

2007
2010
CA
19,134
21,616
CT
2,452
1,582
MA
24,565
26,807
MD
10,154
9,469
MI
4,670
2,759
MO
4,262
3,874
NJ
8,567
9,224
NY
2,679
3,553
NC
7,042
6,275
PA
15,902
12,776
WA
2,499
3,730
2482
2242
-1911
-388
657
-3126
1231
-685
874
-767
WA

PA

NC

NY

NJ

MO

MD

MA

CA

MI

Biotech

R&D Employment, 2007
-
2010

Massachusetts

grew
biotechnology
research
employment
between 2007
-
2010.


Massachusetts
was outpaced
only by
California.

Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)

0
1
2
3
4
5
6
7
8
CA
MD
MA
MO
NJ
NC
PA
WA
2007
2009
2010
2007
2009
2010
CA
1.22
1.34
1.39
MD
4.1
3.77
3.74
MA
7.32
7.58
7.42
MO
1.56
1.55
1.4
NJ
2.15
2.20
2.29
NC
1.75
1.68
1.57
PA
2.71
2.19
2.09
WA
0.87
0.90
1.27
Biotechnology Research Concentration

What is a Location
Quotient?


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.

Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)

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.

0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
Worcester, MA
Wake, NC
Mercer, NJ
Middlesex, NJ
Somerset, NJ
Durham, NC
Chester, PA
St. Louis, MO
Essex, MA
Santa Clara
San Mateo, CA
Suffolk, MA
Montgomery, MD
Montgomery, PA
San Diego, CA
Middlesex, MA
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.

Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)

Only
Massachusetts,
Maryland, and
North Carolina
have grown
biopharma
manufacturing
jobs since 2006.

BioPharma Manufacturing Employment

Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)

7,944

9,514

2006

2010

Massachusetts
was one of only 3
states to grow
biopharma

manufacturing
jobs between 2006
and 2010.

Total Trials
PC
I
II
III
PA
% of US
9.41%
11.00%
11.99%
8.26%
8.46%
3.89%
% of Global
4.91%
5.88%
6.43%
4.56%
3.52%
1.44%
Drug Development Pipeline August 2011

Pre
-
Clinical

316

Phase I

216

Phase II

275

Phase III

76

Pending Approval

14

Candidate medicines of Massachusetts
-
headquartered* companies, by clinical trials stage

Massachusetts
-
headquartered companies’ share of U.S. and Global drug development
pipeline

* 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.

Massachusetts
-

headquartered
companies*
account for
about 10% of
the U.S. drug
development
pipeline and
5% of the
global pipeline.

Source: MedTrack Online, Life Sciences Analytics, Inc.

57
Preclinical
Studies
Phase I
Phase II
Phase III
Pending
Approval
Approvals
79
46
20
12
3
16
40 terminated trials
3
Non
-
approvals
Discontinued
PC studies
16 clinical candidates
acquired by out
-
of
-
state acquisition
27
PC
candidates
acquired by
by
out
-
of
-
state
acquisition
57
Preclinical
Studies
Phase I
Phase II
Phase III
Pending
Approval
Approvals
79
46
20
12
3
16
40 terminated trials
3
Non
-
approvals
Discontinued
PC studies
16 clinical candidates
acquired by out
-
of
-
state acquisition
27
PC
candidates
acquired by
by
out
-
of
-
state
acquisition
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 pre
-
clinical trials through
advancing to
approval by the
FDA.


Source: MedTrack Online, Life Sciences Analytics, Inc.

430+

Biotech

Companies

122

Colleges &

Universities

Top 5

NIH funded

Research

Hospitals

1

st

in

Venture Capital

& SBIR funds

per worker

1

st

in

Education

Level of

workforce

500+

Biopharma

Companies

122

Colleges &

Universities

Top

5

NIH funded

Research

Hospitals

1

st

in

Venture Capital

& federal research

funds per worker

1

st

in

Education

Level of

Workforce (US)

Why Massachusetts?

Supportive

Local, State Government


Life Sciences Initiative

Biotech Caucus

15

Top 5 NIH Funded Hospitals in U.S., FY 2011

Source: National Institute of Health; 2009

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)

16

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

Top 5 Massachusetts NIH
-
funded Universities, FY 2010*

*includes ARRA funds.

National Institutes of Health Funding, 2010

$89
$374
$103
$158
$56
$176
$98
$139
$57
$57
CA
MA
NY
PA
TX
MD
NC
WA
IL
OH
On a NIH
-
funding
per capita basis
,
Massachusetts far
exceeded other
leading NIH
-
recipient states.

CALIFORNIA
$3,332,378,004
MASSACHUSETTS
$2,447,323,040
NEW YORK
$2,001,047,954
PENNSYLVANIA
$1,405,917,085
TEXAS
$1,078,078,997
MARYLAND
$1,018,825,272
NORTH CAROLINA
$931,973,222
WASHINGTON
$846,526,930
ILLINOIS
$732,681,496
OHIO
$662,354,991
Sources:

National Institutes of Health, U.S. Census Bureau
.

Source Data: 2011 PricewaterhouseCoopers, National Venture Capital Association, MoneyTree
TM

Report, Historical Trend Data, and
MassBio analysis.

Venture Capital Investment

$1.071
billion
invested in MA
biotechs in
2011 is an
historic high.


$8.054

billion

since 2002

Source: 2011 PricewaterhouseCoopers, National Venture Capital Association,
MoneyTree
TM

Report, Historical Trend Data, 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.

$4,615,364,513 in payroll (2010)

$95,628 in average salary (2010)

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.


Source: U.S. Census, County Business Patterns, MassBio estimate using 2009 base data, MassExport Center.

Leading BioPharma Employers (MA), 2011

1. Genzyme
(Sanofi)



4,356

2.
Pfizer




2,600

3. Biogen Idec



2,300

4.
Novartis



2,100

5. Thermo Fisher Scientific


1,700

6.
Shire




1,500

7. Vertex




1,310

8.
EMD

Millipore



1,237

9. Parexel International


1,200

10. Millenium:
Takeda

Oncology


1,050

11. Charles River Laboratories



970

12.
AstraZeneca





900

13.
EMD

Serono




850

14. Hologic





800

15. Abbott Laboratories



750

16. Sunovion Pharmaceuticals (
DSP
)


690


17. Nova Biomedical





631

18. Cubist






626

19. Lantheus




550

19.
Merck





330

20.
Bristol
-
Myers Squibb



320

Sources: MassBio, membership reports, survey, Boston Business Journal Book of Lists, 2011.

MA has
benefited from
the pharma
industry’s
embrace of
biotechnology.

The $1 Billion Massachusetts Life Sciences Initiative





10 years



$1 billion

Investment

Over time, the
industry
demonstrated its
value,
commitment to
the region, and
promise for the
future . . . and
state government
responded.

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

Bachelors Degree

3,416

Associate’s Degree, 200

Master’s Degree, 717

PhD, 797

Unspecified

810

HS/Vocational/Certificate
4.5%
Associate's Degree
3.2%
Master's Degree
11.5%
PhD
12.8%
Unspecified
13.0%
Bachelor's Degree
54.9%
6,223 jobs listed in 2011

Projected Job Growth by Industry and Selected Occupations

Source: Massachusetts Industry
-
Occupation Employment Matrix, 2008
-
2018, MA DLWD.

Industry & Occupations

2008

Projected 2018

Projected
Increase

% 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

“Middle skill”
occupations

Biotech/
Pharma

Buildings

Abbott Bioresearch, Worcester, MA

EMD Serono, Rockland, MA

AstraZeneca R&D Boston, Waltham, MA

Biotechnology
Laboratory

Facilities

Biotechnology
Manufacturing

Facilities

Biotech/
Pharma

Buildings

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.

BioSafety Level 1

BioSafety Level 2

BioSafety Level 3

Source: Centers for Disease Control

Laboratory 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.

Facilities
Control Room

Labeling in Laboratory

Laboratory Instrumentation

Quality assurance

Validation

Quality Control

Source: Learning Plus, Inc.

Manufacturing Safety

30

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
Pilot Manufacturing
24 hours a day, 7
days a week
18-25'
15 KV
2,400 GPH per
1,000 s.f. (approx.
60,000 GPD for 30
K s.f. facility)
Adequate public
sewer capacity.
Discharges require kill
syetems and pH
pretreatment
Higher volume
than research or
process
facilities.
Manufacturing
24 hours a day, 7
days a week
20-40'
25 KV with
redundant supply
Varies, greater than
Pilot facility,
redundent supply
often required. (1.5
M GPD for 100 k
mfg space an
example)
Adequate public
sewer capacity.
Discharges require kill
syetems and pH
pretreatment
High volume
Fill and Finish Facility
5 days of operation,
24/7 on utilities
25' minimum
12.5 KV
Varies, but
significantly less
than mfg. facility
Required
Snapshot of Lab & Plant Physical Requirements

BioReady
TM

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

BioReady
TM

Communities Map

Community Guide for Biotechnology

Available for
download at
MassBio
BioReady
web pages.

Next Steps


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BioReady
TM

guidance at
www.massbio.org


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BioReady
TM

survey


Call with any questions:


Pete Abair, 617
-
674
-
5130


peter.abair@massbio.org


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TM

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TM

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