The Massachusetts BioReady TM Community Campaign Presented to South Shore/Canal Regional Economic Development District March 22, 2012

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

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.

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 figure is a preliminary estimate. 32,571 49, % 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)

WA PA NC NY NJ MO MD MA CA MI Biotech R&D Employment, Massachusetts grew biotechnology research employment between Massachusetts was outpaced only by California. Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW)

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.

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 BioPharma Manufacturing Employment Source: U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW) 7,944 9, Massachusetts was one of only 3 states to grow biopharma manufacturing jobs between 2006 and 2010.

Drug Development Pipeline August 2011 Pre-Clinical316 Phase I216 Phase II275 Phase III76 Pending Approval14 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.

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; 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 On a NIH-funding per capita basis, Massachusetts far exceeded other leading NIH- recipient states. 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), Genzyme (Sanofi)4, Pfizer2, Biogen Idec2, Novartis2, Thermo Fisher Scientific1, Shire1, Vertex1, EMD Millipore 1, Parexel International1, Millenium: Takeda Oncology1, Charles River Laboratories AstraZeneca EMD Serono Hologic Abbott Laboratories Sunovion Pharmaceuticals (DSP) Nova Biomedical Cubist Lantheus Merck Bristol-Myers Squibb 320 Sources: MassBio, membership reports, survey, Boston Business Journal Book of Lists, MA has benefited from the pharma industry’s embrace of biotechnology.

The $1 Billion Massachusetts Life Sciences Initiative 10 years $1 billion Investment $500 million Capital Fund $250 million Tax Incentive Program $250m Investment Fund (subject to appropriation) 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 ,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 6,223 jobs listed in 2011

Projected Job Growth by Industry and Selected Occupations Source: Massachusetts Industry-Occupation Employment Matrix, , MA DLWD. Industry & Occupations2008Projected 2018 Projected Increase% increase Scientific Research43,700 59,000 15, Medical Scientists, not Epidemiologists 4,400 6,970 2, Biological Technicians1,9202, Biochemists and Biophysicists 1,530 2, Computer Software engineers1,5402, Biomedical Engineers BioPharma Manufacturing9,590 12,100 2, Biochemists and Biophysicists 780 1, Biological Technicians Medical Scientists, not Epidemiologists Machine operators and tenders Separating, Filtering, Clarifying, etc Hospitals183, ,860 22, Medical Scientists, not Epidemiologists 1,580 2, Registered Nurses48,86058,1909, Colleges & Universities146, ,680 9, Medical Scientists, not Epidemiologists 910 1, Biological Sciences Teachers, postsecondary 3,1103, “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.Food and Drug Administration Human pharmaceutical products and veterinary products (21 CFR )21 CFR Biologically derived products (21 CFR 600 and 21 CFR 620)21 CFR 600 Medical devices (21 CFR 820)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 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 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.

BioReady TM Communities Map

Community Guide for Biotechnology Available for download at MassBio BioReady web pages.

Next Steps See BioReady TM guidance at Download Biotechnology Community Guide Take a look at the BioReady TM survey Call with any questions: Pete Abair, We travel! Happy to visit your town to discuss. When you are ready, submit a BioReady TM Survey for your municipality Get you BioReady TM buildings and sites onto MassBio.org’s real estate web pages