Programs & Initiatives Advancing the Biopharmaceutical Industry

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Tennessee Programs & Initiatives Advancing the Biopharmaceutical Industry Tennessee State Profile 1 Key Programs & Initiatives The opportunities generated by the biopharmaceutical sector as a leader in innovation and high quality job creation are not limited to just a few states, but have a substantial national footprint across states. States proactively pursue the development of the biopharmaceutical sector because it represents: a large-scale, geographically dispersed supply chain spanning R&D through to production and distribution; a key driver of the economy including the recent economic recovery; and a sector paying high wage rates in quality jobs. States are deploying a range of programs and initiatives to support and grow the biopharmaceutical industry, including: comprehensive state development strategies; investments in R&D and related infrastructure; programs to boost venture capital, entrepreneurship, and innovation development; advanced manufacturing; economic incentive initiatives; and programs working to advance STEM education and training. In recent years, Tennessee has supported its bioscience industry primarily through regional efforts. Quick Guide: Tennessee s Programs & Initiatives Advancing the Biopharmaceutical Industry Comprehensive State Strategies to Support Biopharmaceutical Development: Regional Initiatives Life Science Tennessee Tennessee Department of Economic & Community Development R&D Investment: Centers of Excellence Oak Ridge National Lab The Hartwell Foundation and the Hartwell Center St. Jude Children s Hospital Vanderbilt University Medical Center Biosciences Infrastructure Development: UT-Baptist Research Park TriMetis Specialized Laboratory Venture Capital, Entrepreneurship, and Other Innovation Related Programs and Initiatives: Cumberland Emerging Technologies Memphis Bioworks Foundation Entrepreneurial Efforts INCITE Initiative Launch Tennessee Life Science Tennessee Statewide Mentor Network East Tennessee State University (ETSU) Innovation Lab TNIvestco Innova Impacts STEM Workforce & Education: Memphis Bioworks Workforce Development Initiatives Tennessee STEM Education Network Bioworks Entrepreneurial initiatives start-up businesses receiving more than $50 million in investments; support of 60 companies and the creation of more than 800 jobs; annual revenue of over $50 million from both Innova and Bioworks Business Incubator portfolio companies. Launch Tennessee since 2012, has accelerated the development of 480 companies, leading to the creation of over 1,000 jobs; invested $116 million (via INCITE Co-investment fund) and more than $1 billion in venture investment in Tennessee; assisted companies have gone on to raise over $80 million in capital. Innova 36 start-up companies have received over $15 million in investments attracting more than $50 million in outside capital. Investments have led to an annual impact of more than $90 million supporting more than 150 direct jobs. TNInvestco funded companies have received $402.2 million in follow-on capital and have created 1,517 new full-time jobs.

2 Tennessee State Profile Tennessee by the Numbers 1.6% TN 2.6% U.S. R&D as a Share of GSP, 2010 3.0% TN 4.6% U.S. Persons in S&E Occupations as Share of all Occupations, 2012 11.6 Patents TN 20.3 Patents Patents per 1,000 people in S&E Occupations, 2012 6.6% TN 8.8% U.S. High-Tech Establishments as a Share of Total, 2010 Source: National Science Foundation, Science & Engineering Indicators 2014. U.S. that roughly parallels the Tennessee River Valley, was disbanded in the Spring of 2016. This corridor had taken on an increasingly bioscience orientation over the years, as Oak Ridge National Laboratory (ORNL) continued to gather bioscience assets as part of its role in the Human Genome Project. ORNL is also involved with one of the state s flagship institutions: The University of Tennessee (UT). Because of this partnership, more than 150 students work ORNL-related labs and more than 200 faculty members serve with joint appointments. The Graduate School of Genome Science and Technology (GST) was created through this partnership and offers next-generation sequencing, high-performance computing, molecular cell biology and other genetics-related resources to UT students. The Governor s Chairs program is a joint program funded by ORNL that works to draw highly talented researchers to work joint positions at UT and ORNL. Researchers are recruited in the fields of biological sciences, advanced manufacturing, advanced materials, energy sciences, urban design and nuclear security. Comprehensive State Strategies to Support Biopharmaceutical Development Regional Initiatives. Bioscience development has largely been pursued at the regional level in Tennessee, with each region focusing on different industry strengths and subsectors. In Memphis, the Memphis Bioworks Foundation (MBF) is a non-profit organization focused on developing the region s bioscience industry through investments in venture capital and entrepreneurial training, improving bioscience-related infrastructure, and developing a bioscience workforce. MBF has helped to foster commercialization, education, and research activities and catalyzed development intended to capitalize on the region s bioscience industry and research base. To date, MBF has invested $2.1 billion in the Memphis Medical Center district (anchored by the University of Tennessee Health Science Center, the district is home to major hospitals, emergency rooms, physicians offices, medical supply manufacturers and distributors, and medical laboratories) and invested $140 million in the UT-Baptist Research Park, which is a growing major bioscience research complex located in the heart of the Memphis Medical Center. In eastern Tennessee (Oak Ridge/Knoxville), the Technology 2020 regional partnership, whose mission had been to position the area as part of a Tennessee Technology Corridor In middle Tennessee (Nashville/Franklin/Brentwood), a major bioscience economic development strategy for the region was developed for the Cool Springs Life Sciences Center (CSLSC), a 10-acre campus specifically designed to accommodate the unique needs of life science and biotechnology firms, particularly those engaged in biologics, pharmaceuticals, therapeutics, and medical devices. However, in January of 2016, OakPoint Real Estate purchased the two buildings, representing nearly 65,000 sq. ft. of vacant space, and rebranded the property Innovation Park. The private developer indicates that while it is still targeting biotech companies, it is making the property available to a wider base of tenants. Life Science Tennessee (formerly known as the Tennessee Biotechnology Association). This organization is dedicated to the growth and promotion of the life science industry in Tennessee. LifeSciTN does this through advocating for policies at both the state and federal levels that would benefit the industry, life science-related outreach and education efforts, and develops partnerships with research organizations, universities and government entities. Tennessee Department of Economic & Community Development. This department works to attract, retain and support businesses in the state. The department focuses on ten key industries, one of which is Healthcare & Medical Devices. Forty-five projects have been announced in this industry sector during the Governor s administration, which has led to the investment of over $804 million and the creation of 8,100 new jobs. Over 341.5 thousand Tennessee residents are employed in the healthcare and medical device industry, an industry which has grown by 36 percent since 2010.

Tennessee State Profile 3 R&D Investment Programs and Initiatives Centers of Excellence. The Centers of Excellence Program was created by the Tennessee state government in 1984, and was designed to improve the competitive advantage of Tennessee by capitalizing on the research strengths of the state s institutions of higher education. There are currently 26 such centers located at 12 different Tennessee universities. Relevant centers include: The Science Alliance: This center was created in 1984 and works to recruit distinguished researchers and promote collaborative research in a number of fields, including bioinformatics. The Science Alliance also develops joint research and development initiatives between UT faculty, students and scientists at ORNL. Neuroscience Institute: Started in 1985, this multidisciplinary neuroscience program offers a graduate degree in neuroscience, as well as a light and electron microscopy imaging center. The center is made up of 90 faculty from 14 different departments and allows for multidisciplinary research and education to take place. Molecular Resource Center: Established in 1985, this center facilitates research on the molecular and biological underpinnings of diseases. The center offers services in, among other things, nucleic acid purification, quantification and quality control, gene expression analysis, genotyping and real time PCR. The center is continually investing in outstanding faculty and state of the art equipment. Center for Pediatric Pharmacokinetics and Therapeutics (CPPT): This center is conducting research in a large number of areas related to pediatric pharmacotherapy, some of which are molecular pharmacology, pharmacokinetics and pharmacodynamics. Its main research goal is to provide the laboratory space and resources needed to research drug effects on children. The center offers education program for high school through graduate level students, and supports the Pediatric Pharmacology Research Unit, which is a federal program researching medical labeling for children. The CPPT, in partnership with the University of Chicago, is part of the National Pharmacogenetic Research Network and works to evaluate the effects of anticancer drugs in children. Livestock Diseases and Human Health: This center is focused on the relationship between animal and human health by investigating animal diseases that are similar to human diseases and develop new treatment methods. The center s two investigative strengths are: Animal Models & Comparative Medicine Mechanisms of Disease, Pathogenesis, and Immunity Oak Ridge National Lab Joint Institute for Biological Sciences (JIBS). JIBS was started in 2007 for the advancement of research and training in bioenergy and bioenvironmental systems. The research instruments housed in JIBS has given UT and ORNL researchers (as well as students) access to stateof-the-art genomic, proteomic, metabolic and transcriptomic instrumentation. JIBS is also where the only Roche 454 titanium pyrosequencing system can be found in the region. Currently, JIBS three main focus areas are promoting a bioenergy collaboration between China and the U.S., development of a Synthetic Biology core at the institute, and enhancing metagenomics and post-genomic research for UT and ORNL staff and students. The Hartwell Foundation and the Hartwell Center. Located in Memphis, the Hartwell Foundation is a philanthropic organization whose primary mission is to award grants to individuals who are conducting early-stage applied research projects in the biomedical field, with a focus on projects that benefit children s health. Each year the foundation selects ten institutions nationwide that it considers outstanding in the biomedical field. Those institutions can nominate individuals to receive the Hartwell Individual Biomedical Research Award, which provides $100,000 per year for three years. Through its primary mission, the Hartwell Foundation also supports the Hartwell Center at St. Jude Children s Hospital. The Hartwell Center for Bioinformatics and Biotechnology is a biomedical research center that combines academic programs with state-of-the-art biotechnology and bioinformatics to help instigate life changing discoveries and improve the treatment of pediatric cancers and other diseases. Established in 1999, the Hartwell Center is made up of the Bioinformatics-Research Computing, Biotechnology and Molecular Biotechnology divisions. St. Jude Children s Hospital. Located in Memphis, St. Jude Children s Hospital is an epicenter of biomedical research in the area. The hospital has a large number of shared resources and facilities that researchers can access, and teams of consultants that are ready to support researchers who want to use the hospitals technologies and innovations. The hospital has a technology licensing department that is focused on patenting and commercializing the innovations that are generated at the hospital, including biological and pharmaceutical products and technologies. Vanderbilt University Medical Center (VUMC). Comprised of hospitals and clinics in Nashville as well as locations throughout Middle Tennessee, the VUMC conducts research in a number of different fields from the brain and stem cells to psychology and behavioral sciences. Bio-related core facilities and centers include: The Vanderbilt Epidemiology Center (VEC): The goal of the VEC is to conduct cutting edge research in disease prevention and collaborate with others to turn that research

4 Tennessee State Profile into effective disease prevention strategies. Besides providing training in doctoral-level education in epidemiology, the VEC conducts research in nine distinct areas, including genetics and pharmacology. VEC researchers received more than $25 million in contracts and research grants in 2012. The VEC also supports three core facilities at Vanderbilt University: the Epidemiology Statistical Core, the Molecular Epidemiology Lab and the Survey Research Shared Resource. The Vanderbilt Genetics Institute (VGI): The recently established VGI (January of 2015) seeks to use the experience and research infrastructure at Vanderbilt to make cutting edge discoveries in the field of genomics. Two core facilities supported by the VGI are: Vanderbilt Technologies for Advanced Genomics (VAN- TAGE): Established through an $8.6 million NIH award to the VUMC, VANTAGE offers a range of services for genomic researchers, including DNA biobanking, genotyping, next-generation sequencing and array expression analysis. This center works closely with VANGUARD for data analysis needs. Vanderbilt Technologies for Advanced Genomics Analysis and Research Design (VANGUARD): Overseen by the Office of Research and the Vanderbilt Center for Quantitative Sciences, VANGUARD offers services in experimental design as well as data storage, data quality assessment and analysis and interpretation. The Vanderbilt Vaccine Center (VVC): The VVC is a multidisciplinary center that works to connect different Vanderbilt researchers in order to promote vaccine research. Investigators at the VVC conduct research in the fields of immunology vaccines and viruses. The Immunology Core supported by the VVC offers a number of immune monitoring assays and techniques, including clinical and experimental trial design services, cell proliferation assays and sample processing, just to name a few. This core also works to develop new monitoring technologies through collaborations with academic and industry players. The Flow Cytometry Core offers a cell imaging station, cell sorters and other stateof-the-art devices related to flow cytometry research. Programs and Initiatives to Build Bioscience Infrastructure UT-Baptist Research Park. As mentioned in the previous section, the UT-Baptist Research Park is located in the middle of the Memphis Medical Center and is a prominent bioscience research center that has received substantial investments from the MBF. This research park offers a range of amenities and resources for bioscience companies. Office and wet lab space is offered, as well as early-stage capital sourcing assistance, entrepreneurship mentoring, and other business planning services. The BioWorks Innovation Center is currently under development which is the first of four buildings to be constructed in the center of the research park. Currently the research park has more than 52,000 square feet of wet lab and office space available for use. The park presently has 30 tenants, 14 of which are bioscience-related. When completed, the park will boast laboratory, research, and education space of 1.2 million square feet. TriMetis Specialized Laboratory. A private preclinical services company located in Memphis, TriMetis supports research conducted by pharmaceutical, biotech and medical device companies, as well as academic institutions. The TriMetis Specialized Laboratory, located in the UT-Baptist Research Park, is a pre-clinical Good Laboratory Practices-compliant facility with 26,000 square feet of space. This facility, which is the only one of its kind in the state, offers research suites for lease as well as office space, and allows for telecommuting through a secure video streaming service so that research at the facility can be remotely observed. The $26 million facility was the third phase of the UT-Baptist Research Park. In July of 2016, the VUMC was chosen to establish and lead the Research Support Center for the Precision Medicine Initiative Cohort Program. This nationwide program seeks to understand the environmental, behavioral and biological factors that influence diseases and their treatment methods. VUMC will be given $71.6 million (the largest research grant VUMC has ever received) over five years by the NIH to establish and run the Research and Support Center. The center (along with a number of collaborators) will support the PMI Cohort Program through the use of VUMC s research and analysis tools and by gathering and organizing medical indicator data.

Tennessee State Profile 5 Venture Capital, Entrepreneurship, and Other Innovation Related Programs and Initiatives Innovation Development Cumberland Emerging Technologies (CET). Started as a joint public-private-academic endeavor between Vanderbilt University, the State of Tennessee and Cumberland Pharmaceuticals Inc., CET offers corporate partnerships with scientists, entrepreneurs and others who are hoping to develop and commercialize biopharmaceutical and other therapeutic products. CET offers access to a number of biopharmaceutical and other biomedical product candidates for development and commercialization, and will partner to develop both early and late stage products, assists in building marketing strategies, product and regulatory development plans and other product development needs. CET also runs a biomedical company incubator known as the Life Sciences Center. Designed to help early-stage biomedical companies, the center offers networking and collaboration opportunities, small business grant proposal assistance, business planning and other services. The Life Sciences Center also offers a number of shared resources including lab space, high resolution imaging system and refrigerated centrifuges. The center has four biomedical and biopharmaceutical-related tenants. Entrepreneurial Development MBF Entrepreneurial Efforts. The MBF is home to a number of entrepreneurial programs that focus on Memphis industry strengths, which include healthcare and the biosciences among others. MBF manages both an agricultural technology accelerator (AgLaunch) and a medical device accelerator (Zeroto510). It also operates the Bioworks Business Incubator located in the UT-Baptist Research Park, which boasts a metal prototype and fabrication facility (for use by medical device and other companies) as well 34,000 square feet of office space, wet labs and support equipment for biotech and related start-ups. MBF also offers strategic business consulting services and promotes collaboration in the state s innovation ecosystem through the Entrepreneurship-Powered Innovation Center initiative. This initiative, led by the MBF and partner organizations, acts as the central point of information and resources from the various entrepreneurial support organizations in the region. Finally, MBF established the Innova investment fund (discussed in more detail below) to help companies in the biosciences, bioagriculture, and other technology-related fields obtain the capital they need to grow in the region. Outcomes: Entrepreneurial initiatives facilitated to date through Bioworks have led to start-up businesses receiving more than $50 million in investment, the support of 60 companies and the creation of more than 800 jobs, and an annual revenue of over $50 million from both Innova and Bioworks Business Incubator portfolio companies. INCITE Initiative. In 2011, the Governor created the $50 million INCITE initiative with the focus of promoting Tennessee s image as a state for knowledge-based jobs and innovation-based economic development. The majority of the funding went toward increasing seed, early-stage and mezzanine level capital funds. A portion of the fund also went toward increasing entrepreneurship in the state through funding business incubators and created an incubator network. Launch Tennessee. This public-private partnership supports high-growth companies in Tennessee through five focus points: entrepreneurship, commercialization, capital, corporate engagement and outreach. Launch Tennessee helps to build relationships between startup companies and investors, has built up a network of accelerators within the state, and connects inventors to investors and entrepreneurs, as well as many other activities. Outcomes: Since its creation in 2012, Launch Tennessee has accelerated the development of 480 companies, leading to the creation of over 1,000 jobs. It has also invested $116 million (via INCITE Co-investment fund) and more than $1 billion in venture investment in Tennessee. Companies that have been assisted by Launch Tennessee have gone on to raise over $80 million in capital. Life Science Tennessee Statewide Mentor Network. This program connects life science start-up companies to a team of mentors that will help guide the company through the stage-gate process. Companies graduate from the program after giving a public presentation to investors and others. This program was started in the Spring of 2015, and was modeled after San Diego s CONNECT Springboard Program. East Tennessee State University (ETSU) Innovation Lab. The ETSU Innovation Lab is a business incubator that offers facilities and support services for both local and international start-ups. It offers funding acquisition assistance, networking and mentoring opportunities, and access to university faculty and facility resources. The Innovation Lab has both wet and dry lab spaces available as well as office space, and earned the International Business Innovation Association s Soft Landings designation, indicating the lab has the ability to help international companies break into the U.S. market. There are currently nine in-house members at the Innovation Lab, roughly half are bioscience-related companies.

6 Tennessee State Profile Venture Financing Innova. Innova is an investment firm created by the Memphis Bioworks foundation in 2007. It invests in pre-seed, seed, and early-stage startup companies primarily in the bioscience, technology and agritech industries. Innova s portfolio of 62 companies includes two biotechnology firms, three healthcare services companies, and 33 medical device companies. Outcomes: According to Innova s website, 36 start-up companies have received over $15 million in investments from Innova, which attracted more than $50 million in outside capital. These investments have led to an annual impact of more than $90 million supporting more than 150 direct jobs. TNInvestco. The TNInvestco program was created in 2009 through a $200 million investment from the state, and was charged with helping innovative start-ups in Tennessee obtain the capital they needed to grow and develop. The $200 million investment is given to ten qualifying venture capital funds which then allocate the money to promising start-up companies in the form of tax breaks. Those tax breaks are then sold to insurance companies allowing the start-ups to acquire capital. TNInvestco funds invest in a range of different companies, including ones engaged in the health and life sciences. Outcomes: As of the end of 2015, the TNInvestco program funded 181 companies using $128.8 million. This led to $402.2 million in follow-on capital and the creation of 1,517 new full-time jobs. STEM Workforce & Education Programs and Initiatives Memphis Bioworks Workforce Development Initiatives. The Memphis Bioworks Foundation offers free job training programs to unemployed individuals in Tennessee, including: The free Ready to Work Training Program trains Mid-South residents in bioscience and IT careers. Strengthening Working Families Program: in mid-2016, Bioworks was awarded nearly $4 million by the U.S. Department of Labor to train Tennessee s long-term unemployed in healthcare, advanced manufacturing and IT careers. Known as the Strengthening Working Families Program, the program is still in development. Tennessee STEM Education Network. Utilizing STEM Platform Schools and Regional STEM Innovation Hubs, the Tennessee STEM Education Network promotes STEM programs to help students as they prepare to enter the workforce or obtain higher education. Connecting with STEM industry partners, the STEM Platform Schools use new methods of teaching STEM subjects as a testing ground for the rest of the state. If a method is found to be useful, the information is disseminated through the Regional Hubs. The network also hosts the Innovative Leaders Institute, which is a 1-year training and mentoring program for teachers that helps them to learn innovative leadership skills and prepares them to administer curriculum in a successful manner. Regional Hubs also engage in professional development seminars for teachers, and work to bring STEM professionals into the classroom as well as providing opportunities for STEM-based internships for students. Prepared for PhRMA to accompany Driving Innovation and Economic Growth for the 21st Century: State Efforts to Attract and Grow the Biopharmaceutical Industry, by TEConomy Partners, LLC. Information prepared in 2016.