The Steering Committee to Strengthen Biotechnology in Western A Project of the North Carolina Biotechnology Center and Western North Carolina Partners

Biotechnology Fits Nicely Eleven Imperatives for Western North Carolina

Report of The Steering Committee to Strengthen Biotechnology in Western North Carolina

spring 2002 “We will decades from now look back on this initiative as one of the most important and prescient for Western North Carolina’s Economic Development.” The Honorable Martin Lancaster • President, North Carolina Community College System

Biotechnology Fits Nicely Eleven Imperatives for Western North Carolina

Report of The Steering Committee to Strengthen Biotechnology in Western North Carolina

Directing the sciences and applications of biotechnology to economic and cultural benefit throughout Western North Carolina in coming years is a task as challenging as important.

Addressing the task proved to be welcome, interesting, and remarkably instructive for members of The Steering Committee to Strengthen Biotechnology in Western North Carolina and for those diverse persons who so well contributed to its work.

We convey with pride this Report on the work and recommendations of the Committee.

John W. Bardo Mr. W. Steven Burke Committee Chair Committee Vice Chair Chancellor, Senior Vice President, Western Carolina University Corporate Affairs and External Relations, North Carolina Biotechnology Center Report of the Steering Committee to Strengthen Biotechnology in Western North Carolina

Members, The Steering Committee to Strengthen Biotechnology in Western North Carolina

Mr. Ray Bailey President • Asheville-Buncombe Technical Community College John W. Bardo Chancellor • Western Carolina University Mr. George Briggs Executive Director • The N.C. Arboretum Mr. Robert F. Burgin President and CEO • Mission St. Joseph’s Health System Mr. W. Steven Burke Senior Vice President for Corporate Affairs and External Relations • North Carolina Biotechnology Center Mr. Dale Carroll President and CEO • Advantage West The Honorable Charles Carter Senator • North Carolina General Assembly Mr. John F.A.V. Cecil President • Biltmore Farms Dennis Depew, Ph.D. Dean, College of Applied Sciences • Western Carolina University Charles E. Hamner, DVM, PhD President and Chief Executive Officer • North Carolina Biotechnology Center Mr. Thomas E. McClure Director, Office of Regional Affairs • Western Carolina University The Honorable Stephen Metcalf Senator • North Carolina General Assembly James H. Mullen, Jr., Ph.D. Chancellor • University of North Carolina at Asheville Mr. Teck Penland President and CEO • MAHEC Mr. Frank E. Taylor President & CEO • Great Smokies Diagnostic Laboratory

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Contents 6 Project Premise 7 Committee Approach 7 Learning and Meetings 9 Imperative 1 Targeted Application of Biotechnology Can Preserve and Improve the Quality of Life in Western North Carolina in Varied Ways, Including Strengthening of the Area’s Economy and of Individual Incomes

11 Imperative 2 Targeted and Integrated Programs for Education and Workforce Training are Required

13 Imperative 3 The Sciences and Applications of Biotechnology Can be Applied to the Environmental and Conservation Benefit of Western North Carolina

14 Imperative 4 The Sciences and Applications of Biotechnology Can Be Applied to the Health Benefit of Western North Carolina

15 Imperative 5 The Biotechnology Incubation and Training Center Provides an Extraordinarily Rich Foundation and Focus, and Should Be Funded, Developed, and Utilized

16 Imperative 6 Increased Clinical Trials Activities Can be Targeted and Supported, in Particular Those Directed to Therapeutics

17 Imperative 7 A Biomanufacturing Capability is Well Worthy of Exploration

18 Imperative 8 Traditional and Alternative Indigenous Agriculture, Forestry and Horticulture Products Important to Western North Carolina Can Be Appropriately Targeted

20 Imperative 9 New Strategies and Responses for an Unfolding Technology Must be Anticipated — and Acted Upon — in Coming Years

21 Imperative 10 Partnerships Realistic in Goals and Drawn Across Geography Are Required

23 Imperative 11 Sustained Direction and Leadership Over the Next Decade Are Unequivocally Necessary for an Effective Western North Carolina Biotechnology Initiative

24 Meeting Speakers

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Project Premise

The sciences and applications of biotechnology can over time yield benefit to the economic, academic, cultural, and environmental life of Western North Carolina. A group of Western North Carolina leaders began in early 2001 to consider this reasonable premise. How might it be explored? How might benefits be gained in both the short- and long-term? How can diverse vantage points — urban and rural, economic and public interest, policy and environmental — be somehow accommodated, and brought into appropriate balance? How can an area not traditionally directed to technology effectively incorporate it into planning, resources, and vision? How can vision meet the challenging reality of technological development? Undaunted and in fact soundly inspired by the challenge, the leaders moved soon from idea to plan. Working cohesively with senior staff from the North Carolina Biotechnology Center, Research Triangle Park, the group laid out a methodology and framework. Building from a core group and from the initial catalysts so key to any visionary endeavor — Mr. Jack Cecil, Dr. John Bardo, Dr. Jim Mullen, Mr. George Briggs — The Steering Committee to Strengthen Biotechnology in Western North Carolina was established in March of 2001. The task of the Committee was as ambitious as clear: draft a strategic plan for application of biotechnology to Western North Carolina.

The Committee recognized early that seven imperatives necessarily shaped its task and approach: 1 • A thoughtful and detailed analysis of resources, participants, and appropriate areas of application was required. 2 • The specific resources and capabilities of Western North Carolina must be built upon, including in particular target niche markets, niche areas of science and research, and niche resources. 3 • Biotechnology could yield an effective tool for community development, broader in impact and more progressive in intent than traditional economic development. 4 • Guiding recommendations and strategies must address both the short and long terms. 5 • Appropriate and realistic attention must be paid to both rural and urban outcomes. 6 • Effective and thoughtful development of biotechnology requires balanced attention simultaneously to four areas: science, industry, economic outcomes, as well as attendant societal, environmental, public, and policy issues. 7 • Imagination, partnership, and sustained attention would be required over time.

Committee members were briefed early by partners from the North Carolina Biotechnology Center, the private non-profit corporation established by the North Carolina General Assembly in 1984 to catalyze the State’s long-term commitment to biotechnology. Center staff outlined the process, strategies, and issues of biotechnology development, and informed the group about the manifest value of North Carolina’s sustained attention to the technology. Because that commitment over the past two decades has gained the state a richly comprehensive biotechnology community and enviable reputation as a place for thoughtful biotechnology development, a foundation is in place for committed attention in the Western counties of North Carolina.

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Committee Approach Biotechnology — complex, broad in applications and needed resources, and wide in definition — must be brought to manageable focus. Accordingly, the Committee shaped its learning and public meetings under five key topic areas. In total, these headings provided a useful and appropriate framework through which to consider targeted application of biotechnology in Western North Carolina:

Agriculture How can the technology offer gain to crops, growers, and processors important to the area?

Health How can the technology support or enrich the health care endeavor created by area hospitals, companies, and service providers?

Manufacturing How can biomanufacturing and related activities be targeted as strengths and offerings?

Training and Support How can the area develop the specialized workforce so increasingly in demand by companies and facilities, and so central to their location decisions?

Environment and Culture What factors — ecological, cultural, institutional, or behavioral — specific to this place clearly impel or possibly constrain targeted attention to biotechnology?

Learning and Meetings The Steering Committee held three public meetings, each addressing key topic areas as well as other appropriate information. Each meeting combined discussion with presentations from content area leaders, external as well as from the Committee itself. A fourth meeting of the Steering Committee reviewed information, ideas, and possibilities from those three meetings, yielding a feasible approach for shaping the technology to the resources, economy, and culture of Western North Carolina — the imperatives that follow. The richly diverse roster of meeting presenters — representing varied content, planning, and resource areas — is included at the end of this Report.

Meeting One • May 4, 2001 • Western Carolina University, Cullowhee The goals and approach of the Steering Committee were laid out, as was information on biotechnology development: a combination of process, participants, and issues. Two topic areas were addressed. In Agriculture, presentations outlined possible gain from biotechnology to forestry, Christmas trees, native plants and herbals, and value-added crops. In Training and Support, planning in genomics and bioinformatics, integrated educational programs, and other supporting resources at Western Carolina University and UNC–Asheville were outlined. A report on how Pitt County has over the years targeted biotechnology development revealed the model of another regional endeavor.

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Meeting Two • May 16, 2001 • Biotechnology Incubation and Training Center, Enka-Asheville The former BASF facility recently donated to Asheville-Buncombe Technology Community College provided a meeting site as well as tangible evidence of the area’s foundation for biotechnology development. Presentations addressed two topic areas, Health and Related Resources and Biomanufacturing. Speakers and discussion addressed: current and future activities of area bioscience-related companies, recruiting bioscience companies, clinical research and related services, potential health gain from native plants, genomics and bioinformatics, and plans to develop at the Enka facility a new Biotechnology Incubation and Training Center. The imperative for partnerships among diverse parties working from diverse vantage points was a key thematic emphasis of presentations.

Meeting Three • June 12, 2001 • UNC–Asheville Two of the Committee’s key topic areas shaped its third and final public meeting: Environment and Culture and Training and Support. For the first area, presentations addressed the strong sense of place, environment, and pride that so shape Western North Carolina — characteristics to be both honored and appropriately built upon by application of new technology. For Training and Support, the commitment and central role of both community colleges and investment partners were conveyed. In addition, four area citizens, representing different vantage points, served as Community Voices, informally offering personal thoughts on how biotechnology can affect the future of Western North Carolina.

Meeting Four • August 29, 2001 • Biotechnology Incubation and Training Center, Enka-Asheville Replete and challenged with information gained from the three initial meetings, the Committee met for purposeful work. Collegial and interactive, practical and imaginative, the group: • Verified with pride and pleasure that information, advocacy, and foundation had been gained in a remarkably short time. • Reaffirmed its commitment to the long-term planning, partnership, and vision required to apply biotechnology effectively in Western North Carolina. • Shaped a framework for action over time: the approach and imperatives contained in this document. Eleven Imperatives The Committee synthesized content, vision, and practical reality into eleven key areas of attention required in coming years for effective and thoughtful application of biotechnology to Western North Carolina. Members concede realistically that the tasks are substantial, requiring resources and leadership over time. Members also note with justifiable pride that Western North Carolina seems clearly to possess the leadership, interactive spirit, long-term commitment, and responsiveness to complicated issues necessary to address these imperatives.

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Imperative 1 Targeted Application of Biotechnology Can Preserve and Improve the Quality of Life in Western North Carolina in Varied Ways, Including Strengthening of the Area’s Economy and of Individual Incomes

Rationale The sciences and applications of biotechnology can yield benefit to Western North Carolina. Consonance between the technology and the region can be outlined in three main ways: Biotechnology Fits Nicely Western North Carolina is well suited for targeted attention to biotechnology, which can be practically directed to varied areas important to the life and economy of the area — ranging from the natural environment and citizen health to native plants, trees, and educational resources. The region possesses resources, foundations, and logical points of application for biotechnology. Biotechnology Expands Economic Strategies Targeted attention to biotechnology can yield a practical strategy to address two key economic challenges of the region. • First, varied activities and jobs in biotechnology can over time lessen the out migration that has traditionally vexed Western North Carolina; rippling expansion from a developing sector can strengthen the jobs, incomes, pride, and new activities necessary to keep local graduates and other citizens in the area. • Second, biotechnology offers a different and stable new sector to complement tourism, health, and other areas on which the area has been traditionally dependent, at times with shifting results. Biotechnology Suits the Culture The culture, values, and work ethic of the area yield a measurably important foundation, one often overlooked or lacking in other places. Development of an effective biotechnology endeavor in any place requires characteristics traditionally displayed by persons and institutions in Western North Carolina: pride in people and resources, independent thinking, good work and good outcomes, long-term commitment, attention to environmental implications, and an earnest determination to work together for a greater good. The importance of such spirit to technology development cannot be underestimated and is as real a resource as funding, programs or buildings.

Existing Resources on Which to Build • Members of The Steering Committee to Strengthen Biotechnology in Western North Carolina • Smart leaders inclined to partnership and long-term vision • The natural environment • Natural and institutional resources • Work force and work ethic • Culture and values • Pride in community and place • Policy and economic development organizations listed below in Imperatives 2–11, including for example but not limited to: Advantage West Regional Partnership, Western North Carolina Development Association, Western North Carolina Tomorrow, Chambers of Commerce, economic developers, the North Carolina Department of Commerce, the North Carolina Biotechnology Center • Educational institutions listed below in Imperatives 2–11, including for example but not limited to: Asheville- Buncombe Technical Community College, the University of North Carolina at Asheville, Western Carolina University, , Brevard College and high schools

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• Plant- and agriculturally-directed organizations listed below in Imperatives 2–11, including but not limited to: the North Carolina Arboretum, Biltmore Estate, and the American Chestnut Foundation • Medical and health care organizations listed below in Imperatives 2–11, including but not limited to: Mission St. Joseph’s Health System and the Mountain Area Health Education Center • Biotechnology-related companies and organizations • The Biotechnology Incubation and Training Center detailed in Imperative 5 • The Western North Carolina Biotechnology Commission recommended in Imperative 11 • The other organizations listed below in Imperatives 2–11

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Establish the Western North Carolina Biotechnology Commission recommended in Imperative 11 to move from this Report to reality over time. • Inform public and institutional constituencies about the approach and goals of the biotechnology endeavor in Western North Carolina. • Catalyze, by partnership and joint activities, the placement of biotechnology into the goals and plans of area institutions that address policy, economic development, culture, education, or agriculture. • Establish regular biotechnology meetings or roundtables.

Subsequent Priorities • Market Western North Carolina’s biotechnology endeavor to geographically proximal regions, including Atlanta, Nashville, Oak Ridge, and the Research Triangle Park.

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Imperative 2 Targeted and Integrated Programs for Education and Workforce Training are Required

Rationale To yield thoughtful and effective benefit to society, biotechnology must be understood by citizens, developed by industry, and utilized by consumers, companies, and institutions. To gain such understanding requires comprehensive, integrated educational programs in schools, community colleges, colleges, and universities. Targeted 2-year training programs at community colleges are increasingly key in an area seeking biotechnology development, application, and manufacturing. Programs dovetailed between community colleges and four-year institutions also prove valuable to students as well as employers. Increasingly, life science institutions and biotechnology companies cite a specifically skilled, highly trained workforce as required for their presence in an area.

Existing Resources on Which to Build • A practical predisposition to integrated programs among educational institutions at all levels in Western North Carolina • High schools and middle schools — and perhaps elementary schools as well • Asheville-Buncombe Technical Community College and other area community colleges • The Biotechnology Incubation and Training Center • The University of North Carolina at Asheville, Western Carolina University, Warren Wilson College, Brevard College, Appalachian State University • Western North Carolina companies • The Pisgah Institute • The North Carolina Department of Community Colleges • North Carolina Biotechnology Center • Mountain Area Health Education Center • Mission St. Joseph’s Health System • North Carolina Arboretum • Western North Carolina Nature Center • Federal funding programs, including those at the National Science Foundation and the National Institutes of Health

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Survey current or potential area companies and institutes for workforce needs, to ensure that new degree programs are designed appropriately. • Establish new 2-year degree biotechnology program at Asheville-Buncombe Technical Community College. • Create a seamless, dovetailed 2+2 biotechnology degree program between Asheville-Buncombe Technical Community College, the University of North Carolina at Asheville, and Western Carolina University. • Establish a bioinformatics program and emphasis at Western Carolina University.

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Subsequent Priorities • Develop and teach biotechnology short courses at community colleges. • Develop middle through high school curricula, activities, and science fair emphases on the science, applications, and issues of biotechnology. • Complete Advantage West Underemployed Workforce report. • Foster biotechnology-related professional development activities among faculty at community colleges, universities, hospitals, and related institutions.

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Imperative 3 The Sciences and Applications of Biotechnology Can Be Applied to the Environmental and Conservation Benefit of Western North Carolina

Rationale The natural environment of Southern Appalachia is unique and rich . . . and threatened. Air and water quality, acid rain, pollution, invasive plants and animals, diminishment of key native plants and high-altitude trees, and impacts of human intervention all demand careful short- and long-term solutions. Because it is based on living organisms, biotechnology can be carefully and appropriately applied to these threats — as a new tool or solution as well as a means to better understand and protect, rather than change, plants and animals.

Existing Resources on Which to Build • The North Carolina Arboretum • Environmental and science programs at UNC–Asheville, Western Carolina University, Brevard College and Warren Wilson College • Public interest and environmental groups working from diverse vantage points for the environmental benefit of Western North Carolina • Government agencies and policy-makers working practically to address environmental threats • Key area facilities, including but not limited to: Highlands Biological Station, Bent Creek Environmental Forest, Coweeta Hydrologic Laboratory, The Pisgah Institute • Mountain Horticultural Crops Research Station and Extension Center, North Carolina State University, Fletcher • North Carolina State University • Federal facilities, including but not limited to: National Climatic Data Center, The Cradle of Forestry, U.S. Forestry Service, and U.S. Park Service • American Chestnut Foundation • North Carolina Department of Environment and Natural Resources

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Commission a scientifically sound study on how the sciences of biotechnology can be applied by area agencies and persons to address environmental challenges safely and effectively.

Subsequent Priorities • Identify ways to help the American Chestnut Foundation use biotechnology as a tool for regaining this diminished species.

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Imperative 4 The Sciences and Applications of Biotechnology Can Be Applied to the Health Benefit of Western North Carolina

Rationale Ensuring the health of its citizens is a prime goal of any society. The imperative is felt with notable commitment in Western North Carolina, which seeks to be The Healthiest Region. The goal reflects the reality that health is the most important component of the quality of life as well as factors specific to the area, ranging from traditionally uncertain rural health care to an increasing number of retirees, gerontological issues, and high allergen counts. Biotechnology, largely directed worldwide to improved health of humans, offers the area the best possible combination of applied tools, economic gain, and sector appropriately built from existing strong resources.

Existing Resources on Which to Build • Mission St. Joseph’s Health System and other health care providers • Mountain Area Health Education Center • Asheville-Buncombe Technical Community College health programs • Purposeful exploration of the genomics and applications of native plants and other alternative health strategies • Yellow Creek Botanical Institute, Gaia Herbs, Pisgah Labs • Research Triangle Institute • Involved industry, including Great Smokies Diagnostic Labs and Applera Corporation

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Commission a scientifically sound and economically realistic study on how native plants might be better understood and applied for medical outcomes. • Increase and strengthen resources and activities in clinical trials, expanding scope of involved entities as well as areas of attention — as further detailed in Imperative 6. • Determine what improved community resources or goals might strengthen the capabilities of existing entities — industry, such as Great Smokies Diagnostic Labs, or institutional, such as Mission St. Joseph’s Health System — or even trigger growth of additional such entities in the area. • Develop programs and activities — at Mission St. Joseph’s Health System and Western Carolina University — to apply bioinformatics to clinical trials and newer areas such as patient and database security. • Develop programs and capabilities — at the University of North Carolina-Asheville and other appropriate sites — in biomedical ethics, likely to be valuable practically in clinical trials as well as academically.

Subsequent Priorities • The Committee felt that none could be confidently or appropriately set at this time.

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Imperative 5 The Biotechnology Incubation and Training Center Provides an Extraordinarily Rich Foundation and Focus, and Should Be Funded, Developed, and Utilized

Rationale Evidence is clear from throughout the United States and worldwide: biotechnology endeavors benefit from a central facility for interaction, learning, or business development. Such a facility can simultaneously serve as: a tangible sign of area commitment, an incubator of ideas as well as companies, a foundation for virtual as well as established companies, a very real selling point for potential or recruited companies, site for training and internships, a location for meetings and planning, and a focal point for energy, excitement, and the unexpected outcomes so often springing from active hubs. Moreover, such a facility can manifest, in support and activities, the kinds of partnerships and clustering required for effective biotechnology development in an area. Because the new Biotechnology Incubation and Training Center can serve all such functions, it provides a resource unmatched in most places and is enormously valuable to Western North Carolina.

Existing Resources on Which to Build • The facility donated by BASF to Asheville-Buncombe Technical Community College • Asheville-Buncombe Technical Community College • North Carolina Biotechnology Center • Research Triangle Institute

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Create a realistic five-year plan for facility upfitting, activities, and expenses. Key content should include a survey of company needs for incubator or later-stage sites as well as analysis of requirements for biomanufacturing detailed below in Imperative 7. • Secure funding and other required commitments.

Subsequent Priorities • Market the facility to Western North Carolina, elsewhere in North Carolina, and to other proximal communities, including Atlanta, Nashville, Research Triangle Park, and Oak Ridge. • Recruit companies to the facility. • Grow locally-directed companies within the facility.

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Imperative 6 Increased Clinical Trials Activities Can Be Targeted and Supported, in Particular Those Directed to Therapeutics

Rationale Application of biotechnology to human health requires attention to interrelated stages, each based on specific capabilities and resources: research and discovery, clinical trials and evaluation of outcomes, and biomanufacturing. Possessed of an extensive and well integrated health care network, and already well grounded in clinical trials, Western North Carolina is prepared to serve the region, state, and nation as an expanded site for such trials. Specific area characteristics — demographics, costs, scale and efficiency of tasks, and proximity to North Carolina’s unparalleled community of over 70 CROs (clinical research organizations) — further impel the logic of targeting this activity.

Existing Resources on Which to Build • Mission St. Joseph’s Health System and other health care providers • Mountain Area Health Education Center • Asheville-Buncombe Technical Community College health programs, including Medical Laboratory Technician and Nursing • Involved industry, including Pisgah Labs and Molecular Toxicology • The health-related mission and Clinical Laboratory Sciences program at Western Carolina University • 70 Contract Research Organizations (CROs) in North Carolina • Research Triangle Institute • Great Smokies Diagnostic Labs • The North Carolina Genomics and Bioinformatics Consortium

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Obtain FDA/CEBR certification for biologics testing at Mission St. Joseph’s Health System. • Contract for short-term consultancy with representative of a leading North Carolina CRO to determine strategies to increase CRO presence in Western North Carolina.

Subsequent Priorities • Increase presence of CRO industry in Western North Carolina, by partnership with existing companies, recruitment, or establishment of new organization targeted to the area. • Strengthen or redirect as necessary the Med Lab Tech Program at Asheville-Buncombe Technical Community College. • Develop new Clinical Sciences degree at Western Carolina University.

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Imperative 7 A Biomanufacturing Capability is Well Worthy of Exploration

Rationale As stated in Imperative 6, application of biotechnology requires attention to several interrelated stages, including biomanufacturing. Biomanufacturing can be undertaken in locations different from research and trials, which often are places judged less expensive, appealing in resources or characteristics, appropriate to a given product, and possessed of a well-trained workforce. Western North Carolina can reasonably pursue biomanufacturing facilities, which will provide key benefits: existing manufacturing capabilities are built from or even strategically replaced; positions pay well; and positions are often accessible to retrained displaced workers as well as compelling enough to keep recent graduates in the area.

Existing Resources on Which to Build • Geography Western North Carolina is close to growing biotechnology and pharmaceutical development communities, including those in central North Carolina, the mid-Atlantic, Tennessee, and Georgia • Appeal Western North Carolina offers high appeal for location of facilities and employees not necessarily tied to research • The Biotechnology Incubation and Training Center/former BASF manufacturing site • The Millennium campus at Western Carolina University • North Carolina Department of Commerce, state and regional offices • Advantage West Regional Partnership • Local economic developers • North Carolina Biotechnology Center

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Learn from a representative small sampling of companies their needs for biomanufacturing capabilities — and what resources or offerings would induce their attention to Western North Carolina. • Ensure as soon as possible training capabilities, at Asheville-Buncombe Technical Community College and/or other area educational institutions. • Secure public or private monies for loans, upfitting, or incentives; biomanufacturing facilities, however constituted, are complex and costly.

Subsequent Priorities • Development of a contract or trial biomanufacturing facility certified for good manufacturing practices. • Creation of a new Western North Carolina Center for Quality Assurance. • Development of a biomanufacturing capability specifically targeted for extraction of proteins and components from the value-added crops described in Imperative 8.

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Imperative 8 Traditional and Alternative Indigenous Agriculture, Forestry and Horticulture Products Important to Western North Carolina Can Be Appropriately Targeted

Rationale Although rich in biodiversity, Western North Carolina has traditionally been reliant on a comparatively small number of plant species for economic gain. Application of biotechnology offers strategies by which to expand that number, strengthen existing agricultural sectors, and preserve threatened species. Opportunities are promising in four initially identified areas: Native Plants and Herbs Western North Carolina is one of the nation’s most distinctive biosystems, site of an estimated 2,500 plant species. Many are not found elsewhere. Few have been explored for medicinal, alternative health, herbal, nutritional, or other properties. Key techniques of biotechnology, including genomics and genetic transformation, will enable precise exploration and utilization of properties of interest — and of economic value. Forestry The entire forestry endeavor in Western North Carolina — including Christmas trees, fruit and plantation trees, and the trees so important to the landscape of the place — can benefit from the sciences of genomics and molecular biology. Key areas of attention include: use of biotechnology as one strategy to assist restoration of the American Chestnut; development of resistance to disease, fungal, and environmental stresses; diminished reliance on expensive and environmentally equivocal chemical inputs; and development of new characteristics suited to area growing conditions. Value-added Crops Biotechnology will in coming years enable development of row crops or other plants altered to yield, in their biomass or fruits, economically strong products such as pharmaceutical proteins and nutraceutical components. Smaller plots — characteristic of Western North Carolina’s terrain — will likely not be a liability. Crops particularly suited to the area can be explored and targeted. Horticulture and Nursery stock Biotechnology can be applied to an existing or increasing range of fruit, nursery, and ornamental stock, yielding species or strains with new, targeted, or desirable characteristics. The area’s biodiversity might well prove a rich foundation for new species.

Existing Resources on Which to Build • North Carolina Arboretum • Yellow Creek Botanical Institute • Gaia Herbs • Research Triangle Institute • American Chestnut Foundation • Mountain Horticultural Crops Research Station and Extension Center, North Carolina State University, Fletcher • North Carolina State University • North Carolina Department of Agriculture • North Carolina Cooperative Extension Service • Research Triangle Park agricultural biotechnology companies • U.S. Forestry Service • Golden Leaf Foundation • North Carolina Biotechnology Center

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• The North Carolina Genomics and Bioinformatics Consortium • Institute of Forest Biotechnology, Research Triangle Park • Western North Carolina Development Association • The Pisgah Institute

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Commission an ongoing and methodical analysis of the characteristics of certain native plants, of how they might be better understood by genomics, and of how biotechnology might gain higher-yield commercialization. • Develop appropriate genomics and bioinformatics infrastructure — through programs or research support — at Western Carolina University. • Explore development of a nationally unique resource: a database on the genomics of native plants. • Gain information on value-added crops likely to be feasibly grown in Western North Carolina and on strategies to bring them to fields, processing, and economic outcomes, drawing in particular on the Mountain Horticultural Crops Research Station and Extension Center.

Subsequent Priorities • The Committee felt that none could be confidently or appropriately set at this time.

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Imperative 9 New Strategies and Responses for an Unfolding Technology Must be Anticipated — and Acted Upon — in Coming Years

Rationale Biotechnology is barely explored; science, applications, and potential will unfold for many decades. The horizon of discovery continually unfolds. Accordingly, leaders and places working for benefit from biotechnology must constantly be attentive to the future, to possibilities, to imaginative exploration. Biotechnology is future-directed, and so must be its developers. Leaders and places with a considered eye on the future will be advantaged, better prepared to chart and capture opportunities. Attention to the future possibilities and implications of biotechnology yields a strong imperative, that three areas must always be considered simultaneously: science and research; industry and products; and the societal, ethical, environmental, and policy issues attendant to a new technology. Thoughtfully considering the interrelationship of these areas is necessary for effective, appropriate, and accepted long-term biotechnology development in a place.

Existing Resources on Which to Build • The Western North Carolina Biotechnology Commission recommended in Imperative 11 • The North Carolina Biotechnology Center • University programs and faculty • The North Carolina Arboretum • The unusually full grouping of public interest and environmental groups found throughout Western North Carolina • Companies and institutions considering future activities and products • The Asheville Citizen-Times and other media attentive to societal change • The diverse public and private entities listed under this heading at every Imperative • Any other entity — in North Carolina or beyond — judged useful and appropriate in coming years to a given idea, goal, or project

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Establishment of the Western North Carolina Biotechnology Commission recommended in Imperative 11, with due attention to unfolding biotechnology outcomes and issues among its given mandates

Subsequent Priorities • The Committee felt that none could be confidently or appropriately set at this time.

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Imperative 10 Partnerships Realistic in Goals and Drawn Across Geography Are Required

Rationale Development, application, and use of biotechnology is intrinsically a matter of partnership. Many parties diverse in tasks and responsibilities must be brought into a purposeful endeavor: researchers, universities and educational institutions at all levels, workers and workforce trainers, companies and biomanufacturers, institutions addressing health and agriculture, media, investors, ethicists, policy makers and leaders, individuals and public groups. Appropriate and considered outcomes are possible only if such diverse parties work in partnership, for two main reasons: the complexity of biotechnology can seldom be addressed by any one entity; and an endeavor of such societal importance must spring from a range of parties and vantage points. Partnerships must transcend geography, must combine public and private entities, must diminish the territorial imperative, and must be based on shared goals.

Existing Resources on Which to Build • The diverse public and private entities listed under this heading at every Imperative • Any other entity — in North Carolina or beyond — judged useful and appropriate in coming years to a given idea, goal, or project

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities Representative examples of practical partnerships might early be: • Between Yellow Creek Botanical Institute and the Research Triangle Institute in exploration and development of medical applications from native plants in Western North Carolina • Between Asheville-Buncombe Technical Community College, Western Carolina University, and UNC- Asheville for integrated educational programs • Asheville-Buncombe Technical Community College and other community colleges working together on shared curricula • Investors, banks, and The Biotechnology Incubation and Training Center, to establish funding and lines of credit for new companies and facilities • Economic Developers and potential biomanufacturers seeking sites • The Western North Carolina Biotechnology Commission and biotechnology companies in the Research Triangle Park area considering new sites for expansion or biomanufacturing • The North Carolina Genomics and Bioinformatics Consortium and new university emphases at Western Carolina University

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• The North Carolina Arboretum, Yellow Creek Botanical Institute, and Gaia Herbs • Humanities faculty at UNC–Asheville and Warren Wilson College, the Western North Carolina Biotechnology Commission, and area public interest or environmental groups • The North Carolina Biotechnology Center, Advantage West, and area economic developers • Between Mission St. Joseph’s Health System and the Research Triangle Institute in protocols and administration of clinical trials of alternative medicines

Subsequent Priorities • The Committee felt that none could be confidently or appropriately set at this time.

spring 2002 22 Report of the Steering Committee to Strengthen Biotechnology in Western North Carolina

Imperative 11 Sustained Direction and Leadership Over the Next Decade Are Unequivocally Necessary for An Effective Western North Carolina Biotechnology Initiative

Rationale The Steering Committee to Strengthen Biotechnology in Western North Carolina recognizes a key reality: a committee and a report can organize information and lay out reasonable broad recommendations, but ongoing results are seldom assured without a responsible and directing party. No committee or report, however spirited and sensible, can alone ensure movement from need and idea to outcome. Never easy to meet, the challenges of this movement are further increased when many involved parties must be brought to cohesive action, when tangible results often realistically require years, and when the subject comes new to the life of a place. Accordingly, the Committee regards establishment of a permanent framework — the Western North Carolina Biotechnology Commission — as essential. The Commission will: • Be composed of eight persons, leaders of institutions key for long-term commitment to biotechnology in Western North Carolina. • Catalyze, chart, and direct a long-term biotechnology endeavor. • Commission and oversee the studies and information-gathering necessary for informed projects and decision- making. • Gain funding for its activities. • Gain in-kind support from the institutions of its members and from other parties. • Oversee a first position: the Western North Carolina Biotechnology Coordinator. • Serve as a visible public focal point for activity, commitment, policy, and attention to issues — societal, ethical, environmental, or cultural. • Explore the possibility of forming a community-based “seed investment fund.”

Existing Resources on Which to Build The Biotechnology Incubation and Training Center provides a logical site for the Commission and the Coordinator, for it: shows new territory and new spirit combined; has from the beginning been seen as a place of multi-party and multi- institutional partnership; and will be seen as a neutral, central site for varied area-wide meetings, training, and companies. Varied parties in Western North Carolina and perhaps beyond must together ensure the financial and other resources required for the Commission and its activities.

Bold But Practical New Ideas, First Priorities and Subsequent Priorities

First Priorities • Establishment and funding of the Western North Carolina Biotechnology Commission.

Subsequent Priorities • The Committee felt that none could be confidently or appropriately set at this time.

23 spring 2002 Report of the Steering Committee to Strengthen Biotechnology in Western North Carolina

Meeting Speakers • John Ashley, M.D. • Senior Vice President for Clinical Services, Mission St. Josephs • Mr. Ray Bailey • President, Asheville-Buncombe Technical Community College • John W. Bardo • Chancellor, Western Carolina University • Ms. Joanne Bartsch • Science Teacher, Carolina Day School • Mr. David W. Bristol • President, Pisgah Labs • Mr. W. Steven Burke • Senior Vice President for Corporate Affairs and External Relations, North Carolina Biotechnology Center • Mr. Rick Carlisle • Managing Partner, Dogwood Equity (Managers of the North Carolina Economic Opportunities Fund) • Mr. John D. Chaffee • Executive Director, Pitt County Development Commission • Robert L. Doudrick, PhD• Assistant Director, Southern Research Station, USDA Forest Service • John Frampton, PhD• Associate Professor and Christmas Tree Geneticist, North Carolina State University • Mr. Phillip Gibson • Chairman-Board of Trustees, Yellow Creek Botanical Institute • Gilbert W. Gleim, PhD• Director of Research Institute, Mission St. Josephs • Charles E. Hamner, DVM, PhD • President, North Carolina Biotechnology Center • Ms. Betty Huskins • Vice President, Advantage West • The Honorable Martin Lancaster • President, North Carolina Community College System • The Honorable Stephen Metcalf • Senator, North Carolina General Assembly • Mr. Matt Meyer • Dean, Business and Industry Services, Asheville-Buncombe Technical Community College • James H. Mullen, Jr., PhD • Chancellor, University of North Carolina at Asheville • Nicholas Oberlies, PhD • Research Chemist, Research Triangle Institute • Mr. Dave Porter • Vice President for Economic Development, Asheville Area Chamber of Commerce • Dr. John Rundell • President and CEO, Molecular Toxicology Inc. • Paul H. Sisco, PhD • Staff Geneticist, The American Chestnut Foundation • Mr. Virgil Smith • President and Publisher, Asheville Citizen Times • Mr. Robin Suggs • Executive Director, Yellow Creek Botanicals • Ken Tindall, PhD • Senior Vice President for Science and Business Development, North Carolina Biotechnology Center • Mr. Jason Walls • Economic Development Director, Swain County DECK • Mr. David Williams • Vice President, Technical Operations, CropTech • Mr. Paul Wood • Industrial Development Specialist, North Carolina Biotechnology Center

spring 2002 24 15 T.W. Alexander Drive • PO Box 13547 Research Triangle Park, NC 27709-3547

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