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Request to PlanLast updated 1/12/16

Tracking No. GR 16/17 20

UNIVERSITY OF NORTH CAROLINA

REQUEST TO PLAN

A NEW DEGREE PROGRAM – ANY DELIVERY METHOD

THE PURPOSE OF ACADEMIC PROGRAM PLANNING: Planning a new academic degree program provides an opportunity for an institution to make the case for need and demand and for its ability to offer a quality program. The notification and planning activity described below do not guarantee that authorization to establish will be granted.

Date: 13 September 2016

Constituent Institution: North Carolina State University

Is the proposed program a joint degree program? Yes X No

Joint Partner campus University of North Carolina – Chapel Hill

Title of Authorized Program: JOINT UNC CH N C STATE UNIVERSITY BIOMEDICAL ENGINEERING DEPARTMENT – PROFESSIONAL SCIENCE MASTERS’ DEGREE

Abbreviation: PSM

CIP Code (6-digit): 14.0501 Level: B M X I D

CIP Code Title: Biomedical Engineering

Does the program require one or more UNC Teacher Licensure Specialty Area Code? Yes No__ X __

If yes, list suggested UNC Specialty Area Code(s) here __________________________

If master’s, is it a terminal master’s (i.e. not solely awarded en route to Ph.D.)? Yes _X_ No____

Proposed term to enroll first students in degree program: Term Summer Year 2017

Provide a brief statement from the university SACSCOC liaison regarding whether the new program is or is not a substantive change.

http://www.sacscoc.org/pdf/081705/SubstantiveChange.pdf(To be coordinated with the assistance of Dr. George Hodge, Assistant Dean for Program Development, The Graduate School, N. C. State University)

Definition: Substantive change is a significant modification or expansion of the nature and scope of an accredited institution. Under federal regulations, substantive change includes

NO SUBSTANTIVE CHANGES – Questions to be addressed by/for SACS

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http://www.sacscoc.org/pdf/081705/SubstantiveChange.pdf



No. Question/Change Yes/No1 Any change in the established mission or objectives of the institution No2 Any change in legal status, form of control, or ownership of the institution No

3 The addition of courses or programs that represent a significant departure, either in content or method of delivery, from those that were offered when the institution was last evaluated

No

4 The addition of courses or programs of study at a degree or credential level different from that which is included in the institution’s current accreditation or reaffirmation. No

5 A change from clock hours to credit hours No

6 A substantial increase in the number of clock or credit hours awarded for successful completion of a program No

7 The establishment of an additional location geographically apart from the main campus at which the institution offers at least 50% of an educational program. No

8 The establishment of a branch campus No9 Closing a program, off-campus site, branch campus or institution No

10 Entering into a collaborative academic arrangement that includes only the initiation of a dual or joint academic program with another institution No

11 Acquiring another institution or a program or location of another institution No

12 Adding a permanent location at a site where the institution is conducting a teach-out program for a closed institution No

13 Entering into a contract by which an entity not eligible for Title IV funding offers 25% or more of one or more of the accredited institution’s programs No

Identify the objective of this request (select one or more of the following)

☒ Launch new program on campus ☐ Launch new program online; Maximum percent offered online ___________

☐ Program will be listed in UNC Online☐ One or more online courses in the program will be listed in UNC Online

☐ Launch new site-based program (list new sites below; add lines as needed)☐ Instructor present (off-campus delivery)☐ Instructor remote (site-based distance education)

Supply basic program information for UNC Academic Program Inventory (API) and UNC Online

Minimum credit hours required __34__Expected number of full-time terms to completion 12 contiguous months beginning with 2

summer sessions followed by subsequent Fall and Spring sessions

1. Review Status. (Draft provided to those identified below – awaiting response)

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a. List the campus bodies that reviewed and commented on this request to Plan proposal before submission to UNC General Administration. What were their determinations? Include any votes, if applicable.

Last First Title University Department or College

Hodge George Assistant Dean for Program Development NC STATE Graduate School

Larick Duane K.Senior Vice Provost for Academic Strategy & Resource Management

NC STATE Graduate School

Martin-Vega Louis Dean NC STATE College of Engineering

Byerley Julie Vice Dean of Education UNC School of Medicine

Goldstein Eric EVP & COO, UNC Hospitals, Prof of Medicine UNC UNC Hospitals

Guskiewicz Kevin Senior Associate Dean UNC College of Arts and Sciences

Harkins Heidi Professional Science Masters’ Program, Director UNC Graduate School

Matson Steve Dean UNC Graduate School

Schmitt Stephanie Associate Dean for Academics UNC Graduate School

Thornton CourtneyAssociate Vice President for Research and Graduate Education

UNC General Administration

b. Summarize any issues, concerns or opposition raised throughout the campus process and comment periods. Describe revisions made to address areas of concern. No Substantive Issues

2. Description and Purpose

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a. Provide a 250-word or less description of the proposed program, including target audience, delivery method, hours required, program core and concentrations (if applicable), post-graduate outcomes for which graduates will be prepared, and other special features. For programs with an online component, describe whether the delivery is synchronous with an on-campus course, partially synchronous, asynchronous, or other.

Description of the Joint UNC CH NC STATE University Department of Biomedical Engineering Professional Science Masters’ Program

Members of the Joint UNC CH - N C STATE Biomedical Engineering Department, working in cooperation with:

(a) the Biomedical Engineering Program in the Department of Engineering at East Carolina University; (b)The Department of Chemical, Biological, and Bioengineering in the College of Engineering at The North Carolina Agricultural and Technical State University; and (c) the UNC Professional Science Masters’ Program

are in the process of developing a BME Professional Science Masters’ Program (PSM), identified as “TraIn” for Translation of Innovations.

At this stage, the program, having a strong innovation and entrepreneurship bias, has two tracks: one focusing on biomedical products; the other on biomedical processes.

The detailed product and process work is to be conducted in such a manner to protect the intellectual property of the University and confidentiality of those organizations partnering in the work.

Both practical, application oriented tracks are designed to be completed in a single 12 month period beginning with a summer immersion, a Fall Semester emphasizing engineering design, with a final Spring Semester focusing on licensing and/or deployment.

The curriculum is tentatively composed of 34 semester hours of course work addressing management, design, business, and focused STEM electives.

There are four components of the proposed program of essential value to candidates, to UNC-CH and NC STATE University, to the economic development of North Carolina, and to prospective employers …

1. Delivers newly “discovered” biotech products and processes to the licensing stage (i.e. having demonstrated proof of concept)

2. Translates “on the cusp” research into IDFs and Provisional Patents to licensing level3. Prepares masters’ candidates with strong biotechnical/biomedical knowledge to immediately

contribute in the biotech/biomedical environment with the following skills and practical

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experiences: manufacturing, development, management, leadership, design, process enhancement, intellectual property protection, and business assessment and planning

4. Provides a pipeline of experienced early stage biomedical start-up engineering managers

Target Audience • graduates with 0 to 5 years’ experience• individuals with BS degrees in STEM curricula• minimum undergraduate GPAs of 3.2 • non-PhD candidates focusing on practice and industry• individuals with biases to innovation and entrepreneurship• high performing individuals who can finance themselves or may be financed by their

employer• professionals recognizing the financial benefits of a one year intense immersion, design,

development, deployment, engineering, business, and team leadership experience

Delivery Method • immersion, shadowing, coaching, mentoring – summer sessions• conventional classroom – Fall and Spring Semester• asynchronous lectures with real-time remote and on-site advising, mentoring, and coaching • year-long product and/or process design or enhancement practicum

Hours Required –34 semester hours + minimum 520 person-hours of immersion/shadowing/observing/discovery

Summer Sessions - 9 semester hours - with - 240 person-hours of immersion, shadowing, observing, discovery

• Fall Semester - 13 semester hours– with - 140 person-hours product/process design and pitching

• Spring Semester - 12 semester hours – with - 140 person-hours proof of concept prototype and pursuit of licensing/deployment

Program Core and Concentrations – four key areas identified by industry/economic development demands

• Management & leadership – 6 courses/10 semester hours• Discovery and design – 3 course/9 semester hours• Technology electives - 3 courses/9 semester hours• Business – 2 course/6 semester hours

Post-Graduate Outcomes for Which Graduates Will Be Prepared • one year opportunity income/cost saved for each candidate• 24%, $17,000 increase in annual income potential (BME undergraduate salary compared to

graduate degree) • potential to start own company• start with or return to employer with targeted, ready to deploy skills• enhanced technical, business, management, and leadership skills essential to success in the

technically challenging biomedical innovation and entrepreneurship business environment of 26



• improved potential for promotion

Special Features 1. partnering among the N C Biotech Center, North Carolina State University, the University of

North Carolina at Chapel Hill, The North Carolina Agricultural and Technical State University, and East Carolina University

2. employment multiplier of 3 to 3.4; i.e. adding support jobs to the economy for each graduate3. attraction, expansion, and retention of biomedical companies in North Carolina4. increased number of viable start-up companies5. addresses “management gap” in North Carolina biotech industry staffing needs: individuals with

management/leadership, business, engineering, and BME specific technology skills6. partnering across multiple organizations at UNC CH and NC STATE together with NC A&T and

ECU7. deliver viable IDFs to UNC CH and/or NC STATE Technology Transfer Offices8. supports key strategic education and economic development plans

o UNC System – Our Time Our Futureo UNC CH - Innovate at Carolinao UNC CH School of Medicine – Strategic Plan for the UNC School of Medicineo NC STATE University - Pathway to the Futureo N C Biotech Center – Bridging the Gaps

9. leverages existing co-operative programs with other colleges and universities, e.g. Elon, Furman, Campbell, etc.

10. brings “on-the-cusp” research from the lab to IDF and Provisional Patent Applicationo Regenerative medicineo Unltrasound imagingo Pharmaco-engineeringo Rehabilitation engineeringo Biomedical Micro- and Nanodeviceso Other heath and health care STEM disciplines

11. provide demonstrated new and/or improved key process to clinical and biomedical manufacturing partnering organizations

b. How does the proposed program align with system, institutional and unit missions and strategic plans?

System – NC Constitution 1776 – “All useful learning shall be duly encouraged and promoted by one or more universities.”

Our Time Our Future – UNC COMPACT: The Commitment to North Carolina - 2013No. Commitments Alignment (H, M, L)

1 Academic excellence and the opportunity for success for all students

H

2 Value for students and for North Carolina H3 Solutions to North Carolina’s biggest challenges H4 Connection and engagement with North Carolina communities H

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Institutional UNC CH – Mission – “to serve as a center for research, scholarship, and creativity and to teach a diverse community of undergraduate, graduate, and professional students to become the next generation of leaders. Through the efforts of our exceptional faculty and staff, and with generous support from North Carolina’s citizens, we invest our knowledge and resources to enhance access to learning and to foster the success and prosperity of each rising generation. We also extend knowledge-based services and other resources of the University to the citizens of North Carolina and their institutions to enhance the quality of life for all people in the State.”

UNC Innovations – 2010No

. Recommendations Alignment (H, M, L)

1Prepare faculty, graduate and undergraduate students, staff, and the broader Carolina community with the knowledge, skills, and connections necessary to translate new ideas into innovations

H

2 Collaborate with diverse groups on campus and beyond to explore issues, options, and creative approaches that may lead to innovations H

3 Translate important new ideas more expediently and at an increased volume into innovations that improve society H

4 Align people, incentives, resources, and processes to strengthen an intentional culture of innovation at Carolina H

5 Catalyze innovation at Carolina by facilitating the work of faculty, staff, and students as they put important ideas to use for a better world H

UNC CH – School of Medicine

The mission of the School of Medicine and the Health Care System is to advance the health of the people of North Carolina. Both plans share an emphasis on quality, innovation and efficiency in the delivery of medical care. Key elements of the Health Care System strategic plan that are not addressed in the SOM strategic plan include clinical network development, identification of core business opportunities as a means to strengthen the network and reduce costs (including integration of certain business functions across the HCS) and information services related to health care delivery.

Focus and Strategy Alignment (H, M, L)

Research

SP1. Set translational and multidisciplinary team science as a vision for UNC research, and provide the tools needed to foster successful teams

H

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Focus and Strategy Alignment (H, M, L)

SP2. Stimulate team-based, translational research with targeted investments in key translational research areas H

SP3. Streamline the organization and management of the research infrastructure to ensure it is best positioned to meet the future needs of SOM investigators

L

Education

SP1. Restructure the curriculum to prepare students to be leaders of 21st century medicine M

SP2. Optimize student recruitment and admission practices and programs to provide physicians needed for theState of NC and the nation

N/A

SP3: Develop and support infrastructure that will ensure our continued ability to train physicians, both withinChapel Hill and across the state

M

Clinical Care

SP1. Establish a UNC HCS-wide quality program, building on existing efforts, to ensure the greatest possible patient safety and highest quality care for all

M

SP2. Establish a mechanism for innovation and entrepreneurship in clinical care delivery and financing H

SP3. Institute a cross SOM-HCS informatics strategy to enable highest quality care and innovation L

Faculty

SP1: Enable data-driven management by defining and systematically tracking performance at both the institutional and individual level

L

SP2: Align faculty performance expectations, evaluations and rewards systems N/A

SP3: Establish the conditions to help faculty succeed, both generally and for specific sub-groups L

NC STATE – Mission – “dedicated to excellent teaching, the creation and application of knowledge, and engagement with public and private partners. By uniting our strength in science and technology with a commitment to excellence in a comprehensive range of disciplines,

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NC STATE promotes an integrated approach to problem solving that transforms lives and provides leadership for social, economic, and technological development across North Carolina and around the world.”

The Pathway to the Future – Strategic Plan 2011 – 2020No. Goals Alignment (H, M, L

1 Enhance the success of our students through educational innovation H2 Enhance scholarship and research by investing in faculty and infrastructure L

3 Enhance interdisciplinary scholarship to address the grand challenges of society H

4 Enhance organizational excellence by creating a culture of constant improvement H

5 Enhance local and global engagement through strategic partnerships H

Unit Joint UNC CH NC STATE BME Department – Mission StatementCurrent – “to improve human health and quality of life by educating and training students and conducting cutting edge research that integrates engineering, biology, and medicine.

Proposed – “Combine engineering and medicine to improve lives”

Joint BME Strategies and InitiativesNo. Strategies and Supporting Initiatives Alignment (H, M, L1 Create a transformative inter-institutional model

a Create BME charter N/Ab Enable joint departmental personnel and students Hc Reposition the department externally H

2 Grow global impacta Educate a high quality workforce Hb Accomplish high-impact, innovative research N/Ac Translate and transition technology H

3 Secure resources to enable strategya Establish a BME endowment Hb Grow industrial partnerships Hc Create new revenue-generating programs H

c. What student-level educational objectives will be met by the proposed program?

Masters Level Objectives Met by Program of 26



Professionals successfully completing the program:will have practical, "in the field", behavioral and performance level experience in 1 or more of the following1 starting up an innovative entrepreneurial med-tech company

2 prioritizing and taking technically proven research ideas to license

3 designing and delivering clinical processes enhancing both health and financial benefits for Accountable Care Organizations and others

4 designing and delivering manufacturing processes of high value

will have received classroom, "on the job", formal explicit and tacit training in each of the following areas1 acceptable culture and behavior in a healthcare, medical, and/or FDA compliant manufacturing environment

2 managing cross-functional professionals in a deliverable driven, business team environment

3 design and delivery of effectively functioning real healthcare devices and/or processes

4 business assessment and planning for new products and processes or improvement thereof

5 new technical skills

will have presented, pitched, and documented their observations, analyses, and designs, often in a competitive environment, to competent, practical professionals seeking to benefit from the work products of the candidates, including1 selected angel investors

2 key venture capitalists

3 key UNC CH and N C STATE officers, at the Vice Chancellor level, responsible for Innovation, Entrepreneurship, and Economic Development

4 executives of leading biomedical manufacturing organizations

5 recognized expert leaders in healthcare inside and outside of the UNC and N C STATE organizations

6 leading legal and regulatory experts

Partner benefits1 carefully prepared, attractive ROI, IDFs and Provisional Patent Applications reflective of sound legal, market, regulatory,

reimbursement, and technical considerations2 receipt of well vetted business investment proposals3 improved operational capabilities - manufacturing and/or clinical processes

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4 "first-look" assessment of prospective professional employees5 advancement of technically proven, laboratory assessed, inventions to license6 development of a cadre of university professionals and graduates that may substantively contribute to the economic

development of NC

3. Student Demand Provide documentation of student demand. Discuss the extent to which students will be drawn from a pool of students not previously served by the institution.

Current and Projected DemandThe Graduate Program in the Joint Department of Biomedical Engineering currently has over 100 graduate students enrolled, with an approximate 80/20 split between PhD and MS students. Historically, there has been a greater emphasis on the recruitment of PhD students into the program, which has been driven by a number of factors to be addressed later in this section.

Unlike the thesis masters, the PSM provides a meaningfully different offering to a typical MS applicant. It has

a clear and defined time investment; a standardized training program; as well as obvious and direct application to industry needs.

Looking at our previous round of 117 MS applicants, 58 were domestic, with approximately half (31) of the domestic applicants appearing to readily satisfy our academic requirements. Being relatively strict on Verbal GRE levels for international applicants would provide at least 25 very strong applicants and likely more if TOEFL scores are considered rather than the GRE. Transferring these current MS numbers to the PSM, there is a potential starting pool of 50-60 high-quality applicants for the PSM program.

With a historic acceptance rate of between 30-50% (PhD), we would expect 20-30 students to be a reasonable projection for the number of students who could enter the program in the relatively near future, with further growth to be expected as knowledge of the program expands.

In summary, we would expect that the PSM would be in high demand and achieve a significant level of applicant interest, with a strong pool of high-quality applicants. We would further expect the potential for significant growth as both the recognition and reputation of the program increases.

Background and JustificationFirst, faculty in BME are typically funded through longer duration grants, with a typical initial duration of 4-5 years. Using these funds, faculty prefer to hire a student who will be involved in the project for an extended period of time - where they have the time to both learn the academic and research skills they need as well as then perform the proposed research through which they are funded. Their work also is likely to enhance the success of downstream grant applications and this situation generally favors PhD students, whose typical time to graduation is between 5 and 6 years.

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Second, there has been greater institutional focus on increasing the number of PhD graduates, in part due to national ranking metrics.

Finally, increasing the number of students into the program is tied to the resources available to support them such as administrative support, teaching loads, etc. As much of this support is tied to grant proposals, PhD student recruitment is a natural focus. As a result, investment has tended to be towards PhD students rather than MS students.

Despite this previous emphasis, the lower number of MS students in the Joint BME program is not due to the lack of quality applicants. Broadly speaking, MS applicants to our program are strong, with this year’s applicant pool (2016 admission) having a mean GPA and Quantitative GRE score of 3.36 and 77%, respectively. This was mirrored in the previous year, with MS applicants having a mean GPA of 3.39 and a Quantitative GRE score of 74%. Offers of admission to MS students are given, but have tended to be kept to a relatively small slice of the applicant pool, often linked to where there has been specific interest in recruiting a student by a faculty member.

In addition to the high-selectivity of MS students into our program, there are several other factors that reduce the number of students that join the MS program. First, we do not guarantee funding for any MS applicant, though many do end up being funded by a lab. These costs can be non-trivial, especially for non-resident and international students. Second, the requirement of a thesis presents specific challenges to MS students. In particular, the time to degree is highly dependent on the lab they join as well as the overall success of their project. Given that students must assume that they are paying for all education and living expenses throughout the course of their degree, the unknown time to completion is often a negative factor. Finally, translation of their learned skills to industry can sometimes be a challenge depending on the area of research that the student pursued.

4. Societal demand. Provide evidence of societal demand and employability of graduates from each of the following source types.

a. Labor market information (projections, job posting analyses, and wages) i. specific to North Carolina (source - ncworks.gov)

a. Employment change 2012 to 2022; 174 positionsb. Entry Level = $51,150; Median = $73,290; Experienced = $92,780

ii. available from national occupational and industry projections (US Bureau of Labor Statistics)

a. The Economic Value of College Majors – Georgetown University 2015 – Executive Summary: Biomedical Engineer1. 25th percentile change equals $45,000 to $55,00, 22% differential2. 50th percentile change equals 24.1%, $17,0003. 75th percentile change equals $100,000 to $140,000, 40% differential

b. Job growth rate (US Bureau of Labor Statistics) – 23% from 2014 to 2024, compared to all engineers at 4%, BLS Job Outlook - Much Faster than Average, 5100 employment increase to 27,200

c. BLS Median salary estimate by 2015 - $86,220

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b. Projections from professional associations or industry reports.

There are hundreds of articles of value to this request to plan. Two are of direct substantive value. The first is a 2011 publication of the N C Biotechnology Center. The second is a “policy/white paper” authored by Michael Easley, Jr. from 2009. The key points from each appear to be crisply delivered: insightful and supportive of the proposed PSM TraIn Program. These are presented as direct quotes, with limited commentary. These should be considered carefully … the explicit coursework included in the proposed curriculum integrated with the tacit training and experience are closely aligned with the ideas, concepts, and observations presented below.

I. NC Biotechnology Strategic Plana. The North Carolina General Assembly, acting through Session Law 2010-3I, Senate Bill

897, in 2009 requested the following: “The North Carolina Biotechnology Center shall prepare a strategic plan to accelerate the commercialization of promising life science technologies and discoveries being developed in universities and private companies in North Carolina and the related development and production of new commercial products.” This request resulted in the document, “Bridging the Gaps, a Strategic Plan to Accelerate the Commercialization of Life Science Technologies in North Carolina.”

b. The state’s life science companies face critical challenges along the path toward the commercialization of their products, as evidenced by:

i. The low number of established (i.e., revenue-generating or public) biotechnology companies headquartered here

ii. The frequency with which North Carolina-based life science companies are acquired when on the cusp of success

iii. The mixed commercial results generated by the state’s strong academic bioscience research institutions.

c. To assess the nature of these challenges, the North Carolina Biotechnology Center gathered input from more than 50 key life science industry stakeholders. These stakeholders included technology transfer officers, life science company executives (from small, mid-sized and large companies), investors, bankers, service providers, and executives representing the state’s life science-focused non-profit organizations. These discussions revealed that the major challenges to commercialization of life science technologies are:

i. the limited availability of funding required by companies at critical junctures in their evolution

ANDii. the shortage of highly experienced life science executives in North Carolina ---

with …1. product development,2. commercialization, and 3. financing experience

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was viewed by many stakeholders (especially those in the investment community) as a significant impediment to bringing products to market successfully.

iii. There are far more promising, innovation-driven companies at all stages of maturity in North Carolina than there are accomplished executives to drive them, creating a management gap. The limited size of this talent pool appears to constitute a rate-limiting step that prevents more promising North Carolina-based life science companies from reaching a commercial plateau that reaps benefits to the state in the form of jobs and tax revenue.

d. Market Opportunityi. Life Science Definition – incorporates pharmaceuticals and diagnostics (including

biotechnology-derived products), medical devices and equipment, industrial and environmental biotechnology, and agricultural biotechnology (including biofuels).

ii. The Importance of Start-up Companies to Industry Growth: 1. Entrepreneurs and bioscience start-up companies played an important

role in growth … Small businesses with fewer than 500 employees accounted for 65 percent of the net new jobs created during the 1993 – 2009 period. In their first year, new firms collectively add an average of three million jobs, while older companies lose one million jobs annually.

2. Most successful biotech drugs emerge from start-ups. According to AdvaMed, 28% of the medical technology industry research and development spending comes from smaller companies. While these start-up companies may leave the ultimate commercialization of their products to larger companies, the life sciences industry is highly dependent on discoveries initially developed from start-ups.

e. Life Science Opportunity in North Carolina – Mixed Returns from Academic Bioscience Research

i. North Carolina ranks 5th in the US with over $1.5 billion spent on academic bioscience research and development.

ii. The state ranked only 14th among all states in terms of bioscience patents issued during the 2004 – 2009 period.

iii. North Carolina’s biotechnology patents accounted for 2% of the country’s biotechnology patents in 2009.

iv. These data suggest a significant disconnect between North Carolina’s strong academic research enterprise and the efficiency of translating that research into products that will be developed further in the state.

f. North Carolina faces a management gap resulting from an insufficient supply of local serial entrepreneurs and top-tier executives relative to the number of commercial opportunities being generated within the state.

i. It is understandable that it takes a special type of executive to create and grow a successful life science company. Each stage of company development is associated with a distinct set of challenges that requires a leader with stage-specific skills who understands all of the moving parts and has the ability to

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navigate with agility through a myriad of complex issues. Orchestration of these complexities requires command of:

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1. the underlying science,

2. intellectual property,

3. regulatory affairs,

4. product development,

5. board and investor management,

6. manufacturing, 7. workforce, and 8. sales and

marketing.

ii. For the inception-stage company funded solely with money from its founders, the ideal CEO candidate may be the builder shaper of a vision who understands and synchronizes all company activities, finds the compelling story and focuses the company efforts accordingly. Further, this individual has a knack for effectively channeling the energy of the inventor and corporate team, has a passion for building opportunities from scratch, is resourceful at finding start-up funding and managing risk, and is willing to work for an equity stake in the company. There are few individuals with these characteristics coupled with the track record of success.

II. Tar Heel BioTech: The Policies, Trends, and Investments that Continue to Promote Growth in North Carolina’s Biotechnology Sector, by Michael R. Easley, Jr., attorney with Michael Woods, LLP, Life Sciences Industry Group

a. Over the last 20 years, biotech has grown from a small fraction to a crucial piece of North Carolina’s economy.

i. Large North Carolina operations include GlaxoSmithKline, Bayer, Novartis, Wyeth, Merck, Syngenta, Biogen, and many more.

ii. North Carolina is home to 528 biotechnology companies, making it the third leading state in the industry, behind only California and Massachusetts. This growing sector accounts for $45.8 billion in economic activity and generates 1.4 billion in state and local taxes annually.

iii. The sector employs nearly 57,000 North Carolinians, paying out an estimated $4.5 billion to employees annually.

iv. The average salary for jobs in the field is $74,650. v. The average annual wage for all types of manufacturing in the state is $36,000.vi. When economists factor in the “multiplier effect,” the total number of jobs

supporting the industry totals 180,000.b. The state’s general economic development strategy focuses on three main goals:

i. quality job creation – focusing on long-term, sustainable, high paying jobs that are less prone to outsourcing than traditional manufacturing

ii. development of economically distressed areas – ensuring industry-ready, skilled workforce, and core infrastructure

iii. maintaining economic competitiveness in global markets – targeting industries that are strategically coherent with state’s other industries and resources

c. The state’s success is largely attributable to:

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i. Tendency of biotech firms to clusteri. Clusters allow large firms to invest locally in promising young

technologies by giving small firms access to funding, laboratory space, manufacturing facilities or marketing expertise.

ii. A key source of startup funding comes from research and development contracts with large local firms in exchange for future marketing rights.

iii. The local agglomeration resulting from these relationships has dramatically shaped the industry’s national geographic distribution.

iv. In an industry where specialized information is crucial, industry clusters also generate clusters of professional talent.

1. corporate leaders with valuable industry experience2. specialized accountants and lawyers3. strong research universities, saturated with academics who

are strongly contributing to the scienceii. An ample supply of intellectual human capital from high-caliber research

universitiesi. Recruit star scientists to the area

ii. Promote research and developmentiii. Actively transfer new technologies to the market – i.e. encourage

entrepreneurial research facultyiii. Public and private support for innovation commercialization

i. Universities have created technology transfer programs to streamline innovation to market commercialization

ii. Modern universities … enact policies encouraging faculty to bring new ideas to market

iii. … by employing dedicated technology transfer staff … the value of new technology is more likely to be realized locally

iv. A 1999 study found that 82% of firms formed with university licenses set up in the same state as the university

c. Other (alumni surveys, insights from existing programs, etc.)

Reflecting further on detailed analysis of data from the period 2005 through 2014 indicate a high demand for our Masters’ program. As explained in section no. 3 above, Student Demand, the current filtering/selection process yielded the values presented in the table immediately below.

Table 4-1: Historical Enrollment

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INT = International applicants/candidates meeting the specific needs of faculty engaged in research NC = Residents of North Carolina applicants/candidates Cleared = Applicants further screened and “cleared,”Non-Res = Non-residents of North Carolina applicants/candidates having no legal or visa issuesRecommended = Applicants with acceptable credentials AND Enrolled = Applicants presenting for class

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Start Da

teINT

NCNon

-ResINT

NCNon

-ResINT

NCNon

-ResINT

NCNon

-ResINT

NCNon

-ResTota

l200

532

718

15

81

58

14

6200

661

1213

17

51

75

03

01

76

14200

736

911

37

11

71

17

01

100

11200

848

85

13

00

30

02

01

90

10200

968

718

32

62

26

21

32

33

8201

076

916

13

61

36

12

53

38

14201

179

1011

12

61

25

12

22

47

13201

266

1218

07

70

77

06

21

84

13201

344

119

19

71

97

16

31

125

18201

437

415

21

52

15

21

03

73

13Tota

ls547

89134

1441

5110

4650

934

211.67

7.004.00

12.67

13.2%

55.3%

31.6%

100.0%

Applied

Recomm

ended

Cleared

Enrolled

Rolling

2 year,

4 semes

ter enro

llment

Average

Distrib

ution



Detailed analysis reflecting eligibility and recommended admission without focus on matriculation at the PhD level is shown below in Table 4-2. Noting that past recruiting practice may have dissuaded a number of attractive Masters’ candidates from applying, it seems reasonable to project a steady state enrollment without additional recruitment effort on the order of 30 candidates.

Table: 4-2 Enrollment Potential from most recent 10 years (see discussion in section no. 3, Student Demand

With modest additional effort, working with current partners at NC A&T, ECU, Furman, Elon, Campbell, etc., the enrollment may be forecast at 50 per year.

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Start D

ateINT

NCNo

n-Res

INTNC

Non-R

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NCNo

n-Res

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Non-R

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tal200

532

718

134

913

49

123

418

2006

6112

1326

67

266

723

43

30200

736

911

155

615

56

143

219

2008

488

520

43

204

318

31

22200

968

718

294

929

49

263

432

2010

769

1632

58

325

829

33

35201

179

1011

335

633

56

304

236

2012

6612

1828

69

286

925

44

33201

344

119

186

518

65

174

223

2014

374

1516

28

162

814

13

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4167

23045

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5. Unnecessary duplication.

a. List all other public and private four-year institutions of higher education in North Carolina currently operating programs similar to the proposed new degree program, including their mode of delivery. Show a four-year history of enrollments and degrees awarded in similar programs offered at other UNC institutions (using the format below for each institution with a similar program); describe what was learned in consultation with each program regarding their experience with student demand and job placement. Indicate how their experiences influenced your enrollment projections.

According to information gleaned from, the National Society of Professional Engineers, the Bureau of Labor statistics, the National Center for Education Statistics, and American Engineering Association, there are ten ABET accredited, post-secondary schools in North Carolina offering degrees in Biomedical Engineering. These are listed below:

Caldwell Community CollegeDuke UniversityEast Carolina UniversityGaston Community CollegeNorth Carolina Agricultural and Technical State University

North Carolina Central UniversityNorth Carolina State UniversityStanley Community CollegeUniversity of North Carolina at Chapel HillWake Forest University

According to the UNC Systems “Degree Finder” http://www.northcarolina.edu/apps/programs/index.php), only three UNC schools offer Biomedical Engineering: East Carolina University, N. C. State University, and the University of North Carolina at Chapel Hill. It appears from personal emails, phone communications, and visits that the North Carolina Agricultural and Technical State University offers both a BS and MS in Biomedical Engineering.

Based on information gathered from the website of the National Center for Education Services, (http://nces.ed.gov/collegenavigator/), the table below lists the schools and degrees conferred as of academic year 2014 – 2015.

Table 5-1: Universities in North Carolina Conferring Degrees in Biomedical EngineeringNumber of Degrees Conferred 2014-2015

Institution (NCES.edu.gov) Bachelors Masters PhDs TotalDuke University 121 50 31 202NC State University 50 6 8 64East Carolina University 0 0 0 0NC A & T State University 6 5 0 11University of North Carolina CH 0 4 2 6Wake Forest University 0 5 12 17

Currently no North Carolina ABET accredited engineering program offers a contiguous 12-month Biomedical Engineering, Professional Science Masters’ Program focusing on Translation of Innovation. All current Masters’ degrees require 18 to 24 months plus either a summer internship or thesis.

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http://nces.ed.gov/collegenavigator/

http://www.northcarolina.edu/apps/programs/index.php



b. Identify opportunities for collaboration with institutions offering related degrees and discuss what steps have been or will be taken to actively pursue those opportunities where appropriate and advantageous.

i. Meetings were held with Barbara Muller-Borer, PhD – BME area leader in the Department of Engineering at East Carolina University and with Stephen Knisley, BME Department Head at NC A & T University on 8 August and 9 August to discuss the Joint UNC – N C STATE BME PSM TraIn Program in detail.

ii. Both Dr. Muller-Borer and Dr. Knisley responded favorably to the in-progress planning. Both plan to discuss the program with their Department Head and Dean respectively.

iii. Next steps include (a) additional meetings to consider the detail curriculum and (b) the potential to move ahead jointly; perhaps with East Carolina University leading clinical process design and improvement and NC A & T University leading manufacturing biomedical process design and improvement initiatives.

iv. A number of other colleges and universities currently work with N C STATE and UNC CH in 3 plus 2 programs, including Furman, Elon, and Campbell Universities. These programs have the potential to provide a steady stream of PSM candidates. Outreach to these programs is planned.

v. Extensive joint planning between the Executive Director of the Joint BME PSM Program and the Director of Professional Science Masters’ Programs in the UNC Graduate School is underway.

The intent is to utilize “as is” or modestly modified UNC PSM courses together with current faculty to support the management and leadership components of the proposed Joint PSM TraIn Program.

Working together, the two leaders seek to ensure compliance of the Program with key requirements of the National Professional Science Masters’ Association.

c. Present documentation that the establishment of this program would not create unnecessary program duplication. In cases where other UNC institutions provide similar online, site-based distance education, or off-campus programs, directly address how the proposed program meets unmet need.

The proposed Joint UNC – NC STATE Professional Science Masters’ Program, TraIn, focuses entirely on translation of current, existing knowledge to commercial practice: biomedical products and/or biomedical processes. It is designed to address four key areas, essential to the economic development of North Carolina, as identified by theN C Biotechnology Center in their 2011 report entitled Bridging the Gaps:

I. Management and Leadership – 10 semester hoursII. Discovery and Design – 9 semester hours

III. Technology enhancement and application – 9 semester hoursIV. Business/Finance – 6 semester hours

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A fifth area of emphasis in the proposed program is hands-on, experience and application of leading edge technology in real-world environments.

The program emphasizes Theodore von Karman’s admonition: “Scientists discover the world that exists; engineers create the world that never was.”

Below are extracts, with links, to the traditional, Master of Science programs, evolving at ECU and NC A & T. Clearly the proposed TraIn, terminal degree, Professional Masters’ Program, focuses on the acquisition and translation of current knowledge through the integration of engineering, management, and business practices as opposed to the evermore focused, traditional pathway of research and publication … leading toward the doctoral degree.

i. East Carolina University – Department of Engineering MS in Biomedical Engineering - http://www.ecu.edu/cs-cet/engineering/MSBiomedicalEngineering.cfmTwo-year program with thesis

14 semester hours in the Department of Engineering 6 semester hours thesis credit Additional courses selected from the Departments of Physiology,

Pharmacology, Kinesiology, Biology, Physics, Computer Science, Mathematics and Biostatistics.

Core Curriculum Introduction to Biomedical Engineering Research Life Science Biostatistics Mathematics Thesis Electives

Biomedical Instrumentation and Measurement Biomedical Signal Processing Cardiac Electrophysiology Cardiovascular Biomechanics Biomaterials in Medicine Biomolecular Engineering Introduction to Tissue Engineering Selected Topics in Biomedical Engineering

Suggested areas of focused study: Cardiovascular Biomedical Engineering (Cardiovascular Biomechanics,

Cardiovascular Electrophysiology, Biomedical Instrumentation or Biomedical Signal Processing)

Biomolecular and Tissue Engineering (Introduction to Tissue Engineering, Biomolecular Engineering, Biomaterials, Biomedical Instrumentation)

Biosensors and Biosignals (Biomedical Instrumentation, Biomedical Signal Processing, Cardiovascular Electrophysiology)

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http://www.ecu.edu/cs-cet/engineering/MSBiomedicalEngineering.cfm



ii. North Carolina Central Agricultural and Technical State University – Department of Chemical, Biological and Bio-engineering, http://www.ncat.edu/coe/departments/cbbe/Files/graduate-bioengineering.htmlMaster of Science in BioengineeringThe Master of Science in Bioengineering program is a two-year engineering program and will be open to students who have completed their BS degree in science or engineering. The Master of Science in Bioengineering (MS BMEN) emphasizes advanced study in two specialization areas: (i) biomaterials and biomechanics, and (ii) bioimaging, biosignals and biosensors. The program provides graduate level education designed to prepare the graduate for Ph.D. level studies or for advanced bioengineering practice in industry, consulting, or government service.

North Carolina A&T State University (NCAT), in partnership with University of Pittsburgh and University of Cincinnati, currently has been awarded an NSF Engineering Research Center (ERC) on metallic biomaterials. The strategic plan of NCAT’s college of engineering to develop programs in Bioengineering is consistent with the research and educational activities proposed in the ERC. The ERC will be instrumental in providing the bioengineering program with intramural internships involving the research efforts related to the ERC, in particular in the three Engineered Systems (ESs), namely Craniofacial and Orthopedic Applications; Cardiovascular Devices; and Responsive Biosensors for Implants. Bioengineering students will have the opportunity to work in the laboratories of the faculty members associated with the ERC at the three lead academic institutions. Additionally, the electives in bioengineering will be developed based on the knowledge base required to perform state-of-the art R&D related to the ESs; for example, Biomaterials and Biocompatibility; Tissue Engineering & Regenerative Medicine; and Nanoscience and Nanofabrication. Courses will be developed by the participating ERC faculty and taught either on the NCAT campus or online using internet technology and originating from Pitt and UC.

6. Enrollment. Estimate the total number of students that would be enrolled in the program during the first year of operation and in each delivery mode (campus, online, site – add lines as needed). Detailed explanation is presented in the earlier Section 2: Student Demand.

Delivery Mode campus Full-Time 30 Part-Time N/A

Estimate the total number of students that would be enrolled in the program during the fourth year of operation and in each delivery mode (campus, online, site – add lines as needed):

Delivery Mode campus Full-Time 50 Part-Time N/A

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http://www.ncat.edu/coe/departments/cbbe/Files/graduate-bioengineering.html

http://www.ncat.edu/coe/departments/cbbe/Files/graduate-bioengineering.html



7. Resources. Will any of the resources listed below be required to deliver this program? (If yes, please briefly explain in the space below each item, state the estimated new dollars required at steady state after four years, and state the source of the new funding and

resources required.)

a. New Faculty: Yes_____ No __X___

b. Faculty Program Coordination: Yes X__ No _____

Executive Director – UNC CH NC STATE Joint BME PSM TraIn Program = Salary + Fringe = $195,000

c. Additional Library Resources: Yes _____ No X

d. Additional Facilities and Equipment: Yes _____ No X

e. Additional Other Program Support: Yes X___ No _____(for example, additional administrative staff, new Master’s program graduate

student assistantships, etc.)

Administrative staff support Funds for

o compensation of angel investors, venture capitalists, industry partners, etc., participating in vetting Need Specifications, product and process designs, inventions, IDFs, and Provisional Patents;

o development of proof of concept prototype devices;o advertising, travel, conferences, etc.;o coordination of activities among Joint UNC and NC STATE

personnel and ECU and NC A & T professionals in the development of mutually supportive programs; and

o adjuncts and salary supplements for faculty teaching existing courses to best meet the tight time constraints of PSM TraIn Masters’ candidates.

8. Curriculum leverage . Will the proposed program require development of any new courses? If yes, briefly explain. YES

One course, Biomedical Innovation and Entrepreneurship, not currently delivered at UNC CH – NC STATE will be required. This course was developed at another ABET accredited university and consequently, should not require substantial alteration.

Two other courses may require upgrading to meet the demands of more senior Masters’ candidates: BME 451 and 452, the senior design sequence to accommodate the needs for Design and Prototyping.

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A new course, Grad 701 (1.5 semester hours) – Working in the Clinical Environment, will need to be developed. However, much of the content may be adapted from current courseware in the first year med-school curriculum.

All other courses are currently approved and actively delivered.

9. Funding Sources. Does the program require enrollment growth funding in order to be implemented and sustained? If so, can the campus implement and sustain the program should enrollment growth funding be unavailable? Letters of commitment should be provided. The TraIn PSM Program is envisioned to require 4 years to become fully operational. Without additional funding the program is projected to result in a total, i.e. 4 year, shortfall of approximately $3.2 million

9a. For graduate programs only:

Does the program require a tuition differential or program specific fee in order to be implemented and sustained? YES

i. If yes, state the amount of tuition differential or fee being considered, and give a brief justification.i. As currently envisioned, without Premium Tuition, the program will

incur a shortfall over a 4 year period of approximately $3.2 million.ii. Comparing the PSM TraIn Program to similar programs at

benchmark universities (e.g. Georgia Tech, UVA, University of Michigan, etc.,), an increase in semester charges as Premium Tuition in the amount of $7000 seems reasonable. The TraIn non-Resident Tuition at N C STATE would increase from approximately $13,000 to $20,000 and at UNC CH from about $14,000 to $21,000; Resident Tuition will also need to rise by $7000 per semester.

iii. Current tuition for the benchmark programs identified above varies from $19,000 at Georgia Tech to $24,500 at UVA.

iv. Note that the summer period is treated as a full semester in this proposal. This “Premium Tuition” will eliminate any shortfall.

v. With Premium Tuition alone, in the early years, inadequate funds will be available to support proof of concept prototype development and testing, a key element of the program, estimated at an annual cost of $150,000.

vi. To address this challenge, it is proposed to phase in the Executive Director salary over the start-up four year period as follows: year 1, $0; year 2, 25%; year 3, 50%; year 4, 100%. During the initial years, the Executive Director compensation will need to be funded from existing sources supporting the Joint UNC CH NC STATE BME Program.

vii. Proceeding in the manner recommended above for the first four years of the program, results in full recovery of the Exec Directors’ salary and an annual on-going surplus of approximately $190,000.

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ii. Can the campus implement and sustain the program if the tuition differential or program fee is not approved? No! Letters of commitment from the Chancellor and/or Chief Academic Officer should be provided. TO BE PURSUED pursuant to cross-functional review of this draft Request to Plan

10. For doctoral programs only: Not Applicable

a. Describe the research and scholarly infrastructure in place (including faculty) to support the proposed program.

b. Describe the method of financing the proposed new program (including extramural research funding and other sources) and indicate the extent to which additional state funding may be required.

c. State the number, amount, and source of proposed graduate student stipends and related tuition benefits that will be required to initiate the program.

Contact. List the names, titles, e-mail addresses and telephone numbers of the person(s) responsible for planning the proposed program.

Zhen Gu, Ph.D. Associate Professor Joint Department of Biomedical Engineering | Pharmacoengineering Track Director, Professional Science Masters’ Program - TraIn University of North Carolina at Chapel Hill | North Carolina State University Eshelman School of Pharmacy | Molecular Pharmaceutics Division Department of Medicine | Endocrinology and Metabolism Division University of North Carolina at Chapel Hill Email: zgu3@N C STATE.edu | [email protected] Phone: (919) 515-7944 Fax: (919) 513-3814

B. D. Barnes Ph.D. PE PMPExecutive Director UNC CH NC STATE Joint BME Professional Masters’ Program - TraInAdjunct Professor of the PracticeNorth Carolina State University - College of Engineering+1 (919) 349-2074 [email protected]@mindspring.com

This request for authorization to plan a new program has been reviewed and approved by the appropriate campus committees and authorities.

Chancellor: _______________________________________ Date:__________________

Chancellor (Joint Partner Campus): _________________________Date:_____________________

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