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1 Cover/Signature Page Full Template Institution Submitting Request: Utah Valley University Proposed Title: Graduate Certificate in Regulatory Affairs for Life Sciences School or Division or Location: College of Science and Health Department(s) or Area(s) Location: Department of Biology Recommended Classification of Instructional Programs (CIP) Code Proposed Beginning Date: 08/01/2014 Institutional Board of Trustees Approval Date: Pending Proposal Type (check all that apply): Regents Agenda Items R401-4 and R401-5 Approval by Committee of the Whole SECTION NO. ITEM (AAS) Associate of Applied Science Degree (AA) Associate of Arts Degree (AS) Associate of Science Degree Specialized Associate Degree Baccalaureate Degree K-12 School Personnel Programs Master s Degree Doctoral Degree (CER C) Certificate of Completion x Graduate Certificate Fast Tracked Certificate Chief Academic Officer (or Designee) Signature: I certify that all required institutional approvals have been obtained prior to submitting this request to the Office of the Commissioner. Signature Date: 02/03/2014 Printed Name: Ian Wilson 1 CIP codes must be recommended by the submitting institution. For CIP code classifications, please see

2 Executive Summary Full Template Utah Valley University Graduate Certificate in Regulatory Affairs for Life Sciences 12/20/2013 Program Description The Regulatory Affairs for Life Sciences Graduate Certificate program will provide students with the skills required to interpret and manage regulatory and quality compliance issues that are critical for the Life Sciences. The curriculum materials include formal studies that are specific to regulatory sciences (domestic and international), quality management system, and design control. Students will gain experience in technical communications with an emphasis on the theory and practice of technical writing as it relates to industry-based submissions. Students will participate in an internship or capstone project with a medical device, pharmaceutical, diagnostics, or biotechnology company. A baccalaureate degree in a science or a technology-related area of study will be required. Role and Mission Fit The UVU mission statement states, The University prepares professionally competent people of integrity who, as lifelong learners and leaders, serve as stewards of a globally interdependent community. There is clear demand for competent regulatory affairs talent in the work force. The ability to gain regulatory affairs skills will bring value to those with existing baccalaureate degrees and help them to contribute to a growing life sciences industry. The university and the students benefit by contributing to the growth of companies in their community and ultimately the regional economy. Faculty The skills required for regulatory affairs are not associated with traditional academic programs or research efforts at most universities. The skills and aptitudes are specific to industry and bringing products to market. Thus, it is not typical that universities will have faculty members with the ability to teach in regulatory affairs. Dr. Goetz, in the Dean s Office, has sufficient knowledge to have provided the initial guidance for program design, course development, and creation of the certificate proposal. A Director for the proposed program was recently hired. Dr. Haven McCall has a D.R.Sc. and M.S. in Regulatory Sciences from the University of Southern California and an M.S. in Business Management from Northern Arizona University. He has 13 years of experience working for global life science companies in the areas of regulatory affairs (domestic and international), quality, clinical research, and product surveillance. His work experience gives him a broad base of skills, which make him an adept leader that is able to build and manage programs and teams, develop budgets, and create strategic plans. Dr. McCall has spent the last several years helping to design and teach graduate level courses in Regulatory Affairs at Arizona State University. Finally, his participation in a national consortium of university regulatory affairs programs will help to build credibility to the new UVU program. Dr. McCall, as the Director, will teach BIOL 5000, BIOL 579R, and portions of BIOL 5010 and He will oversee and monitor the internships (BIOL 581R) and the Capstone projects (BIOL 580R). One adjunct instructor will co-instruct BIOL 5010 and A faculty member from the English Department will teach ENGL It is not anticipated that additional full-time faculty members will be needed. New faculty members will participate in all required training and orientation and remain current on program subject matter through ongoing industry relations. Market Demand The Utah Department of Workforce Services (DWS) Labor Market Information (LMI) reports an average of 70 jobs posted annually for regulatory and compliance. These jobs are listed as five stars which indicates a job area with the strongest employment outlook and highest wages. Battelle generated a report for the Utah Cluster Acceleration Partnership (UCAP)

3 program in August of 2012, which indicated that there would be an annual projected growth of approximately new hires in these regulatory and compliance positions over the next five years. The UCAP report independently confirmed, through interviews with industry representatives, that a current critical shortage of skilled regulatory affairs professionals is adversely affecting their ability to develop and bring their medical products to market. A search conducted on several websites 2 listed a total of jobs posted for regulatory affairs positions in Utah. The positions ranged from entry-level to managerial and all of them required a baccalaureate degree. The majority of the posted positions were with life science companies; a few were associated with technical talent agencies ( headhunters ) and law firms. It is important to note that the Utah life science industry continues to grow at approximately two percent annually, and it is one of two Utah industries that did not experience a reduction or even flattening of job growth during the economic decline. Further, it is anticipated that the increase in Federal Drug Administration (FDA) oversight of the natural products and dietary supplement industry will result in a need for additional regulatory talent. This creates a compelling reason to create a new certificate to help the industry meet current and projected needs for its continued growth. Student Demand While there is no program available currently for regulatory affairs (in UVU or Utah), two courses have been developed and were piloted during the Fall of There were 24 inquiries into the courses, with the majority of the inquiries from current employees in Utah companies. Student demand is projected to be high, especially for biology graduates. The certificate will add considerable value to an existing baccalaureate degree. The employment opportunity will be high, there will be increased job security, and a significant increase in wages for those with regulatory affairs skills. There were 90 biology graduates (plus 22 from chemistry and biotechnology) that graduated with a baccalaureate degree in There are a total of 681 biology majors enrolled at UVU, with 349 of these students being seniors. Biology Department advisors estimate, based upon their experience, that students will enroll annually in the program. There is a more than adequate pool of prospective students at UVU, and it is anticipated that with advertising of the program there should be significant interest for students at other institutions of higher education. It is expected that there will be considerable interest in the program by existing employees in Utah life science companies. Statement of Financial Support Appropriated Fund. Special Legislative Appropriation Grants and Contracts Special Fees. Differential Tuition (must be approved by the Regents).. Other (please describe) Similar Programs Already Offered in the USHE A benchmarking study was performed by the UCAP Life Sciences Talent Committee to determine where and to what extent related programs exist in other states. The study found 43 other regulatory programs offered by higher education institutions, none within the State of Utah. Of these programs, 22 offer master s programs and 27 offer certificate programs. The College of Engineering at the University of Utah offers a course in design control; however, it is specific for engineering majors. 2 Indeed.com, SimplyHIred.com and Monster.com; (as of 10/22/2013)

4 Program Description Full Template Utah Valley University Graduate Certificate in Regulatory Affairs for Life Sciences 12/20/2013 Section I: The Request Utah Valley University requests approval to offer a Graduate Certificate in Regulatory Affairs for Life Sciences effective Fall Section II: Program Description Complete Program Description The Graduate Certificate in Regulatory Affairs for Life Sciences will provide students with the education required to interpret and manage regulatory and quality compliance issues that are critical to the Life Sciences. The curriculum materials include formal studies that are specific to regulatory sciences (domestic and international), quality management system, and design control. Students will gain experience in technical communications with an emphasis on the theory and practice of technical writing as it relates to industry-based submissions. Students will participate in an internship or capstone project with a medical device, pharmaceutical, or diagnostics company. A baccalaureate degree in a science or technology-related area of study will be required. 3 Purpose of Degree The program will provide a course of study that prepares students for a rewarding career in regulatory affairs. The course content is designed for students with a baccalaureate degree in biology, biotechnology, or chemistry and provides excellent employment opportunities. It will also provide additional skills to current employees that are seeking new opportunities within the life science industry. The UVU College of Science and Health reported 112 graduates in biology, chemistry, and biotechnology in The proposed certificate will give a valuable post-baccalaureate option to these graduates, as well as graduates from other institutions. The College has significant relations with local industry partners and is well aligned to place students into internship and employment opportunities to these graduates. If approved, the Graduate Certificate in Regulatory Affairs for Life Sciences will be the only program of its type in the Intermountain West region. This will provide a unique opportunity for UVU students to have access to careers that are in high demand by Utah companies. Institutional Readiness The College of Science and Health and the Department of Biology are poised to administer the full, proposed program. Funding has been provided from the Utah Cluster Acceleration Partnership (UCAP; funding administered through the Utah System of Higher Education and the Utah Department of Workforce Services) to develop and deliver new pilot courses in regulatory affairs through June 30, This funding includes support for curriculum material development for the new courses, salaries for a full-time instructor (who will also provide administrative support for the new courses), adjunct instructors, and supplies. The University and College administration are working to build the cost of the proposed program into the institutional budget beginning July 1, The proposed program will enroll students per year, which will not put significant additional burden on Student Services (Registration and Records, Academic Advising, Financial Aid, Graduation Office) and other administrative support units (e.g., scheduling). This enrollment projection is based upon anticipated student demand and the cap is determined by program capacity that will ensure quality instruction.

5 The curriculum materials have been developed and incorporated into courses, which are embedded into a one-year sequence for the proposed certificate. Utah Valley University (UVU) faculty designed the course content with significant input from industry experts, to ensure quality, rigor, relevance, and accuracy of content. Faculty members and administration from higher education partners (UVU, Salt Lake Community College, and the University of Utah) provided limited content input and ensured that the courses were developed in adherence to academic rigor and format. Departmental Faculty Faculty Category With Doctoral Degrees (Including MFA and other terminal degrees, as specified by the institution) Faculty Headcount Prior to Program Implementation Faculty Additions to Support Program Faculty Headcount at Full Program Implementation Full-time Tenured Full-time Non-Tenured 5 5 Part-time Tenured Part-time Non-Tenured 2 2 With Master s Degrees Full-time Tenured 0 0 Full-time Non-Tenured Part-time Tenured 9 9 Part-time Non-Tenured 0 0 With Baccalaureate Degrees Full-time Tenured 0 Full-time Non-Tenured 0 Part-time Tenured 0 Part-time Non-Tenured Other Full-time Tenured 0 0 Full-time Non-Tenured 0 Part-time Tenured 0 Part-time Non-Tenured Total Headcount Faculty Full-time Tenured Full-time Non-Tenured 5 6 Part-time Tenured 9 9 Part-time Non-Tenured 32 33

6 Total Department Faculty FTE (As reported in the most recent A- 1/S-11 Institutional Cost Study for prior to program implementation and using the A-1/S-11 Cost Study Definition for the projected at full program implementation. ) 38 X A new Director, Dr. Haven McCall, (Scholar-in-Residence; faculty position) was hired to oversee the implementation and management of the program, including supervision of adjunct instructors. The Director will teach BIOL 5000, BIOL 579R and portions of BIOL 5010 and The Director will oversee and monitor the internships (BIOL 581R) and the capstone projects (BIOL 580R). One adjunct instructor will co-instruct BIOL 5010 and New faculty will participate in all required training and orientation and remain current on program subject matter through ongoing industry relations. The requirements for the adjunct instructor will be equally rigorous. The pool of talent available for adjunct instruction is large and includes individuals engaged in regulatory affairs work in companies. Adjunct instructors will be required to have a bachelors degree or higher in an appropriate discipline and demonstrate significant experience in regulatory affairs. They will also be required to demonstrate teaching ability. Dr. Ethan Sproat, a faculty member in the UVU Department of English and Literature, has been working closely with industry experts to design a 5000-level Technical Communication course. Dr. Sproat recently earned a Ph.D. in English Rhetoric and Composition from Purdue University with one of his emphases in Technical Communication. In addition to his Ph.D. training, Dr. Sproat has significant professional experience in technical communication in the areas of professional communication, copyediting, indexing, digital content development, small press publication, and digital audio/video production management. Staff Administrative: The Director of the program will provide administrative assistance as well as have access to administrative support in the Biology Department. Secretarial: No secretarial staff will be required. Clerical: No clerical staff will be required. Laboratory: This program does not have a laboratory component, thus no laboratory staff will be required. Advisors: The College of Science and Health advisory staff will help to support the program. Teaching/Graduate assistants: There will be no teaching or graduate assistant staff required. Library and Information Resources Library collections for the Regulatory Affairs Graduate Certificate program are difficult to define in specific numbers but can be demonstrated in the following manner: Journals: UVU library uses broadcast or aggregator software (OneSearch) that searches our array of journal databases at one time. For example, some typical OneSearch queries produce the following results, each hit limited to scholarly, full-text articles with further refinement still possible: ISO 9001 and medical devices 207 medical devices and regulatory 6402 medical devices and design control 9026 medical devices and quality control 8223 pharmaceuticals and quality control 5413 These articles are drawn from various journal databases including:

7 ABI/Inform (Business) Applied Science and Technology Abstracts Business Source Premier CINAHL Nursing Directory of Open Access Journals (DOAJ) EconLit Health Source: Academic Legal Collection Lexis/Nexis Academic MEDLINE PsychINFO Science Direct Representative journals would include: American Journal of Life Sciences British Journal of Pharmaceutical Research Clinical Research and Regulatory Affairs European Journal of Medicinal Chemistry International Medical Device Regulatory Monitor International Journal of Medical Marketing Journal of the American Medical Association Journal of Medical Diagnostic Methods Journal of Medical Marketing Journal of Medicinal Chemistry Life Sciences Medical Device Business Week Medical Device Daily Pharmaceutical Regulatory Affairs Research in Pharmaceutical Sciences Interlibrary Loan: Articles not found full-text in the databases may be requested electronically through Interlibrary Loan. Patrons will be delivered an electronic version of the article in their accounts within 2-4 working days. All databases are accessible from any point on the web using authentication. Books: Again, specific numbers are hard to determine but illustrative searches produce the following hits against the catalog: medical devices 260 medical devices and regulatory 93 medical devices and quality control 9 pharmaceuticals and quality control 71 A large percentage of these titles are available from e-book packages and accessible from any web connection. Through the Utah Academic Library Consortium, all student cards are valid at every public or private higher education library in Utah. Librarians are very accessible and are happy to give priority to faculty and graduate students for research support. Requests for new materials that will support 5000-level and graduate programs are given high priority by the Library Director. Admission Requirements The students must be admitted to the University based upon the following graduate admission requirements: 1) completion of the university admissions application and submission of the following documents: official college transcripts from last

8 undergraduate institution attended, resume, and two letters of recommendation. Admission to the Regulatory Affairs for Life Sciences certificate program will require a baccalaureate degree in a science or technology-related discipline. Student Advisement Prospective students will be advised of program matriculation and graduation requirements by the Biology Department advisor. The Biology Department advisor will review the student s career goals and programs in meeting the certificate requirements upon completion of the first semester courses. Additionally, the program director will be available to discuss the program and career goals with the students. Justification for Graduation Standards and Number of Credits Graduation standards are: (1) Completion of the required courses for the certificate at a minimum of 15 credit hours, (2) a GPA of 3.2 or greater, and (3) Residency hours at a minimum of 12 credit hours through courses attended at UVU. The credit hour requirement of 15 hours allows for incorporation of academically rigorous course content into the program yet a reasonable number of hours for completion in one year or less. The required GPA is more than adequate to demonstrate academic abilities and student potential for success in a graduate program. These courses are unique in their content which was co-designed by university faculty members and industry partners. External Review and Accreditation External Review: The Regulatory Affairs for Life Sciences certificate program and its content have been reviewed and validated by industry experts. The following individuals from industry provided guidance for curriculum material, content and course sequencing, and matriculation and enrollment requirements: Peter Knauer, BioUtah; Karen Jones, Edwards Life Sciences; Jeff Nelson, Nelson Labs; Balaji Suddabattula, Megadyne; Haven McCall, GE Medical; Jessica Smith, Bard Access. The program Director from San Diego State University s regulatory affairs program, Steven Dahms, was consulted for advice on overall program design. There is no program-specific accreditation required by any regional or national agency. Projected Program Enrollment and Graduates; Projected Departmental Faculty/Students Current Prior to Projected Projected Projected Projected Projected Data Category New Program Implementation Year 1 Year 2 Year 3 Year 4 Year 5 Data for Proposed Program Number of Graduates in Proposed Program Total # of Declared Majors in Proposed Program Departmental Data For All Programs Within the Department Total Department Faculty FTE (as reported in Faculty table above) Total Department Student FTE (Based on Fall Third Week) Student FTE per Faculty FTE (ratio of Total Department Faculty FTE and Total Department Student FTE above) X X

9 Program accreditation-required ratio of Student FTE/Faculty FTE, if applicable: (Provide ratio here: ) na na na na na na Expansion of Existing Program This is not an expansion of an existing program. Section III: Need Program Need There is a critical shortage of talent in regulatory sciences for Utah companies, and no program currently exists to address this demand. Utah companies have indicated that their success and growth are being impacted negatively due to the lack of available talent. Further, the ability to provide regulatory talent makes it easier to attract life science companies to Utah. Students with baccalaureate degrees in chemistry, biotechnology, and especially biology will benefit from having a postbaccalaureate certificate that increases their employment options. The need for the program to be offered at the postbaccalaureate level was determined by life science companies (medical device, pharmaceutical, diagnostics, biotechnology). Industry partners were adamant that employees in regulatory affairs needed a minimum of a baccalaureate degree due to the nature of the work. Labor Market Demand This program, which benefits Utah s Life Science companies (medical device, diagnostics, biotechnology, and pharmaceutical), will address a significant unmet need. Utah Department of Workforce Services (DWS) Labor Market Information (LMI) reports an average of 70 jobs posted annually for compliance and regulatory. These jobs are listed as five stars which is an indicator of jobs with the strongest employment outlook and the highest wages. The growth of the Life Science industry is supported by additional market data from DWS; specifically, in the second quarter of 2013, there were 439 Life Science businesses operating in Utah and more than $90 million in payroll for this same quarter 4. This data indicates that the life science industry and its companies can be confident of continued growth. Battelle generated a report for the Utah Cluster Acceleration Partnership (UCAP) program in August of 2012, which demonstrated significant growth in demand for regulatory affairs professionals in the next five years. The report indicated that there would be an annual projected growth of approximately new hires in these regulatory positions. The UCAP report independently confirmed through interviews with industry representatives that a current critical shortage of skilled regulatory affairs professionals is adversely affecting their ability to develop and market their medical products. A search conducted on several websites 4 listed a total of jobs posted for regulatory affairs positions in Utah. The positions ranged from entry-level to managerial and all of them required a baccalaureate degree. The majority of the posted positions were with life science companies; a few were associated with technical talent agencies and law firms. It is important to note that the Utah life sciences industry continues to grow at approximately two percent annually, and it is one of two Utah industries that did not experience a reduction or even flattening of job growth during the economic decline. Further, it is anticipated that the increase in Federal Drug Administration (FDA) oversight of the natural products and dietary supplement industry will result in a need for additional regulatory talent. This creates a compelling reason to create a new certificate to help the life science industry meet current and project needs for its continued growth. 4 Indeed.com, SimplyHIred.com and Monster.com; (as of 10/22/2013)

10 Student Demand It is anticipated that student demand will come from recent graduates at UVU (and other higher education institutions) as well as current employees in life science companies. Industry partners (e.g, Nelson Labs, Bard Access, Edwards Life Sciences, Megadyne, BioFire) have committed to reimbursing tuition for employees that wish to enroll in the program. As stated previously, funding was provided by the UCAP program to pilot several new courses in regulatory affairs. The new courses for regulatory affairs were advertised for two weeks in the Fall 2013 semester. There were 24 inquiries into the courses from prospective students (all were current employees in life science companies such as Nelson Labs, Bard Access, and Edwards Life Sciences). Student demand is projected to be high, especially for biology graduates. The certificate will add considerable value to an existing baccalaureate degree. The employment opportunity will be high, job security will be strong, and there will be a significant increase in wages for those with regulatory affairs skills. There were 90 biology graduates with a degree in There are a total of 681 biology majors currently enrolled at UVU, with 349 of these students being seniors. Thus, there is a more than adequate pool of prospective students at UVU. It is expected that there will also be significant enrollment from incumbent employees that are looking to expand their career opportunities. Similar Programs A benchmarking study was performed by the Utah Cluster Acceleration Partnership s (UCAP) Life Sciences Talent Committee to determine where and to what extent related programs exist in the other states. The study found 43 other regulatory programs offered by institutions of higher education, none within the State of Utah. Of these programs, 22 offer Master s programs and 27 offer certificate programs. The College of Engineering at the University of Utah offers a course in design control; however, it is specific for engineering majors. Faculty members from the College of Engineering have indicated that it is not likely that engineering students would pursue jobs in regulatory affairs given the availability of other career options. Collaboration with and Impact on Other USHE Institutions The initial work conducted on the design of the regulatory affairs courses and program was by the UCAP Talent Committee. The UCAP Talent Committee is comprised of faculty members from the University of Utah (UU; College of Engineering), Utah Valley University (UVU; College of Science and Health), and Salt Lake Community College (SLCC; Biomanufacturing and Biotechnology). Industry members are represented by several Utah Life Science companies including Edwards Life Sciences, Nelson Labs, Merit Medical, Becton Dickinson, and BioFire. There continues to be significant involvement from the UofU and SLCC, as well as industry partners, in curriculum design and instruction. The Dean for the College of Science and the Chair of the Biology Department at the University of Utah have expressed interest in working with UVU to facilitate access to the certificate program for their students. The impact of the proposed certificate program will be positive for other USHE institutions. The issue of providing biology graduates with post-graduation options is important for all institutions. The collaborative nature of this project will facilitate access to the program by students at all institutions. Benefits The certificate program evolved in response to a request from industry, through the UCAP process, to help meet a critical demand for regulatory affairs talent. The ability to move quickly to create quality programs in response to industry demand benefits UVU in several ways. It ensures that students have access to programs that provide ample job opportunities that are accompanied by high wages. It also results in a productive relationship with local companies to build partnerships that can help to sustain programs.

11 Consistency with Institutional Mission A university should endeavor to meet student needs in the most marketable areas if it can reasonably do so, and should create strong programs in fields that have a substantial impact upon the world as a whole. It is also critical that a university play an integral role in the economy of the service area to support the growth of local companies. Finally, students should be given options to maximize the value of their education. The proposed certificate will not only align with a critical industry need, but also provide access to a certificate that can add value to a student s education. A certificate in regulatory affairs would fit the mission of UVU because it represents a program that is aligned with industry need and provides the education necessary for students to have access to rewarding careers. Section IV: Program and Student Assessment Program Assessment Assessment of student success will be monitored by the program director. There are no national tests that allow for assessment of UVU students in comparison to national data. Student performance (i.e., student and internship/capstone supervisor satisfaction) in the required internship or capstone project will be tracked and assessed. The program director will track post-graduation employment and monitor employer satisfaction with graduates. Expected Standards of Performance Students must earn a minimum of a 3.0 in all coursework to be recommended to an internship or capstone project. Students will demonstrate an understanding of basic regulatory concepts (domestic and international), be able to analyze and communicate regulatory issues and draft, and analyze and understand the submission process for regulatory affairs documents. Formative Utah Valley University will be using Degree Works program to track individual students during the course of the certificate program. The Biology Advisor, working with the program director, will consult with each student to assess success and progress toward graduation. Adjunct instructors will be consulted on student performance when appropriate. Grades (a B or higher) in pre-requisite courses will be considered as predictors of success in subsequent courses. Completion of required courses with a B or higher will be demonstrative of success in the program. Students will be monitored in the courses to determine satisfaction with instruction. Guest speakers will be evaluated for their ability to communicate a topic appropriately and bring greater understanding of relevant topics to the students. Summative The successful completion of required courses, with a final target GPA of 3.0 or more, will be the culminating factor to define student success. Placement into employment will be tracked and used to assess success of the student s performance and of the program. Questionnaires will be used to assess graduates perceptions about how well the program prepared them for employment. The questionnaires will be completed six months post-employment. Section V: Finance

12 Department Budget Departmental Data Funding Sources The Utah Cluster Acceleration Partnership program (UCAP; administered by the Utah System of Higher Education) has provided support for the first year of course design and implementation of pilot courses (July 1, 2013-June 30, 2014). A second year of funding was secured from the UCAP oversight committee (July 1, 2014-June 30, 2015) to provide continued support of the courses to allow for institutional support to be secured. The Utah DWS will administer the second year of funding for the program. Reallocation No reallocation is needed. Current Departmental Budget - Prior to New Program Three-Year Budget Projection Addition to Budget Departmental Budget Year 1 Year 2 Year 3 Total Budget Addition to Budget Total Budget Addition to Budget Total Budget Personnel Expense Salaries & Wages $2,195,808 $64,650 $2,260,458 $2,586 $2,263,044 $2,689 $2,265,733 Benefits $869,828 $31,713 $901,541 $1,269 $902,809 $1,319 $904,129 Total Personnel Expense $3,065,636 $96,363 $3,161,999 $3,855 $3,165,853 $4,009 $3,169,862 Non-personnel Expense Travel $14,500 $1,000 $15,500 $0 $15,500 $0 $15,500 Capital $0 $0 $0 Library $0 $0 $0 Current Expense $33,030 $2,500 $35,530 $0 $35,530 $0 $35,530 Total Non-personnel Expense $47,530 $3,500 $51,030 $0 $51,030 $0 $51,030 Total Expense (Personnel + Current) $3,113,166 $99,863 $3,213,029 $3,855 $3,216,883 $4,009 $3,220,892 Departmental Funding Year 1 Year 2 Year 3 Appropriated Fund $3,113,166 $0 $3,113,166 $3,717 $3,116,883 $104,009 $3,220,892 Other: Special Legislative Appropriation Grants and Contracts $100,000 $100,000 $100,000 -$100,000 $0 Special Fees/Differential Tuition Total Revenue $3,113,166 $100,000 $3,213,166 $3,717 $3,216,883 $4,009 $3,220,892 Difference Revenue - Expense $0 $137 $137 -$138 $0 $0 $0 Departmental Instructional Cost/Student Credit Hour* (as reported in institutional Cost Study for current and using the same Cost Study Definition for projected ) $88 na $91 na $91 na $91

13 Impact on Existing Budgets No impact expected. Section VI: Program Curriculum All Program Courses (with New Courses in Bold) Course Prefix and Number Title Credit Hours Matriculation Requirements B.S. degree in Biology, Biotechnology, or related field. Required Courses BIOL 5000 Regulatory Affairs for Life Sciences 4.0 BIOL 5010 Quality Management Systems for the Life Sciences 2.0 BIOL 5020 Design Control and Risk Management for the Life Sciences 3.0 ENGL 5340 Technical Communication Theory and Practice 3.0 BIOL 580R or BIOL 581R Capstone Project or Biology Internship 1.0 BIOL 579R Special Topics 2.0 Total Number of Credits 15.0 Program Schedule Fall of First Year (Course Prefix and Number) Course Title Credit Hours BIOL 5000 Regulatory Affairs for Life Sciences 4.0 ENGL 5340 Technical Communication Theory and Practice 3.0 BIOL 579R Special Topics 2.0 Spring of First Year (Course Prefix and Number) Course Title Semester total: 9.0 BIOL 5010 Quality Management Systems for the Life Sciences 2.0 BIOL 5020 Design Control and Risk Management for the Life Sciences 3.0 BIOL 580R or BIOL 581R Capstone Project or Biology Internship 1.0 Credit Hours Section VII: Faculty Semester total: 6.0 Director (Scholar-in-Residence/Faculty) A Director was recently hired to oversee the administration of the program, build partnerships that support the program, and provide instruction. Dr. Haven McCall, the newly hired Director, exceeds the minimum qualifications and required knowledge, skills, and abilities.

14 Dr. Haven McCall Education D.R.Sc., Regulatory Sciences, University of Southern California, Los Angeles M.S., Regulatory Sciences, University of Southern California, Los Angeles M.S., Business Management, Northern Arizona University B.S./B.A., Business Management, Northern Arizona University Work Experience GE Healthcare, Regulatory/Quality Manager; 7/ BD Medical, Senior Quality and Regulatory Systems Engineer; 7/2008-7/2009 Gore Scientific, Regulatory Affairs Leader; 5/2002-6/2008 Adjunct Faculty (teaching pilot course): Dr. Vivian Ngan-Winward Education Ph.D. Molecular Biology and Biochemistry, Wesleyan University B.S. Biology; University of British Columbia Work Experience Salt Lake Community College, Director of Biomanufacturing; 2/2008-current BioFire (formerly Idaho Technology), Scientist II; 12/2002-1/2008 KKBiomed, Scientist; 1/ /2002 ThauMDx, Research Manager; 8/ /2002 (consulting) Jennifer Bolander Education M.S., Quality Management, Eastern Michigan University B.S., Biology, Northern Arizona University Work Experience BHI, Quality Manager; 2/ /2013 NOV Intelliserv Inc., Quality Assurance Specialist; 04/ /2012 USANA Health Sciences, Quality Assurance Specialist II; 03/ /2007 Tandem Labs, Quality Assurance Compliance Specialist; 03/ /2005 Baxter BioLife Plasma Services, Quality Management Representative; 10/ /2004