Masters Of Science In Translational Biotechnology Handbook

Transcription

Master of Science Program in Translational BiotechnologySTUDENT HANDBOOKUNIVERSITY OF FLORIDACOLLEGE OF MEDICINEHEALTH SCIENCE CENTERGAINESVILLE, FLORIDA*NAME:THE UNIVERSITY OF FLORIDA IS AN EQUAL OPPORTUNITY INSTITUTION ANDDOES NOT DISCRIMINATE ON THE BASIS OF RACE, CREED, SEX, NATIONALORIGIN, AGE OR HANDICAP.Updated: 5/17/171

TABLE OF CONTENTSWELCOME FROM THE FACULTY .4PURPOSE OF STUDENT HANDBOOK .4FACULTY AND ADMINISTRATIVE STAFF .5CONTACT INFORMATION.5COLLEGEOF MEDICINEBIOTECH .6MASTER’SPROGRAMinTRANSLATIONALI.Pertinent Arrival InformationA. Payroll Information .8B. Check in with the Master’s Program Office .8C. Keys and Identification Badge .8D. Health Insurance .9E. Mail .9F. Fee Payments .9G. Funding and Financial Aid .9H. Registration .10I.Change of Address .10J.Qualifying for Florida Residency .10K. E-mail Accounts, Internet access .10L. World Wide Web and Email Addresses .11IIUniversity and Administrative Requirements and PoliciesA. Teaching Requirements .11B. Vacation Policy .11C. Other University, HSC and IDP Office InformationC1. Libraries .11C2. Work-related Injuries .12C3. Non-work Related Injuries .12C4. Emergency Contacts and Safety Concerns .12C5. Housing .12C6. Traffic and Parking Regulations .12D. Policy on Sexual Harassment.13E. In-House Counseling & Development Office.13F. Governance of the Master’s Programs.13III.Degree Requirements for Master of Science DegreeA. Business Course Offerings . .14B. Transfer of Credit . 14C. Appointment of Supervisory Committee .152

D.E.F.G.H.Supervisory Committee Meetings .16Thesis .17Thesis Defense and Final Examination.18Certification .19Placement after Graduation.19IV. Course Selection and Curricula .19V.Standards and Grades .20VI. Role of the Advanced Concentration Graduate SecretaryDuring your Graduate Student Tenure.21VII. Grievances.21VIII. Integrity in Graduate Study .22APPENDICESA.B.C.D.E.F.Map of the Health Science Center .23Links and Email Addresses.24Supervisory Committee Appointment Form . .25Supervisory Committee Meeting Report Form.26Thesis Checklist .27Integrity in Graduate Study .293

WELCOME FROM THE FACULTYWe are pleased that you have elected to enroll in the Science Master’s Program in TranslationalBiotechnology at the University of Florida, College of Medicine. Soon you will study alongsidegraduate students engaged at every level of the research and educational enterprise within theCollege. Through dedication and scholarship, you will join this group of men and women andbecome an independent biomedical scientist. Friendships and associations that you will buildduring your graduate training will be of enduring value both personally and professionallythroughout your career. We trust that you will experience the thrill of scientific discovery, thespirit of collaboration, and the scholarly brotherhood felt by the faculty and students in ourprogram.The hallmark of our program is that both basic and clinical faculty members coordinate their effortsfor a common goal; to providing outstanding mentorship in the training of each student. Thus, ourobjective is to provide the highest quality environment and intellectual excitement for everystudent’s research and educational training. The faculty is constantly striving to challenge ourstudents and provide the opportunity for discovery.PURPOSE OF STUDENT HANDBOOKThis handbook is intended to serve as a single-source reference both for our new and continuinggraduate students in the Master’s Program. Retain the handbook and use it as a guide throughoutyour graduate education.This handbook is intended to provide a concise summary of University and master’s programoperating procedures. Your responsibilities and obligations as a graduate student in the Collegeof Medicine are delineated. Please become familiar with the contents of this handbook. It shouldprovide useful information and answer most of the questions that will arise during your tenure inat the University of Florida.Parts of the handbook concerning general University regulations have been copied verbatim. Ifquestions or problems arise that are not covered in the handbook, please feel free to contact theprogram director or the administrative staff (contact information on page 5).Suggestions for improving the program or the handbook are always welcome.There is a map in Appendix A which should help you navigate the Health Science CenterBuildings.4

FACULTY AND ADMINISTRATIVE STAFF:Master’s Program Director:Henry Baker, Ph.D.Master’s Advisory Board:Henry V. Baker, Ph.D, Molecular Genetics and MicrobiologyScott Tibbetts, Ph.D, Molecular Genetics and MicrobiologyPaul Gulig, Ph.D, Molecular Genetics and MicrobiologyLizi Wu, Ph.D, Molecular Genetics & MicrobiologyThomas Rowe, Ph.D, Pharmacology and TherapeuticsGreg Schultz, Ph.D, Obstetrics and GynecologyJohn Kraft, Ph.D, Warrington Business CollegeProgram CoordinatorKris MinkoffCONTACT INFORMATIONNameEmailPhoneRoomHenry BakerPaul GuligJohn KraftKris MinkoffThomas RoweGregory SchultzScott TibbettsLizi -5628273-8205R2-220R2-208100 BryanR2-220R5-244M-337ER2-291CG 3625

Master of Science Program in Translational BiotechnologyThe Master of Science Program in Translational Biotechnology is a two-year thesis program thatis interdisciplinary (biosciences and business), research intensive, has deep industry involvementand includes a formal internship at a company. You will graduate with a major (Master ofScience in medical sciences) and a minor in entrepreneurship (graduate business minor). TheMaster of Science program in Translational Biotechnology has the support of the Provost, theVice President for Research, and Deans of the Colleges of Medicine and BusinessAdministration.The program is focused on applied and translational research. Translational Biotechnologyincludes drug/biologics/device product development, manufacturing process development, assaydevelopment, toxicology studies, quality systems (QC and QA), clinical trial support, andregulatory compliance. These activities are essential for testing new drugs/biologics/devices inhumans and their subsequent commercialization. Translational Biotechnology activities arefoundational for companies, and are increasingly gaining importance in the academic settingwhere new technologies are being tested in humans prior to entering the commercial sector.Biomedical and business courses are brought together to create the curriculum. In theclassroom, you will learn the profiles of major departments/areas (marketing, sales, finance,administration, HR, production, manufacturing support, QC/QA (quality control/qualityassurance), research and development, regulatory affairs, clinical affairs, etc.), the operations ofeach, and how they interact with each other and outside organizations. Each key operation willbe presented in a collection of learning media (classroom, internet-based, case studies). Thecurriculum is focused on the regulatory agencies, the regulations, developing and implementingquality systems, regulatory compliance, document development, documentation systems andcontrol, process and facilities control, product release, auditing, specifications setting,biologics/tissue/device /pharmaceutical manufacturing technology, maintenance and calibration,process development/optimization, analytical instrumentation, analytical/laboratory methods,pre-clinical testing, clinical trials design and conduct. The curriculum navigates the corporateenvironment, and business and economic landscape with a focus on markets, sales andmarketing, supply chain, price controls, import/export practices, and business operations in thecontext of, budgets, timelines, available resources, business regulations, communication barriers,finance and accounting, and legal constraints (intellectual property, contracts, etc.).Courses incorporated into this unique program encompass biotechnology science together withregulatory compliance and best business practices. Graduate courses in product development,regulatory compliance (cGMPs/GTPs/GLPs/GCPs), quality systems QA/QC), processdevelopment, analytical product testing, and bio-manufacturing are essential topics for creatingscientists capable of sustaining translational research and commercialization. Productdevelopment of biotechnological or biomedical products including biopharmaceuticals;diagnostic test materials; enzymes, antibodies, and other protein products; transgenic plants andanimals; tissue and cellular products, and biomedical implants and devices requires that scientistshave the knowledge to carefully complete procedures in compliance with foreign and domesticregulations.6

Other features of the program are the infusion of personal and professional skills(communication, documentation, teamwork, interviewing, work ethic, etc.), ethics andresponsible conduct of research, and international perspectives.Program Specifics1. Two-step Admission: Step 1: A provisional acceptance is given to students who meet therequirements for GRE scores and academic performance of minimum combined GRE scoreof 300 and GPA of 3.0 or higher. Step 2: All students must show proof of funding for twoyears. There are various ways that proof of funds can be accomplished. For more on fundingoptions, please see the “Funding and Financial Aid” section of the handbook.2. Degree Requirements: Completion of your degree will require a total of 48 credits with 36credits comprising of biomedical coursework, laboratory research, and internship for themajor in medical sciences and 6 hours of business coursework for the business minor inentrepreneurship. You will choose your course in consultation with your mentor, programcoordinator and program director based on program requirements and your career goals.3. Full-time Status: In order for you to be considered full time, you need to take 9 credits inboth Fall and Spring Semesters and 6 credits in the summer. Therefore, to satisfy the Master’sprogram requirements the required credits are as follows:Year 1 Fall: 9 cr; Spring: 9 cr; Summer: 6 crYear 2 Fall: 9 cr; Spring: 9 cr; Summer: 6 cr4. Education and Training: A foundation of the program is a high-quality research projectunder the direction of a skilled mentor, with supervision by a committee composed ofmembers of the University's Graduate Research Faculty. Specialization may be in any of thefields of research being pursued in the College of Medicine. During your first year in theprogram you will enroll in, lecture courses and seminar courses, and begin working in yourmentor’s laboratory. The content of the lecture courses addresses the need for a strongfoundation in advanced level biology and chemistry that is applied to biotechnology andbiomedical product development. Courses are available that bridge basic life sciences andapplied research, and these have been brought together with courses in business. Both theseminar series and the lecture courses provide preparation for Master’s research whichshould be well underway by the end of the second semester. Your second year of graduatestudy is devoted to finishing the required courses and doing research. You may also enroll inadditional courses, according to your interests and career goals. During your second yearyou will work with program staff to review available companies and associated projects andan internship will be identified. Following the spring semester of your second year, you willintern in industry.7

A.Initial Check in with the Master’s Program OfficeUpon your arrival, your first stop will the masters program office ARB, R2-220 where you willbe directed to complete the necessary paperwork for your appointment. You will need to providethe following materials: Social Security Card, a voided check, driver’s license and immigrationstatus information including the appropriate permanent residency card, DS2019, VISA frompassport, I-94 form, and F-1 documentation (if applicable). No Copies, originals required.International students must be physically present in the US for ten (10) days before they can requestthe Social Security Card which is necessary to sign up for payroll.B.Minimum Stipend, Tuition, Health CareThe current minimum stipend for master’s students is 15,000, the tuition waiver is 10,800annually, and GatorGradCare health coverage is approximately 1,300. The totalcompensation the faculty member is expected to pay annually is 27,010.Payroll Signup, Letters of Appointment (tuition waiver)Once you have identified a mentor with graduate faculty status and are fully accepted into theprogram you will work with your mentor’s department to complete payroll signup procedures.Payroll is issued bi-weekly and the funds will be direct-deposited into your personal checkingaccount. You will be able to view the amount of payment and any deductions (a paystub) athttp://my.ufl.edu my self service payroll and compensation view paycheck. It can beviewed the Friday of each pay week.Graduate assistantship appointments may be made on a semester-by-semester or annual basis.Dates for appointments are published on the UF Academic Calendar and are available on thefollowing chool.ufl.edu/C.Keys and Identification BadgeDuring normal business hours there is no need for a building key to the general facility, althoughmost doors are locked in the evening and on the weekends. Commonly used facilities, McKnightBrain Institute, Academic Research Building (ARB) and the Cancer Genetics ResearchComplex, are closed and locked from 6:30 p.m. to 6:30 a.m. weekdays as well as all weekendhours. The ARB has an electronic lock system for after-hours. To activate your access bringyour Gator 1 card to ARB room R2-220 where it will be entered into the system to beactivated.Likewise with authorization from your mentor and your departmental administrative office willissue lab keys.8

The Health Center requires that identification badges be worn at all times while personnel are onthe premises. All students should go to either Gator 1 Central located at 1900 Museum Road inthe Reitz Union Student Center Bookstore or to ID Card Services on the ground floor of theHealth Science Service Center (Room NG-10). Please bring a picture ID and tell them you are anew graduate student in the College of Medicine. If you have any problems, please call yourhome department administrative staff.D.Health InsuranceAll students on graduate assistantships are eligible to participate in GatorGradCare at no cost tothem. Insurance registration is done online at adcare/. Be advised it is important to sign up before the initial employmentdeadline or you will have to wait until the next open enrollment period.All international students are required to purchase health insurance that is approved by theFlorida Board of Governors. It is the student’s responsibility to provide proof of insurance to theOffice of International Studies & Programs at 1765 Stadium Rd, suite 170 Hub (352)-392-5323prior to each registration term. Once confirmation for insurance is received, it should beforwarded to insurance@ufic.ufl.edu so that the insurance hold will be lifted.E.MailA branch of the U.S. Post Office is located on the ground floor of the Medical Sciences Building.The address is Your Name, College of Medicine, Department of ., PO Box 100XXX,Gainesville, FL 32610-XXXX.F.Fee PaymentsThe deadline for payment of student fees is early in the semester, it is your responsibility to payfees before the deadline date. There is no basis for petitioning to waiver a late paymentpenalty.The UF Graduate School Academic Calendars are available athttp://gradcatalog.ufl.edu/index.php under academic calendar. The amount of your portion of fees(after tuition payments have been applied), can be found on your ISIS account(http://www.isis.ufl.edu). To find out the amount of your portion of fees (after tuition paymentshave been applied), check with ISIS (http://www.isis.ufl.edu). Failure to pay your portion by thedeadline will result in a 100 late payment penalty. A secure payment drop box is locatedoutside the Bursar’s Office in Criser Hall, Room S113. For a list of other payment options,please visit: ents/payment-options/. If youhave further financial questions, most answers can be found .Funding and Financial AidGraduate Assistantships are sometimes offered by mentors. This includes a stipend with a tuitionwaiver, and GatorGradCare coverage. It is your responsibility to make sure your student fees are9

paid on time. If you are unable to obtain an assistantship you may choose to self-fund or byapplying for various forms of financial aid. For more information on different types of aid nding/financial-aid.For federal loans, please see the student financial aid administration or call at 352-273-7939.For loan deferments of federal student loans, please see the Graduate Education Office in RoomM 134. DO NOT go to Criser Hall for loan deferments.H.RegistrationStudents will be registered for all your fall courses when they check in with the Master’sProgram Office. Students should ensure that they do not have any holds on their record forimmunizations, insurance, emergency contact information, local address, registration checklist,or financial services. You need to clear all holds prior to being registered. Failure to do so willresult in a late fee which will be your responsibility.I.Change of AddressA change of address can be submitted using the student’s ID and PIN number atwww.isis.ufl.edu.J.Qualifying for Florida ResidencyInformation about establishing residency can be found at the following rements.phpK.E-mail Accounts, Internet accessThe University of Florida and the college of medicine uses email to communicate with theirstudents, faculty and staff. The official email system of UF is gatorlink. You are required to havea gator link account. Official programmatic information and announcements will only be sent toyou to your gatorlink account.To set up a gatorlink email account you need to visit the UF Computing Help Desk at:http://helpdesk.ufl.edu/self-help/. Here you will find all the necessary self-help resources to beable to create your GatorLink account.If you encounter problems with your GatorLink account, your username, or your password, youshould contact the UF Computing Help Desk at 392-HELP. All UF applications now requireyour GatorLink user name and password.10

L.Web AddressesWeb address to pages contains useful information regarding the graduate program and studentservices are found in Appendix B.II.University and programmatic Administrative Requirements and PoliciesA.Teaching RequirementsThere are no formal teaching requirements for students in the Master’s program.B.Vacation PolicyStudents on assistantships may take up to 5 days per semester of personal leave. The schedule ofany vacation time must be approved in advance by their mentor. As employees of theUniversity of Florida, graduate assistants are also entitled to days off for designated official paidholidays, declared emergencies, and travel to scientific meetings. University breaks (i.e. SpringBreak) are not considered as additional vacations. According to the GAU contract, vacation daysare not cumulative, i.e. days not taken in one semester do not carry over to the next semester.Since the demands of graduate studies and research do not easily fit into a rigid schedule, it isexpected that students will take a mature committed attitude toward their professionalresponsibilities.Students planning any extended travel for personal reasons, e.g. vacation or marriage, shouldplan to take a leave of absence from the program for 6 weeks during either the summer A orsummer B term. While on leave of absence you will not be: 1) Paid a stipend, 2) registered forclasses, or research credits, 3) will not be liable for payment of student fees. GatorGradCarehealth insurance will still cover you for the full summer (if you were previously enrolled in theSpring term).C.Other University, Health Science Center and Programatic InformationC1.LibrariesThe Medical Center Library is located in the Communicore of the J. Hillis Miller Health Center.It contains a large collection of medical, chemical, and biological journals, as well as a widearray of texts and reference materials. Students are required to present their identification badgeswhen checking out materials. hsc-libraries/)Another excellent source is the Marston Science Library on Newell Drive diagonally across fromCentury Tower. It houses the combined holdings of the Agriculture, Life Sciences, Engineering,Physical sciences, Mathematics and Earth Sciences libraries.11

C2.Work-Related InjuriesFor non-serious injuries you should first contact the worker's comp contact person in yourdepartmental area to fill out the forms. You may then go to the Student Infirmary for treatment.For serious injuries you should go directly to the Shands Emergency Room for treatment. Uponarrival you should inform the admitting clerk of your graduate status and that the injury is workrelated. As soon as possible after treatment, contact your department so that a worker’scompensation form and accident/injury form can be prepared.C3.Non-Work Related InjuriesFor injuries that are not related to your work, you may contact the student infirmary or healthunit of your choice. You should present your health insurance card when you sign in. Althoughyou will be billed at either place, the student infirmary costs are usually fully covered by yourstudent activities fees. (See Student Health Care Center website: http://shcc.ufl.edu/Do not go to a UF Health clinic without first going to the Infirmary for referral.This is important because your health insurance policy may require referral by theinfirmary.C4.Emergency Contacts and Safety ConcernsAll emergencies pertaining to fire or police should be reported to the University PoliceDepartment, Phone: 392-1111. SNAP (Student Nighttime Auxiliary Patrol) can provide anescort after dark to anywhere on campus. They can be reached at 392-SNAP (7627) or bydownloading the TapRide SNAP app. Directions for downloading the app can be found -campus housing is available on a very limited basis for both single and married students.Generally a waiting period of at least several months is encountered. Contact the Division ofHousing for information (352)392-2171 or http://www.housing.ufl.edu/. The Housing officealso distributes extensive lists of off-campus apartments and houses available for rent, andprovides useful information about each. The Division is located at Museum Road and 13thStreet just east of Beatty Towers.C6.Traffic and Parking RegulationsOnly University vehicles are permitted to drive on the central campus Monday-Friday between8:30 a.m. and 4:30 p.m. Any student of the University can register a car. Eligibility for aparking permit is determined by the student's local address and academic classification. ContactTraffic and Parking Services for additional information. They are located at 1273 GaleLemerand Drive. Phone: 352-392-PARK (7275) or http://www.parking.ufl.edu.12

D.Policy on Sexual HarassmentWHAT IS SEXUAL HARASSMENT?According to the Sex Discrimination Guidelines promulgated by the Equal Employment OpportunityCommission (EEOC), sexual harassment is a form of sex discrimination. The guidelines define sexualharassment at 29 C. F. R., Section 1604.11 as follows:Unwelcome sexual advances, requests for sexual favors, and other verbal or physical conduct of asexual nature constitute sexual harassment when:1)2)3)submission to such conduct is made, either explicitly or implicitly, a term or condition of anindividual's employment or academic performance.submission to or rejection of such conduct by an individual is used as the basis for employmentor academic decisions affecting such individual, or job applicant, and between graduateassistant and student.such conduct has the purpose or effect of unreasonably interfering with an individual's workor academic performance or creating an intimidating, hostile or offensive working oreducational environment.For more information, please see the website:http://www.ufsa.ufl.edu/faculty staff/fees resources policies/sexual harassment/E.In-House Counseling & Development OfficeThe Office of Student Counseling and Development is available to graduate students in the Collegeof Medicine who may have personal or professional issues that could be helped with consultationfrom a qualified counselor. Student-counselor conversations are strictly confidential. You mayreach counseling services at www.counseling.ufl.edu/cwc/ or by calling 352-392-1575. Thisoffice also sponsors workshops throughout the year that may be helpful in your personal or careerdevelopment. More information can be found at: http://counseling.med.ufl.edu/.F.Governance of the Masters of Science Program in Translational BiotechnologyAn advisory board makes the policies that govern the Masters of Science and Masters of ScienceCombined Degree programs. Members are invited to serve by the Director and serve for two years.The Chair of the Molecular Genetics and Microbiology Department are permanent members of theBoard. The current Board members are listed on page 5.13

III.Degree Requirements for Master of Science in Translational BiotechnologyA. 48 credit hours of graded coursework including the internshipa. 24 credits of formal courses.i. A minimum of twelve (12) credits will consist of graded GMS courses.Most students take about 18 cedits. In some cases, other non-GMSgraduate level courses may help satisfy this requirement with approvalof the student’s graduate supervisory committee and director of theprogram.1. Biologic Drug Developme

The Master of Science Program in Translational Biotechnology is a two-year thesis program that is interdisciplinary (biosciences and business), research intensive, has deep industry involvement . your first stop will the masters program office ARB, R2-220 where you will be directed to complete the necessary paperwork for your appointment. You .