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Graduate Course Proposal Form Submission Detail - PHA6585
Tracking Number - 4961
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Current Status:
Removed from DB by orginator - 2016-02-04
Campus: Tampa
Submission Type: New
Course Change Information (for course changes only):
Comments: recd after 3/1. To Chair - For Certificate. Objectives revised. To chair 6/2/14. Approved. To USF Sys 11/4; HOLD for concurrence. GMS 6010 -Personalized Medicine already on books. PENDING RESOLUTION. Revised and resubmitted. Withdrawn 2/416
Detail Information
- Date & Time Submitted: 2014-02-20
- Department: Pharmacy - Graduate Programs
- College: RX
- Budget Account Number: 84080
- Contact Person: Shyam S Mohapatra
- Phone: 8139748568
- Email: smohapat@health.usf.edu
- Prefix: PHA
- Number: 6585
- Full Title: Introduction to Pharmacogenetics
- Credit Hours: 3
- Section Type: C -
Class Lecture (Primarily)
- Is the course title variable?: N
- Is a permit required for registration?: Y
- Are the credit hours variable?: N
- Is this course repeatable?: Y
- If repeatable, how many times?: 1
- Abbreviated Title (30 characters maximum): Intro to Pharmacogenetics
- Course Online?: O -
Online (100% online)
- Percentage Online: 0
- Grading Option:
-
- Prerequisites: none
- Corequisites: none
- Course Description: This course provides an introduction to the principles and applications of personalized pharmacy & how an individual's treatment can be customized to their own gene expression profile, providing students with current theory and practical information
- Please briefly explain why it is necessary and/or desirable to add this course: Needed for new program/concentration/certificate
- What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service? Personalized Pharmacy will be the major therapeutic paradigm for the future as patients demand treatment tailored to their genetic and metabolic make-up. The field of Personalized Medicine and Pharmaceuticals is still in the formative stages but growing quickly and it is necessary that students and healthcare workers are up to date with current knowledge and policies so that they can participate intelligently in implementing PP programs around the country.
Given the widespread and continuing interest in customized therapy, we believe that now is the time to create a course specifically focused on teaching students the basics of PP, the current applicability and plans for future implementation.
This course would service the College of Engineering in the MS in Biomedical Engineering with a Concentration in Pharmacy.
- Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times? No
- What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.) Ph.D, MD, and/or PharmD
- Objectives: The objectives for this course are:
- outline what personalized pharmacy (PP) is and the ways that it can be applied
- discuss methods for evaluating disease susceptibility and drug responsiveness
- discus how personal genetic information is obtained, stored and used in a clinical setting
- discuss the legal, ethical and societal aspects of PP and there place in healthcare
- evaluate specific cases in terms of disease risk and customized drug therapy
NOTE: The National Institutes of Health defines Personalized Medicine as “an emerging practice of medicine that uses an individual's genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease”. This knowledge of a patient's genetic profile in the context of other clinical information can be used by pharmacists and other health care providers to design optimal drug therapy. Thus, the goal of this course is to prepare students to develop rational drug therapy plans based on a patient's unique clinical, genetic, and other information.
- Learning Outcomes: Successful completion of this course will provide student with:
• understanding of the current status of PP and its potential for the future of medicine
• knowledge of how genomic information is obtained and be able to evaluate its reliability and applicability as a predictor in complex, multifactorial disease states
• Identify the varied roles of the physician, pharmacist, healthcare
workers, legislators, attorneys and other involved individuals in the
implementation of PP
• Working knowledge of how to deal with the legal and social aspects of PP
• Understanding of the evolving role of the pharmacist in pharmacogenomics
- Major Topics: The major topics covered in this course include:
• How PP can improve health through comprehensive risk assessment
• Application of PP to custom-tailored therapeutic regimens
• Evaluation of genomic information in terms of proteomics and transcriptomics
• Case studies of successful PP-based disease treatment
• How to deal with the legal and ethical issues related to PP and risk assessment
• Different approaches to implementing PP into the current healthcare system
• PP in under-developed and resource-poor countries
TENTATIVE LECTURE TOPICS
1. Introduction to personalized medicine (PP)
History of PP
Applications of new technology to PP
Uses of PP
2. Methods for obtaining genomic and proteomic data
Rapid DNA sequencing methods
DNA screening by real-time quantitative PCR
What are the ‘omics—transcriptomics, proteomics, metabolomics?
3. Evaluating PP data for disease susceptibility
Disease susceptibility genes for cardiovascular disease, cancer, diabetes and neurodegenerative conditions
PM data from patient history and environmental exposure
Genetic screening and counseling
Translating disease susceptibility information into practice. Case studies.
4. Evaluating PP data for disease treatment
Types of disease-specific information from genomic and proteomic data
Pharmacogenomics and the customization of drug-treatment regimens
Case studies
5. Applications of new technology to PP
3D scaffolds as models for testing drug sensitivity
Nanofabrication methods for improved drug delivery
Implantable, remote-reading sensors for monitoring PM regimens
6. Legal, ethical and legislative aspects of PP
The roles of physician, pharmacist and data acquisition and handling staff
Legal aspects of PM and need for new and more specific legislation
7. How to implement a PP program in clinical practice
Outsourcing of genetic and proteomic assays
Electronic record keeping and access management of PP data
Timeline for implementation of a PP program
8. The future of personalized medicine
Aggressive screening for disease susceptibility and intervention to prevent disease
New methods for obtaining useful PP data
New research into the role of epigenetics in disease susceptibility and progression
The goal—a customized, lifetime screening and counseling plan for each person
- Textbooks: REQUIRED:
Yao, Jallal & Ranade. (2013). Genomic Biomarkers for Pharmaceutical Development: Advancing Personalized Heath Care.(1st Ed). ISBN: 9780123973368)
and
Jain, K. K. (2009). Textbook of Personalized Medicine.
ISBN: 978-1-4419-0768-4 (Print) 978-1-4419-0769-1 (Online) downloadable at no cost to the faculty or students at this link: http://link.springer.com/book/10.1007%2F978-1-4419-0769-1
- Course Readings, Online Resources, and Other Purchases: Primary articles from the literature and/or reviews relevant to the lecture topics may be assigned on a weekly basis.
- Student Expectations/Requirements and Grading Policy: Students should study ALL materials covered in class. There will be
two exams - a mid-term and a final exam. In addition, there will be two homework assignments, two project write-ups and one debate. The grade will be assessed as follows:
One mid-term exam 25%
One final exam 35%
Projects - one literature review and one case study 15%
Homework assignments based on reading and research 15%
On-line Debate 10%
TOTAL 100%
Grading Scale:
A 89.5-100 %
B 79.5-89.4 %
C 69.5-79.4 %
F < 69.5 %
- Assignments, Exams and Tests: The completion of two scheduled projects, two assignments, one debate and two exams is compulsory for every student as follows:
TOPIC: Introduction to personalized Pharmacy (PP)
a. The history and principals of PP
b. Applications of new technology to PP
c. Uses of PP in research and in practice
TOPIC: Methods for obtaining genomic and proteomic data
a. Rapid DNA sequencing methods
b. DNA screening by real-time quantitative PCR
c. What are the ‘omics—transcriptomics, proteomics, metabolomics?
HOMEWORK: Assignment related to readings and research conducted in the first two topics discussed in this course.
TOPIC: Evaluating PP data for disease susceptibility
a. Disease susceptibility genes for cardiovascular disease, cancer, diabetes and neurodegenerative conditions
b. PP data from patient history and environmental exposure
c. Genetic screening and counseling
d. Translating disease susceptibility information into practice.
e. Case studies.
PROJECT: Case study analysis based on a study not discussed in class and approved by the professor.
TOPIC: Evaluating PP data for disease treatment
a. Types of disease-specific information from genomic and proteomic
data
b. Pharmacogenomics and the customization of drug-treatment
regimens
c. Case study review
MID-TERM EXAM
TOPIC: Applications of new technology in PP
a. 3D scaffolds as models for testing drug sensitivity
b. Nanofabrication methods for improved drug delivery
c. Implantable, remote-reading sensors for monitoring PP regimens
TOPIC: Legal, ethical, social, economic and legislative aspects of PP
a. The roles of physician, pharmacist and data acquisition and handling staff
b. Legal aspects of PP and need for new and more specific legislation
c. Social and economic aspects and public opinions
HOMEWORK ASSIGNMENT based on readings.
TOPIC: How to implement a PP program in clinical and research practice
a. Outsourcing of genetic and proteomic assays
b. Electronic record keeping and access management of PP data
c. Timeline for implementation of a PP program
PROJECT: Explain how to manage PP in clinical and research practice.
TOPIC: The future of personalized Pharmacy
a. Aggressive screening for disease susceptibility and intervention to prevent disease
b. New methods for obtaining useful PP data
c. New research into the role of epigenetics in disease susceptibility and progression
d. The goal—a customized, lifetime screening and counseling plan for each person
DEBATE: on relevant subject matter related to personalize medicine.
FINAL EXAM
- Attendance Policy: Course Attendance at First Class Meeting – Policy for Graduate Students: For structured courses, 6000 and above, the College/Campus Dean will set the first-day class attendance requirement. Check with the College for specific information. This policy is not applicable to courses in the following categories: Educational Outreach, Open University (TV), FEEDS Program, Community Experiential Learning (CEL), Cooperative Education Training, and courses that do not have regularly scheduled meeting days/times (such as, directed reading/research or study, individual research, thesis, dissertation, internship, practica, etc.). Students are responsible for dropping undesired courses in these categories by the 5th day of classes to avoid fee liability and academic penalty. (See USF Regulation – Registration - 4.0101,
http://usfweb2.usf.edu/usfgc/ogc%20web/currentreg.htm)
Attendance Policy for the Observance of Religious Days by Students: In accordance with Sections 1006.53 and 1001.74(10)(g) Florida Statutes and Board of Governors Regulation 6C-6.0115, the University of South Florida (University/USF) has established the following policy regarding religious observances: (http://usfweb2.usf.edu/usfgc/gc_pp/acadaf/gc10-045.htm)
In the event of an emergency, it may be necessary for USF to suspend normal operations. During this time, USF may opt to continue delivery of instruction through methods that include but are not limited to: Blackboard, Elluminate, Skype, and email messaging and/or an alternate schedule. It’s the responsibility of the student to monitor Blackboard site for each class for course specific communication, and the main USF, College, and department websites, emails, and MoBull messages for important general information.
- Policy on Make-up Work: Students will be allowed to make up missing coursework only for documented student absences. Excused absences are caused by (1) personal illness, (2) religious holiday or (3) an illness or death in the immediate family. The instructor must be notified in writing about absences for religious holidays at least two weeks before observance. In the case of an emergency, the student should contact the course coordinator by e-mail and provide written documentation as soon as possible. If the student fails to provide proper written documentation of the emergency, he/she will get a zero for the course work and/or exam(s) that are missed. Further information and University Policy will be outlined in the course syllabus.
Students will be required to abide by USF policy outlined in the University's policy on academic integrity described in course syllabus.
- Program This Course Supports: Most of the programs offered in the College of Pharmacy's Graduate Programs - Proposed M.S. Degree program, and all of the Graduate Certificates as a required or in some cases as elective course.
- Course Concurrence Information: Master’s Master of Science in Pharmaceutical Nanotechnology and/or MS in Biomedical Engineering with a Concentration in Pharmacy
- if you have questions about any of these fields, please contact chinescobb@grad.usf.edu or joe@grad.usf.edu.