PHAR 6624 Pharmacogenomics: Genetic Basis for Variability in Drug Response Course Syllabus: Spring 2014

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1 PHAR 6624 Pharmacogenomics: Genetic Basis for Variability in Drug Response Course Syllabus: Spring Table of Contents: COURSE SYLLABUS: About this course Course Schedule Course Overview Course Content Course Format Course Instructor & Staff Course Instructors Prerequisites Computer/Technology Requirements Participation & Communication Learner Responsibilities Online Participation Guide Communication Guide COURSE SYLLABUS: Course requirements Course Goals & Objectives College of Pharmacy Competency Domains Attendance Policy Required Readings and Materials Required Text and Materials Course Website Assessment and Grading Non-graded Interactive Questions/Activities Graded Forum Activities (Online Discussions) Exams Grading Information Accessibility General Course Policies Detailed Course Outline & Schedule* COURSE SYLLABUS: About this course Course Schedule 2 credits Course Web Site: Course dates: January 21 - May 9,. This is a fully online course and will be delivered via the Moodle online learning management system; all course information and materials will be found on your Moodle course site. Please see information on the homepage of the 1

2 course web site regarding how to navigate and use the site. This information will also be sent via before the first day of class. Course Overview Course Content Phar 6224 is a 2 credit elective course primarily oriented for students in their 2nd year or beyond of an accredited health care education program, such as pharmacy, medical school, nursing, pharmacy, dental school, veterinary school, occupational therapy, or another similar program, or with a mix of equivalent work and educational experience. This course consists of lectures designed to introduce the theory and practice of pharmacogenomics. It is most likely that in coming years personalized medicine will revolutionize the practice of medical disciplines by offering efficacious pharmacotherapy guided by the genetic variants in individual patients. The genetic basis of variability in drug response can contribute to drug efficacy and toxicity, adverse drug reactions and drug-drug interaction. As such, pharmacists need a thorough understanding of the genetic component of patient variability to deliver effective individualized pharmaceutical care. Understanding of the basics of pharmacogenomics will enable pharmacy students to better understand and manage the new genomics based diagnostic tools as they become available as well as make best treatment choices. We understand that pharmacogenomics currently has a modest impact on day to day practice. However, the principles covered in this course will soon become part of clinical care, such that a well-trained pharmacist will need to know how to critically evaluate, interpret, and apply this information on a daily basis. Course Format This is a 15 week course; you are expected to log in to the course website a minimum of 3 times per week for that period of time. You can expect to spend about 6 hours per week on this course. This course is divided into six learning modules, each comprised of one or more lessons. The modules will become available to students based on a set time; when the due date for the first module has passed, the second module will become available. When the due date for the second module has passed, the content from the third module will become available. The previous modules will remain available to students as study aids throughout the semester. Content will be organized into course Modules and delivered online through recorded lectures, online activities, and readings. Learners will assess their knowledge and progression via assignments and a final exam. You will participate in assignments and activities each week, some of which will be graded and some of which are not-graded, but are intended for you to apply course concepts. All course content, learning activities, assignments, and assessments will be delivered through the course website. Quizzes and exams will be delivered online. Additional software applications may be used as well. You may always choose to engage your fellow students in study groups, seeking or offering help, and sharing resources in the online discussion Peer Forum, listed on the main Moodle course webpage. 2

3 Course Instructors Course Directors Dr. Jatinder K. Lamba, Ph.D., Associate Professor Video Introduction Phone Preferred contact: Office hours: by appointment Dr. William S. Oetting, PhD, Professor Phone Preferred contact: Office hours: by appointment Course Instructors Dr. Pam Jacobson, Pharm.D (ECP) Video introduction Dr. Robert Straka, Pharm.D (ECP) Video introduction Dr. Vishal Lamba, Ph.D (ECP) Dr. Michael Walters, Ph.D (ITDD) Video introduction Prerequisites This course is designed for health care professional students, or students with similar combination of experience and education, including a basic understanding of the requisite chemistry, biology, physiology, anatomy, pharmaceutics and pharmacokinetics that would be covered in a first-year PharmD program. This prerequisite knowledge is assumed and will not be reviewed in this course. Computer/Technology Requirements To be successful in this course, please ensure that your computer meets the minimum technological requirements and specifications that are outlined and listed on the University of Minnesota Technical Requirements webpage. This page includes information regarding browsers, hardware, pop-up configuration, and free downloads. You will need a word processing application for this course. Acceptable file formats for submitted work include.rtf,.doc,.docx,.txt, or.pdf. The University of Minnesota offers students free access to Microsoft Office; click here for details. 3

4 If, at any time, you experience technical difficulty, please feel free to contact the University of Minnesota Technology Helpline, or contact your course coordinator. Please be advised that taking an online course requires consistent access to the Internet. Please plan accordingly. Participation & Communication Learner Responsibilities As an online learner, you must take an active role in your own learning. Below are some expectations for online learners in this course: 1. Ask for help as soon as you need it. 2. Ensure that your technology is working. 3. Have a back-up plan for technology breakdowns. Please note that limited or lack of access to technology will not be accepted as an excuse for lack of participation in any course activity or assignment. 4. Manage your time each week in order to meet the assignment and activity deadlines. 5. Be a responsible group member on all group assignments. 6. Communicate in a respectful, professional and appropriate manner. Online Participation Guide Active, Ongoing Participation You are responsible for keeping current on all relevant course communications and notifications. You are required to check your University of Minnesota at least twice a week; you are encouraged to check your U of M daily if possible. You are expected to keep up with course work and to submit assignments on time. For online activities, this means adhering to the activity and assignment schedules within each course module and lesson. You are expected to participate actively in group work. Group Work Policy We have high expectations for performance on all group work; if and when an assignment calls for group work, you will be expected to participate actively. Social loafing, or not participating in group work but taking credit for the work of the group, will not be tolerated and will result in a loss of points for the corresponding assignment. If you are assigned a group project and you perceive that a group member is not participating, follow these steps: 1. Confer with your other team members to confirm that your perception is accurate. 2. Promptly articulate the concern to the group member who is not contributing in writing with adequate notice, copying the other team members, the course coordinator, and the instructor(s). 3. If the problem does not correct, escalate the issue directly to the instructors, copying *all* team members, including the person who has not contributed, asking the instructor(s) to intervene directly. 4. If you receive an from a team member indicating that they think you are not contributing, and you disagree, you should respond to the entire team, copying the course coordinator and the instructors, with a simple, clear articulation of what you contributed, and when, to the assignment. Providing supporting evidence of the contribution, such as s, or access to online documents, is helpful. 5. The instructor(s) are your "supervisors" in this course and reserve the right to assign points on any group assignment differentially to each team member or to retroactively downgrade any specific team member's grade on an assignment, if credible evidence of non-participation emerges. Other General Rules Be respectful of your fellow students and the instructor. Engage actively; encourage your fellow learners, including your instructors, to explore intellectually. 4

5 When communicating virtually, please be professional and courteous in your words and manners. Disruptive Behavior Instructors have the authority and discretion to set rules that foster student learning. As a matter of academic freedom, these rules can be tailored to the subject matter and the instructor s teaching methods and learning objectives. For these reasons, the course instructor is the one who makes a determination about what constitutes disruptive behavior. Online Classroom Etiquette You are expected to be good classroom "citizens" by exhibiting professional behavior towards classmates and instructors at all times. Being a good classroom citizen includes following the rules and guidelines listed below. Be respectful; disagreement is fine, but try to disagree without being disagreeable. Keep your responses on-topic; if you would like to engage a member of the learning community in an off-topic discussion, use private or the Peer Forum. Post messages to the appropriate audience; please don't put administrative questions or concerns or feedback about the course in your discussion board topics. Use quotations, from the readings, the instructor, or your classmates, responsibly and reply substantially; quote as little as you need to in order to set the context for your response, and be sure to add something original and thoughtful of your own. Simply saying, "I agree" or "I disagree" will not suffice. Always define terms and acronyms for your fellow students and for the instructor. Communication Guide There is a course coordinator assigned to this course, and he/she will be your first point of contact for course questions. The course coordinator will respond to or phone messages within two business days. Your course instructor will respond to or phone messages within three business days. Important course announcements will be posted in the Moodle online discussion forum titled Course Announcements. This forum is also set to automatically send you an with the text of the posting. Note that if you miss the , you will always find a complete listing of announcements in that Course Announcements forum. You are responsible for all information that is distributed via Course Announcements. You will be able to interact with the instructor via , phone, and through the Moodle course website discussion forum titled Peer Forum. You will be able to interact with other students in the online discussion forum titled online Peer Forum and/or the online chat tool titled Peer Chat, both found on the main Moodle course page. Feel free to also connect with other students to form study groups or to ask each other questions. The instructor will respond to questions within two business days of receiving an and will respond to online discussion questions within two business days as well. Note about privacy: all communication (academic and personal) that occurs within the context of this course should be considered private. COURSE SYLLABUS: Course requirements Course Goals & Objectives At the conclusion of the course, you will be able to: Explain the basic principles of human genetics and heredity as they apply to inter-individual variation in treatment response. Apply the principles of molecular and cellular biology to explain the genetic basis of variability in drug response. 5

6 Discuss how genetic variability in genes encoding drug metabolizing enzymes, drug transporting proteins, and drug receptors (targets) can contribute to variability in drug disposition and action, leading to changes in pharmacokinetics, pharmacodynamics, and clinical outcome. Discuss impact of pharmacogenomics in different therapeutic areas. Discuss case studies reporting the clinical consequences of pharmacogenomics on therapeutic efficacy or toxicity. Apply pharmacogenomic concepts to a particular drug therapy to solve relevant problems in pharmaceutical care. Recognize the societal and ethical implications of genetic testing and the resultant individualization of drug therapy. Critically evaluate the current and future literature in the area of pharmacogenomics. Identify key sources and reliable databases with pharmacogenomics knowledge base. College of Pharmacy Competency Domains Please identify the Competency Domains and Sections met by this course. Domains Section covered*: (6.4.2 for example) Domain 1: Patient-Centered Care As a provider of care, the pharmacist is ethical, benevolent, empathetic, competent, open-minded, prudent in making judgments, and devoted to serving others. The pharmacist applies knowledge, experience, and skills to protect the welfare of humanity. The pharmacist willingly and respectfully cares for patients to assure optimal therapeutic outcomes Domain 2: Population Health & Vulnerable Communities As a promoter of public health, the pharmacist uses his/her expertise to partner with others to improve care for vulnerable communities or at risk populations. The pharmacist recognizes the differences between populations of individuals and seeks to alleviate disparities that exist. Domain 3: Health Systems Management As a manager of health system resources, the pharmacist examines critical issues, assumptions, and limitations to produce and validate ways to deliver medications safely, effectively, and in a timely manner. The pharmacist demonstrates imagination, inventiveness, and courage by undertaking new endeavors to produce improved quality, productivity, efficiency, effectiveness, and innovation. Domain 4: Leadership & Engagement In leading, the pharmacist demonstrates integrity and is habitually resolute, focused on excellence, knowledgeable about the big picture, strategic, focused, persuasive, open to feedback, decisive, visionary, empowering, and service-oriented. Domain 5: Professional & Interprofessional Development When collaborating, the pharmacist demonstrates critical thinking, excellent communication and leadership, and is goal-oriented, cooperative, assertive, respectful, enthusiastic, and reliable. The pharmacist consistently and consciously demonstrates high ethical and moral standards by considering how and when to act, acting in a manner that is clearly consistent with those standards and exercising accountability for those actions. Domain 6: Knowledge, Scientific Inquiry, and Scholarly Thinking In making use of scientific knowledge, the pharmacist explains with thoroughly researched, evidence based accounts of facts and data, and provides interpretations based on analysis of the importance, meaning, and significance. The pharmacist applies knowledge fluently, flexibly, and efficiently in diverse contexts. * refer to College of Pharmacy Competency Domains for Section descriptions 6

7 Attendance Policy This course is entirely online and does not meet face to face at any point in the semester. You will be required to complete readings and take exams on a schedule. Required Readings and Materials Text and Course Materials There is no required textbook for this course. Any course readings will be available online and will be listed in the appropriate Moodle Module, as required. However, you may find the following optional textbook helpful as a reference: McLeod, et. al (eds.) (2009). Pharmacogenomics: Applications to Patient Care, 2nd Ed. American Association of Colleges of Pharmacy. The textbook can be purchased at the University of Minnesota Bookstore on either the Twin Cities or Duluth Campuses, or online from Amazon.com. Course Website The course calendar, including dates and times of all assignments and assessments, can be found on the Moodle course web site. An abbreviated version is available at the end of this syllabus (Course schedule and outline). Please note that all students are expected to check in to the course Moodle site at least 3 times a week. Assessment and Grading Non-graded Interactive Questions/Activities Within course lessons, there may be interactive questions and activities. While these will not be represented in your final grade as such, they are designed to help assimilate and learn the course content. They provide a critical aspect to the learning in this course. Graded Assignments The following graded assignments will count toward your final grade for this course in the following amounts: Due Date Title/ Description Brief Description / Learning Objectives Points % of final grade FEB 03, MODULE 1 QUIZ This summary quiz will cover all topics in Module 1. This quiz is open book and open note and does not require proctoring. FEB 24, MODULE 2 QUIZ This summary quiz will cover all topics in Module 2. This quiz is open book and open note and does not require proctoring. MARCH 14, MID TERM EXAM This midterm exam is closed book and closed note, It will cover all material that has been covered through 7.5% 7.5% 35% 7

8 (Modules 1, 2, 3) Modules 1, 2 and 3. APRIL 28, FINAL EXAM (Modules 1, 2, 3, 4, 5) The course final exam is closed book and closed note and will cover all material from Modules 1-5. Students will have two choices: they may take the exam. 35% Choose article: April 21, Submit Presentation: May 06, Peer review : May 09, STUDENT PRESENTATIONS Students will choose an article about current research related to pharmacogenomics and develop a presentation that summarizes the literature, provides some consideration of unresolved issues, and possible next steps, and peer review each other's work. 10% Ongoing, specific due dates in Moodle site. PARTICIPATION Drug Discovery Assignment Warfarin Dosing and Package Insert Assignments Ethics Assignment Concept Map assignment 05% Grade Review Requests Students who have questions regarding the grading of any assessment must submit them in writing to the instructor within one week following the return of the exam. Exam Policy Absence from Exam Absence from exam with acceptable cause If a student feels too ill or is unable for any reason to take an exam within the required time frame, the student must contact the course instructor by or phone prior to the exam. Further, the student must provide the course instructor with a written and signed statement from a licensed health care provider (i.e., physician, nurse practitioner or physician assistant). This statement must explain the reason for absence. For more details and make-up policy see below. Absence from exam without acceptable cause If a student is absent without notifying the course instructor and providing a written and signed statement from a licensed health care provider, a score of zero will be recorded for the exam. Make-up Policy for Exams A make-up exam will be given only under the following circumstances: Illness verified by a note from a physician prior to or after the exam Emergency verified by a health care professional in attendance Family emergency verified by a note from a health care professional in attendance University-sponsored event verified by the sponsoring organization in advance of the event or absence If an acceptable circumstance or adequate documentation is not provided, a grade of zero on the exam will be assigned by the course instructor. Unless there are extenuating circumstances, students must contact the Course Instructor (by and phone) at least 24 hours in advance of the scheduled exam in order to be considered for a make-up exam. 8

9 Grading Information Your final grade in the course will be determined by the scores you earn on the course assignments, quizzes, exams. Course Letter Grades Grade Percentage A A B B B C C C D F 0-59 Feedback You will receive feedback on assessments within two weeks of the due date. Accessibility The University of Minnesota is committed to providing all students equal access to learning opportunities. Disability Services is the campus office that works with students who have disabilities to provide and/or arrange reasonable accommodations. Students registered with Disability Services, who have a letter requesting accommodations, are encouraged to contact the course coordinator early in the semester. Students who have, or think they may have, a disability (e.g. psychiatric, attentional, learning, vision, hearing, physical, or systemic), are invited to contact Disability Services for a confidential discussion at (V/TTY) or at [email protected]. Additional information is available at the University of MN Disability Services website. Because this is an online course with a strong technological component, students with disabilities may find this information on adaptive technologies useful. 9

10 General Course Policies Copyright All original materials for this course, including all recorded lectures, are protected by United States copyright law and may not be reproduced, distributed, transmitted, displayed, published or broadcast without the prior written permission of the Regents of the University of Minnesota. Honor Code Academic misconduct is any unauthorized act which may give a student an unfair advantage over other students, including but not limited to: falsification, plagiarism, misuse of test materials, receiving unauthorized assistance and giving unauthorized assistance. Instructors or a fellow student may report academic misconduct during an exam to the Course Instructors and the Honor Council for investigation. Course Evaluations Students will have an opportunity to complete online course evaluations for instructors and the course itself (including instructional strategies, etc) at the end of the semester. You are encouraged to contact one of the course directors or the Course Support Specialist any time you have concerns about the course or your progress in the course. Disability Accommodations The University of Minnesota is committed to providing all students equal access to learning opportunities. Disability Services is the campus office that works with students who have disabilities to provide and/or arrange reasonable accommodations. Students registered with Disability Services, who have a letter requesting accommodations, are encouraged to contact the instructor early in the semester. Students who have, or think they may have, a disability (e.g. psychiatric, attentional, learning, vision, hearing, physical, or systemic), are invited to contact Disability Services. All information will be kept confidential! Minneapolis Campus Duluth Campus Disability Services Disability Services & Resources McNamara Alumni Center 256 Kirby Student Center 200 Oak St SE Suite Kirby Drive Minneapolis, MN Duluth, MN Mental Health Accommodations As a student you may experience a range of issues that can cause barriers to learning, such as strained relationships, increased anxiety, alcohol/drug problems, feeling down, difficulty concentrating and/or lack of motivation. These mental health concerns or stressful events may lead to diminished academic performance or reduce a student s ability to participate in daily activities. University of Minnesota services are also available to assist you with addressing these and other concerns you may be experiencing. You can learn more about the broad range of confidential mental health services available on campus via the Student Mental Health Website at Student Academic Integrity and Scholastic Dishonesty Academic integrity is essential to a positive teaching and learning environment. All students enrolled in University courses are expected to complete coursework responsibilities with fairness and honesty. Failure to do so by seeking an unfair advantage over others or misrepresenting someone else s work as your own can result in disciplinary action. The University Student Conduct Code defines scholastic dishonesty as follows: Scholastic Dishonesty: Scholastic dishonesty means plagiarizing; cheating on assignments or examinations; engaging in unauthorized collaboration on academic work; taking, acquiring, or using test materials without faculty permission; submitting false or incomplete records of academic achievement; acting alone or in cooperation with another to falsify records or to obtain dishonestly grades, honors, awards, or professional endorsement; altering 10

11 forging, or misusing a University academic record; or fabricating or falsifying data, research procedures, or data analysis. FERPA Per University statement regarding FERPA (Family Educational Rights and Privacy Act): In this class, our use of technology may make students names and U of M Internet IDs visible within the course website, but only to other students in the same class. Since we are using a secure, password-protected course website, this should not increase the risk of identity theft or spamming for anyone in the class. If you have concerns about the visibility of your Internet ID, please contact our office. Visit for more information. Academic Freedom and Responsibility Academic freedom is a cornerstone of the University. Within the scope and content of the course as defined by the instructor, it includes the freedom to discuss relevant matters in the classroom. Along with this freedom comes responsibility. Students are encouraged to develop the capacity for critical judgment and to engage in a sustained and independent search for truth. Students are free to take reasoned exception to the views offered in any course of study and to reserve judgment about matters of opinion, but they are responsible for learning the content of any course of study for which they are enrolled.* Reports of concerns about academic freedom are taken seriously, and there are individuals and offices available for help. Contact the instructor, the Department Chair, your adviser, the associate dean of the college, or the Vice Provost for Faculty and Academic Affairs in the Office of the Provost. *Language adapted from the American Association of University Professors Joint Statement on Rights and Freedoms of Students University of Minnesota and College of Pharmacy Policy Reference The University of Minnesota has several campuses, which may follow varying policies and procedures. Students will generally follow the policies and contact information for their respective campuses. Visiting students (not officially admitted to any UMN school or program) in fully online courses will follow the policies and contact information for the Twin Cities campus, unless otherwise specified. Any questions can be directed to the course coordinator for your course. University Faculty Senate has determined that instructors must have as part of the syllabus copies of, references to, or statements on the following and are encouraged to discuss elements of the policies particularly applicable to their course. Appropriate Student Use of Class Notes and Course Materials Equity, Diversity, Equal Employment Opportunity, and Affirmative Action Grading College of Pharmacy: University of Minnesota: Honor Code (College of Pharmacy) Student Conduct Code (University of Minnesota) 11

12 Makeup Work for Legitimate Absences Teaching and Learning: Instructor and Unit Responsibilities Teaching and Learning: Student Responsibilities Use of Personal Electronic Devices in the Classroom Board of Regents Sexual Harassment Policy Detailed Course Outline & Schedule* Class Dates Topics Instructor Activities/Assignments /Assessments MODULE 1 INTRODUCTION TO PHARMACOGENOMICS AND REVIEW OF MOLECULAR BIOLOGY LESSON 1 LESSON 2 (2 weeks) Tue JAN 21 - Mon FEB 03, PHARMACOGENOMICS Introduction to basic concept of pharmacogenomics. Importance, clinical application and challenges in Pharmacogenomics. 1 Why Study Pharmacogenomics? 1.1 Inter-patient variability 1.2 Definition of Pharmacogenomics 1.3 CYP2D6 and codeine poisoning cases 1.4 Clinical Applications and Challenges in Pharmacogenomics 1.5 Role of Pharmacist in clinical pharmacogenomics services MOLECULAR BIOLOGY REVIEW Basic principles and paradigms of molecular biology (DNA RNA Protein) information on gene promoters, mirna, identification of targets, splicing/alternate splicing. OETTING LESSON Molecular Biology: A Brief Introduction 2.2 Molecular Biology: The ENCODE Project 2.3 The Major Histocompatibility Complex (MHC) 2.4 Basic Genetics: Family History 2.5 Statistics Used in Genetic Studies GENETIC VARIATION Introduction to genetic variation, types of variants, SNPs, coding and cis/trans regulatory variants, insertion/deletions, copy number variants SNPs, allele nomenclature (rs#, *#), databases, National pharmacogenetics resources/efforts (PGRN), population/allele frequency distribution. OETTING 12

13 LESSON Introduction to Genetic Variation 3.2 The Human Genome Project 3.3 Identification of Genetic Variation: Isolation of DNA 3.4 Identification of Genetic Variation: Detection of Genetic Variation 3.5 Identification of Genetic Variation: DNA Sequencing 3.6 Identification of Genetic Variation: Databases PHARMACY AND GENETIC DISEASES 4.1 Introduction / Change the Environment 4.2 Fix the Mutated Gene Product 4.3 Provide the Missing Gene Product 4.4 Example: Marfan Syndrome OETTING DUE FEB 03, MODULE 2 ASSESSMENT: Module 1 Quiz (Lessons 1, 2, 3, 4) PHARMACOGENOMICS MODULE 1 QUIZ (3 WEEKS) Mon FEB 03 - Mon FEB 24, LESSON 5 THE INFLUENCE OF PHARMACOGENETICS ON PHARMACOKINETICS AND PHARMACODYNAMICS Introduction to proteins of importance in drug pharmacokinetics. Understanding the role of proteins involved in phase I drug metabolism in pharmacogenomics. LESSON 6 LESSON Proteins Involved in Pharmacogenetics 5.2 Pharmacogenetics of Phase I drug metabolizing enzymes 5.3 CYP2C9 Pharmacogenetics 5.4 CYP2D6 Pharmacogenomics 5.5 CYP2D19 Pharmacogenetics Pharmacogenetics of Phase II Drug Metabolizing Enzymes The role of proteins involved in phase I drug metabolism in pharmacogenomics. DRUG TRANSPORTER PHARMACOGENETICS Introduction to drug transporters and understanding how genetic variation in drug transporters contribute to inter-individual differences in drug PK and PD. LESSON 8 DRUG TARGET PHARMACOGENETICS LESSON 9 ETHICAL, SOCIAL, LEGAL, AND ECONOMIC ISSUES Student discussion groups. Using references provided and other resources students will initiate discussions on topics listed. ASSIGNMENT DUE FEB 24, ASSESSMENT: Module 2 Quiz (Lessons 5, 6, 7, 8, 9) MODULE 2 QUIZ MODULE 3 PHARMACOGENOMICS IN THERAPEUTIC AREAS (3 WEEKS) Mon FEB 24 - Fri MAR 14, LESSON 10 PHARMACOGENOMICS IN CARDIOLOGY STRAKA 9.1: Cardiovascular Clinical Example Clopidogrel: Clinical Outcome Trials 13

14 LESSON 11 LESSON 12 LESSON 13 comparing Clopidogrel vs. Prasugrel 9.2: Ex vivo/healthy volunteer trials investigating drug metabolic pathways and Platelet aggregation models for testing clopidogrel vs. prasugrel 9.3: CYP2C19 based analysis of outcome trials for Clopidogrel vs. Prasugrel 9.4: Clinical Approaches to Drug Selection based on Genotype Clopidogrel vs. Prasugrel/others CLINICAL CONSEQUENCES OF PHARMACOGENOMICS BASED DRUG INTERACTIONS 10.1: Pharmacokinetic profiles for metabolic CYP2D6 metabolizers (Metoprolol as Example Compound) 10.2: Pharmacodynamic response profiles for metabolic CYP2D6 metabolizers (Metoprolol as Example Compound) 10.3: Combined consideration and Clinical interpretation of significance of CYP2D6 metabolizer status for metoprolol 10.4: Cardiovascular Example of pharmacogenomic based drugdrug interaction differential for statin based therapy 10.5: Other Cardiovascular based examples of the significance of pharmacogenomics PHARMACOGENOMICS OF SOLID TUMORS 12.1 Pharmacogenomics of Tamoxifin 12.2 Epidermal Growth Factor Receptors and KRAS 12.3 Irinotecan and UGT1A Capecitabine and 5-FU PHARMACOGENOMICS OF HEMATOLOGICAL MALIGNANCIES 13.1 Pharmacogenomocs of Hematological Malignancies 13.2 TPMT and 6-MP in ALL 13.3 Chronic Myelogenous Leukemia (CML) 13.4 Rasburicase and G6PD STRAKA DUE MARCH 14, DUE MARCH 14, MAR 17 21, MODULE 4 Lesson 14 Mid term Self assessment of Learning Submit to online discussion Forum Activity ASSESSMENT: MIDTERM EXAM SPRING BREAK PHARMACOGENOMICS IN THERAPEUTIC AREAS (CONTINUED) (4 WEEKS) Mon MAR 24 - Mon APR 28, TRANSLATING PHARMACOGENOMICS DATA INTO THE CLINICAL AREA (NOTE: This lesson has specific due dates that must be followed. See Moodle course site for dates.) MID TERM SELF- ASSESSMENT OF LEARNING MIDTERM EXAM MODULES 1, 2 3 JACOBSON Wednesday March 26. Sunday March

15 Mon MAR 24 - Mon MAR 31, Mon MAR 25 - Mon APR Tailoring Drug Dosing with Genetics Genotype-based Dosing Equations Activity: Warfarin Case Studies 14.2 Interpreting Genetic Data from Drug Packet Inserts Activity: Drug Packet Inserts Forum Assignments due. Wednesday March 28,. Sunday March 31. Forum assignments due. Wednesday March 28,. Sunday March 30,. Lesson 15 PHARMACOGENOMICS IN PSYCHIATRY How inter-patient genetic differences influence response to asthma medication. V LAMBA Lesson 16 PHARMACOGENOMICS OF ASTHMA Understanding how inter-patient genetic differences influence response to asthma medication 16.1 Pharmacognomics of Asthma 16.2 β2-agonists 16.3 Coricosteroids 16.4 Leukotrienes Lesson 17 PHARMACOGENOMICS AND ADVERSE DRUG REACTIONS 17.1 Pharmacogenomics and Adverse Drug Reaction 17.2 Carbamazepine and Abacavir induced ADRs Lesson 18 PHARMACOGENOMICS IN DRUG DISCOVERY AND DEVELOPMENT 18.1 An Introduction to Drug Discovery and Development 18.2a The Impact of Pharmacogenomics on Drug Discovery and Development (I) 18.2b The Impact of Pharmacogenomics on Drug Discovery and Development (II) 18.3 Recent Pharmacogenomics in the News WALTERS Forum Assignment Due Apr 28,. APR 21, STUDENT SELECTED RESEARCH ARTICLES DUE IN FORUM APR 28, ASSESSMENT: FINAL EXAM FINAL EXAM MODULES 1, 2, 3, 4, 5 MODULE 5 CURRENT LITERATURE AND RESEARCH IN PHARMACOGENOMICS DUE MAY 05, DUE MAY 9, DUE MAY 9, MAY 12 17, (2 WEEKS) Mon APR 28 - Fri MAY 9, Student Presentations PEER REVIEW: Student Presentations Final self assessment of learning Submit to online discussion Forum Activity FINALS WEEK PRESENTATIONS DUE PEER REVIEW DUE Final self-assessment of learning * Subject to change at course instructor s discretion. 15