Curriculum: MS Pharm Sci: Pharmacogenomics and Personalized Healthcare

Basics of Cellular Metabolism, Molecular Biology and Pharmacogenomics. Provide the pharmacy student with foundational knowledge of cellular metabolism, biological information processing, and an introduction to pharmacogenomics.

Students will learn about the various ethical and moral issues that are often encountered in scientific research including ways to identify and analyze them in the practice of research. The course is designed as an option to meet the NIH and NSF requirements for training in RCR (Responsible conduct of research). Topics to be covered include: RCR principles and guidelines, mentorship, collaborative research, conflict of interests, authorship and plagiarism, intellectual property and data handling, research involving human and animal subjects, scientific integrity and misconduct and social responsibility.

Human Genetics is the root of pharmacogenomics. Students must be able to understand human genetics to fully grasp Pharmacogenomics as many inheritance patterns, genome organization, and clinical techniques depend on the human genome. Techniques used in human genetics will be integrated with principles and concepts presented during lecture.

This course provides students with the basic knowledge of Molecular Biology and technologies commonly used in Pharmaceutical Sciences. Emphasis is placed on the development of biological drugs andcell/animal models. Genome-wide techniques are discussed, particularly those related to disease development and response to drug therapy.

The course begins with basic statistical concepts, introduces essential descriptive and inferential statistical tests, demonstrates some data analysis tools and collection instruments, then discusses common research methodology for pharmaceutical and cosmetic sciences. Students will learn how to use statistics and research designs to evaluate scientific evidence to make individual and population-based decisions. Students will conduct some simple statistical analysis based on given data sets and interpret the results, as well review clinical research literature.

The course builds and expands on foundational topics of genetics and molecular biology that are taught to first year pharmacy students in the course of “Metabolism, Molecular biology and Pharmacogenomics”. Students will progressively learn how to apply pharmacogenetic knowledge to patient cases, integrating clinical and genomic data to drive clinical decisions. This course aims to provide student pharmacists with pharmacogenetic knowledge and enable them to use genomic data alongside other clinical data to optimize clinical care. In this course, students will review foundations of genetics and will be introduced to principles of population genetics and genomic medicine. The knowledge acquired will allow them to understand ethnic/racial differences of drug response. Students will be familiarized with logistics and important infrastructure for implementing pharmacogenetics in clinics. The course will focus on high evidence and clinically implemented gene-drug pairs.

This is the first of a two-course sequence. The overall objective is for the students to undertake a hypothesis driven research project or a comprehensive evaluation of a contemporary issue in the development of drugs/biologicals/devices. A committee comprising of three faculty members identified by the student will be constituted to guide the student in the undertaking. The project findings should demonstrate competency in multidisciplinary didactic coursework and scientific, regulatory and business aspects of new drug/drug product or device development.

This course follows Drug Development Project I. The overall objective of the effort in the two-course sequence is for the students to undertake a hypothesis driven research project or a comprehensive evaluation of a contemporary issue in the development of drugs/biologicals/devices. A committee comprising of three faculty members guides the student in the undertaking. The project findings should demonstrate competency in multidisciplinary didactic coursework and scientific, regulatory and business aspects of new drug/drug product or device development. At the end of the study, the student will be required to prepare a manuscript and also present a seminar as an "oral defense" that will be open to all students and faculty on campus.

The course requires the student to present a seminar on a contemporary issue in the developmentof drugs/biologicals/devices. Each student is expected to conduct an in-depth analysis on current issues in drug development and apply the best practices in making scientific presentations.

Advanced pharmacogenomics utilizes the basic understanding of pharmacogenomics and allows the students to expand upon their existing knowledge using pharmacokinetics and basic coding. The expansion of knowledge in pharmacogenomics allows the students to develop more sound hypotheses pertaining to scientific literature, while taking a deeper dive into how pharmacogenomics is used in research and development.

The science behind cancer genomics is growing at an exponential rate. Students should understand the not only the history of cancer genomics, technology, and targeted therapy, but also be able to adapt to new technology, clinical trial implications and newly approved diagnostics and therapies. This class provides the learner the ability to assess and implement the theory of techniques into real-world data.

This course provides not only the fundamentals in human macronutrient metabolism and its role in health and disease but also the genetics related to nutrition and athleticism. Just as Pharmacogenomics studies how drug therapy interacts with genes in the human body, nutrigenomics, and exercise genomics is the science of how food and training can impact the human body

Implementation Science is defined as the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services. In this class students will work across healthcare disciplines to solve multiple clinical case studies.

This class has a wide variety of companies that will be presenting on the work they do. This class will provide an area for students to network with employers, to ask questions about the job market, and the learn what types of jobs are available to them.

The course is designed to teach students regulatory framework for the pre-clinical evaluation of the safety and efficacy of a molecular entity/lead compound identified in the drug discovery/early development phases for submission of the IND application. Major emphasis will be placed on the principles of pharmacokinetics/toxicokinetics and ADME processes(Absorption, Distribution, Metabolism and Excretion) so that safe (and efficacious) dosing regimens can be recommended for the early clinicaldevelopment phases. Differences between conventional (small molecules) vs. macromolecules and biologicals will be underscored.

This course will provide an understanding on the early clinical drug development activities for newchemical entity that has received IND approval. Concepts of early clinical pharmacology studies, typically conducted in a Phase I setting such as single and multiple dose pharmacokinetics, dose escalation studies to determine the safety and tolerability of drug, mass balance and drug metabolism studies and bioavailability studies will be taught. Emphasis will then be placed on Phase II trials as proof-of-principle, and on the dose-ranging requirements for Phase II. Trial designs including cross-over and parallel group will be discussed. The importance of Phase I/II trials for making dose selections for Phase III will be explored, as will the use of Phase II trials as a go/no-go decision point. The importance of exposure-response (PK/PD) information in guiding the go/no-go decision will also be discussed. The use of biomarkers and pharmacogenomic information in decision making will be addressed. Activities which run in parallel to PhaseI/II trials, including formulation development and clinical supplies and toxicology studies will be discussed.

This course will provide a comprehensive background in the design and conduct of large, multicenter Phase III clinical trials of investigational compounds. Emphasis will be placedon the conduct of studies that include patients with varying demographics (age, gender, genetic background and disease state such as renal and hepatic). Issues pertaining to clinical operations, project management, human subjects protections and data safety monitoring will be discussed. An introduction to principles of population pharmacokinetics and pharmacodynamics will be included. The course will include conceptsof post marketing surveillance of approved drugs for drug safety and idiosyncratic reactions, global approaches for pharmacovigilance and compliance with ICH guidelines for recording and dissemination of adverse events. Issues pertainingto pharmacoepidemiology and clinical utilization/effectiveness of the drug will also bediscussed.

This course provides an introduction and overview to healthcare leadership, human resources management, and organizational behavior in healthcare settings, reflecting the uniqueness of this sector as well as the universal concepts and principles utilized in the development of effective healthcare administrators and leaders. This course integrates theory with practice through readings, written assignments, group projects, and discussion boards from different organizational perspectives. The development of leadership, managerial and organizational skills will be accomplished through a strong emphasis on self-reflection and self-analysis utilizing the tools of the course. This course aims to provide a relevant understanding of organizational dynamics such as performance, organizational culture, teamwork, individual and shared values, and cultural competency. It will examine how healthcare leaders and their organizations relate to each other internally and to their external environments. Topics include values-driven leadership, team effectiveness, self-awareness, emotional intelligence, conflict management, human resources management, employee behavior and appraisal, and assessment and evaluation of leadership performance. This course emphasizes the reflection of the students’ past and current experiences with the integration of current evidence-based leadership and human resources management principles. The students will be required to submit their feedback from self-evaluation assignments, surveys, inventory tools, and group work that is intended to provide insight, awareness, interdisciplinary collaboration, and professional and personal development for ongoing growth in healthcare leadership roles.

This course present students with a comprehensive overview of quality management principles, concepts and tools used in healthcare with a special emphasis in pharmacy practice. Through an analysis of pharmacy -related cases, students will have the opportunity to evaluate the relationship between leadership principles and quality improvement. Topics include quality performance measurement, culture of quality, techniques for quality leadership, patient engagement in quality and the use of technology in quality improvement.

Course will provide an understanding of Human Resources as it pertains to management in Pharmacy. It will include presentations and discussion on employment laws, discipline, the selection and the placement process as well as, developing and recognizing your employees.

This course presents students with techniques , methods and concepts to develop effective communication skills as a pharmacy leader. Through the utilization of scenario exercises, online discussion boards, video technology and respective field work, students will develop a comprehensive set of communication skills. Topics include analysis of multiple communication techniques, recognition of cultural differences with respect to communication expectations, developing and spreading a vision, applying the art of both persuasion and feedback, and identifying and framing audiences. Skills learned through this coursework will prepare students to communication their viewpoints, expectations and vision as a leader in the profession of pharmacy.

This course covers the elements of the medication use system and will assist students in developing skills to assume a leadership role in devising and implementing process improvements of use of health care technologies (electronic health record, bar codes, robotics, smart devices) in the medication system along with HIT standards for interface and integration, and mobile health technologies. Students will gain an understanding of personal health records and models of community and regional information networks. Course content will include activities in workflow process mapping and workflow redesign, project management, and processes for documentation and coding.

This course provides an overview of economics and marketplace topics related to pharmacy, with particular emphasis on topics relevant to the pharmaceutical industry and health benefit payment models. This course will provide an introduction to the fundamentals of Pharmacoeconomics and outcomes research. Pharmacy business aspects of pharmaceutical regulation and pricing, contracts and purchasing models, group purchasing organizations, MTM reimbursement, specialty pharmacy, and value based clinical and financial models for future health care delivery will all be addressed in the course content. Innovation and marketing will also be included with cases and application activities.

This course covers selected financial and managerial aspects of healthcare financial management, specifically designed for Pharmacists. It provides a broad introduction to key concepts, issues, tools, and vocabulary useful for managers, department heads, and owners. There are three main topic areas covered in the course: financial accounting; finance; and managerial accounting. The focus is on the understanding and application of the accounting information in healthcare with emphasis on addressing use within the pharmacy.