Curriculum: MS in Pharmacogenomics and Personalized Healthcare

April 01, 2021
30

curriculum icon Curriculum at a Glance

For the MS Pharmaceutical Sciences: Pharmacogenomics and Personalized Healthcare online program, the curriculum includes a total of 30 required semester credit hours to satisfy degree requirements. The curriculum is customizable and students can choose their courses.

Below is a sample curriculum. Please note, this is subject to change based on university discretion. The proposed schedule is a guide and is subject to change based on curriculum modifications and faculty availability.

Metabolism, Molecular Biology and Pharmacogenomics

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.

Pharmaceutical Biotechnology

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.

BIostatistics & Research Methods

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.

Clinical Application of Pharmacogenetics

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.

Drug Development Project I

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.

Drug Development Project II

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.

Pre-Clinical/Non-Clinical Studies for IND Approval

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.

Phase I/II Clinical Trials Research and Design

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.

Phase III/IV Clinical Trials and Research

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.

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