Curriculum: MS Pharmaceutical Sciences: Pharmacogenomics and Personalized Healthcare

December 01, 2020

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.

Pharmacoepidemiology and Drug Safety

This course is designed to introduce research methodology in Pharmacoepidemiology studies, and drug safety research applications in pre- and post-marketing surveillance. It covers practical applications of Pharmacoepidemiology in different pharmacotherapies, describes health care data sources for research; and discusses pregnancy registry, drug utilization review, risk management, adverse event monitoring system, as well as the U.S. and international regulations in drug safety.

Pharmaceutical Economics and Management

This course will provide students a background in project management issues in the conduct of global clinical trials, financial aspects of drug development and pharmacoeconomics of approved drug/drug products. The first module will focus on logistic and strategic issues of project management encountered in modern drug development. It includes exposure to principles of project management of complex programs involving: pharmaceutical development, operations, and regulatory affairs. In addition, the corporate challenges involved with portfolio management and optimization will be presented focusing on tools used for optimum decision making. This knowledge base will be applied towards selective case presentations with the goal to identify critical decision points in the process that dramatically impact the successful launch of a new product. The second module will emphasize the business and financial aspects of drug development, including biotechnology and other innovative small pharmaceutical companies that derive their funding primarily from venture capital funding, business strategies, outsourcing and merger and acquisitions. Valuation of the new chemical/molecule as it evolves in the drug development pipeline will be discussed.

Discovery of Drugs and Therapeutic Biologicals

This course is an introduction to the discovery and early development (ie, prior to pre-clinical) of small molecule therapeutics and biopharmaceuticals such as proteins, peptides, vaccines, cell and gene therapies, and nucleotide based products. Introductions to the major classesand categories of drugs and biological will be provided including some principles of pharmacologysuch as drug targets/receptors and drug-receptor interactions. Methods and principles of drug/biologics discovery will be addressed from serendipitous observation to current approaches such as HTS, computational, combinatorial chemistry, and bioinformatics. Comparison of manufacturing methodology of drugs and biologics will be provided along with special clinical and regulatory considerations for biologic products. Additionally, emphasis will be given to major therapeutic areas (oncology, CNS, cardiovascular, Infectious Diseases/AIDS) in terms of approaches currently in use and in development along with addressing the unmet needs in each area.

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.

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.

Biochemistry and Molecular Biology

This course will review the chemistry of biologically important molecules, their metabolismand tehir roles, to provide a foundation for understanding disease states, mechanisms of drug action and drug metabolism. In addition it will provide a foundation for understanding the genesisof new and emerging molecular based therapeutics.

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.

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