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.

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 comprehensive study and/or participate in case studies that blend all the key concepts of didactic coursework in the program and demonstrate acquired competency in the application of the multi-disciplinary contemporary issues impacting development of new drugs, biologicals and devices, post-marketing surveillance/pharmacovigilance, health outcomes and optimizing drug therapy.

This course follows Drug Development Project I and is the second course of a two part series. The overall objective is for the students to continue to undertake a comprehensive study and/or participate in case studies that blend all the key concepts of didactic coursework in the program and demonstrate acquired competency in the application of the multi-disciplinary contemporary issues impacting development of new drugs, biologicals and devices, post-marketing surveillance/pharmacovigilance, health outcomes and optimizing drug therapy. At the end of the study, the student may be required to prepare a manuscript and present a seminar as an "oral defense" that will be open to all students and faculty.

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.