Curriculum: MS Pharm Sci: Health Outcomes & Pharmacoeconomics

This course provides graduate students with an overview on legal and regulatory aspects relevant to drug and medical device development. This includes intellectual properties protection, global legal and regulatory requirements, protection of human subjects and ethics in clinical research and essential elements of management of global projects. Case studies will be included to underline how regulatory strategiesimpact product marketing and life cycle management. Throughout the course, students will integrate knowledge using specific industry examples with the goal to identify critical decision points in the development that impact success of a new drug or medical device on the market.

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.

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.

The objective of this graduate course is to prepare students to evaluate outcomes, comparative effectiveness, and health services research using real-world data (RWD) to generate Real World Evidence (RWE). In this course, students will learn about the contents and structure of typical healthcare databases used to perform outcomes, comparative effectiveness, and health services research, discuss the relative advantages and disadvantages of RWD data and identify methodological challenges of using RWD. Additionally, recent the regulatory framework for RWE and RWD 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.

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.

This course is designed to provide an understanding of the theory and application of economic evaluation methods used in healthcare decision-making. Various methods such as cost-effectiveness analysis, cost-utility analysis, cost-minimization analysis, and cost-benefit analysis will be discussed to evaluate healthcare services, pharmaceuticals, and medical device products. Additionally, techniques to measure costs and outcomes will be discussed in detail along with assigning the monetary value to outcomes. Different types of models such as decision trees and Markov models will be taught. Students will have a chance to conduct independent group projects using a decision-analytic software package by which they will be able to conduct a cost-effectiveness analysis to compare different therapeutic options.

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.

This course is designed to provide students with an overview of how policy is developed and how policies can affect health care in the United States. The course prepares students to understand the steps in the policy creation process and then apply concepts in policy analysis and advocacy. There are five focus areas: need and demand, healthcare finance, ethics & law, preparedness, and policy evaluation. Within the five focus areas, we will examine topics using Bardach’s Eightfold Path: problem definition, agenda setting, implementation, evaluation, and modification. The course will present case studies and readings about real-world problems that health professionals face.

The course is intended to provide health systems management students with a systems perspective of US health and healthcare structure and function. As the Program’s introductory course, it provides a basis for all subsequent courses including leadership, systems analysis, finance and economics, quality improvement, policy and law, and others. Topics include an overview of the social, political, economic, and structural dynamics which shape health care in the United States as well as current and likely future imperatives health care managers will face.

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 introduces the discipline of health informatics and covers emerging trends. Various information systems, technologies and applications utilized in the context of health and healthcare are introduced. Their characteristics, strengths, challenges, purpose and impact are taught. Impact on patients, populations and healthcare providers is emphasized. Factors influencing adoption and use of various clinical and health information systems and technologies are taught. Key information technologies and systems such as electronic health records, health information exchanges, personal health records, public health information systems and mobile health technologies are introduced in this course. Topics such as telemedicine, interoperability and technical concepts are taught, and evaluation framework is introduced.

This course teaches the use of healthcare data to make decisions and transform healthcare delivery and the health of individuals and populations. The course concentrates on big and small data, and structured and unstructured data. Tools, applications and approaches for health data analytics are taught. This course covers topics such as statistical approaches; data, web and textmining; data visualization, simulation, modeling and forecasting. Key regulatory health and healthcare reporting requirements are taught.

This course will introduce students to a variety of cutting edge analytics and business intelligence tools applicable to health or healthcare data. Both structured and unstructured data will be introduced in this course. The coursewill also address topics related to data governance and data quality and various other topics relevant to health data management. This course is predominately hands-on and students willcomplete a project to demonstrate skills acquired.Students will learn how other industries have applied similar or the same tools.

This course introduces legislation relevant to electronic health information privacy and information security. Topics such as electronic health information privacy and security safeguards, risk assessment methodology and contingency planning are taught. Students learn how to mitigate risk to business continuity and plan for disaster recovery.