Curriculum: MS Pharm Sci: Health Outcomes & Pharmacoeconomics

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.

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.

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.

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 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 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 will provide students with a basic understanding of writing, communication, and presentation skills that medical writers use to effectively facilitate regulatory communication in drug development. Medical writing encompasses a broad scope of activities, consisting of medical communications (literature researching, scientific publishing, and presenting) and regulatory medical writing (preparing and presenting documents for regulatory Agencies, such as FDA, EMA, etc.). Medical writing across the regulatory lifecycle will be emphasizes in this course, including initial interactions with the agencies on IND/IDE filings, interim interactions like end-of-phase (EOP) meetings and handling requests for information, and compiling pre-market applications like NDA/BLA/PMA using the common technical document (CTD) format. Regulatory communication and presentation skills at each stage will be emphasized. The importance of medical writing and regulatory communication in collaborative transdisciplinary teams to successfully bringing new molecular entities, devices, and biologics to market will be taught, along with a pragmatic overview of United States, European, and global regulatory Agency interactions.

Scientific Communication in Pharmacy prepares you for your Capstone project by mastering specific techniques to make your scientific writing clearer for your audience and to meet the conventions of the scientific community. At the end of the term, you will be prepared to professionally communicate your future Capstone work by producing a journal ready paper. Throughout the semester, we will spend time drafting, revising, and finalizing such a paper. Your final written paper should demonstrate that you have mastered the conventions of scientific communication, clear writing, and proper style.

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 is designed to provide students with an overview of the structure, systems and policies of health care delivery in the United States. The major structural/system issues include the "big three" or "universal issues" i.e., access quality and costs, which includes Medicare, Medicaid and private insurance. Other system topics include the uninsured, health care professions, hospitals, long-term care, mental health, integrated health care systems, the Veterans Administration Health Systems, pharmaceuticals and technology. The course prepares learners to confront the underlying values and ethics that drive the politics of the health care system and to understand and apply basic concepts in policy analysis and advocacy in practice settings. Discussions and assignments will focus on the development of public policy concerning medical care and public health and the relationship between public decisions and the marketplace. Topics include health policy formulation, implementation and evaluation.

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 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

The objective of this graduate course is to prepare students to evaluate outcomes, comparative effectiveness, and health services research using real-world data (RWD). In this course, students will learn about the contents and structure of typical secondary 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.