Course Descriptions

Core Disciplines

Regulatory Affairs I

Introduces the pharmaceutical, biotechnology and biologics industries and the laws and regulations of these products. Discussion of company organization, product development, and commercialization-associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control, and marketing. This course is offered online.

Regulatory Affairs II

Introduces the laws and regulations governing medical device and diagnostic products. Discussion of Federal Food, Drug & Cosmetic Act, U.S. Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments, Quality Controls, and GxPs. This course is offered online.

Statistical Methods in Clinical Trials

This course encompasses an overview of the experimental designs, statistical analyses, and clinical-scientific-regulatory issues common to clinical trials research. Coursework includes understanding the elements of a statistical analysis plan, conducting statistical analyses that meet constraints of regulatory agencies, reporting results, and data monitoring. Prerequisites: Satisfactory completion of a college-level introductory course in statistics and probability.

Bioinformatics and Data Management in Medical Product Development

This course discusses application of information technologies, processes, and standards in the conduct of data management of clinical trials in the medical product industries. Special emphasis is given to data collection, patient-reported outcomes, electronic data capture, and clinical data management processes. Regulatory requirements for electronic records will be addressed.

Management Track

Developing and Managing People

Successful management requires knowledge of human behavior and organizational processes. This course provides an overview of the challenges that arise for managers in organizational settings and introduces the key concepts and theories needed by successful managers and leaders. Despite their technical skills, the careers of scientists and engineers are often limited by their inability to work effectively with others from other disciplines, a necessary part of teamwork in product development. Good interpersonal and leadership skills are an essential ingredient in the complex activity of medical product development.

Project Management

This course offers a comprehensive overview of the skills needed, tools required, and challenges faced in managing complex projects and programs. In the complex, multidisciplinary clinical biomedical product development process, a project or program manager must deliver project results within limited time and resource constraints. A poorly managed development project, despite the technical skill of all involved, can result in large cost overruns, lack of approval by the regulatory authority, or late delivery to the market, resulting in lost revenues. Because this skill is crucial in so many different industries, Fortune magazine named project management the #1 career choice for the coming decade.

Managerial Accounting and Financial Aspects of Medical Product Development

This course will provide an in-depth overview of managerial accounting in the biomedical industry with emphasis on the financial aspects of the development of drugs, biopharmaceuticals, diagnostics, and medical devices. Topics will include: understanding profit and loss statements and their implications for the business and for specific projects; preparing and following a budget; patent life and its financial implications; rationale and impacts of mergers and acquisitions; and financial and strategic implications of outsourcing clinical or other product development activities.

Managing Medical Product Development

This capstone course is offered in the last semester of the program and is intended to bring the management principles above into alignment with the variety of FDA-regulated medical product development processes to which the student has been previously exposed. The material treats medical product development as a cross-functional business process involving value chain management. It examines the key concepts and management challenges involved in structuring clinical development and in strategically managing a portfolio of projects. The course delves into relevant cases and examines industry practices with the intent of identifying best practices for the wide variety of types of medical products.

Clinical Development Seminars I and II

Fundamentals of Medical Products Development and Clinical Research

Clinical Development Seminars I and II are evening symposia taught and managed by the program director utilizing industry experts discussing the defining and distinguishing features of the invention/discovery, non-clinical development, manufacturing development, and clinical development (clinical trials) of medical products.

The major classes of products whose design, development, manufacture and performance characteristics are regulated by the Food and Drug Administration are addressed. These products include small molecule drugs, large molecule biopharmaceuticals and biologicals, medical diagnostics (blood tests, biomarkers, genetic screens, disease markers, home test kits and automated laboratory tests), and medical/surgical devices such as cardiac stents, implants, prosthetic devices, to list a few.

The scientific and technical principles underlying each of the major classes of medical products will be introduced through independent reading assignments and supported with presentations on current practices by expert guest lecturers. At the end of each eight-week course, the students will give oral presentations and submit papers to satisfy the graduate writing requirement. At the conclusion of these core symposia, the students will have a comprehensive knowledge of medical products and a foundational overview of the development processes involved for each. Such knowledge will form the framework upon which in-depth instruction in the methodologies and processes of clinical trials is given in the remainder of the program.

Special Topics in Clinical Trials I and II

Clinical Trials Seminar I and II, offered in the second year of the program are weekly evening symposia which will include expert speakers, panel presentations and open discussions of current issues and advanced topics critical to clinical trial management. Topics will include in-depth discussions of the various phases of clinical studies, clinical issues in the design of clinical trials, ethical and social issues, safety surveillance/risk analysis and management, among others.

This final symposium session is the capstone of the program challenging the student to demonstrate a professional manner and technical proficiency in clinical trial management. By the end of this symposium, students will have gained a clear understanding of the profession of clinical trial management and the issues related to the field, and will have developed tools to deal with controversial issues that arise during medical product development.

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