The FDA Regulatory Sciences and Entrepreneurship Program is a dynamic curricular initiative that bridges academia, industry, and regulatory agencies. Led by distinguished faculty, this interdisciplinary program equips students for careers in clinical research, regulatory compliance, and biomedical entrepreneurship.
The program operates at the intersection of medicine, business, and law, collaborating across schools—including the School of Medicine, Weatherhead School of Management, School of Law, and more. To meet the diverse needs of students, faculty, and staff across campuses and affiliated institutions, interdisciplinary courses are offered through the Graduate Education Office to provide participants opportunities to explore FDA regulations, clinical trials, intellectual property, and business development. Participants not only learn from industry experts, but from each other, fostering a supportive environment to facilitate research breakthroughs through the entrepreneurial and FDA regulatory process.
Below are the current program offerings that are open to all students, faculty, and staff at CWRU and affiliated institutions. Please note that all courses are synchronously, online at this time. If you are interested in participating or have questions please contact tawna.mangosh@case.edu.
Students: Register for 1 or 3 CR via SIS. Offered as MGRD/CRSP/PHRM/RGME 529
Faculty and Staff: Email tawna.mangosh@case.edu for registration instructions.
The FDA Regulation in Entrepreneurship and Clinical Research course is designed to provide foundational knowledge in the FDA approval and regulatory process while highlighting scientific, clinical, ethical, and other related emergent factors for consideration. The course includes a series of lecture-based classes delivered by content experts and interdisciplinary team-based learning discussions of case studies designed for the application of lecture content. Students who elect to take the course for three credits as opposed to one credit will go through the process of reviewing an example Investigational New Drug (IND) or Investigational Drug Exemption (IDE) Application (midterm project) and preparing an IND or IDE for submission (final project) with the guidance of nationally renowned experts in FDA regulation and law. The primary goal of this course is that upon completion, students will be able to take the knowledge gained from content experts and apply it to facilitate the movement of their current or future technologies through the FDA approval process.
Students: Register for 3 CR via SIS. Offered as MGRD 530
Faculty and Staff: Email tawna.mangosh@case.edu for registration instructions.
The Regulatory Strategy and FDA Communications course is a class structured to give students the knowledge and resources to generate strategic approaches for regulated medical products in the US. These include drug products, medical devices, biologic products, and combination products. The course will review common sources for regulatory intelligence gathering and their applicability to each type of medical product. Additionally, students will be tasked to craft a fully formed regulatory strategy for a medical product of their choosing to reinforce their learning and understanding of course concepts. Proposed strategies include pre-development testing of possible market products as well as post-market corporate development plans. Additionally, FDA regulatory requirements for product development and marketing and FDA communication mechanisms will be covered as well as common types of meetings conducted. Students will learn to integrate key timepoints, communications, and/or meetings for the development of their regulatory strategies.
Students: Register for 1 CR via SIS. Offered as MGRD 531
Faculty and Staff: Email tawna.mangosh@case.edu for registration instructions.
This course is designed for graduate students in the School of Medicine but graduate students from other schools will also be offered course enrollment. We will explore the fundamental principles of patent law generally and, in several classes, apply these principles to biomedical discoveries, including pharmaceuticals, diagnostics, devices, and biologics. The specific patent law topics covered include an exploration of the patent document itself, the major patentability requirements, how to obtain a patent and patenting drafting strategies with a focus on biomedical-related inventions, the rights associated with an issued patent, the Hatch-Waxman Act and generic competition as applied to pharmaceutical patents, and issues associated with access to medicines for the developing world. Familiarization with patent law is crucial for graduate students who aspire to be biomedical researchers that can leverage the knowledge learned during this course to protect their intellectual property, incentivize innovation, navigate legal complexities, and maximize the societal benefits of their biomedical discoveries. It equips researchers with the tools and knowledge needed to advance their work and contribute to the field while also considering ethical, legal, and commercial aspects.