By Philip A. Cola, PhD, the Winkle Healthcare Management Professor and faculty director of Healthcare Management Programs at Weatherhead School of Management
Bridging Disciplines to Advance Medical Innovation: The FDA Regulatory Sciences and Entrepreneurship Program at Case Western Reserve University
In writing a piece for the DM Digest, we are always thinking about examples of practitioner scholarship applied to real-world management contexts. It is from this that I began writing about the work I have been imagining for more than a decade on the topic of managing translational science in medicine.
The vision included ideas about a flexible interdisciplinary or transdisciplinary curriculum that can be explored to earn 1 or 3 credit hours at the Master’s Degree level or applied to certificate credits for individuals not currently otherwise enrolled in programs at the University. Therefore, the question we attempted to solve was: How does a practitioner scholar in management bring to fruition practical change in the academic curriculum for the long-term benefit of practitioners across disciplines (i.e., medicine, management, engineering, law, nursing, etc.)? After years of pitching ideas, revising those ideas, and persevering until others began to see the value in such a flexible and innovative curriculum we have now begun to see results.
In the ever-evolving landscape of biomedical innovation, understanding the regulatory environment is critical to efficiently advancing groundbreaking research from the laboratory to patient care. At Case Western Reserve University (CWRU), the Food and Drug Administration (FDA) Regulatory Sciences and Entrepreneurship Program stands as a testament to the power of interdisciplinary collaboration, bringing together expertise from the School of Medicine, Weatherhead School of Management, Case School of Engineering, Frances Payne Bolton School of Nursing and the School of Law. Now in its fourth year, the program continues to shape the next generation of clinical researchers and industry leaders, equipping them with the knowledge and skills needed to navigate the complexities of FDA regulations and biomedical entrepreneurship.
Originally launched in 2021 as an experimental certificate course, the program has rapidly expanded, attracting a diverse cohort of students (N=30 to 40 per year), faculty, and professionals from across the university and its affiliated medical institutions. By blending regulatory sciences with entrepreneurial principles, the curriculum prepares participants for careers that require a nuanced understanding of compliance, commercialization, and innovation in the medical and biotechnology sectors.
One of the program’s defining strengths is its interdisciplinary nature. While housed in the School of Medicine’s Graduate Education Office, it operates in true partnership with Weatherhead, integrating business acumen with scientific rigor. This collaboration ensures that students not only grasp regulatory frameworks but also develop strategic thinking skills essential for translating medical breakthroughs into viable products and therapies (Cola & Mangosh, 2005). Recent curriculum developments, including a course on patent law in biomedical science and another on regulatory strategy and FDA communication, reflect this integrative approach.
Beyond coursework, the program plays a crucial role in workforce development, addressing the increasing demand for regulatory expertise in the biotechnology and pharmaceutical industries. Graduates emerge with a competitive edge, well versed in both the scientific, legal, and business dimensions of medical product development. The program also emphasizes ethical decision-making, fostering a balanced perspective that prioritizes patient safety while encouraging innovation.
Looking ahead, faculty leaders and university administrators have outlined an ambitious roadmap for continued growth in the curriculum. Plans include expanding course offerings, incorporating experiential learning opportunities, and ultimately establishing a master’s degree track. As the program continues to evolve, it remains committed to fostering interdisciplinary education, driving innovation, and elevating CWRU as a national leader in practitioner scholarship surrounding the regulatory sciences and entrepreneurship.
We believe that by equipping healthcare professionals and related individuals with knowledge of FDA processes and biomedical commercialization, such programs empower individual stakeholders to translate research and clinical insights into tangible healthcare solutions. This is a strong example of practitioner scholarship, as it applies academic knowledge to real-world medical challenges, fostering innovation while maintaining a rigorous evidence-based approach.
Cola PA & Mangosh TL (2025) Empowering biomedical learners to navigate FDA regulatory processes and entrepreneurship with a novel interdisciplinary training approach. Frontiers Medicine 12, 1522572
