Cola Philip A, Mangosh Tawna L
Department of Design, Innovation and Organizational Behavior, Weatherhead School of Management, Case Western Reserve University, Cleveland, OH, United States.
Department of Population and Quantitative Health Sciences, School of Medicine, Case Western Reserve University, Cleveland, OH, United States.
Front Med (Lausanne). 2025 Feb 6;12:1522572. doi: 10.3389/fmed.2025.1522572. eCollection 2025.
For rising professionals to meet the needs of contemporary healthcare and biomedical innovation, educators must develop new teaching and learning approaches. Specifically, biomedical innovations are significantly influenced by the FDA's regulatory framework, requiring professionals to be equipped with regulatory science knowledge, entrepreneurial skills, and interdisciplinary training. However, biomedical education often fails to integrate these skills in an environment that mimics the interdisciplinary setting required for translational science, leaving learners unprepared for unique challenges in practice. This study details an FDA Regulation and Entrepreneurship curriculum at Case Western Reserve University and its affiliated community, leveraging a novel approach for biomedical education. Focused on preparing biomedical professionals to navigate FDA regulatory processes and innovative entrepreneurship endeavors, the curriculum is built upon five core principles: integrating multiple disciplines, ensuring real world applicability, developing a systems thinking approach, incorporating ethical considerations, and fostering a collaborative and experiential learning environment. These principles are supported by a flexible course format, targeted learning objectives, team-based learning sessions, experiential learning opportunities, a diverse participant population, and an interdisciplinary team of faculty and experts. High participant engagement and broad representation across fields over the curriculum's three-year lifespan to date affirm its relevance and value with participants representing the fields of basic science, medicine, law, business, and engineering. The flexible course format, team-based learning, and experiential learning proved instrumental in enhancing engagement, reinforcing practical learning outcomes, and supporting personalized learning goals. The flexible course format further aligns with professional needs of participants, providing a model for other institutions navigating similar challenges in biomedical education. In conclusion, participant feedback demonstrated the value of the interdisciplinary and transdisciplinary training approach in promoting knowledge retention and skill development in complex medical, business management and legal contexts. Moving forward, targeted outreach and flexible engagement options will be necessary to expand the curricular reach and diverse participant population. The success of the curriculum suggests promising implications for similar approaches aimed at empowering biomedical professionals with essential regulatory, entrepreneurial and interdisciplinary competencies, ultimately advancing translational science and improving healthcare outcomes.
为了让新兴专业人士满足当代医疗保健和生物医学创新的需求，教育工作者必须开发新的教学方法。具体而言，生物医学创新受到美国食品药品监督管理局（FDA）监管框架的重大影响，这要求专业人士具备监管科学知识、创业技能和跨学科培训。然而，生物医学教育往往未能在模拟转化科学所需的跨学科环境中整合这些技能，使学习者对实践中的独特挑战毫无准备。本研究详细介绍了凯斯西储大学及其附属社区的一门FDA法规与创业课程，该课程采用了一种新颖的生物医学教育方法。该课程旨在培养生物医学专业人士应对FDA监管流程和创新创业活动，基于五个核心原则构建：整合多学科、确保实际适用性、培养系统思维方法、纳入伦理考量以及营造协作和体验式学习环境。这些原则得到了灵活的课程形式、有针对性的学习目标、基于团队的学习课程、体验式学习机会、多样化的参与者群体以及跨学科的教师和专家团队的支持。在该课程迄今三年的运行期间，参与者的高度参与和各领域的广泛代表性证实了其对代表基础科学、医学、法律、商业和工程领域的参与者的相关性和价值。灵活的课程形式、基于团队的学习和体验式学习被证明有助于提高参与度、强化实践学习成果并支持个性化学习目标。灵活的课程形式进一步符合参与者的专业需求，为其他在生物医学教育中面临类似挑战的机构提供了一个模式。总之，参与者的反馈表明，跨学科和跨领域培训方法在促进复杂医疗、商业管理和法律背景下的知识保留和技能发展方面具有价值。展望未来，有必要进行有针对性的推广和灵活的参与选项，以扩大课程的覆盖范围和多样化的参与者群体。该课程的成功对类似方法具有启示意义，旨在使生物医学专业人士具备基本的监管、创业和跨学科能力，最终推动转化科学并改善医疗保健成果。
