Translating Therapies into Clinic and onto the Market
Full course description
In this course ‘Translating therapies into the clinic and onto the market’ we will make the scientific journey from science and technology to the clinic and products. Using actual clinical challenges, students have to work out a new solution to that clinical problem supported by experts in the field. Students will know where to put biomedical solutions in the Technology Readiness Level chain and learn how to take it a step further and learn to communicate specialized knowledge to a group of scientists from different disciplines.
This course has actual clinical challenges from the field of Orthopedic Surgery, Craniomaxillofacial surgery, Experimental Surgery, Gastrointestinal surgery and Endocrinology. Challenged by an expert doctor, students will have to work in small teams to come up with a new strategy to repair damaged tissue or organs which the body can’t heal itself using a regenerative medicine multidisciplinary combination of materials science, fundamental biology, smart fabrication technology and bioengineering based on knowledge gained in course MBS1401. Additionally, we will pay attention to valorization which is the process of creating value from knowledge, by making this knowledge available and suitable for economic and social exploitation and to translate this knowledge into products, services, processes and new business. This valorization process is of course bound by European and International rules and regulations such as FDA and ISO standards and clinical trial directives.
Students have to write a project proposal with predefined sections and present this to their peers and expert in the field at a mini-symposium. This process is closely guided by an expert in the field and students can gain knowledge (additional to literature) in interactive lectures.
Course objectives
- Develop and describe a new research strategy together with team members, to solve a clinical problem based on state of the art technology, biomaterials, biology and medical practice
- Explain and discuss scientific background of (chosen/given) clinical problem, current medical practice and ongoing developments in this field.
- Explain when and how to protect a new innovation and what is required to create a patent
- Explain and discuss the regulatory affairs involved in product development for biomedical applications (animal, human, GLP/GMP)
- Design a translational biomedical study, and write a project proposal
- Present and defend a new project proposal
- Adjusts communication written or oral, to specific global audience/readership and international setting
- Communicates professionally with peers and staff originating from diverse cultural and disciplinary backgrounds
- Shows awareness of team roles and takes responsibly her/his position in a diversely composed international team