Jed Johnson, Ph.D. will discuss the pathways (and barriers) to bringing tissue engineered constructs to the bedside. He will explore the role of clinical collaborations, as well as the regulatory challenges with commercialization:
- Advantages of clinical collaborations: experience, facilities, patient populations
- Regulatory challenges: synthetic devices, cell-based devices, combination devices
- Funding challenges: animal studies, ISO 10993 biocompatibility studies, clinical trials
- Commercialization challenges: reimbursement, sales channels, manufacturing scale-up, cost