ABSTRACT
Regenerative medicine has made a substantial progress in the last decade with more technologies ready to help patients. Translation of these therapies from the benchtop to the bedside is not always a straight pathway, and many issues need to be addressed to achieve a successful outcome. The science, the industrial partner, the clinical partner, the regulations, and the implementation within a health-care center are the key aspects to be strictly analyzed and combined before attempting clinical translation. Scientic merit forms the basis of any new medical therapy as it gives rationale for its existence
CONTENTS
25.1 Introduction ................................................................................................ 521 25.2 Science ......................................................................................................... 522
25.2.1 Methodology and Translational Feasibility ............................... 522 25.2.2 Understanding the Needs and the “Gold Standard” ............... 524
25.3 Industrial Partner ...................................................................................... 525 25.3.1 Large Companies vs. Start-Up in Biotechnology ...................... 525 25.3.2 Market Size Matters ....................................................................... 526 25.3.3 Challenging the Reimbursement Pathway ................................ 526
25.4 Clinical Partners......................................................................................... 527 25.4.1 Early Involvement in the Preclinical Process............................. 527 25.4.2 Identifying the Right Partner ....................................................... 527
25.5 Regulations ................................................................................................. 528 25.6 Ethics ............................................................................................................ 528 25.7 Health-Care Institutions ........................................................................... 529
25.7.1 Clinical Translation Unit Concept ............................................... 529 25.7.2 Tissue Engineering and Regenerative Medicine Division ....... 529
25.8 Conclusions .................................................................................................530 References ............................................................................................................. 531
and it is usually the easiest part of the translational pathway. Identifying the right industrial partner can often be challenging since tissue engineering tools are frequently sophisticated and expensive to execute with little appeal for the immediate anxiety of the business-oriented population. The clinical partners, responsible for calling the indication of the medical therapy, are a critical step of this chain and need to be involved from the early stages of the process to guarantee a smooth transition into patients. Regulations are still emerging while the area of regenerative medicine evolves and, opposed to other medical devices or drugs, these technologies involve a complexity of steps that create many regulatory hurdles that can hamper the most powerful scientic discovery. Finally, implementation of regenerative medicine within a health-care center outside of a clinical trial is still a challenge, and the right space or model needs to be created. A comprehensive picture of this translational process is presented in this chapter with a detailed analysis of all the key aspects introduced earlier.
