James J Hickman
University of Central Florida, USA
Title: Regulatory issues for validation and qualifi cation for new human-on-a-chip systems
Biography
Biography: James J Hickman
Abstract
It is well known that the cost of drug discovery and subsequent regulatory approval for each new candidate now exceeds $2B and in most cases requires 10-15 years of development time before general availability is granted by either the FDA or EMA. The industry would benefit greatly from better pre-clinical screening technologies to reduce the attrition rate during clinical trials as well as to begin to pre-select specific genetic sub-populations for optimal drug efficacy with limited distribution. A promising technology to help reduce the cost and time of this process are body-on-a-chip or human-on-a-chip systems either at the single organ level or more advanced systems where multiple organ mimics are integrated to allow organ to organ communication and interaction. There is currently a focus at the NIH, FDA and EMA to understand how one could validate these systems such that qualification could be granted for their use to augment and possibly replace animal studies. This talk will give examples of some of the more advanced body-on-a-chip systems being developed as well as the results of five workshops held at NIH as collaboration between the American Institute for Medical and Biological Engineering (AIMBE) and NIH to explore what is needed for validation and qualification of these new systems.
