About

The adoption of microfluidics, lab-on-a-chip, organ-on-a-chip, and other advanced in vitro three-dimensional (3D) modeling techniques are increasingly used in studying normal functions, disease state and developing drugs and theranostics. In addition to advantages they may offer over conventional in vitro cell culture and animal experimentation, these technologies have their own specific properties and limitations. Many approaches use the same biomaterials and microfabrication techniques, and some have advanced to commercialization, but there are still biomaterial and process-based risks which must be reasonably determined, addressed and reduced to an acceptable level. These emerging technologies are noted in priority by FDA, evidenced by participation in the NIH Tissue Chip Consortium and through FDA publications and meetings over the past several years. There are notable examples of products in different countries, and there has been early adoption in various research-level projects. The ultimate promise is the potential to use these technologies as an accepted drug testing modality, which when validated and standardized may largely reduce the use of experimental animals and reduce problems associated with two-dimensional (2D) cell culture models. Adoption will be reflected by industrial advancement of biomedical products well beyond the current limits. This special panel comprises presentations and a discussion focused on various translational considerations of 3D on-a-chip devices, including (1) advancing technology out of the lab, and (2) commercialization of technologies into products for broad clinical use. This will include also discussion of standards, safety, regulatory and funding aspects.

Moderator: 

Nureddin Ashammakhi, MD, PhD
Scott Taylor