Abstract

Microphysiological Systems – Why is Industry Adopting Slowly?

Marian Raschke, Head of Advanced Cellular Models, Bayer AG, Pharmaceuticals Division

Advanced cellular models and microphysiological systems (MPS) have the potential to fundamentally change the test and assessment strategies in pharma industry’s R&D which for decades relied to a great extent on animal experimentation complemented with rather simple in vitro assays. This has led the so-called “valley of death”, an evident translational gap between preclinical and clinical observations related to both safety and efficacy assessments, which ranks among the leading causes of drug failure. The ongoing transformation of the pharma industry, moving from small molecule drugs to highly diverse therapeutic modalities, including cell and gene therapy, together with increasing public and regulatory expectations for alternatives to animal testing, provides a fertile ground for MPS and other advanced cellular models. The talk will provide a general introduction of the past, present, and anticipated future role of in vitro testing in the pharma industry with focus on the application of MPS in the field of safety testing. This will be complemented by a pharma end-user perspective on opportunities and current limitations hindering a more widespread use of MPS. Moreover, recent in-house use-cases involving MPS in Investigational Toxicology will be shared to contextualize the outlined perspective.