The Promise of Innovation: Organ Chips and the Making of Novel Biomedical Models - PROJECT SUMMARY The use of animal models in biomedical research, and specifically in pharmaceutical safety and efficacy testing, has been foundational to biomedicine. However, the translational failures of animal models in pharmaceutical testing have been well documented, and developing new technologies to augment the use of animal models and better predict human relevance, safety, and efficacy in pre-clinical testing has been an area of significant investment over the past several decades. Researchers have focused on constructing new tools—leveraging developments in human-cell based models, in vitro platforms, and computational and machine learning technologies—to revolutionize pre-clinical drug testing. The proposed book project traces the emergence and development of translational technologies called organ chips to unpack the social, organizational, and scientific factors that shape whether and how novel technologies become successful. The project has three aims: (1) situate the emergence of organ chip technologies in a sociohistorical perspective, (2) document how scientific, social, and technical factors have shaped the design and uptake of organ chip technologies as models in biomedical research, and (3) analyze the ethical, legal and social implications (ELSI) of organ chips. The book will draw on an empirical, sociological study of the emergence and construction of organ chips, drawing on a research that has taken a rigorous mixed methods approach through extensive observations in an organ chip lab, in-depth interviews with organ chip researchers and other stakeholders, and content analysis of scientific publications and popular media. There have been very few scholarly books that bring together accounts of the emergence and construction of novel biomedical models and none have focused on the rising prominence of biomedical engineering approaches in medicine. In addition to contributing to this understudied area and analyzing the emergence of organ chips through a social scientific lens, this project has several other innovative dimensions, including how it situates technologies in sociohistorical perspective, examines biomedical model construction, and interrogates the role of hype building and scientific storytelling in the development of novel biotechnologies. The book will engage disciplinarily diverse audiences in science and technology studies, sociology, history of technology, bioethics, and engineering ethics. The book will appeal to those interested in biomedical innovation, the organizational and institutional dynamics that enable and constrain novel biotechnologies, and the ethics of innovation.
