Advancing Regulatory Science Through Innovation: In Vitro Microphysiological Systems

Advancing regulatory science, advancing regulatory practice

In an Editorial of Science in 2011, Margaret A. Hamburg, the then Commissioner of the US Food and Drug Administration highlighted that a strong field of regulatory science is required to develop new tools, standards and approaches that efficiently and consistently assess the safety, efficacy and performance of products, and that this field has long been underappreciated and underfunded.1 During...

Advancing FDA's regulatory science through weight of evidence evaluations.

Advancing a Vision for Regulatory Science Training.

Regulatory science, a complex field which draws on science, law, and policy, is a growing discipline in medical-related applications. Competencies help define both a discipline and the criteria to measure high-quality learning experiences. This paper identifies competencies for regulatory science, how they were developed, and broader recommendations to enhance education and training in this bur...

Engineering challenges in microphysiological systems

Modeling human physiology with the microphysiological systems In humans, tissues and organs are made of hierarchically assembled structures of mul­ tiple compositions to achieve biological func­ tions. The different tissues and organs are then organized in a specific order enabled by a circuitry of vascular network, further achieving physiological interactions. On the one hand, many of these co...

Advancing Sustainability Through Change and Innovation: A Co- evolutionary Perspective

This article addresses the problem of how change and innovation can create a fuller voice for ecological interests in organizations and public policy, raising issues about change mechanisms at the institutional versus organizational level. First, it suggests that the newer, systems-based and inclusive approaches to organizational development practice and theory may overcome shortcomings of earl...