The translation of cutting-edge technologies from research applications to meaningful therapeutics is inherently complex and requires substantial planning and knowledge that is difficult to obtain in the absence of hands-on experience. Additionally, academics are generally not familiar with many industry best practices, requirements for manufacturing at scale, and/or commercial pressures inherent to commercial therapeutic production. To bridge this knowledge gap, we propose to develop a robust, innovative process that supports navigation of the regulatory landscape for academic innovators working on therapies in early-to-mid-stage development. First, we will leverage our team’s experience and connections within the clinical arena to conduct a survey of industry professionals from three groups based on their familiarity with preclinical development: naïve, familiar, and experts. We will then use this information to construct a process map that outlines the interdependent steps involved in navigating the complex preclinical process, identifying critical points for de-risking therapeutic technology. Finally, this process map will enable our team to disseminate this milestone-driven approach to researchers using an interactive, centralized, online resource, which can be easily updated and disseminated as the field advances. Successful completion of these Aims will result in an effective decision-making process that will be refined in an iterative process for implementation in larger test groups, adapting to the requirements of preclinical development as they expand.
William Murphy, PhD, College of Engineering
Collaborators: Christian Capitini, SMPH; Philip Keegan, Cathy Rasmussen, COE
