The Novel Clinical and Translational Methodologies key function focuses on developing processes intended to accelerate research through the first major translational block, the transfer of research findings into Phase I clinical trials. This is accomplished through a product development process that defines both pilot project screening and selection, and pilot project monitoring and evaluation. The process adopted by the Novel Methodologies Steering Committee is comprised of the following steps:

• Select specific pilot projects for acceleration that have been developed through research at UK and its CCTS partners in areas of medical devices and diagnostics, drug delivery, and nanomedicine. Screening of potential projects will be based on analysis of industrial context, market position, intellectual property rights and potential for new product development.
  
• Work closely with CCTS Pilot Studies, the CATalysts, and the Drug Development program to present selected projects to the CCTS Scientific Advisory Committee for approval and funding, as appropriate.
  
• Stage gate new product testing and development plan via ~24-month campaigns tailored to each project to accelerate development toward specific endpoints, such as IDE applications to the FDA. Campaigns will address high risk elements early in the development pathway with specific milestones and metrics for evaluating progress.
  
• Initiate the stage gate plan and monitor project development based on milestones and metrics.
  
• Graduate or sunset projects based on performance, with special attention to lessons learned to improve our acceleration process. Lessons learned will be communicated throughout our CCTS to improve the transparency of our Novel Methodologies process.
  
• Review and improve our novel methodologies development process and repeat for additional cycles.
  

Services: To schedule a Novel Methodologies consultation, please contact Elodie Elayi, MS, Research Development Director/Concierge: elodie.elayi@uky.edu.

Novel Methodologies Steering Committee

The UK Office for Commercialization and Economic Development oversees commercial development/licensing of university-based technologies, new and existing business development, management of the Advanced Science & Technology Commercialization Center (ASTeCC) and of Coldstream Research Campus, and statewide economic development initiatives.