Director: Mireille Rosenberg, PhD
The Translational Support Program is a core CIMIT program dedicated to fulfill the CIMIT mission to foster collaborations and impact patient care by providing services in two major areas:
The Small Business Grant Program
The Translation Support program at CIMIT provides support for collaborative grant applications involving a small business partnering with institutional investigator(s) on projects aligned with CIMIT mission. CIMIT can add value in the SBIR/STTR application process at every stage, depending on the needs of the investigators and companies involved. CIMIT can play a critical role prior to the application process, when CIMIT serves as the convener and facilitator for bringing the appropriate parties together. The three primary roles of the program are education, facilitation, and project management. A process has been defined and established, ranging from first meeting to grant planning (Phase I and II), grant writing, grant submission, and grant implementation.
The process can start from a CIMIT investigator interest, an Industry Liaison Program (ILP) member, an SBIR solicitation, or most likely, as part of the implementation plan for a CIMIT project. The Office of Translational Support provides facilitation, support and management as needed, from initial team matching through the application process and implementation of awards.
The Clinical Affairs Program
The Clinical Affairs Program is focused on clinical support and facilitation for trials involving devices and/or technology. It supports investigator-initiated projects and relies on existing clinical support system in place at each institution. It facilitates interactions between institutions and adds a level of expertise specifically aimed at devices and technology. Similarly to the small business grant program, it provides education, consulting, facilitation and project management as needed. The program looks at identifying and establishing supplemental support not currently provided by the investigators institutions. Areas currently identified as critical and currently in progress are IRB application to multiple institutions and preparation of manuals of operations for multicenter device trials. Support is also provided for IDE application and the associated establishment of control designs and quality systems as mandated by the FDA. Small business members of ILP interested in initiating multicenter clinical trials funded via SBIR can also be supported by this program.