Therapeutic Development Center FY23

Therapeutic Development Center Project Summary Therapeutics Development Centers (TDCs) are CF clinical research centers that have been chosen through a competitive process to become part of the TDN and receive infrastructure funding from CFF. To become a TDC, a center must be a CFF-accredited care center with established clinical research programs. A TDC’s participation in the TDN includes consultative, administrative, and research-support activities. In addition to conducting clinical studies, TDCs also participate in other TDN initiatives. The functions of a TDC vary depending on current trial activity and network needs. See expectations of a TDC below. TDC Selection and Funding Center Selection All policies regarding the selection of centers to become TDCs are determined by CFF. A competitive renewal process is conducted every 2 years, and the size of the network may change over time based on an assessment of CF clinical research needs and available funds. Details regarding the application and review processes for TDN membership and any current Requests for Application are available on the Centers page of CFCRNet. Centers selected to be TDCs receive an award notification letter from CFF, including the terms and conditions of the award. Infrastructure Funding Centers approved for funding as TDCs receive infrastructure support from CFF to ensure staff continuity and efficiency in the conduct of clinical studies. The award is intended to cover personnel, attendance at specific network meetings, equipment, and supplies. Payment of these award funds is made from CFF to the TDC on a quarterly basis, contingent upon centers entering key study metrics data into the CF Center Portal. CFF determines the award size for the upcoming year based on the following factors: 1) the total available funds within the CFF budget for the upcoming year, 2) the total number of centers to be funded, 3) the number of patients in the CFF registry at a particular center, and 4) the level of CFF-sanctioned clinical trial activity at that center. Funding renewal is on an annual basis contingent upon performance and is granted entirely at CFF’s discretion. Site performance will be reviewed regularly by the TDN Steering Committee, which may make recommendations to CFF about continued funding (See Site Performance Review section below). TDCs must submit an annual progress report including an expenditure report.