A pharmaceutical client with a new theranostic needed support with the imaging aspects in the development of the nuclear medicine and PET imaging aspects using 68Ga.
Staff “embedded” in the clinical team, provided support in developing the clinical program for the diagnostic, including identifying the need for a new study to confirm the dosing (both peptide mass and radioactivity). Support also included developing the study and choosing core labs, as well as developing a unique read system to maximize the limited number of subjects. FDA approval ensued. A recent poster presented the read system as a design.
The therapeutic trials required coordination with imaging as the end points have to be considered for therapy and to support the INDO for imaging. The clinical program is therefore complex and requires knowledge of diagnostics and therapeutics and the interplay between the two’. This led to an FDA Type C meeting in which the consultant participated (see “Early Engagement with FDA to Discuss Novel Surrogate Endpoints,” CDER SBIA Chronicles, Nov. 27, 2018).
The client has an inbuilt imaging expert to allow the successful development of the novel theranostic.