Schouw, H. M., Huisman, L. A., Janssen, Y. F., Slart, R. H. J. A., Borra, R. J. H., Willemsen, A. T. M., Brouwers, A. H., van Dijl, J. M., Dierckx, R. A., van Dam, G. M., Szymanski, W., Boersma, H. H., Kruijff, S. European Journal Of Nuclear Medicine And Molecular Imaging. doi: 10.1007/s00259-021-05504-y
Akston Biosciences and TRACER Announce Positive Phase I Data for Second-Generation COVID-19 Vaccine Candidate
At TRACER we are specialized in first-in-human studies with the use of nuclear and optical molecular imaging techniques.
By labeling an antibody, small molecule, peptide, nanoparticle, protein, or any other compound of interest with a fluorescent dye or a radionuclide, fast in human data can be obtained with an indication of the potential efficacy of the novel drug, even before the classical phase 1-3 clinical trials. This can lead to a more efficient and less costly drug development process.
We assist our sponsors in the labeling of their lead compounds and execute first-in-human studies to visualize and quantify the biodistribution and pharmacokinetics of the compound. With this information a “ go/no-go” decision can be made before the compound proceeds to the next phase in clinical development where costs are larger and time is valuable.
Early in-human studies are approved by the EMA and FDA through the so-called principle of microdosing. It allows you to often skip (large) animal models and go straight into the patient population.
Meet our team at these upcoming events.