Practical considerations for the establishment of a screening procedure for the assessment of biological response modifiers.

Studies in therapeutic immunopharmacology have identified a large array of natural and synthetic biological response modifiers (BRM) that can be entered into clinical trials. However, it is obvious that a preclinical screen is needed to limit entry of BRM into Phase I trials to those with the greatest clinical potential. In this article we discuss the development of a preclinical screen for BRM and the necessary attributes for such a screen. During the development of our preclinical screen, we noted numerous immunological and biological criteria crucial to the establishment of relevant and reproducible models of immunomodulation and immunotherapy. These or similar considerations are critical to the development of a strong scientific base needed to establish the principles of biological response modification and to allow their translation into a successful program of clinical immunotherapy.