Host: The Japanese Society of Toxicology
Proposed streamlined development approaches for vaccines for SDLT indications and non-oncology SDLT small molecule therapeutics will be presented. For therapeutics, this proposed approach would allow rapid initiation of patient trials and continued treatment beyond the conclusion of the early therapeutic studies regardless of availability of nonclinical safety data, as well as elimination or deferment of nonclinical studies that are not considered essential to supporting patient safety given the high unmet medical need. This approach would allow patients with SDLT conditions earlier and continued access to therapeutics and increase the speed of progression through development. For both therapeutics and vaccines, these approaches would enable an early understanding of potential efficacy and allow patients or participants, in conjunction with their physicians, to make more informed decisions regarding potential initiation and/or continuation of treatment in the context of benefit versus risk considerations. This may additionally increase the SDLT indication therapeutic pipeline, directly benefiting patients and reducing the economic and societal burden of SDLT conditions.
