Innovative Analytical Characterization of New Drug Modalities and Drug Delivery Tools

Nowadays, the landscape of the forefront of medical innovation changes rapidly overtime. Novel modalities offer unprecedented potential to treat, cure, and even prevent a wide array of diseases that were once considered untreatable. We saw a surge on the number of medicine outside the traditional small molecule and biologic approvals from health authorities in the past several years. mRNA based vaccine help people to fight the global pandemic from COVID-19. The first CRIPSR based therapy was approved in 2024 by FDA. GLP-1 peptide shines in the obesity field. Even for small molecule drugs, degraders and molecule glues are very different from the traditional Lipinski-5 drugs. These rapid advancements in new modality bring real benefits to the patients. However, on the Chemistry, Manufacturing and Control (CMC) side, these novel modalities present significant analytical challenges due to the novel drug modalities, diversity of species, and the complex manufacturing and delivery method. There are emerging interest in the analytical chemistry field in discovery, characterization and quality control of these new molecules and delivery systems. This session will focus on solutions to solve these analytical problems coming from academic, fundamental, and applied research laboratories. This session dedicated to the analytical development of novel modalities will not only showcase the latest scientific breakthroughs in solving the analytical challenge of the new modalities but also inspire discussions on the manufacturing, control and regulatory bringing these cutting-edge therapies from the lab to the clinic. This is an exciting opportunity for the audience to engage with the industrial leads and to explore its future impact.