By Riya Muckom
Rahul Aggarwal, MD, assistant clinical professor at UCSF, specializes in developmental therapeutics and genitourinary malignancies. During his presentation on Early Stage Clinical Trials, he began outlining the scope of the research involved in the pre-clinical studies of a therapeutic/device intended for human use. Aspects of a potential small molecule therapeutic that need to be understood before starting clinical trials are: physical & chemical properties, pharmacodynamics & efficacy (with in vitro proliferation assays and in vivo xenograft models), pharmacokinetics & metabolism (absorption and distribution of molecule), and toxicology (typically performed on animal models). An interesting development in the field is the shift toward quantifying an “Optimal Biological Dose,” rather than a “Maximum Toxicity Dose” the former being a more relevant measurement in biological systems. Inspired by the increases in computational power, a potential area of research in this field involves developing an algorithm to predict the preclinical results of a potential therapeutic based on prior knowledge of molecular structure and similarly tested molecules. Aggarwal shared his work on molecular imaging biomarkers with the vision that they can one day be used in humans as a screening technique to determine the virulence of a tumor and whether or not treatment is required. These biomarkers are an example of a non-therapeutic technology that must undergo clinical trials to be translated from bench-side to bedside.