The cost of bringing a new drug to market carries a high price, however it is even more costly when that drug fails during late stage clinical trials. An estimated 95% of new drug candidates fail clinical trials with 50% of these failures attributed to a lack of efficacy and downstream biomarker discovery.
While the drug development world still faces many challenges in the clinical setting, one way to curtail this drastic loss is to establish robust preclinical practices to better predict how a drug will perform prior to entering the clinic. The ability to perform predictive surrogate clinical trials in a preclinical setting is key to answering essential questions around a drug’s effectiveness, indication targeting, and patient stratification before advancing to the clinic.
Using patient-derived xenograft (PDX) models, which are established by isolating tumor fragments directly from cancer patients and growing them in mice, researchers can begin to identify responders and non-responders to a treatment regimen, and discover and validate biomarkers of response through mouse clinical trials (MCT). Understanding which type of MCT will best suit the needs for specific drug development is critical for preclinical success.
Dr. John MacDougall, Crown Bioscience, is trained as a Cancer Biologist, having received his PhD from the Department of Medical Biophysics at The University of Toronto and a Susan G. Komen Foundation Post-Doctoral Fellowship in the Department of Cell Biology at Vanderbilt University. Following his formal training, John joined the Northwestern Ontario Regional Cancer Center as a Career Scientist and as an adjunct Professor in the Department of Biology at Lakehead University.
In 2000, John began his career in oncology drug discovery and has held a variety of roles across the discovery spectrum - Target ID through in vitro and in vivo pharmacology and toxicology. Through the companies he has represented (CuraGen, Serono, Infinity, ImmuneXcite, Aura) John has worked on numerous drug modalities, including small molecules, antibody-drug conjugates and nanoparticles, that have advanced through preclinical studies into clinical trials.