Empowered Patient Podcast

David Young, President of R&D at Processa Pharmaceuticals, talks about the FDA's Project Optimus draft guidance on optimal dosage regimens for specific patients. Processa is modifying existing cancer-killing molecules to improve efficacy and decrease side effects by taking into account genetic factors and the benefit-risk profile of each patient. This precision medicine approach will inform clinical trial recruitment, dosing regimens and the number of patients who can be effectively helped.   David explains, "There are a couple of things that make us unique. One is that we're taking the active cancer-killing molecules on the market. It's a given drug that's approved by the FDA, and we know it kills cancer. We've taken that molecule and either changed it slightly or administered it with another drug in some way to decrease or change the drug’s metabolism and then to distribute more drug to the cancer cell."   "So, we started to learn how they look at the benefit-risk profile, and we started to develop our