Nov 21, 2023
David Young, President of R&D at Processa Pharmaceuticals, talks about the FDA's Project Optimus draft guidance on optimal dosage regimens for specific patients.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 version of regulatory science, and that's expanded now over the last 30 years. That expansion into regulatory science now encompasses Project Optimus, which the FDA recently has put out draft guidance on in terms of optimal dosage regimens. They as well put out some documentation on the Project Optimus initiative where you go in to determine the optimal regimen for your patient. Not just any regimen, but the optimal regimen for your patients. If you get an optimal regimen for your patients, maybe that has a certain balance of efficacy and safety. You might come up with something different than we used to do five years ago in terms of the dosage regimen."
#ProcessaPharmaceuticals #ProjectOptimus #BenefitRiskProfile #Cancer #PrecisionMedicine #ClinicalTrials