Perspectives

Turning Anticancer Therapy Inside-Out (Part I): From Exogenous to Endogenous—Moving Treatment In Situ
Let us begin with the evolution of cancer therapy in a few clauses (and a long Proustian sentence and paragraph): killing the tumor with small molecules (first chemotherapy, then targeted agents like kinase inhibitors, and ultimately via targeting of the specific genetic aberrations in a given patient employing precision medicine); killing the tumor with antibodies of increasing complexity (e.g., naked antibodies, then antibody-drug conjugates, and more recently bispecifics); modulating the tumor microenvironment (i.e., primarily the immune cells in the TME) to enable their recognizing and attacking (that is, killing), the tumor, right now using T-cell directed checkpoint inhibitors to alleviate the immunosuppression caused by the cancer; and perhaps the hottest area in Oncology lately (and for our Oncology Practice) being the approach of moving to ex vivo manipulation/bio-engineering of each patient's own immune cells exogenously, then introducing them back into the patient to kill the tumor (e.g., Adoptive Cell Therapy, or ACT, of which autologous CAR-T products are the first generation of products) . The next generation of ACT is of course trying to make it "off-the-shelf" with allogeneic immune cells.
Jul 30, 2020
Will the FDA Authorize Your Product Health Claims?
According to FDA regulation, conventional food and dietary supplements are allowed to make three categories of claims: health claims, nutrient content claims, and structure/function claims.
View Jun 15, 2020