Jan Theys, PhD, Maastricht University, Maastricht, Netherlands, discusses the unique regulatory challenges posed by using live bacteria in cancer treatment. Unlike conventional drugs, live bacteria require tailored regulatory frameworks, particularly in determining dosage and ensuring compliance with Good Manufacturing Practice (GMP) and clinical trial standards. Collaboration between researchers, medical oncologists, and regulatory bodies is essential to streamline processes, prevent contamination, and fully unlock the therapeutic potential of live bacterial treatments. This interview took place at the European Society for Medical Oncology (ESMO) 2024 Congress in Barcelona, Spain.
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