With the emergence of basket trials in the early-phase oncology setting, clinical research teams are…
Developing oncology compounds is a constantly evolving process, and with the dramatic rise in costs, making every step count is now more critical than ever. There are, however, three essential assets that your team should look to acquire before you launch an oncology clinical trial. Today’s post will outline the first: Strong Science.
Prerequisite #1: Strong Science (Tweet This)
A potent compound originates from rigorous pre-clinical models, so these models should take several factors into account, including the selection of the patient populations, the mode of administration of the drug as well as the formulation. The use of pharmacodynamic markers (PD markers), which may lead to the development of a companion diagnostic tool, are also developed during this important first step.
The validation of the appropriate pre-clinical models is the first prerequisite in the development process. Those models will provide some efficacy and safety data and will generate interest in the new compound. This is followed by a series of toxicological studies as defined by ICH guidelines for pre-clinical studies that will define the toxicological profile of the drug to establish the initial dosage in humans. Having a strong model at the beginning of the process will lead to more successful translational studies, meaning more relevant and robust pre-clinical data, which has a direct impact on the potential commercialization of that compound.
Academic/biotech researchers are creative minds that must fit within stringent regulatory and commercial boundaries. This can sometimes be a challenge when faced with the competitive realities of compound development, where profit potential and opportunities for licensing deals may trump scientific interest. For small drug companies especially, the early stages of development are the most challenging from a financial standpoint as well as in terms of innovation. To avoid costly missteps along the way, it can be prudent to rely on the guidance of those who have been through the process before.
Stay tuned for Essential Asset #2: A Visionary Drug Development Plan
In the meantime register now to attend The Clinical Operations in Oncology East Coast event on July 15-16, 2014 in Boston. You’ll want to hear Scimega’s President Denise Deakin tell the story of how three drug developers expanded their clinical trials to Canada and met their patient recruitment objectives ahead of schedule.