Advancing Safety and Efficacy Studies with Novel Surgical Applications

Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery, novel treatments for wound healing, cardiovascular disease, and bone regeneration,  and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy. Because of the nature of these therapeutics and medical devices being used in new ways to treat disease, there are concerns, from both the medical and public communities, about whether realistic checks are being done on these groundbreaking treatments. This paper provides examples of some of the ways that surgical research in targeted delivery of therapeutics and device development is rising to the challenge of providing reliable safety and efficacy data from preclinical trials for these therapies.