By Brian Murphy, M.D., MPH Vice President, Medical Department, Infectious Diseases and Vaccines and Lorie Nugent, Sr. Director, Clinical Trial Management, Medpace
The clinical development of biologics, phages, microbiome-related products, as well as other newer technologies can encounter numerous questions from country regulators and local ethics committees needing to become familiar with the technology.
Many of these questions can be anticipated prior to submission and are for the most part addressable. Otherwise, additional review times with back-and-forth questions can significantly impact timelines, especially among groups or indications that have mainly been accustomed to small molecule drug development.
While you may not be able to anticipate everything, many of the risks and challenges outlined below can in fact be averted if you understand the landscape and prepare accordingly.