By Bikash Chatterjee, CEO, Pharmatech Associates
The pharmaceutical industry has seen more innovation in the last decade than in the past 50 years. The tools we use today to characterize and construct drug therapies, from next-generation gene sequencing technologies to CRISPR/Cas9, give us unprecedented capabilities to identify and treat new disease states. However, these technologies would not have been so influential in the absence of a regulatory framework within which to apply them. The FDA regulates the largest pharmaceutical market in the world and, as such, sets the bar suitably high for drug sponsors to demonstrate safety and efficacy.
In 2020, the FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. The acronym is apt, as the report is remarkably far reaching. Across the myriad of focus areas of the report’s major FDA Strategic Initiatives, examine five key elements that deserve our attention and provide meaningful regulatory insight on new and emerging approaches to drug development and governance.