This year marks roughly fifty years since the modern biotechnology era began — an era defined by recombinant DNA, monoclonal antibodies, genomics, and platform technologies once belonging to science fiction. Biotech has transformed what it means to diagnose, treat, and prevent disease. Faith in that innovation is a promise made to patients, and momentum has carried it forward. 

It comes at a particularly incidental time. The U.S. administration just put an industry veteran with an interest in accelerating clinical trials as the new head of the FDA Center for Biologics Evaluation and Research (CBER), along with an acting Commissioner who has committed to clearing the decks for speedier outcomes. An appetite for change is evident in the FDA; the mood has shifted towards speed and efficiency.