Controversy and upheaval have roiled the Food and Drug Administration this year, but there’s one issue on which industry leaders and regulatory officials remain aligned — the need to accelerate early-stage clinical trials and bring them back to the U.S.
Will recent leadership changes, including the exit of FDA Commissioner Martin Makary, and turnover at the divisions responsible for reviewing biologics and drugs, derail momentum toward that goal? It’s unlikely, according to Tala Fakhouri, the chief artificial intelligence and regulatory strategy officer at Parexel, and a former FDA AI policy official.
“The White House and HHS have unequivocally declared they want the U.S. to remain No. 1 and highly competitive for drug development, and bring early trials to the U.S. and manufacturing back,” she said. “I don’t think these policies and priorities are going to change.”
Even so, it’s not a straight line from intention to trial acceleration, she added. “The secret will be in how you actually do that. We need more implementation than just policy,” Fakhouri said.
Moves to accelerate trials
