William Holtz Examines New FDA Approach to Clinical Trial Development

Foley & Lardner LLP of counsel William Holtz is quoted in the PharmaVoice article, “5 Key Facts About the FDA Expedited IND Pilot Program,” examining the FDA’s new pilot program and its potential to accelerate clinical research.

Holtz explained that the initiative aims to help the U.S. remain competitive in early-stage drug development, noting that the FDA is “working to clarify expectations to make getting to phase 1 easier.”

On the program’s potential benefits, Holtz said it offers an “opportunity for early, earlier and more frequent interaction” with the FDA. He added that the pilot also formalizes existing sponsor-QRI relationships and is intended to explore ways to expedite the path to initial human trials.

Holtz further commented that the pilot will test whether IRB review and clinical trial site preparation can take place during the IND development process, potentially supporting earlier review of proposed studies.

“It’s going to have to be a pretty efficient program to overcome the benefits that going to China currently represents.” Holtz concluded, “It’s an interesting model that has potential.”