Amgen and academic centers discuss FDA pilot to accelerate first-in-human trials

The U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid timelines seen in China and Australia for early‑phase trials.

Amgen and Memorial Sloan Kettering Cancer Center are among the stakeholders reviewing the proposal. Both parties see potential benefits in getting promising compounds into patients faster, but they also note possible conflicts that could arise from a more streamlined process.

Key details of the pilot are still being negotiated, including eligibility criteria and safety oversight mechanisms. The FDA hopes the program will maintain rigorous standards while reducing administrative delays.

If successful, the initiative could reshape how early drug development is conducted in the United States, offering a more competitive alternative to overseas pathways.