Diminishing Risk for Risk-Averse Regulators

In PM360 Magazine, Saama Founder and CEO, Suresh Katta, along with Chief Life Sciences Officer Kenneth L. Massey, explain how AI-powered analytics can help sponsors and regulators strike the right balance between risk and reward.

“Common perception is that [the FDA] is solely risk-averse,” write the authors. “However, regulators have also demonstrated a notable inclination for embracing risk when it is clearly in the public’s best interests.”

Noting the FDA’s openness to innovation, the article makes a compelling case for the power of disruptive technology—specifically AI-informed analytics platforms—to reduce inherent risks along the drug development, review, and approval continuum.