RE:RE:RE:Inflation Reduction Act (IRA) boosts biological drugs Michelle McMurry-Heath, MD, PhD, former president and CEO of the Biotechnology Innovation Organization (BIO), said that the Orphan Drug Act and breakthrough designation and accelerated approval have really given an advantage to diseases that target small patient populations with first-in-class treatments.
McMurry-Heath also commented on AI’s role in improving precision in patient selection in clinical trials. “AI is going to help us with one of our biggest barriers—cost,” she said. “AI is going to shrink clinical trials, allowing us to really pinpoint which patients are needed to prove the new drug or compound is safe and effective and hopefully cut out a lot of the noise.
ONCY has been able to effectively incorporate patient selectivity into its clinical studies by developing biomarkers that identify the precise patients who will respond to pelareorep drug therapy in combination with checkpoint inhibitors, like PD-L/1 antagonists, for example.