QUANTUM LEAP HEALTHCARE COLLABORATIVE

I-SPY TRIALS: QUANTUM LEAP SPONSORS THE I-SPY TRIALS (INVESTIGATION OF SERIAL STUDIES TO PREDICT YOUR THERAPEUTIC RESPONSE WITH IMAGING AND MOLECULAR ANALYSIS). I-SPY HAS BEEN RE-ENGINEERING THE APPROACH TO CLINICAL TRIALS, WITH A GOAL OF GETTING THE RIGHT DRUG TO THE RIGHT PATIENT AT THE TIME WHEN THEY WILL BENEFIT MOST, AND TO ACHIEVE THIS FASTER THAN POSSIBLE IN PREVIOUS TRIAL MODELS. ADDITIONALLY, I-SPY AIMS TO SIGNIFICANTLY REDUCE THE OVERALL COST, TIME, AND NUMBER OF PATIENTS REQUIRED TO BRING NEW DRUGS TO MARKET. THE I-SPY TRIAL PROGRAM INTEGRATES AND LINKS PHASE I (I-SPY PHASE 1), PHASE II (I-SPY 2), AND FUTURE PHASES TO BUILD A PIPELINE OF NOVEL AGENTS AND ACCELERATE THE PROCESS OF IDENTIFYING THE SUBSET OF HIGH-RISK BREAST CANCER PATIENTS THAT WILL BENEFIT FROM THESE NEW AGENTS, AND GET THESE DRUG INTO THE CLINIC IN A TIMELY MANNER.

THE COVID/ARDS STUDY TRIAL FOCUSED ON PATIENTS WHOSE REACTIONS TO THE VIRUS MAKE THEM CRITICALLY ILL AND, IN MANY CASES, RESULT IN DEATH. THE TRIAL'S PRIMARY FOCUS WAS TO IDENTIFY PROMISING DRUGS THAT EITHER NEUTRALIZE THE VIRUS, HELP HEAL THE LUNG DAMAGE FROM THE VIRUS (WHICH CAUSED ACUTE RESPIRATORY DISTRESS SYNDROME), OR CHANGE THE IMMUNE SYSTEM REACTION RESULTING IN ILLNESS. THE TRIAL OPENED IN JUNE 2020 AND WILL CONTINUE UNTIL A DRUG OR COMBINATIONS OF DRUGS ARE FOUND THAT PREVENT THE NECESSITY FOR VENTILATION TREATMENT AND ELIMINATE DEATH FROM THE DISEASE. IN FISCAL YEAR 2022, THE PROTOCOL WAS AMENDED TO EXPAND TO ALL ILLNESSES CONTRIBUTING TO ADULT RESPIRATORY DISTRESS SYNDROME, OR ARDS.