Cooperative Agreement 2233429

SBIR PHASE II: A DIGITAL PLATFORM TO SUPPORT FOOD ALLERGY ORAL IMMUNOTHERAPY TREATMENTS -THE BROADER/COMMERCIAL IMPACT POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE II PROJECT IS TO PROVIDE THE FOOD ALLERGY PATIENT COMMUNITY WITH A DIGITAL PLATFORM IN ORDER TO IMPROVE CARE AND SUPPORT THE IMPLEMENTATION OF EMERGING FOOD ALLERGY ORAL IMMUNOTHERAPY TREATMENTS. TODAY THERE ARE NO CURES FOR FOOD ALLERGIES. PATIENTS AND THEIR FAMILIES ARE IN CONSTANT FEAR OF ANAPHYLAXIS REACTIONS. THE PROPOSED TECHNOLOGY IS A COMPREHENSIVE PLATFORM ADDRESSING PAIN POINTS OF FOOD ALLERGY ORAL IMMUNOTHERAPY, MEETING THE NEEDS OF PATIENTS, FAMILIES, AND CAREGIVERS. THE PLATFORM ENHANCES PATIENT TREATMENT ADHERENCE AND ALLOWS HEALTHCARE PROFESSIONALS TO ASSESS THE PROGRESS OF THE PATIENT?S CONDITION REMOTELY AND EFFICIENTLY. FURTHERMORE, THE SOLUTION PROVIDES ARTIFICIAL INTELLIGENCE ANALYTICAL CAPABILITIES FOR A SYSTEMATIC APPROACH TO FOOD ALLERGY ORAL IMMUNOTHERAPY THAT IS CURRENTLY NOT AVAILABLE. THERE IS A PROMISING COMMERCIAL OPPORTUNITY IN DEVELOPING AND COMMERCIALIZING SUCH A HOLISTIC DIGITAL PLATFORM. WHILE THE PLATFORM WILL ENABLE THE CREATION OF A CLINICAL DATABASE OF FOOD ALLERGY IMMUNOTHERAPY EXPERIENCES NOT AVAILABLE PREVIOUSLY, IT WILL ALSO SHED LIGHT ON YET UNKNOWN FACTORS OF FOOD ALLERGY CONDITIONS AND THEIR POTENTIAL TREATMENTS. THIS PROJECT ADDRESSES THE CHALLENGE OF PATIENT ADHERENCE TO ORAL IMMUNOTHERAPY TREATMENTS. ORAL IMMUNOTHERAPY IS STILL AN EMERGING TREATMENT THAT CONSISTS OF FEEDING AN ALLERGIC INDIVIDUAL AN INCREASING AMOUNT OF AN ALLERGEN, UNDER CLINICAL SUPERVISION, WITH THE GOAL OF DESENSITIZING THE IMMUNE SYSTEM AGAINST THE ALLERGEN. HOWEVER, PERFECT ADHERENCE OF PATIENTS TO THE TREATMENT PLAN IS ESSENTIAL TO ENSURE SAFETY AND ENHANCE TREATMENT EFFICACY. THIS PLATFORM IS THE FIRST-EVER SOLUTION AIMED AT PROVIDING A SYSTEMATIC AND COMPREHENSIVE APPROACH TO FOOD ALLERGY IMMUNOTHERAPY TREATMENT. THE PLATFORM INCLUDES AN INNOVATIVE EPINEPHRINE AUTO-INJECTOR (EAI) THAT INTEGRATES INTO AN AD-HOC SMARTPHONE CASE AND A SMARTPHONE APP THAT SUPPORTS THE DAILY LIFE OF FOOD ALLERGY PATIENTS. THE TEAM WILL DEVELOP A HIPAA-COMPLIANT DATABASE, A MACHINE LEARNING ENGINE TO ANALYZE RELEVANT CLINICAL DATA AND UNVEIL DATA PATTERNS THAT ALLOW PREDICTING RELEVANT EVENTS IN THE TREATMENT, A WEB-BASED APPLICATION FOR ALLERGISTS TO HELP PATIENTS WITH DATA MANAGEMENT AND ANALYSES, AND A DIGITAL ACCESS POINT FOR PHARMACEUTICAL COMPANIES TO RECEIVE A RAW DATA FEED FOR RESEARCH AND DEVELOPMENT PURPOSES. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.- SUBAWARDS ARE NOT PLANNED FOR THIS AWARD.