SBIR Phase II: A digital platform to support food allergy oral immunotherapy treatments

SBIR II 期：支持食物过敏口服免疫疗法的数字平台

• 批准号: 2233429
• 负责人: Javier Evelyn
• 金额: $ 100万
• 依托单位: ALERJE, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2025-08-31
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2233429&HistoricalAwards=false
• 关键词: SBIR; Phase; II; digital; platform

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.

该小企业创新研究 (SBIR) 第二阶段项目的更广泛/商业影响潜力是为食物过敏患者社区提供一个数字平台，以改善护理并支持新兴食物过敏口服免疫疗法的实施。患者及其家人一直担心过敏反应，该技术是解决食物过敏口服免疫治疗痛点的综合平台，可以满足患者、家人和护理人员的需求。治疗依从性并允许医疗保健专业人员远程有效地评估患者病情的进展。此外，该解决方案为目前尚不可用的系统性食物过敏口服免疫治疗方法提供了人工智能分析功能。并将这样一个整体数字平台商业化。虽然该平台将能够创建以前无法提供的食物过敏免疫治疗经验的临床数据库，但它也将揭示食物过敏状况的未知因素及其潜在的治疗方法。该项目解决了以下问题：患者坚持口腔治疗的挑战口服免疫疗法仍然是一种新兴的治疗方法，包括在临床监督下向过敏个体喂食越来越多的过敏原，目的是使免疫系统对过敏原脱敏。但是，患者必须完全遵守治疗计划。该平台是第一个旨在提供系统且全面的食物过敏免疫治疗方法的解决方案，该平台包括集成到一个创新的肾上腺素自动注射器（EAI）中。该团队将开发一个符合 HIPAA 标准的数据库、一个机器学习引擎，用于分析相关临床数据并揭示数据模式，从而预测治疗中的相关事件。 ，一个基于网络的应用程序，供过敏症专家帮助患者进行数据管理和分析，也是制药公司接收用于研究和开发目的的原始数据的数字接入点。该奖项是 NSF 的法定使命，并被认为值得通过以下方式获得支持：评估使用基金会的智力价值和更广泛的影响审查标准。