SBIR Phase I: Bio-erodible Contraceptive-Releasing Implant

SBIR 第一阶段：生物可蚀避孕释放植入物

• 批准号: 2304404
• 负责人: Sirsendu Bhowmick
• 金额: $ 27.5万
• 依托单位: HERA HEALTH SOLUTIONS INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2304404&HistoricalAwards=false
• 关键词: SBIR; Phase; Bio; erodible; Contraceptive

The broader impact of this Small Business Innovation Research (SBIR) Phase I project will be to provide a highly effective and long-acting implantable contraceptive for the 61 million American women in their childbearing years (ages 15 to 44), 70% of whom are at risk for unintended pregnancies. Unintended pregnancies accounted for half of the total pregnancies in 2022, and over 60% of unplanned pregnancies end in abortion, with an estimated 45% of abortions being unsafe, resulting in 5-13% of all maternal fatalities. Today, an estimated 7.5 million women aged 15–49 receive a treatment or hormonal drug via long-term subcutaneous arm implants. Once they reach the end of their lifespan, these implants must be removed, and complications can quickly arise. Not only are these procedures expensive, but they leave behind heavy bruising and scarring and some instances even require an operation for removal. The proposed product is the world’s first biodegradable contraceptive-releasing implant. The technology combines Food and Drug Administration (FDA)-approved material with a generic drug already on the market. It uses novel manufacturing methods and biodegradable materials, eliminating the need for implant removal and enabling the proper timing and therapeutic dosage. This novel delivery drug technology can be applied to different drug treatments in a sustainable and affordable manner.This Small Business Innovation Research (SBIR) Phase I project aims to advance the future of long-acting reversible contraception by creating a biodegradable arm implant that delivers a consistent hormone dose and does not have to be surgically removed. The goal of this SBIR Phase I project is to characterize the drug delivery scaffold and demonstrate its utility. This project will de-risk the prototype to be used in Pre-Investigational New Drug Applications (IND) studies required by the FDA. The Phase I strategy will be two-fold: (1) de-risking operations by finalizing the prototype after evaluating the physical and chemical properties and (2) test the long-acting contraception implant prototype in a clinically relevant biological model to provide the necessary data for a successful IND launch. Progress of this project will provide a solid foundation for advancing the biodegradable contraception product toward commercial utility.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.

这项小型企业创新研究（SBIR）I阶段项目的更广泛影响将是为6100万美国妇女在育儿年（15至44岁）提供高效且长效的植入式避孕药，其中70％有70％的人有意外怀孕的风险。意外怀孕占2022年总妊娠的一半，超过60％的计划外怀孕的堕胎结束，估计有45％的流产不安全，导致所有主要死亡人数的5-13％。如今，估计有750万名15-49岁的女性通过长期皮下手臂即可接受治疗或骑马药物。一旦它们达到了寿命的尽头，就必须清除这些不安的寿命，并且可能会迅速出现并发症。这些程序不仅昂贵，而且还留下了沉重的瘀伤和疤痕，有些实例甚至需要进行拆除操作。拟议的产品是世界上第一个可生物降解的避孕药释放植入物。该技术结合了食品药品监督管理局（FDA）批准的材料以及已经在市场上的仿制药。它使用新颖的制造方法和可生物降解的材料，消除了去除植入物的需求，并实现了适当的时机和治疗剂量。这种新型的送货药物技术可以以可持续且负担得起的方式应用于不同的药物治疗。这项小型企业创新研究（SBIR）I阶段项目旨在通过创建可生物降解的ARM植入物来促进长效可逆隔离的未来，该植入物提供一致的骑马剂量，而不必通过手术去除。 SBIR I期项目的目标是表征药物输送脚手架并证明其效用。该项目将脱离危险的原型，该原型将用于FDA所需的投资前新药应用（IND）研究。第一阶段策略将是两个方面：（1）在评估物理和化学特性后确定原型的脱离风险操作，以及（2）在临床上相关的生物学模型中测试长效避孕植入物原型，以提供成功的IND发射的必要数据。该项目的进展将为将可生物降解的避孕产品推广到商业公用事业。该奖项反映了NSF的法定任务，并且使用基金会的知识分子优点和更广泛的影响评估标准，认为通过评估值得支持。