SBIR Phase II: Production and formulation of a safe and natural sunscreen to replace ingredients harmful to human and environmental health

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是开发一种安全、有效和可持续生产的天然防晒化合物Gadusol，以取代目前防晒产品中广泛使用的有害成分。全球每年报告的皮肤癌病例为200万至300万例，其中包括13.2万例黑色素瘤。2015年，美国疾病控制和预防中心报告了美国新增的80,442例皮肤黑色素瘤病例。有可能通过有效、安全、美观的防晒产品来扭转这一趋势，这些产品可以提供持久的全光谱紫外线防护。加杜索的可持续生产及其安全性和有效性的保证将使这类产品得以开发。全球防晒产品市场规模为165亿美元，而且还在不断增长，同时对天然、更安全的防晒活性物质的需求也在不断增长，该项目将对国家和全球健康产生全球性、长期的影响。这个SBIR二期项目将证明可持续生产Gadusol的可行性，Gadusol是一种天然的、海洋基化合物，具有经证实的防晒能力。最近的研究证明，广泛使用的防晒成分对环境构成危害，可能还会对人类健康造成危害，导致流行的防晒产品被禁止使用。氧化锌和二氧化钛等矿物活性化合物是更安全的替代品，但会造成审美上的劣势，导致许多消费者不喜欢的产品。Gadusol有可能取代其中一些广泛使用的化学活性物质，成为一种安全、有效和天然的UVB阻断剂。建议的技术范围包括利用合成生物学工具克服可持续生产加杜索的障碍，通过标准的临床前试验确定加杜索的安全性，以及评估其在原型配方中的有效性和适宜性(SPF值)。该项目的成功完成将降低采用Gadusol作为新的防晒成分的风险，使其能够商业化生产，并在启动FDA批准所需的临床测试之前提供必要的安全数据。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of a safe, effective, and sustainably-produced natural sunscreen compound, gadusol, to replace harmful ingredients widely used in current sunscreen products. Two to three million cases of skin cancer are reported globally each year, including 132,000 cases of melanoma. In 2015, the U.S. Centers of Disease Control and Prevention reported 80,442 new cases of melanomas of the skin in the U.S. The potential exists to reverse this trend with effective, safe, aesthetically-pleasing sun protection products that provided long-lasting full-spectrum UV protection. Sustainable production of gadusol and the assurance of its safety and efficacy will enable such products to be developed. With a global sunscreen product market of $16.5 billion and growing, along with the demonstrated need for natural, safer sunscreen actives, this project is poised to have a worldwide, long-term impact on national and global health.This SBIR Phase II project will demonstrate the feasibility of sustainably producing gadusol, a natural, marine-based compound with proven sun protection capability. Recent research has documented that widely used sunscreen ingredients pose hazards to the environment and possibly to human health, leading to bans on popular sunscreen products. Mineral active compounds such as ZnO and TiO2 are safer substitutes but pose aesthetic disadvantages, leading to products that many consumers dislike. Gadusol has the potential to replace some of these widely-used chemical actives as a safe, effective, and natural UVB blocker. The technical scope proposed includes overcoming obstacles to sustainable production of gadusol using the tools of synthetic biology, establishing gadusol's safety through standard pre-clinical tests, and assessing its efficacy and suitability in prototype formulations (SPF value). Successful completion of this project will reduce the risks of adopting gadusol as a new sunscreen ingredient, enable its commercial production, and provide essential safety data prior to initiating clinical testing required for FDA approval.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.