Development and Proof of Concept testing of a novel Intelligent Biobank Platform

生物样本以及从这些样本中产生的临床前和临床数据是许多研发工作的关键组成部分，特别是在将基础研究转化为个性化治疗和疾病诊断的新创新方面。生物库是生物样本及其相关数据的储存库，无论是商业机构还是学术机构，都可以管理其资产的收集、管理、储存和访问。寻找和访问样本和数据的能力仍然是生命科学领域尖端研究的主要障碍，无论是在中小企业生物技术公司，大型制药组织还是研究机构。因此，研究人员要么从英国境外进口样本，要么必须创建新的样本/数据（自我收集），这两种做法都对英国造成了负面影响，导致研究机会的丧失和研究成本的增加，而且是不可持续的。英国在生命科学研究方面处于世界领先地位。然而，由于生物库管理缺乏创新，生物样本和从这些样本中创建的数据管理效率低下，阻碍了进展。例如，许多生物库继续使用Excel电子表格或数据库，不适合生物库数据集、监管框架或捐赠生物样本的特定需求。智能生物库平台（“IBP”）项目将开发一个新的软件平台，将彻底改变生物库部门的沟通、协调和管理。其目的是确保数字监管合规性，建立标准操作程序，捕获全面的数据集，数据分析以及在生物库中使用人工智能（AI）。这种方法与区块链技术相结合的使用远远超出了生物库中使用的最先进技术。它不仅能够跟踪和定位捐赠者的实物样本，监测和确保捐赠者同意书完全数字化，而且还能够跟踪捐赠者样本产生的数据，这些数据的使用以及任何最终的商业产品。因此，它将创建世界上第一个可互操作的安全数据生物库解决方案。这将大大改善英国和全球的生物银行部门，确保更容易，更有效和更具成本效益地获得生物样本，因此，该平台将通过协助定位创新新疗法研究和开发所需的关键样本，特别是在先进的治疗医药产品部门，为创建一个蓬勃发展的生命科学部门做出贡献。

Biological samples and the pre-clinical and clinical data generated from such samples are the key building blocks from which so much R&D builds on, especially in translating fundamental research into new innovations for personalised treatment and diagnosis of diseases. Biobanks are repositories of biological samples and their associated data, be they commercial or academic institutions who manage the collection, curation, storage and access to their assets. The ability to find and access both samples and data remains a major barrier to cutting-edge research in the life sciences sector, be that at SME bio-tech companies, large pharmaceutical organisations or research institutions. Due to this, researchers either import samples from outside the UK or have to create new samples/data (self-collection), both of which negatively impact the UK in terms of lost opportunities and increased cost of research, and are not sustainable.The UK is a world leader in life sciences research. However, inefficient management of biological samples and the data created from these samples due to a lack of innovation in the administration of biobanks, is holding back progress. For example, many biobanks continue to use excel spreadsheets, or databases which are not fit for purpose for biobank data sets, regulatory frameworks or the specific needs on donor bio-samples.The Intelligent Biobanking Platform ("IBP") project will develop a new software platform that will revolutionise the communication, coordination and administration of the biobanking sector. Its aim is to ensure digital regulatory compliance, establishing standard operating procedures, capture of comprehensive data sets, data analytics and use of artificial intelligence (AI) in biobanks. The use of such an approach combined with blockchain technology goes well beyond the state of the art used in biobanks. It will not only be able to track and locate physical samples of donors, monitor and ensure full digital compliance of donor consent but also track the data produced from donor samples, the use of such data and any final commercial products created. Thereby it will create a world-first interoperable, secure data biobank solution. This will significantly improve the biobanking sector in the UK and globally, by ensuring easier, more efficient and cost effective access to bio-samplesAs such, the platform will contribute to creating a thriving life sciences sector through assisting in locating critical samples that are required for the research and development of innovative new treatments, particularly in the advanced therapy medicinal products sector.