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众多研发工作的关键基石，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。生物样本库是生物样本及其相关数据的存储库，无论是商业机构还是学术机构，都负责管理其资产的收集、管理、存储和访问。寻找和获取样本和数据的能力仍然是生命科学领域前沿研究的一个主要障碍，无论是在中小型生物技术公司、大型制药组织还是研究机构。因此，研究人员要么从英国以外的地方进口样本，要么必须创建新的样本/数据（自我收集），这两种情况都对英国产生了负面影响，因为他们失去了机会，增加了研究成本，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，由于生物样本管理缺乏创新，对生物样本和从这些样本中产生的数据的管理效率低下，阻碍了进展。例如，许多生物银行继续使用excel电子表格或数据库，这些数据库不适合生物银行数据集、监管框架或供体生物样本的特定需求。智能生物银行平台（“IBP”）项目将开发一个新的软件平台，彻底改变生物银行部门的沟通、协调和管理。其目标是确保数字监管合规性，建立标准操作程序，捕获综合数据集，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助者的实物样本，监测和确保捐助者同意的完全数字化遵守，而且还能够跟踪从捐助者样本产生的数据、这些数据的使用以及创建的任何最终商业产品。因此，它将创建世界上第一个可互操作、安全的数据生物银行解决方案。通过确保更容易、更高效、更经济地获取生物样本，这将显著改善英国和全球的生物银行部门。因此，该平台将通过协助寻找创新治疗方法研发所需的关键样本，特别是在先进治疗药物产品部门，为创造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.