Biomarker Development in Cancer- Bridging the Translational Gap

每种癌症都是不同的，标准治疗如化疗对某些患者的效果比其他患者更好。将正确的患者与正确的治疗方法相匹配的能力将使癌症医生能够为患者提供最有可能起作用的癌症药物。这种想法被称为“个性化”或“精确”肿瘤学，将为每位患者制定量身定制的治疗计划。预先选择患者也将有利于制药行业，增加临床试验成功和随后癌症药物批准的机会。为了在临床环境中实现精确的肿瘤学，需要准确的测试或生物标志物，这些测试或生物标志物可以使用患者肿瘤的遗传特征来帮助确定最佳治疗策略。尽管有数千种潜在的测试，但只有少数几种能够在医院中进行日常使用;这有很多原因。在大学环境中开发的癌症生物标志物在医院实验室中使用时可能不会产生可靠的结果。这可能是由于它们的设计不准确或实验室程序不足以限制测试批次或不同实验室之间的差异。此外，许多生物标志物是使用不切实际的技术开发的，这些技术不在医院实验室中使用，不提供临床相关结果，或者没有以足够高的标准生产或测试以获得政府批准使用。为了克服这些问题，需要大学、医院和生物技术行业之间的合作。更重要的是，很少有癌症医生具有设计这些测试并在所有这些环境中工作所需的知识和技能。该提案旨在打破这些障碍，并开发一种新的癌症生物标志物开发的合作方法。通过成为UKRI创新学者，Turkington博士将获得设计和开发癌症生物标志物的基本技能。在Almac诊断服务（ADS）借调期间，他将学习如何管理癌症生物标志物测试作为临床试验的一部分。他将获得高级商业环境的经验以及管理和领导方面的基本技能。这些知识将被转移回贝尔法斯特女王大学（QUB），用于研究生物标志物的进展，设计新的癌症治疗策略，并影响更广泛的研究文化。Turkington博士还将参与新的癌症生物标志物和临床试验的设计，这些生物标志物和临床试验将通过UKRI和英国政府资助的区域癌症试验项目进行测试。北方爱尔兰已经拥有强大的健康创新环境，拥有QUB，五家研究活跃的医疗保健信托基金和多家生物技术公司，包括专门从事临床生物标志物开发和交付的ADS。几年来，QUB通过投资精准医学卓越中心（PMC）和NI Biobank等，将自己定位为精准肿瘤学的领导者。PMC得到了UKRI/Innovate UK工业战略挑战基金的支持，使用人工智能为患者选择化疗方案。结合最近提交的UKRI地方实力资助创建NI Precision Biomarkers and Therapeutics Consortium（NIPBT）和英国政府资助的贝尔法斯特地区城市交易“高级临床医疗卓越研究所”（iREACH），北方爱尔兰正在迅速发展一个动态的精准医学生态系统。 总而言之，这项奖学金将通过分享专业知识使ADS和QUB受益，并将使Turkington博士成为一个能够推动精准肿瘤学创新的独特技能人才。它将通过提供有效、精确和量身定制的治疗，使北方爱尔兰更广泛的医疗基础设施和癌症患者受益。

Every cancer is different and standard treatments such as chemotherapy work better for some patients compared to others. The ability to match the right patient to the right treatment would enable cancer doctors to give patients the cancer drugs with the best chance of working. This idea is called 'personalised' or 'precision' oncology and will lead to tailored treatment plans for each patient. Pre-selection of patients will also benefit the pharmaceutical industry by increasing the chance of a successful clinical trial and subsequent cancer drug approval. For precision oncology to be realised in the clinical setting accurate tests, or biomarkers, are needed which can use the genetic features of a patient's tumour to assist in determining the optimal treatment strategy.Historically, developing a cancer biomarker has been difficult. Despite thousands of potential tests only a select few have made it through to day-to-day use in hospitals; there are many reasons for this. Cancer biomarkers developed in a university setting may not produce reliable results when used in hospital laboratories. This could be due to inaccuracies in how they were designed or insufficient laboratory procedures to limit variation between batches of tests or different laboratories. Also, many biomarkers are developed using impractical technologies which are not used in hospital laboratories, do not provide clinically relevant results or are not produced or tested to a high enough standard to gain government approval for use. To overcome these issues collaboration between universities, hospitals and the biotechnology industry is needed. More importantly, there are very few cancer physicians with the knowledge and skills required to design these tests and work in all of these settings. This proposal seeks to break down these barriers and develop a new, collaborative approach to cancer biomarker development. By becoming a UKRI Innovation Scholar, Dr Turkington will gain essential skills in the design and development of cancer biomarkers. During his secondment at Almac Diagnostic Services (ADS) he will learn how to manage cancer biomarker tests as part of clinical trials. He will gain experience of a high-level commercial environment as well as essential skills in management and leadership. This knowledge will be transferred back to Queen's University Belfast (QUB) and used to progress research biomarkers, design new cancer treatment strategies and influence the wider research culture. Dr Turkington will also be integral to the design of new cancer biomarkers and clinical trials, which will be tested through UKRI and UK government funded regional cancer trial programmes.Northern Ireland already has a strong health innovation environment with the presence of QUB, five research-active Healthcare Trusts and multiple biotechnology companies, including ADS, who specialise in clinical biomarker development and delivery. Over several years QUB has positioned itself as a leader in precision oncology through investments such as the Precision Medicine Centre of Excellence (PMC) and NI Biobank. The PMC is supported by the UKRI/Innovate UK Industrial Strategy Challenge Fund to use artificial intelligence to select chemotherapy for patients. Combined with the recent submission for UKRI Strength in Places funding to create the NI Precision Biomarkers and Therapeutics Consortium (NIPBT) and the UK government funded Belfast Region City Deal 'Institute of Research Excellence for Advanced Clinical Healthcare' (iREACH), Northern Ireland is rapidly developing a dynamic ecosystem for precision medicine. In summary, this scholarship will benefit ADS and QUB through the sharing of expertise and will also develop Dr Turkington into a uniquely skilled individual who can drive innovation in precision oncology. It will benefit the wider healthcare infrastructure in Northern Ireland and cancer patients by providing effective, precise and tailored treatment.