Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape.
对生物标志物的新兴焦点
“药物治疗的疗效可以很大，不利影响可能是常见的，但这些参数不容易预测，”Anderson解释说。“这就是为什么基于Biomarker的目标治疗可以指导治疗决策，更好地确定最有可能受益的人。”
在美国，生物标志物数据越来越多地提交给FDA.，表示个性化医学的演变。但在亚太地区的某些地方，生物标志物的发展仍然是一个相对较新的探索领域。
“即使是全球公司仍在考虑如何由于中国的一些独特挑战，如何将生物标志物纳入审判环境中，”安德森说。“在表现出任何类型的基因检测方面，中国的限制比世界其他地方更多。赞助商将需要监管机构的批准，即使是在国内测试。“
商业化考虑因素
Anderson also discussed the challenges presented with commercialization. “In the US, we have reference labs, hospital-based labs and a reimbursement system that facilitates the use and coverage of these tests. In China, there is a more fragmented healthcare system where the mechanism of payment or reimbursement is less certain and may vary from region to region,” he said. “Companies need to carefully determine how to commercialize across the diagnostic landscape in China.”
Despite these hurdles, both emerging biotech and established large pharma in China can benefit from opportunities to bring novel therapeutics to market domestically and then export globally, in contrast with the more common model of developing drugs in the US or EU and then testing them within China.
在p中采用强大的技术ersonlized医学
In China and the rest of the world, evolving technologies will continue to affect the companion diagnostics landscape. Multiplex technologies, such as next-generation sequencing and gene expression profiling, can examine genomic variations and discover clinically relevant biomarkers with increasing power and speed.
Liquid biopsy technologies also have gained recognition as non-invasive methods to provide insights on drug resistance and potentially help determine appropriate, targeted treatments by identifying and analyzing circulating tumor cells (CTCs) and circulating free tumor DNA (cfDNA) from blood.
全球合作伙伴的支持作用
无论使用的技术及其潜在的利益，重要的是要考虑将生物标志物和伴侣诊断纳入开发连续体，以指导规划，利用下游效率。
Anderson cited contract research organizations (CROs) as filling a valuable role by helping pharmaceutical companies proactively plan to become leaders in the use of biomarkers not only within their own country but also globally.
“具有强劲，目前对全球监管要求的知识的合作伙伴可以解决局部试验设计和监管提交的局部差异，”安德森说。“CRO还提供带关键诊断仪器制造商的联盟，以确保开发过程中的开放参与，并提供最广泛的商业外展。”
While most CROs with central lab capabilities have a wide range of installed instrumentation to support standard laboratory testing, they also must have the flexibility to stay current with new technologies and instrumentation as the needs of the clients change. Given the current global nature of clinical trials, any supporting partner should provide global logistics capabilities with laboratories located in key regions of the world to meet turnaround time requirements and overcome any issues with export of samples.
在中国的临yaboapp体育官网床前设施提供非临床安全评估，生物分析，体内药理学和药物代谢和药代动力学（DMPK），Covance可以支持中国生物制药，因为它们从铅优化转变为IND及以外。“我们的经验有助于客户促进和加快中国的发展，然后潜在地出口技术达到全球市场，”安德森说。
了解有关Covance的伴随诊断和生物标志物解决方案的更多信息。
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