Agyralides Gregorios
Medical Division, Boehringer Ingelheim Hellas Single Member S.A., Kallithea, Greece.
Front Med (Lausanne). 2024 Aug 7;11:1391727. doi: 10.3389/fmed.2024.1391727. eCollection 2024.
Currently, there is a lot of discussion about the future of medicine. From research and development to regulatory approval and access to patients until the withdrawal of a medicinal product from the market, there have been many challenges and a lot of barriers to overcome. In parallel, the business environment changes rapidly. So, the big question is how the pharma ecosystem will evolve in the future.
The current literature about the latest business and scientific evolutions and trends was reviewed.
In the business environment, vast changes have taken place via the development of the internet as well as the Internet of Things. A new approach to production has emerged in a frame called Creative Commons; producer and consumer may be gradually identified in the context of the same process. As technology rapidly evolves, it is dominated by Artificial Intelligence (AI), its subset, Machine Learning, and the use of Big Data and Real-World Data (RWD) to produce Real-World Evidence (RWE). Nanotechnology is an inter-science field that gives new opportunities for the manufacturing of devices and products that have dimensions of a billionth of a meter. Artificial Neural Networks and Deep Learning (DL) are mimicking the use of the human brain, combining computer science with new theoretical foundations for complex systems. The implementation of these evolutions has already been initiated in the medicinal products' lifecycle, including screening of drug candidates, clinical trials, pharmacovigilance (PV), marketing authorization, manufacturing, and the supply chain. This has emerged as a new ecosystem which features characteristics such as free online tools and free data available online. Personalized medicine is a breakthrough field where tailor-made therapeutic solutions can be provided customized to the genome of each patient.
Various interactions take place as the pharma ecosystem and technology rapidly evolve. This can lead to better, safer, and more effective treatments that are developed faster and with a more solid, data-driven and evidence-concrete approach, which will drive the benefit for the patient.
当前,关于医学的未来有诸多讨论。从研发到监管审批、患者可及性,直至药品退市,存在诸多挑战和重重障碍需要克服。与此同时,商业环境变化迅速。那么,关键问题在于制药生态系统未来将如何演变。
对有关最新商业和科学进展及趋势的现有文献进行了综述。
在商业环境中,随着互联网以及物联网的发展发生了巨大变化。一种新的生产方式在名为“知识共享”的框架下应运而生;生产者和消费者可能会在同一过程中逐渐被明确。随着技术迅速发展,其主导力量是人工智能(AI)、其子领域机器学习,以及利用大数据和真实世界数据(RWD)来生成真实世界证据(RWE)。纳米技术是一个跨学科领域,为制造尺寸为十亿分之一米的设备和产品带来了新机遇。人工神经网络和深度学习(DL)正在模仿人类大脑的运作方式,将计算机科学与复杂系统的新理论基础相结合。这些进展已在药品生命周期中启动实施,包括候选药物筛选、临床试验、药物警戒(PV)、上市许可、生产及供应链等环节。这已形成一个新的生态系统,其特点包括免费的在线工具和可在线获取的免费数据。精准医学是一个突破性领域,能够根据每位患者的基因组提供量身定制的治疗方案。
随着制药生态系统和技术迅速发展,各种相互作用不断发生。这能够带来更好、更安全、更有效的治疗方法,且研发速度更快,采用更坚实、数据驱动和证据确凿的方法,从而为患者带来益处。