杨森制药聚焦数据科学助力中国药物和医疗创新
杨森制药聚焦数据科学助力中国药物和医疗创新
（2021年12月3日，上海）强生旗下杨森制药公司今日宣布，强生（中国）投资有限公司杨森（中国）研发中心与至本医疗科技（上海）有限公司在上海签署了战略合作谅解备忘录。当天，杨森制药亚太转化科学卓越中心举办了“真实世界数据助力精准医疗及临床研发”科学研讨会。杨森制药秉承合作共赢理念，将数据科学应用于创新药物发现与开发的各个领域，全力探索医学突破，积极筑造健康未来。
杨森制药亚太转化科学卓越中心负责人郑以博士（左）与至本医疗科技CEO 王凯博士(右)在上海签署战略合作备忘录
杨森制药全球研发副总裁兼亚太研发中心负责人李自力博士表示：“中国药监体系国际化和现代化的实践，推动了中国医药创新生态系统的蓬勃发展，为实现‘健康中国2030’的伟大愿景提供了持续的动力。杨森制药是这个创新生态系统坚定的支持者、合作者和推动者。我们希望利用数据科学来强化创新药物发现和开发，为中国和全世界的患者带来具有变革性的创新药物。”
杨森制药亚太转化科学卓越中心将与至本医疗合作，共同探索如何利用真实世界数据支持药物研发，特别是如何创新地使用真实世界数据来加速临床开发。通过启用人工智能(AI)和其他先进的分析方法研究结构化与非结构化数据，以更好地了解真实世界中的患者，加深对现有疗法的认知，识别未被满足的临床需求，优化临床试验的设计，从而在药物研发的每个阶段，真正实现数据驱动科学决策的理念。
自2020年初，国家药品监督管理局发布了《真实世界证据支持药物研发与审评的指导原则（试行）》以来，真实世界证据(RWE)在临床开发中的应用已成为国家发布相关政策的焦点。海南省博鳌乐城国际旅游医疗先行区开拓了真实世界研究“先行先试”的试验田。如因临床急需，先行区内医疗机构可申请使用已在美国、欧盟、日本等国家或地区批准上市，但尚未在国内批准注册的，国内已上市品种无法替代的创新药。这些全新的尝试将产生颇具价值的中国患者的真实世界数据。
杨森制药全球研发首席数据科学官兼研发策略和运营全球负责人Najat Khan博士表示：“医疗大数据的飞速发展和数字医疗的广泛普及，要求真实世界证据研究的设计和实施更加系统和严谨。我们看到了中国的巨大潜力。在杨森制药，我们专注数据科学提升药物研发效率，并期望对真实世界的应用产生积极影响。”
此外，双方还将探索其他合作机会，包括患者早期诊断和伴随诊断产品的开发与注册，并积极支持《粤港澳大湾区药品医疗器械监管创新发展工作方案》等国家生物医药创新政策的落地。
数据科学在应用领域的新突破能够大幅度提高医学诊断的效率与可及性。同时，在合适的时间发现正确的患者，也使患者个性化的治疗成为可能。在中国，数据科学在应用领域的创新需要技术进步和监管改革双重助力。同时，也需要政、产、学、研深度合作，充分发挥各自优势，探索更多新突破，共同构建健康未来。
杨森中国总裁郑磊女士强调：“我们所做的一切都是以患者的需求和福祉为中心。通过靶向治疗改善特定患者人群的临床结局。我们对个性化医疗的未来充满期待。”
杨森制药亚太转化科学卓越中心负责人郑以博士介绍：“我们非常注重与专家和学者的学术交流。通过推动科研向临床的快速转化，不断强化行业和学术伙伴的合作共赢；通过打造卓越的创新解决方案，造福中国和全球的患者，为医务人员和医疗系统提供真正有价值的服务。”
香港中文大学医学院肿瘤学系莫树锦教授、中国科学院上海营养与健康研究所/广州国家实验室李亦学教授、杨森制药全球研发数据科学副总裁Joel Greshock博士以及至本医疗高级副总裁王维锋博士，在随后的研讨会上做了专题报告，介绍了精准医学在肺癌管理、生物信息学大数据、基因组学和生物标记物导向的药物开发等领域的应用。会上，专家们还讨论了真实世界数据在医疗决策中的应用和价值。
Janssen to Apply Data Science to Drive Innovative Healthcare Solutions in China
(December 3, 2021, Shanghai) The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Janssen (China) Research and Development Center of Johnson & Johnson (China) Investment Co., Ltd. (Janssen) has signed a Memorandum of Understanding (MoU) on Strategic Collaboration with Shanghai OrigiMed Co., Ltd. (“OrigiMed”). The signing followed by a scientific symposium on the role of real-world data (RWD) in precision medicine and clinical development, hosted by the Asia Pacific Center of Excellence in Translational Science (AP CoE-TS) under Janssen AP R&D. Janssen seeks medical breakthroughs with the potential to positively affect the future of health through embracing collaboration and driving data sciences into all aspects of discovering and developing transformational medicines .
“China’s streamlined medical regulatory mechanism and vibrant innovation ecosystem are showing incredible potential in pursuit of the Healthy China 2030 initiative,” said Zili Li, M.D., M.P.H., Vice President and Head of Asia Pacific R&D, Janssen Research & Development, LLC. “In this ecosystem, we look to be a supporter, partner and accelerator. A key part of this effort is leveraging data science to transform how we discover and develop drugs, delivering transformative medicines to patients in China and around the world.”
Under the MoU, AP CoE-TS will work with OrigiMed in harnessing RWD for regulatory use and applying innovative applications to accelerate clinical development. By embracing Artificial Intelligence (AI) and other advanced analytics with both structured and unstructured data, we can provide a comprehensive picture of patients in a real-world setting, deepen the understanding of current therapies, optimize clinical trial designs, identify unmet medical needs, and support data driven decision-making in life cycle of drug development.
The use of Real-World Evidence (RWE) in clinical development has been the focus of several key policies released by the Chinese government since the beginning of 2020, including the Guidelines for RWE to Support Drug Development and Review (Interim) issued by the National Medical Products Administration (NMPA). The use of RWE has also been encouraged in Hainan Province’s Bo’ao Lecheng International Medical Pilot Zone, where use of drugs approved in the U.S., Europe or Japan, but not yet in China has generated valuable RWE for Chinese patients.
“We see great potential in China for designing and implementing RWE studies in a more systematic, rigorous way, using high quality data and a standardized infrastructure,” said Najat Khan, PhD, C Chief Data Science Officer and Global Head of R&D Strategy and Operations, Janssen R&D. “At Janssen R&D, we are deeply invested in the potential of data science to increase research and development efficiency and drive real-world impact.”
The collaboration will also explore opportunities for the development and registry of diagnostics and companion diagnostics for early patient access, taking advantage of supportive government policies such as the Plan for the Development of Innovative Regulatory of Drugs and Medical Devices in the Guangdong-Hong Kong-Macao, the Greater Bay Area of China.
New breakthroughs in the application of data science have helped make medical diagnostics more efficient and accessible, allowing medical treatment to be personalized to target the right patients at the right time. In China, innovation in applying data science has been supported by advances in both technological capabilities and regulatory reform. Such trends point to a future for healthcare defined by collaboration between governments, academic institutions, and companies, leveraging their existing strengths while exploring outside current paradigms.
“The needs and well-being of patients are always at the center of everything we do,” said Lei Zheng, President of Janssen China. “We are passionate about the promise of personalized medicine and its potential to improve outcomes for specific patients through targeted therapies.”
“Backed by our great respect for key opinion leaders, scientists and researchers, as well as our firm commitment to the broad community of innovators, we seek to remain imaginative and active in creating win-win situations with both industrial and academic partners to deliver truly remarkable solutions that provide value to patients, healthcare professionals, and healthcare systems in China and across the globe,” said Yi Zheng, PhD, Head of AP CoE-TS, Janssen R&D.
At the symposium, Prof. Tony Mok, Department of Clinical Oncology of the Chinese University of Hong Kong, Prof. Yixue Li at the Institution of Nutrition & Health, Chinese Academy of Sciences/ Guangzhou Laboratory, Joel Greshock, Vice President of Data Science, Janssen R&D, and Weifeng Wang, Senior Vice President of OrigiMed delivered insightful presentations focusing on precision medicine research and development in the aspects of lung cancer management, data sharing and Innovation, and drug development. The symposium was concluded with an expert panel discussion on applying the value of RWD in healthcare decision making.
关于强生旗下杨森制药公司
在杨森，我们努力创造一个没有疾病的未来。我们是强生的制药子公司，以科学战胜疾病，用智慧扩大准入，让关爱带来希望。我们聚焦能够为人类健康带来巨大改变的六大疾病领域：肿瘤学、免疫学、传染病和疫苗、神经科学、心血管与代谢以及肺动脉高压。
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.