(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.