Nordic Life Science 1
”OUR R&D EFFORTS WILL FOCUS ON TWO AREAS WHERE WE
CAN EXPLOIT THE UNIQUE HEALTH DATA INFRASTRUCTURE IN THE NORDICS.” CHRISTIAN JONASSON, BOARD MEMBER, NORDICRWE patient’s experience and insight into important questions about the advantages and the risks with different drugs in a clinical practices, surgical procedures or other health measures, as well as the costs for these. The life science community can also better design and conduct clinical trials and other healthcare studies. In combination with clinical trials, RWE helps to build a “bigger picture” of the effectiveness of a medicine or vaccine in the real-world setting. “RWE can give crucial insight into different steps in the drug development cycle and give evidence that accelerates development, approvals and access as well as benefit/risk surveillance,” says Ketil Widerberg, Chairman of the newly formed company NordicRWE. “If successful, this will give patients earlier access to new treatments and overall a more rational drug utlization.” health-related data is rapidly increasing. At the same time, the healthcare sector is facing major challenges: it must be costefficient and benefit patients better. Clinical researchers are now turning more frequently to what is known as Real-World Evidence to complement data generated from randomized controlled trials. Real-World Evidence (RWE) is derived from the analysis of Real-World Data (RWD), which is patient and health data that comes from an array of sources, but not from conventional clinical trials. These sources could be electronic health records, disease registries, patient-generated data (including in home-use settings), and data gathered from other sources that can inform on health status, such as mobile devices. RWE, in short, is the insights that are generated when this data is analyzed. Creating RWE requires a combination of high-powered analytics, a validated approach and a robust knowledge of available RWD sources. If done correctly, it can provide a holistic view of patients that in many cases cannot be studied through traditional clinical trials. Since clinical trials are controlled they might not always provide the full picture about what happens when a drug is used in real life, because there are different individual conditions and prerequisites in a patient’s life that can play a big role. RWE provides healthcare, researchers and decision makers with additional information about the This is also the aim of NordicRWE. The Norwegian company was recently granted 16 million NOK by the Research Council of Norway for an R&D project that will focus on applying RWE during different steps in the drug development process – in accordance with regulatory demands. “We aim to set a new standard for RWE based on observational data, by showing that our methods can give solid, well-understood and reproducible results that are accepted as regulatory-grade evidence. We are currently hiring and are looking for partners to develop our platform globally,” describes Widerberg. NordicRWE has the ambition to be at the forefront of the data-driven drug development process, adds Christian Jonasson, board member of NordicRWE and co-affiliated senior researcher at the Norwegian University of Science and Technology (NTNU). He joins NordicRWE from the position as Specialist Director Health Data at the Norwegian Institute of Public Health. “Our R&D efforts will focus on two areas where we can exploit the unique health data infrastructure in the Nordics. The first area is constructing regulatory-grade external control arms (ECA) for oncology trial programs. The second focus area is signal detection approaches for various problems and opportunities in drug R&D,” he describes. The company will use observational data, epidemiological research methodology, and also AI and machine learning. In the first steps, the company will construct ECAs for oncology clinical trials and combine machine learning with pharmacoepidemiology for drug signal detection. Pharmacoepidemiology is the study of the utilization and effectiveness of drugs in large numbers of people and it provides an estimate of the probability of beneficial effects of a drug in a population and the probability of adverse effects. In this project, the company has partnered with the AI drug development division in NEC Corporation, the Cancer Registry of Norway, and the University of Oslo. 26 NORDICLIFESCIENCE.ORG