Nordic Life Science 1
he company’s current product is an Epi-dashboard,
developed from standing cohorts of merged RWD for different therapeutic areas. This product is used to gain new and timely insights about the patient journey, new therapeutic areas or markets, to enhance documentation for market access purposes and to guide decisions for the pipeline today. Successful outcomes for the research programs will pave the way for revenue and expansion, Jonasson continues. “In parallel, we will also support pharma companies in delivering high-quality RWE projects that support regulatory and payer decision-making and safety and effectiveness surveillance. NordicRWE is also for the benefit of patients and society and for contributing to a cost-effective health system. Our RWE products can lead to early access to new innovative drugs, but also ways to remove ineffective drugs from the market. Thus, RWE-driven decision-making can lead to more proper use of medicines that help balance both benefit/risk and cost/benefit.” When it comes to regulatory demands, Jonasson believes that the regulators have tried to keep up with the developments. “The rise of precision medicine, and the rapid growth of digitalization of the healthcare sector, have given a further impetus to RWE. Regulators including FDA and EMA have responded to this changing landscape and issued guidance documents for drug developers on how to apply RWE in different steps in the drug development process,” he says. As observational data is more prone to confounding biases than randomized controlled trials (RCTs), reaching solid and reproducible results from RWE is not always an easy task to accomplish, he continues. “Unsolved challenges associated with e.g. data quality, statistical methodology and transparency need to be addressed. RCT will continue to be the gold standard, but RWE can be used more to complement the evidence from RCTs and be an important instrument to contextualize results from highly-selected clinical studies. Furthermore, health data for continuous monitoring of benefit/risk and cost/benefit will be crucial. For that we need to improve data velocity in Nordic health data, working towards the goal of real-time data.” ”NORDIC HEALTH DATA, WITH ITS LONG FOLLOWUPS, PROVIDES INCOMPARABLE COMPLETENESS AND EXTENSIVE LINKING POSSIBILITIES THAT ARE AMONG THE BEST IN THE WORLD.” KETIL WIDERBERG, CHAIRMAN, NORDICRWE The timing is now for RWE, believes Widerberg and his colleagues. “The precision medicine revolution is changing the development and use of drugs. Finding the right information in a timely manner is critical for pharma companies to speed up the time to market,” he says. “Today it is costly, time-consuming and difficult to get access to high-quality data and analytic solutions that can be trusted. However, technology advancements and regulatory innovation make understanding and documentation from RWE possible for new drug development projects.” The Nordics also have a great opportunity to become and maintain a leadership role in this field. Nordic health data, with its long follow-ups, provides incomparable completeness and extensive linking possibilities that are among the best in the world, notes Widerberg. “Investments in collaboration on health data from both public and private sources have increased significantly in recent years and are crucial to position the Nordics in the forthcoming evolution of the RWE supported drug R&D process,” he says. “The data series other countries and regions in the world need to collect, we already have available in the Nordics.” NORDICLIFESCIENCE.ORG 29