PREFER (2016–2022) was an IMI2 flagship project developing methods to incorporate patient preferences into regulatory and clinical benefit-risk decisions across the drug lifecycle.
CSL BEHRING GMBH
Global rare-disease biopharmaceutical company contributing industry expertise in patient evidence, benefit-risk methodology, and digital pharmacovigilance.
Their core work
CSL Behring GmbH is the German operating entity of CSL Behring, a global biopharmaceutical company headquartered in Marburg that specializes in plasma-derived and recombinant protein therapies for rare and serious diseases — including hemophilia, immune deficiencies, and hereditary angioedema. In the H2020 ecosystem, they engaged as an industry partner bringing real-world drug development and regulatory experience to collaborative research, rather than conducting basic science. Their two projects reveal a focused strategic interest: ensuring that patient evidence and digital safety data are properly integrated into how medicines are developed, assessed, and monitored across their lifecycle. This positions them as an industry voice at the intersection of regulatory science, patient engagement, and pharmacovigilance methodology.
What they specialise in
WEB-RADR 2 (2018–2020) used web and mobile technologies to improve detection and reporting of adverse drug reactions at scale.
Both projects address how evidence — from patients and digital sources — should shape regulatory and post-market decisions, reflecting deep familiarity with EMA and ICH frameworks.
Both projects were delivered through large IMI-style or open RIA consortia, with CSL Behring contributing industry validation and real-world product context.
How they've shifted over time
CSL Behring entered H2020 in 2016 with PREFER, a long-running IMI2 project focused on systematically capturing patient preferences to improve benefit-risk methodology — a foundational, methodological endeavor. By 2018, they had added WEB-RADR 2, a more operationally-oriented project applying digital tools to post-market safety surveillance. The shift is subtle but meaningful: from building patient evidence frameworks upstream in drug development, toward real-time safety monitoring downstream. Both directions serve the same underlying need — better real-world evidence for medicines — but the second project shows a move toward applied digital health tooling rather than purely methodological research.
CSL Behring is moving toward applied real-world evidence tools, suggesting future collaboration interest in digital health platforms, patient-reported outcomes systems, and post-market data infrastructure — rather than early-stage basic research.
How they like to work
CSL Behring participates exclusively as a consortium partner rather than a project leader, consistent with how large pharmaceutical companies typically engage in publicly funded research — contributing domain expertise and clinical grounding rather than managing administrative structures. Their two projects involved large, multi-country consortia (44 unique partners across 12 countries), indicating comfort operating in complex multi-stakeholder environments. They are unlikely to be a repeat partner with the same organizations and more likely to join whichever consortium best matches a strategic research priority at a given time.
CSL Behring has built connections with 44 unique partners across 12 countries through just two projects, which reflects the density of the large IMI-style consortia they joined rather than a broad independent network. Their reach is pan-European by participation, though Germany and major EU pharma hubs likely dominate their active relationships.
What sets them apart
CSL Behring brings something most academic or SME partners cannot: the perspective of a global rare-disease drug manufacturer with products already on the market and direct experience with EMA regulatory submissions, pharmacovigilance obligations, and patient engagement at scale. For any consortium working on patient evidence, drug safety, or benefit-risk methodology, their participation adds direct industry validation and a credible pathway to real-world implementation. They are not a research institution generating new science — they are a company that can stress-test methods against commercial and regulatory reality.
Highlights from their portfolio
- PREFERA major IMI2 flagship running six years (2016–2022), aimed at creating an industry-wide standard for how patient preferences should be measured and used in regulatory benefit-risk assessments — directly relevant to drug approvals.
- WEB-RADR 2Applied digital pharmacovigilance at a time when social media and mobile health data were emerging as serious sources for adverse event detection, placing CSL Behring at an early intersection of digital health and drug safety regulation.