PREFER focused on patient preferences in benefit-risk assessments across the drug lifecycle; PARADIGM advanced patient engagement in medicines development.
AMGEN LIMITED
Global biotech company contributing pharmaceutical and regulatory expertise to IMI partnerships in patient-centric drug development and digital health outcomes.
Their core work
Amgen Limited is the UK arm of Amgen Inc., one of the world's largest biotechnology companies, focused on developing and manufacturing human therapeutics. Within H2020, Amgen contributes pharmaceutical industry expertise to projects advancing patient-centric drug development, real-world evidence generation, and digital health outcomes measurement. Their participation centers on Innovative Medicines Initiative (IMI) public-private partnerships, where they bring clinical trial design knowledge, regulatory science capabilities, and large-scale patient data experience to multi-stakeholder research consortia.
What they specialise in
GetReal Initiative worked on integrating real-world data into drug development and regulatory decision-making.
MOBILISE-D connects digital mobility assessment tools to clinical outcomes for regulatory endorsement, covering COPD, Parkinson's disease, MS, and hip fracture recovery.
MOBILISE-D applies sensor-based mobility tracking across multiple disease cohorts including ageing populations.
How they've shifted over time
Amgen's early H2020 involvement (2016–2018) concentrated on regulatory and methodological questions — how to incorporate patient preferences into drug approval decisions (PREFER) and how to use real-world evidence alongside clinical trials (GetReal Initiative). Their more recent participation (2019 onward, MOBILISE-D) signals a shift toward digital health tools and sensor-derived clinical endpoints, particularly for measuring mobility outcomes in chronic disease populations. This evolution mirrors the broader pharmaceutical industry's move from traditional endpoints toward digital biomarkers and decentralized measurement.
Amgen is moving toward digital health endpoints and sensor-based outcome measurement, suggesting future interest in decentralized clinical trials and digital therapeutics validation.
How they like to work
Amgen participates exclusively as a consortium partner, never as coordinator — consistent with large pharmaceutical companies contributing industry expertise and in-kind resources through IMI public-private partnerships rather than leading academic research. With 90 unique partners across just 4 projects, they operate in very large consortia (averaging ~23 partners per project), typical of IMI-scale initiatives. This makes them a reliable industry anchor in large multi-sector consortia rather than a hands-on research driver.
Amgen has collaborated with 90 distinct partners across 16 countries, reflecting the broad pan-European reach of IMI consortia. Their network spans academia, regulatory bodies, patient organizations, and other pharmaceutical companies — a valuable cross-sector web for anyone seeking access to the drug development ecosystem.
What sets them apart
As a top-10 global biotech company participating in IMI partnerships, Amgen brings pharmaceutical-scale clinical development experience that few academic or SME partners can match. Their specific combination of regulatory science expertise (PREFER, PARADIGM) and digital health outcomes work (MOBILISE-D) positions them at the intersection of drug approval reform and digital measurement — a niche where industry validation is essential. For consortium builders, Amgen's involvement signals credibility to regulators and can unlock EFPIA in-kind contributions.
Highlights from their portfolio
- MOBILISE-DAmbitious multi-disease digital mobility study spanning COPD, Parkinson's, MS, and hip fracture recovery — connects wearable sensor data to regulatory-grade clinical endpoints.
- PREFERLandmark IMI project establishing frameworks for incorporating patient preferences into drug benefit-risk assessment throughout the entire product lifecycle.
- GetReal InitiativeDirectly addressed the gap between randomized clinical trials and real-world outcomes, influencing how regulators accept real-world evidence.