The path from molecule to medicine is among the most demanding in science—a long, complex journey where every delay and setback is felt most by patients who are waiting for new treatments.
Amgen is addressing this challenge by embedding artificial intelligence (AI) into every stage of the drug development continuum, creating a connected capability that helps bridge Research and Development—from how molecules are first designed to how clinical trials are executed globally.
In observance of Clinical Trials Day, we spoke with three Amgen leaders, each contributing to a critical stage of this continuum, to explore how AI is helping inform a smarter and more patient-centered development process.
Developing Better Molecules
Meet Marti Head, Associate Vice President, Automation, Research Data Systems, Informatics, and AI, whose team focuses on one of the most consequential questions in drug development: how do we design better molecules before they reach the clinic?
Head’s team applies protein and chemistry language models and other AI-enabled design approaches to drug discovery, operating on the principle that molecule structures are a language—one that AI can learn to read and design—helping scientists to explore and optimize many critical molecular properties at the same time.
The result is a fundamental shift in how Amgen approaches drug discovery, designing molecules with intended therapeutic properties built in from the start, rather than searching through thousands of candidates in hopes that one will succeed.
“The goal is to advance promising molecules into clinical evaluation more efficiently because patients are waiting,” Head explains. “Having a clearer understanding of how our molecules interact with disease biology can better predict their probability of success.”
Designing Smarter Trials
The better a molecule is understood in Research, the smarter we can make clinical trials to test it. That is where Amy Xia, Vice President of the Center for Design and Analysis (CfDA), plays a key role. CfDA drives innovative clinical program and study designs across Amgen’s portfolio, generating evidence and supporting decision-making at every stage of drug development.
One of CfDA’s most powerful applications is the use of digital twins: AI-enabled, patient-level predictive models that help teams design clinical trials around individual patients rather than relying solely on population parameters. This approach can support more precise, efficient, and patient-centered trials—especially in complex and rare diseases, where traditional trial designs are often limited.
In these settings, digital twins use historical trial data and/or real-world data to generate a personalized synthetic control for each enrolled patient, informed by their individual disease characteristics, demographics, and medical history. In some settings, these methods may help reduce reliance on traditional enrollment, subject to study design and regulatory considerations. In this way, the science is built around the patient.
“Digital twins are designed to support clinical trial analyses in ways that align with established regulatory and statistical frameworks, helping improve statistical power and trial efficiency while maintaining rigor,” Xia shares. “For patients, that combination of scientific discipline and patient-centered design changes what is scientifically possible.”
Executing with Confidence
Smarter clinical trial design sets the stage for improved clinical trial execution. That is the mandate of Global Development Operations (GDO), Amgen’s worldwide clinical trial execution function, led by Kate Owen, Senior Vice President of GDO. Across a global network, GDO is integrating AI-powered platforms to drive operational efficiency, enabling a more effective study start-up, improved data oversight, and real-time insights that support more precise trial execution.
Embedded within that efficiency is also a commitment to quality. AI tools enable GDO teams to proactively identify and manage risk earlier, strengthen data integrity and reinforce patient safety throughout a trial’s lifecycle.
“As our pipeline grows and our scientific ambition accelerates, our focus is clear: we aim to advance molecules through development as efficiently as possible for patients in need,” says Owen. “The expectations of regulators globally continue to rise, and how we design and deliver trials must rise to meet them. AI-enabled technologies and standardized processes across our global teams are how we get there.”
The Continuum
Together, these stages of development form a continuum: molecules are discovered, trials are designed and treatments are delivered with each step strengthening the next. While the technologies we use will continue to evolve, Clinical Trials Day reminds us that our purpose must remain steadfast. “Behind every trial are patients who trust Amgen with their participation,” says Owen. “That trust is the reason this work matters, and why we will never stop improving.”