Applying data and advanced technologies to accelerate and improve trials and treatment decisions for patients.
Summary:
- The Center for Observational Research (CfOR) is an organization dedicated to using epidemiologic and data science methods and real-world data (RWD) to support Amgen's mission to serve patients.
- Collaborating with teams across the drug development lifecycle, CfOR scientists work to generate real-world evidence (RWE) that helps to understand the epidemiology of disease and the treatment of disease, accelerate clinical trials and evaluate the benefits and risks of Amgen's medicines when they are used in real-world clinical practice.
- Amgen is paving the way for innovative and effective applications of RWD and RWE in drug development and commercialization, which is delivering meaningful benefit for patients and the broader healthcare community.
The use of high-quality RWE by regulators, reimbursement authorities and providers to inform healthcare decisions is increasing across the globe, helping to deliver new treatments for patients.
Healthcare data including electronic health records (EHRs), administrative claims, and disease registries are key sources of RWD, and are becoming more widely available globally. RWE is derived from analyses of RWD and can include descriptive information on the incidence, prevalence and burden of disease, treatment patterns, as well as complex analyses of the benefits and risks of therapeutic interventions in a real-world setting.
Amgen leverages RWD and RWE to address critical research questions across Research and Development (R&D) to bring innovative medicines to patients facing challenging diseases.
The Evolution of CfOR
The core of the RWD/RWE work at Amgen is executed within the Center for Observational Research (CfOR).
"Harnessing the power of RWE enables us to design and accelerate representative clinical trials, and in certain cases, even replace a trial or trial arm with an RWE-based approach," said Brian Bradbury, vice president and head of CfOR. "The opportunity to use RWE-based approaches to accelerate access to our medicines is not only exciting, but highly motivating, and everyone in CfOR is committed to delivering on that ambition."
In the early days of CfOR, the team, composed of six epidemiologists, was focused on integrating epidemiologic thinking into drug development at Amgen. Today, more than 20 years later, it is a mature, global organization made up of epidemiologists, data scientists, data and statistical programmers, and operations professionals. CfOR scientists work collaboratively with cross-functional team members to design and execute RWE studies to address product evidence generation needs aligned across the drug development lifecycle, from discovery to post-approval. Drug safety evaluation has been a core deliverable since the inception of CfOR by conducting post-authorization safety studies, evaluating adverse events within RWD, implementing new protocols and conducting risk assessments, all while using RWD to accelerate clinical programs across the R&D continuum.
"CfOR's mission has always been to serve patients by leveraging epidemiologic and data science expertise to provide RWE and deliver innovation, efficiency and value across the drug development lifecycle," said Bradbury. "Our capabilities today – vast amounts of RWD, advanced analytic capabilities, deep integration with the cross-functional teams, and talented, mission-driven staff – uniquely position us to be able to deliver for patients around the world."
Bridging the Ampersand Between R&D
CfOR partners across Amgen R&D teams to help better transform molecules into medicines. One area where these capabilities can drive impact is better understanding the prevalence and burden of disease across the globe and within patient sub-populations, helping Amgen teams and the broader healthcare community gain a clearer, more comprehensive understanding of how diseases impact diverse patient populations.
"Using human data-driven discovery, we can identify patient subsets who may benefit the most from our therapies, increasing our probability of success in clinical trials," said Saptarsi Haldar, vice president of research and head of cardiometabolic disorders. "Importantly, this information gets passed over to our development colleagues to inform the advancement of new drugs, bridging the gap between R&D and sparking meaningful collaboration in precision medicine and tailored treatment options that maximize patient impact."
Amgen successfully employs prevalence and burden of disease data to accelerate clinical trials. In a Phase 3 trial, RWE was used to estimate cardiovascular event rates and identify populations with the highest potential treatment responses. This evidence-based strategy informed trial design by predicting outcomes and evaluating risks associated with elevated Lp(a) levels and atherosclerotic cardiovascular disease, leading to more efficient and effective drug development.
"This targeted approach helps us identify target profiles early in the development process to tailor our trials for populations who may most benefit from our medicines," said Keri Monda, executive director within CfOR's Data & Analytic Center (DAC). "This goes beyond cardiovascular applications and can be utilized across therapeutic areas. Ultimately, our goal is to use the best data and tools available to make the development process more representative of and valuable to patients."
Future Growth and Research Advancements
As an industry leader in leveraging RWD and advanced technologies, CfOR seeks to generate RWE that not only serves Amgen's mission but also helps to advance the field and increase trust in this evidence process. A recent JAMA publication showcased how CfOR collaborated with leading academic and industry peers on a demonstration study designed to increase data quality by linking structured and unstructured elements from EHRs, claims and mortality data and curating it using AI methods. The study included data on over 120,000 U.S. asthma patients. The results were compelling and demonstrated a significant improvement in data quality that is designed to meet the new FDA regulatory standard and will enable Amgen's team to generate RWE that addresses a wide array of critical evidence generation questions.
"This study demonstrates that integrating advanced technologies and diverse data sources enhances the accuracy and completeness of medical records, ensuring that real-world healthcare data is trustworthy for critical medical and regulatory decisions," said Monda. "Our commitment remains steadfast in ensuring our decision-making is accurate, reliable and comprehensive, allowing researchers and stakeholders to leverage it effectively."
Empowered by Data to Improve Patient Outcomes
The patient is central to CfOR's work, guiding ways to design, analyze and interpret studies. The team works hard to ensure that the evidence generated accurately reflects the real-world experiences of patients suffering from serious diseases, from small cell lung cancer, to osteoporosis, to myasthenia gravis, and now, obesity and obesity related conditions. It is a privilege, but also an important responsibility for the team to harness the power of RWD to answer questions regarding the use of Amgen medicines, like their benefits and risks, whether they are administered to a small number or hundreds of thousands of patients.
"CfOR is a key differentiator for Amgen, enabling us to harness the power of RWD and advanced analytics to support and expand the impact of our medicines," said Bradbury. "We strive to be at the forefront of RWE in drug development and to meaningfully contribute to our mission to serve patients with serious disease."
