As the coronavirus pandemic continues, its effects continue to grow beyond those diagnosed or hospitalized with the illness. For example, patients being treated for chronic illnesses are growing increasingly reluctant to visit hospitals for therapies because they are at greater risk if exposed to COVID-19, making digital and data solutions more critical than ever. “At Amgen, we are always thinking about how we can improve the healthcare system and better serve patients,” said Julie Kim, a member of the biotechnology company’s Digital Health & Innovation team. Her team is part of a timely, trailblazing new clinical trial that is testing remote monitoring for adverse events in adult patients with acute leukemia being treated with one of Amgen’s therapies.
Typically, the therapy is administered in an inpatient setting where patients can be monitored for adverse effects. But being in the hospital places a high burden on patients and their caregivers, particularly during the backdrop of a global pandemic, while also straining payers and providers from a cost and administration standpoint. In the United States, the typical care setting for patients with acute leukemia has shifted to smaller community clinics, which often lack the resources and infrastructure to easily offer inpatient care. A recent review of the literature shows negative effects of prolonged hospital stays on patients with leukemia receiving induction therapy with curative intent. The review concludes that outpatient treatment could provide significant benefits, including reduced financial costs and improved quality of life for both patients and caregivers, as well as decreased risk of hospital-acquired infections.
Amgen is a pioneer in utilizing innovative digital solutions in oncology. Using FDA-cleared wearable devices and platforms, this will be one of the first clinical trials where clinical decisions will be made based on data captured through remote monitoring digital technologies that will trigger an instant communication to doctors. For patients with leukemia involved in the trial, the leading indicators of a clinically significant adverse event that will be measured include changes to vital signs such as heart rate/pulse rate, oxygen saturation, axillary temperature, respiratory rate and blood pressure, in addition to the ability for direct live video communication between patient and health care provider. There are existing devices on the market that can collect data over a period of time and then send to a physician, but when treating oncology patients, that lag time can be critical. For this trial, Amgen has partnered with top-tier tech startups to ensure there is a real-time feedback loop. Novel digital technologies will enable treating physicians to review the data generated by their patients in real time, make an immediate assessment, and intervene as appropriate.
“In addition to the longstanding effects of prolonged hospital stays, patients without COVID-19 are being impacted by the pandemic in how it’s limited access to care for so many,” said PK Morrow, VP Global Development and Product General Manager. “It’s critical that we adapt and take care of patients on therapies for other disease indications in a way that minimizes risk for everyone. Real-time remote monitoring, where appropriate, may offer a key part of a longer-term outpatient solution through the pandemic and beyond.”
This trial will take place across the United States, and is expected to be completed in about two years. “There’s a lot of thought about safety and efficacy that has to be built in to the protocol to ensure that the digital technology is seamless and doesn’t become cumbersome for study participants.” While focused on oncology, the study could set the precedent for a major shift in the healthcare landscape for both patients and providers. Patients affected by serious diseases across the spectrum could receive continual monitoring while at home, decreasing the stress and infection exposure that a hospital stay could induce. Successful remote monitoring could also attract patients who would otherwise refuse treatment that involves a hospital stay. “Doctors are equally as eager to enable patients to be managed more in the outpatient setting,” added Julie. “It’s important during this pandemic to have hospital beds more readily available.”
Since Amgen’s founding in April of 1980, Amgen’s concentration on biology, technology, and innovation has led to major discoveries and the development of breakthrough therapies. “In the early days of the company, we successfully isolated and cloned the epoetin gene to stimulate red blood cell production,” said Julie. The result was Amgen’s first medical therapy, Epogen, which treats anemia from chronic kidney disease in patients on dialysis. “Fast forward 40 years, and we continue to capitalize on our strength in human genetics and molecular engineering.”
Amgen today offers 23 approved medicines globally, with 13 considered first in class. That designation comes from the FDA definition, and indicates that the drug has a new and unique mechanism for treating a particular medical condition. Amgen has always been ahead of the curve in its research and development of precision medicine: “We look at advancing therapies that target specific gene mutations, allowing doctors to go beyond the molecule or a ‘one size fits all’ therapy plan,” Julie said. “I think the COVID-19 pandemic has really showcased how important healthcare transformation is, and the use of digital solutions is going to be increasingly important.” This new clinical trial embodies Amgen’s commitment to leveraging cutting-edge technology to transform and expand access to treatment.
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This story was produced by WIRED Brand Lab for Amgen
