Policymakers: Cloud can Accelerate Life Sciences Innovation
U.S. policymakers have increasingly embraced the promise of cloud to discover new cures, accelerate biomedical innovation, and spur development of life-saving medical technologies. With the growing adoption of the cloud in life sciences, cloud use can help product developers and regulators get data more quickly and enable manufacturers to meet and exceed their compliance requirements.
Most recently, lawmakers that fund the Food and Drug Administration (FDA) urged the agency to support the shift to cloud by life science organizations. As part of the FDA appropriations package released earlier this year, congressional lawmakers emphasized the importance of cloud and called for more guidance from the agency.
The lawmakers stated: “The increased adoption of cloud-based technologies by FDA-regulated companies, the innovations facilitated via cloud to improved product development, and the value of additional FDA guidance on the use of cloud throughout the product lifestyle.”
In parallel, the FDA is developing a series of cloud-focused pilot projects to facilitate how drug companies share regulatory data with the agency. The pilots were included as part of an agreement between the FDA and pharmaceutical manufacturers on how the agency can spend user fee funding.
The agreement states: “Cloud and cloud-based technology offer significant advantages over traditional on-premise data repositories and analytics. Combined with interoperable information exchange mechanisms, these advantages open a host of new opportunities to explore, promote and implement innovation in the drug development and regulatory review process.”
As policymakers and regulators increasingly embrace the use of the cloud in life sciences, companies now have the opportunity to become digital natives—incorporating the latest innovations in security management, database technologies, and analytic capabilities. Using the cloud can help drug and medical device manufacturers innovate at scale to meet their mission of developing the next generation of cures, treatments, diagnostics, and devices.
Existing guidance to unlock the benefits of the cloud for life sciences
To increase their pace of advancement and enhance their security and compliance posture, life sciences organizations turn to Amazon Web Services (AWS).
AWS provides cloud services designed to help customers run their most sensitive workloads. In life sciences, these capabilities include the computerized systems that support Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, and related regulatory requirements (collectively referred to as GxPs).
An AWS whitepaper provides information on how AWS approaches GxP-related compliance and security requirements, and provides customers guidance on using AWS services to meet and exceed these requirements. AWS developed the white paper based on experience with and feedback from AWS pharmaceutical and medical device customers, as well as software partners, who are currently using AWS services in their validated GxP systems.
Cloud use can support the entire product life cycle—from research and development through regulatory review and post market surveillance. Moderna has used AWS across its data infrastructure, including to develop its mRNA COVID-19 vaccine. The company used the cloud to scale production of its vaccine, power sophisticated AI/ML (machine learning) tools, and conduct near real-time analytics.
In another example, Bristol Myers Squibb’s achieved more consistent data formats while transitioning to AWS, which gave the company a clearer picture of its data and a new ability to identify information that can get drugs to patients faster.
Through AWS, life sciences companies can maintain continuous compliance by ensuring the right controls over data access, enabling audit logs of changes, and many other controls to protect the security, reliability, and accuracy of data.
Traction on cloud use only growing
The FDA and congressional appropriators have now clearly indicated the benefits to innovation from cloud adoption. In parallel, the FDA should, as encouraged by Congress, publish its current thinking for the industry and agency reviewers on ways to use cloud to promote biomedical innovation and improved patient care. AWS stands ready to help.
You can learn about how AWS supports GxP compliance by reading other customer stories from AstraZeneca, Eli Lilly, Gilead, and Novartis, or reviewing an executive conversation among AWS and FDA leaders. To know what AWS can do for you contact an AWS Representative.