AWS Architecture Monthly

• Ask an Expert: Patrick Combes, Tech Director, Healthcare and Life Sciences, AWS
• Case Study: Inspire Uses ML to Connect Millions of Patients and Caregivers on AWS
• Quick Start: AWS Biotech Blueprint - Core
• Blog: AWS and Novartis: Re-inventing pharma manufacturing
• Executive Summary: Why AWS for GxP regulated workloads?
• Reference Architecture: GxP Compliance Automation
• Solution: Service Workbench on AWS
• Case Study: Bristol Myers Squibb Builds Enterprise Data Lakes on AWS
• Training: Intro to Healthcare and Life Sciences (HCLS) Compliance on AWS
• Reference Architecture: Patient Engagement with Amazon Pinpoint and Amazon Personalize
• Blog: Executive Conversations: Accelerating COVID-19 vaccine development with Marcello Damiani, Chief Digital and Operational Excellence Officer at Moderna
• Executive Brief: Biopharma on AWS
• Reference Architecture: Lab instrument log acquisition and analytics
• Podcast: AWS Innovation with EB Research

Helping our customers deliver safe and effective products while maintaining compliance with government regulations and industry standards is critical. They need to closely adhere to regulations and standards from the moment a researcher records their idea in a lab notebook to establishing the specifics of manufacturing and distribution. For obvious reasons, governments around the world regulate the safety and effectiveness of everything that can be prescribed to patients. This means our biopharma customers need to submit products for approval, retain complete records of the product's development, and enforce rigid controls to ensure consistency and safety. It’s a balance to ensure that these considerations do not become constraints. They should be implemented as a complementary, functional layer within every biopharma customer's architecture.

The next thing to consider is the diversity of workloads. There is no common architectural approach for the process of developing and delivering a drug or therapeutic in biopharma (also known as the “value chain”). The value chain spans fundamental scientific research to post-market surveys of therapeutics for safety and effectiveness with things like manufacturing along the way. The architectural requirements for each step are very different. In early research, tightly coupled high performance computing (HPC) is active for workloads like computational chemistry or molecular modeling. This has a different implementation from the more familiar analytics we support on Amazon EMR used during the commercialization of drugs and therapeutics.

COVID-19 has been a devastating worldwide pandemic. But the rapid development, approval, and ongoing distribution of the vaccine is one of humanity’s greatest scientific and industrial achievements. One of reasons it was so quickly developed is the cloud. Early in the pandemic, all observational and laboratory data regarding COVID-19 was exchanged and analyzed using the cloud. As the vaccines were being developed, all of the modeling, toxicology, and construction of clinical trials was performed using the cloud. Even prior to obtaining approval, the supply chain for the vaccine was established, the manufacturing capability was expanded, and the distribution network was built out using the cloud. Going forward, I know we will continue to apply what we have learned from this pandemic. And we will apply the core mission of our biopharma customers: to improve and help save the lives of all patients, everywhere.