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Omar Serang, Chief Cloud Officer“Computer systems used in clinical trials capture and analyze data which affect either the course of trials or the course of treatment, making computer system validation essential,” explains Omar Serang, Chief Cloud Officer of DNAnexus. These systems require effective tracking of quality, reliability, and reproducibility—a traceability matrix tracking features from specification to production deployment is required to satisfy regulatory requirements for Computer System Validation (CSV). “A formalized process comprising CSV, and installation quality, operational quality, and performance quality testing (IQ/OQ/ PQ) is applied to demonstrate the fitness of software deployed into clinical environments for trials,” says Serang. The DNAnexus system becomes a formal validated system integrating with the clinical systems of record which in turn refer to the high throughput molecular data managed by DNAnexus.
DNAnexus, which complies with HIPAA, FedRAMP, and Quality Management standards, increases the efficiency of companies or contract research organizations (CRO) with its clinical trial platform. DNAnexus interfaces with Medidata, which develops SaaS solutions for clinical trials, through its API, extending the validated clinical trial environment to incorporate the high-throughput molecular data. DNAnexus, which has operational compliance and certification—ISO 27001 for information security and ISO 9001 for quality management—is using cloud computing and storage from Amazon and Azure.
When software is deployed into clinical environments for trials, a formalized qualification and validation process is applied to demonstrate the system’s fitness
“If you have a molecular biomarker heading into a trial, you are a lot closer to a drug or treatment by a long shot,” says Serang. Utilizing genomic data in early phases to discover biomarkers useful in participant stratification and inclusion/ exclusion criteria can increase the efficacy of the treatment and open up opportunities for development of companion diagnostics in the near future. Whole exome sequencing is increasingly being incorporated into trial designs for cancer, immune, inflammatory, cardiovascular, and metabolomic diseases, and understanding participants metagenomics is continuing to gain significance. DNAnexus is expanding its translational informatics capability within a clinical context to enable clinical trial investigators, collaborators, and sponsors to gain insight from this data early in the drug discovery process through combined analysis of patients’ real-world evidence, genomic data, and aggregate data from other studies and programs. Integrated management and analysis of the clinical and genomic data enables understanding of the relationship between the participant’s genomic makeup and their response to therapy.
Serang draws attention to DNAnexus’ work powering precision FDA, a cloud-based platform used by the FDA to advance regulatory standards for NGS-based drugs and devices.
Company
DNAnexus
Management
Omar Serang, Chief Cloud Officer
Description
Provides security, scalability, and collaboration for organizations pursuing genomic-based approaches to health to accelerate medical discovery
MOUNTAIN VIEW - DNAnexus, Inc., announced that the DNAnexus-enabled UK Biobank Research Analysis Platform (UKB-RAP) community has grown to more than 5,000 users around the world. The UKB-RAP was designed to allow researchers to access and analyze the exponentially increasing scale of the UK Biobank (UKB) dataset, which now contains more than 28 petabytes (PB) of biomedical data, making it the world’s largest and most comprehensive resource for researchers looking to advance the understanding of human disease.
Before the introduction of the UKB-RAP, authorized researchers faced the challenge of downloading de-identified participant data for their research analyses. This process demanded substantial local storage capacity, computing resources, and technical support. The advent of the UKB-RAP has transformed access to the most extensive proteomics data release ever. Furthermore, later this year, it will serve as the gateway to the largest-ever release of whole-genome sequencing data. The UKB-RAP, designed with security and scalability in mind, has played a pivotal role in expediting both the pace and scope of health-related research. This has resulted in increased accessibility and cost-effectiveness for a more extensive community of scientists.
“The second year of the UKB-RAP has seen the platform and our community grow tremendously to more than 5,000 users,” said Dr. Mark Effingham, Deputy CEO of UK Biobank. “We are committed to working with DNAnexus as our partner to help democratize access to the world’s largest biomedical database of its kind, allowing researchers around the globe to advance modern medicine.”
The UKB-RAP has fostered increased collaboration among researchers worldwide by enabling users to analyze multiple data types concurrently and collaborate on the same research projects within a cloud-based platform. Over the past year, researchers have harnessed the capabilities of the UKB-RAP for an expanding array of research interests. These include generating fresh insights into obesity development, implementing novel techniques for phasing rare variants in large-scale genomic data, and addressing critical research inquiries such as exploring diverse methods for stratifying cancer patients.
“We’re excited about this milestone and how it demonstrates our commitment to enabling industry-leading science for our global user community,” said Thomas Laur, CEO at DNAnexus. “The team at UK Biobank continues to set the standard for future global health research projects and we are proud to be a part of this collaborative approach that will enable scientists to better understand, treat, and eventually cure many devastating diseases.”
In the coming year, UKB-RAP will persist in hosting data releases for new types of data, incorporating extra tools, and organizing additional awareness and community events. These efforts aim to further promote widespread adoption, enhance workflow efficiency, and foster collaborative initiatives.