Companies have joined with industry leaders and FDA on Project PRISM to advance solutions that can improve the submission, review and ease of communication for human drug and biologics applications
DNAnexus, Inc., provider of the Precision Health Data Cloud, and LORENZ Life Sciences Group, the leader in regulatory information management technology for the life sciences industry, today announced a partnership to offer Trusted Regulatory Spaces — secure, cloud-native environments that improve the submission validation process and ease of sponsor-reviewer communication for human drug and biologics applications to health authorities. The engagement is highlighted by Project PRISM, a research collaboration between Industry and the U.S. Food and Drug Administration (FDA) to demonstrate the feasibility of collaborative regulatory submission validation and scientific review utilizing LORENZ’s eValidator solution deployed on precisionFDA, FDA’s production cloud platform built and powered by DNAnexus for multi-omics and real-world data regulatory science and review. The joint offering leverages in-production solutions that already meet the most stringent security, privacy and data residency requirements and have been adopted by many leading global health authorities and life sciences organizations.
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“The regulatory submission and review process is the perfect opportunity to showcase the secure collaboration capabilities of the DNAnexus platform”
The regulatory submission process is challenging and resource-intensive for sponsors and health authorities. Digital transformation through the deployment of a trusted cloud platform that enables seamless collaboration between regulators and sponsors will accelerate the review and approval of life-changing therapies. To this end, DNAnexus and LORENZ are pioneering Trusted Regulatory Spaces to:
- Enable collaborative validation of regulatory submissions, allowing sponsors and health authority reviewers to leverage a secure cloud environment for eCTD validation and review
- Facilitate real-time communication between sponsors and regulators, for interactive review in collaborative Trusted Regulatory Spaces utilizing regulatory and scientific tools and technologies that enable enhanced sponsor-health authority interactions for the assessment of human d**** and biologics
- Provide sponsors and regulators with both private and shared workspaces, allowing them to maintain secure separation and expose only the data they need to, when they need to
The collaboration between both organizations will be on display during Project PRISM, which is being run in conjunction with FDA and industry collaborators, including two leading global pharmaceutical companies.
Built and powered by DNAnexus, precisionFDA launched in 2015 to enable the advancement of regulatory science and has evolved into a trusted, FedRAMP-authorized platform for secure collaboration and cloud computing. Since its inception, precisionFDA has grown to support collaborative use cases around genomics, multi-omics, real-world data, and AI and machine learning. Project PRISM represents the next adaptation of precisionFDA and seeks to help life science organizations and global health authorities leverage regulatory and scientific cloud platforms to achieve greater efficiencies on a regional and international scale. precisionFDA has a FISMA Authorization to Operate, building on DNAnexus’ FedRAMP authorization and 21 CFR Part 11 Computer System Validation, and platform features, such as chain of provenance tracking and data immutability, to deliver a regulatory-grade service for collaborative science in the cloud.
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LORENZ has been a leader in regulatory technology since 1989 and provides mission critical electronic application review and validation systems to 17 global regulatory authorities across global regions such as North America, Europe and Asia-Pacific. The company is playing a key role enabling technology to support a modernized trans-regional collaborative joint review process for approval of innovative medicines through the ACCESS Consortium NASWSI – New Active Substance Work-Sharing Initiative. Today, 27% of the world’s population is receiving new medicines approved electronically through LORENZ solutions. As part of the start of this collaboration, LORENZ’s off-the-shelf eValidator solution will be leveraged within the secure confines of precisionFDA, enabling sponsors to share eCTD validation results with reviewers using shared interactive workspaces called Trusted Regulatory Spaces.
“The regulatory submission and review process is the perfect opportunity to showcase the secure collaboration capabilities of the DNAnexus platform,” said Thomas Laur, CEO of DNAnexus. “We are excited to work with LORENZ to deliver a trusted cloud solution that is ready to be adopted by global regulators and sponsors today.”
“We are honored to be working with DNAnexus to enable a future where health authorities can collaborate with each other and sponsors can securely process applicant/regulator interactions with various health authorities in all regions, on regulatory submissions in the cloud,” said Wolfgang Witzel, President of LORENZ Life Sciences Group.
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