BridgeBio Builds a Centralized Hub for Smarter Collaboration and Governance

BridgeBio, a commercial-stage biopharmaceutical company, needed a centralized data management solution to enhance efficiency, security, and compliance. Multiple subsidiaries and external partners, such as Contract Research Organizations (CROs), made managing data access, compliance, and governance increasingly complex.

Operating under a hub-and-spoke model, BridgeBio relies on efficient and secure data management across its central hub and various external spokes, including subsidiaries and CROs. This model requires a centralized platform to ensure seamless collaboration, consistent governance, and robust compliance across all entities. By implementing Egnyte’s cloud-based GxP platform, BridgeBio achieved centralized oversight, streamlined collaboration, and reduced risks.

Challenge: Unify Data Management Across Various Partners

With over 200 active GxP users spanning subsidiaries and partners, BridgeBio faced significant challenges in ensuring consistent governance, compliance, and efficiency across its various entities. According to Nick Keenan, Senior Vice President of Information Technology at BridgeBio, “When I joined BridgeBio, we didn’t have a high degree of maturity built into our cybersecurity program, quality and compliance, or risk mitigation programs.”

BridgeBio’s existing systems were fragmented. “We had Dropbox, SharePoint, and Egnyte across various affiliates with no quality compliance or standards around any of those platforms,” Kennan explained. The lack of centralization created gaps in their ability to confidently demonstrate compliance during regulatory audits. The inherent structure of BridgeBio's operating model amplified these challenges. The central hub needed a unified view and control over data originating from and shared with its diverse network of spokes. The lack of standardized systems across these spokes created silos, hindering the central oversight crucial for maintaining quality and compliance within the framework.

Additionally, the affiliate model meant there were multiple teams working independently, often choosing systems based on immediate convenience rather than enterprise-wide alignment. "It was really hard to have a single pane of glass when you have multiple platforms," recalled Tim Seto, Director of IT. "You can't provide consistent governance when your systems are fragmented."

Furthermore, BridgeBio’s rapid growth meant their legacy systems could not keep pace with expanding operations. “2024 was a major year of growth, given the approval of one of our main drugs, Attruby. We launched the product in November and immediately had to scale our commercial systems, sales, medical CRM, and supply chain to support that growth,” explained Kennan.

Kennan’s concerns were heightened during a pre-planning audit with a European regulatory agency. “We needed to instill confidence in auditors that we had the right security, governance, and controls in place for clinical trials data. But we had a major gap in our ecosystem platforms when it came to Part 11 compliance. That would become critical when we prepare submissions to the FDA or European regulatory agencies.”

The urgency to establish a comprehensive compliance framework became abundantly clear.

Solution: Build a Centralized Data Repository in Egnyte

BridgeBio decided to migrate its data into Egnyte’s GxP platform to enhance security, compliance, and efficiency. “We chose Egnyte for its compliance capabilities and expertise in understanding the rigors of a validated, compliant data management platform," said Seto. "Egnyte’s strong audit trails, security controls, integration with our identity provider, and multi-factor capabilities within the platform all work together to enhance our cybersecurity footprint.” This strategic decision directly addressed the complexities of managing data across numerous partners by establishing a central hub for all sensitive information, ensuring consistent security, compliance, and accessibility for all spokes.

The transition to Egnyte provided significant improvements across critical areas:

• Compliance: BridgeBio leveraged Egnyte’s GxP platform to ensure Part 11 compliance, particularly valuable for clinical data and regulatory submissions. "One of the core factors in our decision was Egnyte’s professional services and their deep understanding of Part 11 compliance and GxP," Kennan said. The validation process, which could have taken months with other systems, was completed within three months.
• Security: With Egnyte, BridgeBio implemented advanced cybersecurity controls, including centralized permissions management and robust audit trails. “It’s the ease of implementation and the fact that Egnyte understands Part 11 compliance that really made it work for us,” Kennan noted.
• Operational efficiency: Egnyte’s SFTP technology allowed seamless data migration from CRO partners, enhancing archiving capabilities and ensuring data availability for audits and FDA submissions. During one project, BridgeBio successfully transferred 4TB of clinical research data from an external CRO’s AWS S3 bucket into Egnyte’s centralized repository.
• Scalability and flexibility: Egnyte’s native integrations with tools like DocuSign and Microsoft 365 streamlined collaboration across the organization. Seto praised the system’s flexibility, noting, “The user-access controls are much easier to work with on a day-to-day operational basis.”

Kennan views Egnyte as an almost out-of-the-box solution for Part 11 and GxP compliance. “Unlike other platforms where you have to work with third parties to build a compliance package, Egnyte’s end-to-end audit capabilities, security features, and ease of operation are already built-in.”

The migration process was described as “super simple” by Seto, who added that Egnyte’s Professional Services team was always available to assist with migrations from non-GxP environments, ensuring business continuity and audit readiness.

Benefits: Smarter Data Management for a Hub-and-Spoke Business

By implementing Egnyte as its central data repository, BridgeBio effectively streamlined its operations. This centralized approach yielded significant benefits in terms of security, compliance, governance, and collaboration across its network of subsidiaries and partners. By consolidating all sensitive data into Egnyte’s centralized repository, BridgeBio achieved:

• Improved security and compliance: The company now maintains a validated repository for all clinical and regulatory data, easing the preparation for audits and FDA submissions.
• Enhanced governance: Egnyte’s tools enable consistent governance and oversight across multiple affiliates and partners. “Egnyte is best in class when it comes to content and collaboration, especially with GxP compliance,” noted Seto.
• Streamlined collaboration: Using real-time co-editing and Outlook email capabilities from Egnyte's integration with Microsoft 365, BridgeBio’s teams can collaborate more efficiently on large documents, allowing the organization to focus on innovation rather than technology limitations.
• Scalability: Egnyte’s flexible architecture supports BridgeBio’s continued growth, allowing the company to onboard new affiliates and CRO partners seamlessly. “Our IT strategy is all about building the right culture, driving strategy, and taking the business to the next level,” Kennan explained. “Egnyte’s investment in their product, particularly in life sciences, demonstrates their commitment to meeting our needs. There's no doubt in my mind that they are part of our culture and drive.”

Looking forward, BridgeBio plans to leverage Egnyte’s AI capabilities to further enhance their data management and collaboration framework. As BridgeBio continues to scale, Egnyte is now a critical component of the company’s hub-and-spoke model. By providing the necessary centralized infrastructure for efficient, secure, and compliant data management across BridgeBio’s entire ecosystem, Egnyte helps support innovation and regulatory compliance across their expanding business operations.