On Sept. 16, 2025, more than 150 life sciences leaders gathered in Princeton, New Jersey, for the inaugural ValGenesis ValConnect Innovation Day — U.S. Edition. Against the backdrop of one of the world’s most dynamic pharmaceutical hubs, the one-day forum brought together global enterprises, fast-scaling biotechs, and service providers to explore a central question: How can digital transformation and AI redefine validation, quality, and lifecycle management in life sciences?
From the opening remarks to the closing panel, the Princeton event set a tone of collaboration and forward-looking discussion. ValGenesis customers such as Bayer, GSK, Cardinal Health, Transcat, and Hansa Biopharma shared their journeys toward smarter, faster, and more connected operations. It was also part of something larger: our global ValConnect series, with editions scheduled in Frankfurt, Germany, on Sept. 30 and Hyderabad, India, on Nov. 12.
At ValConnect Princeton, we built the day around a theme that resonated across sessions: “Innovation for better outcomes.” The event was not only an opportunity to showcase the ValGenesis Smart GxP™ platform, but also a forum for the industry to exchange ideas, challenges, and solutions.
The Resource Room was active throughout the day with hands-on demos of Smart GxP applications, advisory services, and ValGenesis University. Participants engaged in lively discussions on the role of AI in validation and the broader shift to digital lifecycle management.
Above all, the event reinforced that digital transformation is not a distant ambition. It is happening now — and companies that embrace it are already realizing tangible benefits in compliance, speed, and scalability.
One of the most compelling stories came from Transcat, a global leader in calibration and validation services supporting more than 120 clients, including 19 of the top 20 pharmaceutical companies. By moving from paper to ValGenesis’ digital validation platform, Transcat cut review and approval turnaround times for validation protocols from weeks to just one or two days, while also improving quality.
Quality review within the system now catches dozens of potential errors before protocols reach clients. Efficiency gains have exceeded 40%, translating into 1,500 hours saved annually. Most tellingly, Transcat has tripled its market share over the past three years, with digital validation playing a central role in supporting that growth. For the full story, see the case study at the end of this post to learn how Transcat successfully digitalized equipment qualification with ValGenesis.
Bayer, one of the world's leading pharmaceutical and life sciences companies, shared how it has partnered with ValGenesis to reimagine cleaning validation at a global scale. What has historically been a compliance-heavy, time-consuming process is now becoming a driver of efficiency and standardization. By adopting ValGenesis, Bayer is streamlining risk-based cleaning validation and creating stronger consistency across its global network.
The company emphasized that cleaning validation is more than a regulatory requirement — it is an opportunity to unlock hidden capacity and reduce operational stress. The initiative reflects how forward-looking organizations are leveraging digital platforms to shift essential processes from bottlenecks to enablers of growth.
Hansa Biopharma, headquartered in Lund, Sweden, is advancing innovative enzyme-based therapies for rare immunologic diseases. Its lead program, imlifidase is conditionally approved in the European Union to enable kidney transplants in highly sensitized patients and is expected to support a future Biologics License Application (BLA) submission in the United States.
At ValConnect Princeton, the company highlighted how digitalization is playing a critical role as it prepares for commercialization. By adopting ValGenesis’ Process Lifecycle Suite, Hansa Biopharma is centralizing process data to strengthen regulatory readiness, ensure data ownership, and preserve knowledge for the future. This digital backbone positions the company to respond quickly to regulatory questions and manage future tech transfers with greater confidence.
A lively panel on digital transformation, AI, and CSA underscored the risks of treating digitalization as “paper on glass.” Simply replicating legacy controls in digital form wastes the opportunity to streamline. Instead, panelists from GSK, Cardinal Health, Axendia, and pharmaceutical consultant Alton Johnson argued for rethinking deliverables from the ground up — challenging every document, adopting risk-based testing, and focusing on modular, high-impact wins.
The consensus: AI must come with guardrails, embedding SOPs and regulatory constraints while leaving higher-value decisions to human experts.
Another recurring theme was closed-loop lifecycle management. ValGenesis experts highlighted how tools such as ValGenesis iCMC™ and iCPV™ create a feedback cycle between risk assessment and real-world evidence. Instead of static documents, organizations gain living knowledge bases that evolve as products mature — an essential shift for companies facing global regulatory scrutiny.
The day closed with a forward-looking discussion on the ValGenesis Smart GxP™ platform. With its dual suites — Validation Lifecycle Suite and Process Lifecycle Suite — Smart GxP unifies the product lifecycle from R&D through commercial operations.
At its core are AI-powered “Val agents”: a Content Generator, Gap Assessor, Executor, and Anomaly Detector. Together, these tools promise another quantum leap in efficiency, projected to deliver 50% gains on top of the roughly 40% already realized in digital validation. As one panelist said, “The risk of doing nothing is simple: loss of competitive advantage.”
For attendees, the day was as much about peer learning as it was about technology. Hearing from Bayer, GSK, Transcat, and Hansa Biopharma reinforced that digital transformation is not only achievable — it is delivering measurable impact today.
Princeton was just the beginning. The ValConnect global series continues with the EU Edition in Frankfurt on Sept. 30, 2025, followed by the APAC Edition in Hyderabad on Nov. 12, 2025. Each event is tailored to regional dynamics, but all share a unifying goal: to accelerate digital transformation across life sciences.
ValConnect Innovation Day Princeton 2025 demonstrated that the future of life sciences is not only digital — it is intelligent, connected, and accelerating. Whether through AI-powered validation, closed-loop lifecycle management, or globally standardized cleaning validation, the innovations showcased in Princeton point toward a more agile, compliant, and competitive industry.
As the series moves forward, ValConnect will remain a forum for collaboration and innovation, showcasing how digital transformation will continue to reshape the future of life sciences worldwide.
Don’t miss the opportunity to be part of the conversation — explore upcoming events on the ValGenesis Events Page.