QbDVision

?? ?? ?? Day 3: Go time. Get ready for even more superb content from the Digital CMC Summit. Leading off, a superb session on revolutionizing digital operations in technical development. Industry leaders from Askbio Inc. and ZAETHER joined some of our QbDVision teammates to show how connected CMC ecosystems are transforming drug development. One especially key highlight: While the industry has made a huge leap by moving away from paper-based batch records, the real future lies in creating integrated digital systems that span both development and manufacturing processes. We loved seeing how organizations are already building the strong data cultures they need to make those systems possible, and rethinking traditional data management approaches across the product lifecycle. The speakers also showed off new QbDVision integrations that will make it possible to take connected CMC ecosystems to enterprise scale. Standardized data governance and cross-system integrations are opening so many new doors for statistical analysis and decision-making. Huge thanks to Lewis Shipp, Bill Pasutti, Tim Adkins, and Andy Zheng for sharing these game-changing insights! #DigitalCMC #DigitalCMCSummit

What a stage of CMC rockstars! At this year's Summit, there was a whole new way to honor the organizations, leaders, and experts who are shaping the future of technical development. And the the inaugural Digital CMC Awards did NOT disappoint. HUGE congrats to this year's winners: ?? Digital CMC Visioneer: Anthony Maguire and Mike Greene of Eli Lilly and Company ?? Digital CMC Connector: Vijay Raju of Flagship Pioneering ?? Digital CMC Champion: Thielges Sabine (accepting on behalf of) Laurent Lefebvre of Novartis And a big thank-you to everyone who made these awards possible: The many colleagues who nominated game-changing organizations, leaders, and teammates, and also the judges who provided the expertise, experience, and perspective that helped identify this year's winners. ???? One last round of applause for all the remarkable organizations and individuals who are taking home a trophy this year. Time to celebrate them, the Summit, and more—it's Soiree o'clock! #DigitalCMC #DigitalCMCSummit #DigitalCMCAwards

THE theme of this year's Digital CMC Summit: The idea stage is over. Digital CMC is happening now—and it's already delivering results at enterprise scale. ???? To see it in action, look no further than this afternoon's panel + presentations moderated by Joschka Buyel. We just heard from three organizations that are already leveraging Digital CMC solutions to streamline workflows, drive efficiency, and accelerate key processes. ?? Mike Greene and Anthony Maguire from Eli Lilly and Company pulled back the curtain on their QbDVision-powered Product Lifecycle Management program, and how it's enabling them to transform their approach to control strategies, manufacturing processes, and development history. ?? Isabel Guerrero Montero from Viralgen Vector Core AskBio showcased how teams are using QbDVision as a single source of truth to simplify platform transfers, enhance real-time collaboration, and accelerate GMP timelines. ??Whitney Pung from Accenture showed us how organizations can best adopt Digital CMC/PLM systems by using an approach that enables multiple deployments in production per year, across modalities and regions Fantastic proof that scalable Digital CMC solutions are delivering tangible value—today, right now, already. But now—drumroll, please—it's time to find out who's been making that impact possible, for patients, for their customers, and for their teams. Let's find out who won this year's Digital CMC Visioneer Awards!! #DigitalCMC #DigitalCMCSummit?

Wondering what Digital CMC's real-world impact looks like? We just saw it at the Digital CMC Summit—and it looks like a quantum leap in tech transfer speed and efficiency. ? ? ? In a series of lightning talks, we heard what made it possible from a series of industry-leading CMC experts: Nupur Sharma, Associate Partner at ZS, Kevin Healy, CRO at DataHow AG, and our own Luke Guerrero and Yash Sabharwal. From in-silico modeling to AI-driven regulatory authoring, they showcased a range of cutting-edge solutions that are accelerating processes while ensuring compliance and efficiency. A few key achievements they featured: ?? Seamless data integration: Breaking down information siloes is helping innovative organizations enhance decision-making and accelerate key exchanges. ?? Automated workflows: Algo-powered solutions are already driving speed and precision in regulatory document production. ?? Effective future-proofing: Digital methodologies are helping industry leaders reduce their risks, enhance scalability, and prepare for the next generation of scientific breakthroughs. Another big highlight: A live demo of a cutting-edge regulatory authoring tool that uses GenAI to supercharge regulatory documentation processes! And if that wasn't enough of a win, we'll hear about even more of them in our next session. Stay tuned for some exciting Digital CMC success stories... #DigitalCMC #DigitalCMCSummit #TechTransfer

We just got a VERY important reminder at from the stage at the Digital CMC Summit: Technology makes transformation possible. But culture makes it stick. ?? It just came down from a panel of experts that included Barry Heavey, Managing Director of Accenture, Tina Beaumont, Managing Director, Life Sciences Strategy at Accenture, Devendra Deshmukh, Head of Strategy, Product, and Partnerships at Thermo Fisher Scientific, Thomas Cronin, Digital Technical Manager at AbbVie, and Matt Schulze ??, Head of Pioneering Medicines at Flagship Pioneering. Their unanimous message: Fostering a digital-first mindset is key to successful change management in pharma. The speakers zoomed in on several key success factors for that effort: ?? Overcoming resistance: Ensuring teams understand the value of digital adoption ?? Effective change management: Aligning people, processes, and technology for seamless implementation ?? Building an enduring digital culture: Encouraging the collaboration and adaptability organizations need to keep pace with transformation After lunch, another incredible group of experts will share quick-fire insights on one CMC workflow where modern digital methodologies are already making a big impact—tech transfer. Get ready! ?????? #DigitalCMC #DigitalCMCSummit

Digital CMC Summit, Day 2—go! ? ? ? After a warm welcome and introduction from our own Luke Guerrero, our first panel discussions dove straight into one of the biggest topics at this year's Summit: the launch of Project Artemis, and how this new initiative is setting the course to a sustainable Digital CMC ecosystem. Inspired by NASA’s “moonshot” approach, Artemis is already being powered by some truly stratospheric expertise. Moderated by life science luminary Mike Stapleton, today's panel also included?Christoph Pistek, VP and Head of Sustainability and Technology for R&D (Pharmaceutical Sciences) at Takeda, Vijay Raju, VP of CMC at Flagship Pioneering, and Jack Morel, Senior Product Manager at QbDVision. By uniting industry leaders in a pre-competitive effort, Artemis aims to lay the foundation for a future where advanced therapies are developed and manufactured efficiently, effectively, and at scale. Together, the panelists dug into some of the initiative's key themes, including: ?? Interoperability: Enabling seamless data flow to accelerate innovation ?? Standardization: Harmonizing frameworks to enable scalability ?? Sustainability: Building a lasting digital infrastructure for CMC With a focus on how to make Digital CMC a reality—through tools, resources, and industry-wide frameworks—Project Artemis is a bold step toward the transformation technical development needs. We can't wait to see it take shape! Next up: A closer look at the culture evolution businesses will need to foster to make that transformation possible. #DigitalCMC #DigitalCMCSummit #ProjectArtemis

And just like that, the 2025 Digital CMC Summit is off to a stellar start—courtesy of a fantastic keynote from NASA and SpaceX legend Douglas Hurley! ????????? An aerospace expert at a biopharma meeting?? Absolutely. Hurley, a trailblazer in human spaceflight, shared how teams like his have achieved exactly what drug developers dream of: defying conventional timelines, embracing digital transformation, breaking industry norms, and balancing speed with precision—all within a stringent regulatory framework. In his keynote, he just hit on several themes near and dear to the heart of drug developers: ? How to accelerate progress while maintaining quality? ? How to enable rapid iteration without increasing risk? ? How to leverage partnerships and digital tech to reimgaine outdated systems and processes Doug's big takeaway for all our attendees: Just as spaceflight evolved at an unprecedented pace, the pharma industry can scale digital solutions and new ways of working across the enterprise. The message is clear: innovation at scale is within reach. And we're just getting started! Even more rich insights and inspiring talks are on the way tomorrow. #DigitalCMC #DigitalCMCSummit

Three, two, one... ignition. It's officially blastoff for the 2025 Digital CMC Summit!!! ?? And what a voyage it will be over the next 3 days. We've got an unbeatable set of presentations, panels, workshops, and celebrations ahead, and the energy at the kickoff is already incredible. At this year's Summit, we won't just be exploring how digital innovation is resaping technical development—industry leaders will share how that transformation is already happening at scale, across some of the industry's biggest derug development enterprises. Ready to see what escape velocity looks like for Digital CMC?? You know we are. Stay tuned for more updates from Austin! #DigitalCMC #DigitalCMCSummit

It's official: for the next 3 days, Austin will be the capital of digital innovation in drug development. The2025 Digital CMC Summit starts today! ?????? Truly groundbreaking content, a world-class speaker lineup, unbeatable industry networking: it's all on the agenda. We can't wait for our speakers, panelists, and attendees to take a journey through the technologies, methods, and strategies that are driving the #digitalCMC movement. Watch our feed for the latest updates and insights from the Summit stage featuring our industry experts: Eli Lilly and Company, AbbVie, Flagship Pioneering, ZAETHER, Asklepios BioPharmaceutical, Inc. (AskBio), Accenture, Rockwell Automation, DataHow AG, and Viralgen

Attending the 2025 Digital CMC Summit this week? Be sure to check out ZAETHER’s workshop, "Beyond the Buzzwords: Architecting a Digital Tech Stack That Actually Delivers” at 10:15 AM on Wednesday, February 26th. Tired of tech jargon and overcomplicated systems? So are we. In this interactive session, Michael Cody, Director of Digital Life Science at ZAETHER will be breaking down what truly matters when building a modern digital integration strategy—from distinguishing essential systems like UNS from mere industry buzzwords to finding the perfect balance between interoperability and fit-for-purpose efficiency. Expect real-world insights, live debates, and actionable takeaways that will help you: ?Build a digital tech stack that drives business value? ?Avoid common integration pitfalls? ?Transform your digital operations for today—and tomorrow Cut through the noise and co-create a digital architecture that works. See you there! Learn more about ZAETHER here: https://www.zaether.com/ Want to attend this workshop and haven’t registered for the summit yet? Get your tickets here: https://lnkd.in/dy862YB7