Axendia, Inc.

We are thrilled to announce that our very own Daniel Matlis will be the featured speaker at the QAD Transform Life Sciences Roundtable. Dan will share Axendia's research on the imperative to transition from Computer System Validation (CSV) to Computer Software Assurance (CSA) to support digital transformation. Be part of this exciting conversation and discover how we can drive transformation in life sciences together: https://lnkd.in/eViaCEkb Grateful to Robyn Coward Claire Daniaux Beth Hespe Monique Guzzi, MBA Anton Chilton Carter Lloyds Tony Winter #LifeSciences #DigitalTransformation #QADTransform #InnovationLeadership #CSA #CSV #QADTransform #QADTransformAmericas Mónica V. M. Sandra Rodriguez Kelly Doering Eric M. Luyer

Excited to kickoff the Scientific Computing & Digital Transformation Symposium at FDA with CIO Vid Desai Connect with Daniel Matlis if you are attending in person

Excited to kickoff the Scientific Computing & Digital Transformation Symposium at FDA with CIO Vid Desai Connect with Daniel Matlis if you are attending in person

We're delighted to announce that Daniel Matlis will be representing Axendia at the FDA Digital Transformation Symposium. This is the premiere annual Digital Transformation event where the FDA showcases its progress and key priorities. Each year, the innovation and dedication displayed at this event continue to amaze us, as they work tirelessly to support the agency's mission. Looking forward to reconnecting with many FDA and Industry thought leaders. If you're planning to attend, reach out to Dan—he'd love to see you there!

🌟 We’re thrilled to share our collaboration with MDIC to help the industry achieve the benefits of advanced technologies and explore the transformative power of Advanced Manufacturing in #MedTech! Together, we’ve developed actionable recommendations to support industry leaders in adopting cutting-edge technologies across the medical product lifecycle. Our goal? To simplify operations, drive collaboration, and boost both innovation and efficiency—ultimately advancing patient care. It’s inspiring to see that 85% of leaders believe #advancedmanufacturing has the potential to reshape medical device production. Curious about what’s fueling this shift and the challenges ahead? Download the full report for insights to help you stay at the forefront of the health technology landscape. Medical Device Innovation Consortium (MDIC) Joseph Sapiente Steven Zera Matthew Victoria Colin Huband Daniel Matlis Daniel Walter Sandra Rodriguez Mónica V. Matlis,

🌐 GEN AI in Life Sciences: From Hype to Reality 🌐 Generative AI is revolutionizing Life Sciences, turning ambitious ideas into real-world possibilities. Yet, while the technology holds incredible promise, there has been limited data on its true impact—until now. To bring clarity and insight, we conducted in-depth research for our latest report: "The State of Generative AI in Life Sciences: The Good, Bad, and Ugly." Our findings reveal GEN AI’s potential to transform R&D, product development, manufacturing, lab operations, and supply chain resilience —and even the FDA is taking notice. In a decisive move, the FDA released their comprehensive glossary defining critical AI terms for the industry. This isn’t just regulatory housekeeping; it’s a clear signal that the agency is preparing to support and oversee the evolving landscape of AI-driven healthcare. Our report goes beyond identifying challenges; it highlights tangible benefits, real-world adoption rates, and actionable strategies for embracing GEN AI in Life Sciences.   To learn more, the report is available here: https://lnkd.in/g4_6Revt #AI #DigitalHealth #HealthcareInnovation #Regulation #FDA #healthcare #lifesciences Daniel Matlis Sandra Rodriguez Mónica V. M. Kelly Doering

The FDA released a comprehensive glossary defining key AI terms for the industry. This move is crucial as it provides clarity and guidance for companies navigating the evolving landscape of AI and digital health technologies. Check out the latest blog from Axendia to dive deeper into what this means for the future of AI in healthcare. 👇 #AI #DigitalHealth #HealthcareInnovation #Regulation #FDA https://lnkd.in/e3m24FMp Daniel Matlis Kelly Doering Sandra Rodriguez Mónica V. M. Thomas Maeder Eric M. Luyer Robyn Barnes

🌟 Exploring the Future of Pharmaceutical Manufacturing with 3D Printing 🌟 Adare Pharma Solutions and Laxxon Medical are collaborating to explore the transformative potential of 3D printing in the pharmaceutical sector. This innovative partnership aims to revolutionize drug manufacturing by enabling customized solutions, reducing waste, and enhancing efficiency. As this partnership evolves, it could lead to more effective and accessible healthcare solutions. 🔗 Read more about this collaboration and its implications for the future of pharmaceutical manufacturing: https://lnkd.in/gN8HhMxx #Collaboration #PharmaceuticalManufacturing #3DPrinting #Innovation #Healthcare #PersonalizedMedicine Exentis Group AG Jared Matlis

🎉 Celebrating 19 Years of Axendia: A Journey of Trust & Innovation 🚀 -Daniel R. Matlis, President & Founder, Axendia, Inc. Nineteen years ago, we founded Axendia with a simple but powerful goal: to provide life sciences executives, technology companies, and regulators with strategic, actionable insights grounded in a deep understanding of our industry’s complexities. Since then, we've remained dedicated to that vision, consistently offering trusted advice that goes beyond buzzwords, trends, and jargon.  We’re proud to have earned your trust along the way, becoming a valued partner in helping your organization navigate the intersection of business, technology, and regulatory domains. As we mark this milestone, it’s clear that the future is already taking shape, and we are privileged to be part of it. Technologies like artificial intelligence, machine learning, and quantum computing are transforming the life sciences landscape, and we remain committed to helping you integrate these advancements in ways that enhance decision-making and improve patient outcomes. However, none of this would have been possible without the trust and confidence of our clients, collaborators, and my fellow Axendians. You have been essential to our journey, and for that, we are deeply grateful.  Your continued support has driven our growth and success, and we look forward to the opportunity to keep providing you with actionable insights. As we enter our 20th year, we are excited about what lies ahead. Together, we will continue shaping the future of life sciences, and for that, we are grateful. https://lnkd.in/e_5PnEM9 Sandra Rodriguez Daniel Matlis Kelly Doering Thomas Maeder Eric M. Luyer Ellyn McMullin Robyn Barnes Giselle C. Matlis Jared Matlis Jordan A. Matlis Mónica V. M. David Lennard

Great panel on “Strategies for Overcoming Digital Transformation Challenges in Life Sciences” moderated by our very own Daniel Matlis at #OperationsCalling. Valuable insights from: Christopher Kopinski Amazon Web Services (AWS) Patrick Hyett Plvs Ultra Dharmesh Ved MBA,BSEE,PMP,6 σ Black Belt,Lean Expert, ZS Grateful to Natan Linder Gilad Langer Phillip Chea Michelle Vuolo Madilynn Castillo Rony Kubat Martin BOISVERT Elise Jones Tulip Interfaces Mónica V. M. Sandra Rodriguez Kelly Doering