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A MESSAGE FROM OUR CEO A2-Ai's 2025 Year in Review Time flew and it is already time to reflect the year 2025. For A2-Ai, this year was defined by pushing boundaries, deepening collaborative partnerships, accelerating technological innovation, and, most importantly, letting our people and culture lead the way. We supported another year of growing submission volume and regulatory engagement for our clients in the U.S. and across our expanding international footprint. Much of this success stemmed from the technology our team has developed: AI-enabled tools, packages, and products that streamline report generation, enhance collaboration, and enable quality control at scale. I'm especially proud to share that all submissions were built using R-based reproducible workflows for authoring and version control on our A2-Ai Cloud platform, along with a 100% agency acceptance rate. Beyond submissions and drug development, we reached an exciting milestone: A2-Ai technologies are now fully implemented across organizations ranging from early preclinical pharma to some of the largest pharmaceutical enterprises in the world, as well as other CROs. But the momentum didn't stop there. We expanded into new industries - including federal, energy, beverage, legal, and more - reinforcing something we believe deeply: when you lead with a solutions-first mindset, impact follows. This progress supports our vision of being more than a life-sciences leader; becoming a solutions company built to empower people across industries to do more, faster, and with greater confidence. Most importantly, A2-Ai continues to grow through the strength of our collaborators, teams and individuals who refuse to accept the status quo in their pursuit of better outcomes for the people who need them most. That shared drive is at the heart of why we do what we do. This year, traveling to conferences like Posit:Conf, ACoP, and ASCPT gave us the chance to meet so many of you in person who make these industries so great. These events helped us deepen our relationships, speak openly about what's working, and stay honest about where we can keep improving - while always staying anchored to our mission. Looking ahead to the new year, we're energized to see how our unique blend of people, culture, and technology helps to transform the development of new therapies and the delivery of solutions to those who need them. Thank you to everyone who has joined us so far on our journey. We are just getting started and can't wait to keep building together. Wishing everyone a prosperous and impactful 2026. - Sunny
updates

A Message from Sunny Chapel: 2025 Year in Review

Eric StormsDecember 16, 2025
The future of MIDD - How are you preparing? The FDA has officially announced their roadmap to phase out animal testing for monoclonal antibodies. How are you preparing? When your regulatory and operational questions inevitably arise, our experts will be there to answer them every step of the way. Jack Cook SVP, Clinical Pharmacology • 30+ years at Pfizer • 35+ years in pharmaceutical sciences • MIDD leader Linh Nguyen EVP, Clinical Pharmacology • 20+ years in Drug Development • Modeling and Clinical Pharmacology leader • Amgen, Exelixis, Medivation, Pfizer, Arcus, and Treadwell Limitations of Animal Testing: • Safety signals - extremely difficult to translate in animals to men for biologics • Variability in immune architecture can obscure translatability • Interspecies differences cause limitations in predicting human toxicity "more effective, human-relevant methods" AI-based computational models Mimic human cognition to analyze data and measure toxicity within a drug - Reliably predict side-effects and the drugs mollecular composition Humanoids/Organoids Mimic human organs, such as the liver, heart, and immune organs to test drug safety Reveals toxic effects that could easily be undetected in animals Real-world Human Data Using Safety data from countries with similar regulatory standards where the drugs with similar targets have already undergone human studies
news

MIDD - FDA Has Officially Announced Their Roadmap to Phase Out Animal Testing for Monoclonal Antibodies

Simonne BruckApril 30, 2025
A2-AI CLOUD COMPUTE PLATFORM a scalable + secure computing environment Are your slow NONMEM/Monolix run times impacting your workflows? Do you have trouble getting access to resources when multiple people are working? Is your system so outdated that you can't access the software you need? A2-Ai Cloud's Solution R and Python Workflows Create custom and industry-compliant environments to harness the power and flexibility of open source for reproducible analyses. Batteries Included for Clin Pharm and Pharmacometrics NONMEM, MATLAB, Monolix, WinNonLin and more to run your analyses while utilizing the platform's scale-out infrastructure. This way, your team always has access to the resources they need. GxP Compliant A2-Ai Cloud will cover your organizations need for data integrity, validation, and auditability. We love talking quality! Analyses using A2-Ai Cloud have been successfully accepted by all major regulatory agencies. BUILT FOR SCIENTIFIC TEAMS A2-Ai Cloud has been built from over a decade of supporting scientists. With A2-Ai Cloud, you can run it your way. Whether you prefer us to fully manage the platform for you, or collaborate with your IT team to deploy it into your environment, we'll work with you to find the design that works for you! Join us and revolutionize the way you approach innovation and compliance in the world of BioTech and Pharma.
productsservices

A2-Ai Cloud - A Cloud-Based Platform for Drug Development, Your Way

Simonne BruckMarch 11, 2025