All posts Tag / clinical pharmacology
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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 Storms December 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 Bruck April 30, 2025
NON-COMPARTMENTAL ANALYSIS (NCA) Accurate Reproducible Results Regulatory Expertise Timely Deliverables Tailored Solutions NCA Services Our Non-Compartmental Analysis (NCA) of PK and PD data are designed to help you make informed, data-driven decisions quickly and accurately in real-time in your on-going studies or throughout your drug development lifecycle. Whether you're in clinical pharmacology, translational sciences, biometrics or clinical operation, precise understanding of absorption, distribution, metabolism and elimination (ADME) of your new drug candidate is critical. Our team delivers accurate results with a strong focus on budget efficiency and meeting deadlines. A left-skewed bell curve graph of plasma concentration over time after dose, with the area under the curve (AUC) and the time to reach the maximum concentration (Tmax and Cmax) highlighted. Meet Linh - our EVP of Clinical Pharmacology. Linh is head of our CP department. Prior to this, she was a Clinical Pharmacology leader at Amgen, Exelixis, Medivation, Pfizer, Arcus and Treadwell. She has also taken on many leadership roles such as DMPK, bioanalytical, PK/PD modeling, trial design and execution, and globally regulatory agency filings.
services

NCA Services - Here to Help You Make Informed, Data-Driven Decisions Quickly and Accurately in Real-Time

Simonne Bruck April 1, 2025
Did you know... A2-Ai supports IND filling? Investigational New Drug (IND) Services: A2-Ai offers expert guidance on IND write-ups, justification, strategy, and development. IND applications are a critical piece of the drug development process and serve as the key gateway from preclinical to clinical research. We will assist you through the application process to help smooth the pathway to FDA approval. The A2-Ai team is available for writing the pre-IND Briefing and IND Document as well as attending the pre-IND meeting with the FDA to defend the dose escalation strategy, study designs, and clinical pharmacology plans Our philosophy: Results on time, on budget. By combining deep technical expertise with agile methodologies, A2-Ai delivers fast, impactful results that drive accurate study conclusions. By focusing on efficiency and smart resource allocation, we provide key results without exceeding budgets, ensuring clients get the most out of their investment. A2-Ai is budget-conscious, delivering high-quality technological solutions that maximize value while minimizing your costs. Preclinical Support: We will design preclinical PK/Tox/Pharmacology studies/ Design your First in Human (FIH) study as a part of the IND package and write IND modules, IB and study protocol. Pharmacometrics: Preclinical PK/PD modelling and simulation to support Dose/Schedule Selection Advanced mathematical and statistical support Clinical Pharmacology: We will draft the Pre-IND Briefing Document, and if needed will attend regulatory meetings to defend the company's position and answer the agency's questions. Education: Hands-on mentorship and educational training Access to our world-class expertise in both pharmacometrics and in instruction to help your team members grow Technology A2-Ai Cloud: scalable, secure computing environment - enabling faster analysis, easier collaboration, and all the reproducibility and traceability requirements needed in both experimental and GxP compliant contexts
services

IND Services - We Support and Assist You in IND Applications to Streamline the FDA Approval Process

Simonne Bruck February 28, 2025