Blog

Explore our latest insights, news, and updates in clinical pharmacology and pharmacometrics and discover new products & services we're working on to help you accelerate your drugs to market.

Handling Missing Covariates

Handling of Missing Covariates

Meg Gonsalves April 30, 2026

Modeling Monday, Part 2: Fixed vs. Mixed Effects Modeling—From Naïve Pooling to Population Pharmacokinetics

Meg Gonsalves March 9, 2026

news services products tooling research spotlights case studies

Handling Missing Covariates

Handling of Missing Covariates

Meg Gonsalves April 30, 2026

Modeling Monday, Part 2: Fixed vs. Mixed Effects Modeling—From Naïve Pooling to Population Pharmacokinetics

Meg Gonsalves March 9, 2026

research spotlights

Mapping the Psychedelic Brain: What Intravenous DMT Reveals About Neurochemistry and Cortical Dynamics

Meg Gonsalves February 18, 2026

Modeling Monday, Part 1: Noncompartmental Analysis as the Foundation of Pharmacokinetic Insight

Meg Gonsalves February 9, 2026

research spotlights

From Mouse to Horse to Human: What Metronidazole Can Teach Us About Translating Pharmacokinetics Across Species

Meg Gonsalves January 20, 2026

A Year of Science at A2-Ai: Reflections from 2025

Meg Gonsalves December 26, 2025

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

A Message from Sunny Chapel: 2025 Year in Review

Eric Storms December 16, 2025

New FDA Guidance on QTc Labeling: What Drug Developers Need to Know

Meg Gonsalves December 8, 2025

research spotlights

Aligning Clinical Trials with Real-World Aging Trends

Meg Gonsalves November 20, 2025

servicescase studies

Accelerating FDA Approval with MIDD: How A2-Ai Secured a New Dose Without a Phase 3 Trial

Eric Storms November 14, 2025

Introducing reportifyr: an R-Based Open-Source Tool for Automated Reporting

Eric Storms June 27, 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

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.

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

Simonne Bruck April 1, 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 Bruck March 11, 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

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

Simonne Bruck February 28, 2025