On the first day of the Phoenix UGM, learn how empirical PK/PD methods like NCA and popPK are complementing in silico approaches like PBPK and QSP to answer the most daunting challenges in development, from optimal first-in-human dosing to presenting clin pharm evidence effectively in your NDA or BLA.
On Day 2, gather with fellow Phoenix users for interactive sessions on our newest capabilities, our roadmap, and the growing role of AI in modeling and reports.
Tuesday, April 14, 2026
Agenda
The Phoenix UGM is co-located with Certainty by Certara. Attendees of the Phoenix UGM are invited to attend Certainty on April 14th for access to plenary & keynote presentations. View Certainty Agenda >
Wednesday, April 15, 2026
7:30 – 8:30
Breakfast & badge pick up
8:30 – 9:00
Sean McGee
From protocol to submission: an optimized digital workflow
Like a decathalon, a clinical study is a series of challenges. Selecting the right endpoints. Drafting a protocol. Setting up data collection. All this needs to happen before the first patient visit. From there, it’s wave after wave of data validation and analysis, reporting and table-creation, and the million-and-one checkpoints of submission.
How much time, cost, and pain might be saved by relying on a suite of interconnected solutions, each purpose-built for its task? Find out in this fast-paced demonstration of Certara capability from protocol to submission. In 30 minutes, you’ll see how our increasingly AI-driven technology supports your organization right from start, when a study is little more than a justified hope. Sean McGee will present solutions for endpoint selection, optimal trial design, data standardization, analysis, reporting, and more. Live 5-plus years of the trial life in a half-hour, all with Certara by your side.
Presenter: Sean McGee, MS, Director of Product, Certara
9:00 – 9:45
The next era of PK/PD: Innovation driving the future of Phoenix
Join us to understand our vision and strategy for modernizing the PK/PD workflow with modern cloud technology, including AI, while ensuring the deterministic engines driving the results of a study remain intact. This session will focus on the Phoenix application in the cloud, and provide an overview what we have delivered so far, and where we will focus our efforts in the next 6 – 18 months.
9:45 – 10:30
Product deep dives:
TFL Studio – From Analysis to Publication-Ready in Minutes
AI PK Reports – From Results to Report: AI-Powered PK Documents
The first two modules of Phoenix Cloud built directly for the web arrived in the last few months of 2025. Given the excellent response from you, our user community, we’re fast- tracking enhancements in 2026.
We’ll start with a deep dive of TFL Studio, Phoenix Cloud’s no-code module for generating Tables, Figures, and Listings (TFLs) for PK/PD workflows. We’ll take a close look at reusable templates, in-app review/commenting, and end-to-end traceability from source data to final rendering for regulatory-ready outputs. A “what’s new” spotlight on TFL Studio v1.1 will showcase expanded Admin Automations (including analysis-level defaults like unit substitutions and dynamic flag footnotes), richer table/figure controls (e.g., error bars from pre-calculated statistics, adjustable legend width), and usability upgrades.
We’ll then connect the dots to AI PK Reports, the generative-AI module that converts your TFLs into fully formatted draft PK/TK reports—using configurable templates, pre-defined prompts, and Phoenix Cloud data integration to compress a process that can take days or weeks into minutes.
10:30 – 11:00
Morning break & future product preview labs
11:00 – 11:30
Fred Mahakian, Jyoti Shah, Jocelyn Webb
Panel discussion - Impact of AI in PK/PD workflows
Hear from leaders at Merck and Charles River Laboratories as they share their progress on, and goals for, AI adoption among PK/PD teams. What are their criteria for a potential move to Phoenix Cloud, and what are the primary scientific, operational, or strategic drivers shaping that decision? How do they see cloud infrastructure and AI capabilities coming together to reshape PK/PD workflows over the next few years, and what implications does that have for how their teams operate?
After a candid discussion led by Fred Mahakian, we’ll open the floor to questions.
Moderator: Fred Mahakian, Senior Director of Product, Certara
Panelists:
Jyoti Shah, Director of Digital Solutions and Product Line Leader, Merck
Jocelyn Webb, Associate Director, Global Pharmacokinetics, Charles River Laboratories
11:30 – 12:15
The future of PopPK - a look into modeling with Phoenix
Preview the Phoenix Cloud experience aimed at making NLME model discovery and early exploration easier. Key components you’ll get a look at:
- Model Library (templates): Quickly find NLME model templates based on model type and the practical problem they solve.
- Guided model design (structural designer): Build models through an intuitive interface (e.g., compartments, absorption, elimination, covariates) rather than starting from scratch.
- Text design with PML output: Generate and work with PML text as you design with the GUI—then continue in a textual workflow when you need full control.
- AI + validation support: Assistance when authoring/editing textual models, plus PML syntax validation to catch issues early.
- Quick simulation + visual output: Run fast simulations on shared cloud compute and review results visually for rapid iteration.
- Take your work offline: Export outputs so you can continue in downstream workflows (e.g., Pirana/rsNLME)
12:15 – 1:00
Elliot Offman
Scientific Keynote: From Preclinical to First-in-Human: Applying Phoenix® to Address Common Questions in Drug Development.
As drug development evolves, empiric cross-species scaling remains a powerful tool for predicting human pharmacokinetics. In this session, we explore time-invariant PK scaling methods—such as the Dedrick and Wajima approaches—that describe the full PK time-course rather than just scaling clearance and volume.
Learn how these techniques can be implemented within Phoenix® to support translational decision-making, improve first-in-human predictions, and strengthen dose selection strategies in a regulatory-ready environment.
1:00 – 2:00
Lunch & future product preview labs
2:00 – 3:30
Your voice, your Phoenix: Product feedback
3:30 – 4:00
Direct access: Q&A with the Phoenix experts & adjourn
Reserve your spot
Reserve your spot for the Certainty US 2026 customer event for exclusive access to the Certara community of experts, industry leaders, and peers as we collectively explore the latest innovations and opportunities to bring greater certainty to drug discovery and development.
