Translating Mechanistic Insight into Confident Predictions
This track at Certainty will focus on current advances and practical applications of physiologically based pharmacokinetic (PBPK) modeling. Scientific sessions will highlight key areas where PBPK informs decision-making across drug development, including first-in-human (FIH) dose prediction, formulation design, drug-drug interaction assessment, and dose optimization in specific populations.
Designed for participants across all levels of PBPK expertise, this track will strengthen confidence in model-informed drug development and regulatory interactions.
Through expert presentations and real-world case studies, this track will provide:
- A deeper understanding of emerging best practices in PBPK modeling
- Actionable insights that can be directly applied to ongoing programs
- An understanding of the strategic value of PBPK modeling in identifying risks early, informing decisions, and preventing avoidable delays.
Tuesday, April 14, 2026
Agenda
The PBPK Workshop is co-located with Certainty by Certara. Attendees of the PBPK Workshop 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: A Certara 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 – 10:30
Amin Rostami
Management Forum: What Scientific Leaders Need to Know About PBPK
Physiologically-based pharmacokinetic (PBPK) modeling has evolved from a research tool into an approach routinely accepted in regulatory submissions, with global regulators affirming its value across a wide range of applications. To date, more than 120 FDA-approved novel drugs have used PBPK modeling via Simcyp® Simulator in lieu of clinical studies.
For leaders of scientific teams, the challenge is less about building models and more about knowing when, why, and how to integrate PBPK models to drive development and regulatory impact. This Management Forum is a unique educational program designed to highlight key benefits and applications of PBPK modeling for members of management teams. It highlights the strategic benefits and practical applications of PBPK modeling, with an emphasis on the industry-leading Simcyp platform.
Key topics include:
- Overview of Simcyp and the landmark EMA qualification of the Simcyp Simulator
- Current applications and emerging trends in PBPK modeling
- Key use cases, including DDI, first-in-human (FIH), and special populations
Don’t miss this opportunity to network with peers and gain insights from leading PBPK experts.
Presenter: Amin Rostami, PhD, FCP, FAAPS, FJSSX, FBPS
10:30 – 11:00
Morning break
11:00 – 12:30
Amin Rostami
Management Forum Continued
12:30 – 1:00
Jingjing Yu
PMRs and PMCs for CYP3A-mediated DDIs: Analysis of FDA Recently Approved Drugs
Addressing knowledge gaps at the time of a new drug approval through DDI-related PMRs and PMCs is critical to ensuring the safe and effective use of new drug products. Recent CYP3A-related PMRs and PMCs, including both clinical studies and PBPK-based approaches, were identified using the Certara Drug Interaction Database (DIDB) and further characterized to understand the nature of these regulatory requests.
Presenter: Jingjing Yu, MD, PhD, Director, Drug Interaction Solutions, Certara
1:00 – 2:00
Lunch and learns
2:00 – 3:30
Afternoon session
This session features real-world case studies from industry leaders on the application of physiologically based pharmacokinetic (PBPK) modeling across drug development programs.
- Amitava Mitra, PhD, FAAPS, Vice President, Clinical Pharmacology at Kura Oncology, Inc.
- Andy Zhu, PhD, DABT, Senior Director at Takeda
- Priyanka Kulkarni, PhD, Associate Scientific Director at Takeda
- Qiang Fu, PhD, Associate Director, Clinical Pharmacology and Pharmacometrics at Bristol Myers Squibb
- Devendra Pade, PhD, Senior Principal Scientist at Amgen
3:30 -3:45
Close of day
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.
