benefits
REASONS TO CONVENE
Discover new solutions
See how other customers have moved with certainty through development with “new to you” solutions.
Dive deep into your core product
Find your tribe and learn directly from product owners during Day 2 user group meetings.
See the future
Where is biosimulation headed next? Will we ever automate our way to full data standardization? Find out from thought leaders inside and outside of Certara.
AI in Drug Development
Can GPTs speed compound identification? Where is biosimulation headed next? What's new in regulatory submissions? Find out from thought leaders inside and outside of Certara.
our schedule
Building on the success of Certainty events held around the world in 2024, Certainty 2025 will focus on how the model-informed drug development (MIDD) community is expanding its global reach and impact. This year’s program will showcase the latest science, technologies, case studies, and the tangible value MIDD is delivering across the industry.
The agenda will feature expert-led lectures and dynamic panel discussions covering real-world MIDD applications, emerging regulatory trends, and cutting-edge technologies—all presented by industry leaders and distinguished guest speakers.
9:00 – 9:30
William Feehery, CEO
Greater Certainty in Drug Discovery and Development
As drug development becomes increasingly complex and the regulatory environment continues to evolve, the need for earlier, smarter decisions has never been more urgent. Together with our clients, Certara is leading the shift toward predictive, and data driven R&D—empowering scientists to transform data into knowledge faster than ever and identify the most promising drug candidates earlier in the process.
Attendees will gain insight into:
- Why regulatory and industry trends are accelerating the adoption of biosimulation and in silico approaches
- How AI-driven technologies are reshaping every stage of the drug development lifecycle
- The latest innovations from Certara and their impact on decision-making and speed to market
Speaker: William Feehery, CEO, Certara
9:30 – 10:00
Stefan Platz
Keynote Session: Accelerating Drug Development – A Vision for 2030
AstraZeneca’s commitment to deliver 20 new medicines by 2030 is driving a fundamental transformation in how the company approaches R&D. This keynote will explore how that ambition is reshaping decision-making, accelerating technology adoption, and fostering deeper collaborations. Through the strategic integration of modeling and simulation, AI, and digital data flows, AstraZeneca is building a more agile, predictive, and sustainable development model. This session will highlight practical examples of how these innovations are advancing scientific discovery, strengthening organizational leadership, and increasing the likelihood of success in bringing new medicines to patients.
10:00 – 10:30
Robert Aspbury
Revolutionizing Drug Development: The Transformative Role of Biosimulation in Enhancing Innovation and Efficiency
As the adoption and utility of biosimulation in drug development grows, the supporting technology, use cases, and scientific applications are rapidly evolving. In this session, Certara will share its vision for the future of biosimulation and highlight new platform capabilities designed to deliver deeper predictive insights earlier in discovery, streamline collaboration, and improve confidence in decision-making. Learn how these innovations are helping accelerate the development of safer, more effective medicines — and bringing them to patients faster.
Speaker: Robert Aspbury, PhD, President, Certara Predictive Technologies
11:00-11:45
Stefano Zamuner, Stefan Platz, Andrea Manfrin
Driving Smart Decisions from Discovery to the Clinic
This panel will highlight how modeling can support decision making across phases of development. What early decisions are created, how is that information and insight tracked and shared with others? Both mechanistic and empirically based decision making will be discussed as well as regulatory perspectives and expectations along with impact to other decisions and stakeholders.
Speakers:
Stefano Zamuner, Vice President and Head, Clinical Pharmacology Modelling & Simulation, GSK
Stefan Platz, Senior Vice President Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca
Dr. Andrea Manfrin, Deputy Director of Clinical Investigations and Trials, MHRA
11:45-12:30
Eva Gil Berglund, Justin Hay
Shift in Regulatory Approaches to Support Totality of Evidence Thinking
This session will explore how regulatory evolution is enabling a broader, more integrated approach to drug development, one that embraces the Totality of Evidence (ToE) by incorporating clinical data, New Approach Methodologies (NAMs), and modeling and simulation. This broadened regulatory thinking is creating new opportunities to accelerate development and improve decision-making. Experts will share perspectives on this shift and preview real-world case studies that illustrate how ToE is being applied in practice to support more innovative and efficient drug development pathways.
Speakers:
Eva Berglund, PhD, Senior Director, Regulatory Strategy and Clinical Pharmacology, Certara Drug Development Solutions
Justin Hay, PhD, Senior Director, Regulatory Strategy and Clinical Pharmacology, Certara Drug Development Solutions
13:30 – 14:15
Helen-Marie Dunmore
NAMs in Action: Real-World Progress and Future Directions in Nonclinical Safety
As the pharmaceutical industry shifts toward more predictive and ethical approaches in nonclinical safety, New Approach Methodologies (NAMs) are gaining momentum. But how are they really being used today and what’s next? In this session, we’ll explore findings from recent cross-industry insights on the adoption of NAMs, including barriers, opportunities, and the path to regulatory confidence. Hear from industry leaders as they discuss real-world applications of NAMs in drug development, strategies for integrating these tools alongside traditional methods, and how to advance science while reducing reliance on animal studies. This conversation will highlight what’s working, what’s still needed, and how to stay ahead as safety science evolves.
Speaker:
Helen-Marie Dunmore, PhD, Senior Director, Toxicology, Certara Drug Development Solutions
14:15 – 15:00
Rik de Greef, Mirjam Trame, Paul Matthias Diderichsen, Gareth Lewis
Leveraging Modeling and Simulation to Accelerate Drug Development and Regulatory Success
This session explores how advanced modeling and simulation approaches are transforming drug development by enabling faster, more informed decisions and regulatory alignment. We will highlight three case studies illustrating the breadth and impact of these tools. The first showcases how physiologically-based pharmacokinetic (PBPK) modeling was used to address drug-drug interaction (DDI) questions for niraparib, a PARP inhibitor, in lieu of clinical studies, leading to model-informed labeling language adopted by Health Canada. The second examines how Model-Based Meta-Analysis (MBMA) synthesizes data across clinical trials to inform dose selection, benchmark efficacy, and optimize trial design, especially where traditional comparative data are unavailable. A third presentation will focus on the application of pharmacometrics to support development strategy, enhance decision-making, and address specific regulatory questions. Collectively, these talks underscore how quantitative pharmacology enables innovation, efficiency, and confidence in global drug development.
Panelists:
Rik de Greef, MSc, SVP, Global Quantitative Sciences Services, Certara Drug Development Solutions
Mirjam Trame, VP, Certara Drug Development Solutions, Head of Pharmacometrics USA – Division II
Paul Matthias Diderichsen, SVP, Quantitative Science Services (Europe/Africa)
Gareth Lewis, PhD, Director in PBPK Modelling, DMPK, UK, GSK
15:30 – 16:00
Andrea Manfrin
Driving innovation in regulatory science with advanced technologies
Speaker: Dr. Andrea Manfrin, Deputy Director of Clinical Investigations and Trials, MHRA
Regulators including MHRA are increasingly taking a totality of integrated evidence approach and collaborating across the industry to support innovative frameworks that align with regulatory objectives. This talk will share a vision for model-informed evidence (MIE) and model-informed drug development (MIDD) along with practical applications of these approaches that improve the safety, quality, and speed of clinical trial applications, assessments, and authorizations.
16:00 – 16:45
Erin Erginer
From Standardization to Validation with Pinnacle 21
Validated datasets are essential to analysis and submission. Consequently, it’s no surprise that organizations bring programming experts and solutions like Certara Pinnacle 21 to the all-important task of validation. But if speed and consistency are just as critical as accuracy in this task, then standardization represents an under-used lever. Standards governing trial design, eCRFs, vendor data transfers, and specs for mapping source data to CDISC domains—along with other study content—can dramatically reduce cycle times and validation burden.
Learn how Pinnacle 21’s standards-based modules, including its Clinical Metadata Repository, Data Exchange for transfer spec and validation, and Form Studio, are building on the proven capabilities of its validation engine, issue management workspace, and tools for creating Define.xml and xDRGs. Finally, see how these modules operate together to foster re-use and expedite the path from clinical question to documented answer.
Presenter: Erin Erginer, Senior Director of Product, Certara
16:45 – 17:30
Panel Discussion: The Digital Data Flow from Protocol to Submission
Have we reached a tipping point in the effort to digitalize clinical trials? With the rise of metadata repositories to standardize data at the point of acquisition, to the AI-powered drafting of eCTD reports, the right technology now exists to support a truly digital data flow. But technology alone can’t unite data collection, analysis, and reporting. Industry standards—such as the Unified Study Definitions Model (USDM)—must provide a common language for digital protocols to flow seamlessly across systems, functions, and stakeholders.
This session will explore how USDM supports automation, standardization, and system interoperability—helping organizations reduce cycle times, increase data quality, and improve submission readiness. Drawing on current trends and frameworks from TransCelerate and CDISC, the discussion will focus on high-impact strategies for leveraging USDM to future-proof trial operations and drive enterprise-level value.
Moderator: Erin Erginer, Senior Director of Product, Certara
Panelist: Peter Van Reusel, CDISC
17:30 – 17:40
Conclusions for CERTAINTY 2025 EMEA
18:00 – 20:00
Customer Appreciation Dinner
| Certara Demos - Estocolmo | 10:30- |
12:30- |
13:00- |
15:00- |
|---|---|---|---|---|
| D360™ | ||||
| Drug Interaction Database (DIDB®) | ||||
| SEND Explorer® | ||||
| Phoenix® | ||||
| Toxicology/NAMs | ||||
| TFL Studio | ||||
| Certara.AI | ||||
| Pinnacle 21® | ||||
| Drug Development Strategy | ||||
| Pediatrics | ||||
| Simcyp®/QSP | ||||
| Pirana® Darwin | ||||
| DDI Innovation Engine | ||||
| BDSA |
9:00 – 10:30
Concurrent Morning Sessions
Plenary Session
Phoenix Training
Details coming soon.
How to Simulate Steady-State Profiles from a Single Dose
(Using Non-Parametric Superposition and WinNonlin Modeling)
Trainer: Ana Henry, Executive Director, Training and Certara University
This hands-on workshop will demonstrate how to simulate steady-state concentration-time profiles using single-dose data in Phoenix WinNonlin. Participants will learn how to apply Non-Parametric Superposition (NPS) and compartmental modeling approaches to predict steady-state behavior, compare results, and explore key assumptions behind each method. Whether you're new to simulation or looking to refresh your skills, this session will provide practical guidance on steady-state predictions using Phoenix tools.
Key topics include:
- Introduction to Non-Parametric Superposition (NPS)
- Simulating steady-state using compartmental models
- Interpreting and comparing simulated profiles
Requirements:
Working knowledge of Phoenix WinNonlin NCA
10:30 – 12:00
Breakouts Tracks
P21 User Group Meeting
Phoenix User Group Meeting
Failure to Launch: Smarter Strategy to Get the Right Drug to the Right Patient
10:30 - 11:00 - Roadmap & Vision with Erin Erginer, Senior Director of Product
A strategic look at the unified product roadmap across Pinnacle 21 and ryze. Erin will highlight upcoming innovations, including a new Rules Editor for customizable validation, enhanced Metadata Repository (MDR) capabilities, and support for mapping specifications to streamline dataset standardization. The session will also cover improvements to data exchange, foundational platform enhancements, and the broader vision for an integrated ecosystem designed to accelerate submission readiness and data quality.
11:00 - 12:00 - Panel Discussion: Metadata Repository and Standards
As clinical trials grow in complexity, metadata plays a critical role in enabling consistency, traceability, and reuse across the data lifecycle. This panel will explore the evolving landscape of metadata repositories and industry standards, including CDISC, controlled terminology, and automation-enabling metadata models. Experts from sponsor organizations, technology providers, and regulatory perspectives will discuss practical challenges and solutions in implementing scalable metadata strategies to support faster study builds, submission readiness, and long-term data governance.
Morning Theme
Advancing with Phoenix: Innovation, Automation, and AI Integration
Join us for a comprehensive look at the present and future of Phoenix and a forward-looking discussion on how Phoenix is integrating innovation to empower users and accelerate results.
10:30 - 11:00 Product Overview, Vision, and Roadmap
Fred Mahakian, Sr. Director Product, Phoenix Portfolio
This session offers a present- and forward-looking view of the Phoenix Platform, focusing on its long-term vision and strategic roadmap. Following an exploration of what's next in Phoenix 8.6, we’ll share how the product is being reimagined to meet emerging needs, modernize its foundation, and support future innovation—while staying true to its core strengths.
With decades of legacy behind it, Phoenix is entering a new phase of evolution. Join us to see where Phoenix is now, where it's headed, headed and how we’re preparing it for what’s next.
11:00 - 11:30 Streamlining TFL Production in Phoenix Cloud
This session introduces the Phoenix Cloud TFL module—a purpose-built solution for scientific data visualization and analysis in life sciences. Designed to complement the desktop Phoenix environment, the module enables high-quality, submission-ready tables, figures, and listings in a modern cloud-native platform. We’ll explore how this new capability supports the unique needs of clinical teams, enhances scientific communication, and reflects our broader vision for the future of data visualization in regulated research.
11:30 - 12:00 The Growing Role of Artificial Intelligence in Pharmacometrics
Explore how AI is already enhancing PK report generation and paving the way for smarter, faster modeling and analysis.
11:15 - 11:30 - Failure to Launch: The Hidden Cost of Poor Strategy
This session sets the stage by exploring why so many promising therapies never reach patients. With only ~40% of approved drugs recouping their development costs, the stakes are high, and the root cause is often strategic, not scientific. We’ll examine how early misalignment across scientific, regulatory, and commercial functions leads to costly inefficiencies and missed opportunities. Attendees will learn to identify these blind spots early and how integrating biosimulation, regulatory foresight, and a compelling business case improves both development outcomes and investor readiness. This session also highlights how data-driven development plans can build confidence with stakeholders and unlock critical funding at each stage of the journey.
Speaker: Fran Brown, PhD, Global Head Drug Development Science
11:30 - 12:00 - Getting the Right Clinical Candidate
Selecting the right clinical candidate is one of the most pivotal decisions in drug development. This session explores how model-informed translational strategies, especially Quantitative Systems Pharmacology (QSP), can be used to pressure-test the mechanism of action, predict downstream performance, and evaluate whether the candidate has the right attributes to succeed in the clinic. We’ll also discuss how integrating scientific modeling with early development strategy helps avoid false starts, prioritize assets with the strongest potential, and set the foundation for an efficient and successful development trajectory.
Speakers:
Pablo Morentin Gutierrez, Director of Translational PK/PD, AstraZeneca
Piet van der Graaf, PharmD, PhD, Senior Vice President, Quantitative Systems Pharmacology
Arne van Schanke, PhD, Director, Early Development, Certara
13:00 – 15:00
Breakouts Tracks Continued
P21 User Group Meeting
Phoenix User Group Meeting
Failure to Launch: Smarter Strategy to Get the Right Drug to the Right Patient
13:00 - 13:30 - Challenges in Representing Real-world Data in CDISC SDTM
Leveraging real-world data (RWD) and real-world evidence (RWE) to support postmarket safety and label expansion of approved drugs is an emerging opportunity. Learn how Pinnacle 21 team and technology have helped to map RWD to regulatory accepted SDTM datasets, supporting safety and efficacy from registry and other observational studies.
13:30 - 14:15 - Integrating Data Managers into P21
This session shares lessons learned and progress made in expanding data manager involvement in a Pinnacle 21 Enterprise implementation. The presenter will discuss how roles, processes, and training have evolved to better integrate data managers into validation workflows, from issue review to standards alignment. Practical examples will highlight improved collaboration between data management and programming teams, along with ongoing challenges and next steps for scaling this approach across studies and functions.
14:15 - 15:00 - Creating Custom Issue Metadata
Issue resolution can be time consuming for data management and programming teams, as setting the actual source values could be different than the Pinnacle 21 Enterprise (P21E) default values. See how P21E allows organizations to create Custom Issue Metadata, which includes fix tips, explanations, and default statuses and sources. These capabilities offer organizations the option to set company recommended default values based on internal approaches and leverage past successes and lessons learned, streamlining the validation process.
Afternoon Theme
User Feedback Session
This interactive session is your chance to share your ideas for how to make Phoenix even better. We will have a feedback-driven conversation about what’s working, what’s not, and what you'd love to see next in Phoenix. Through some creative prompts, we’ll gather insights straight from the people who know the software best—you! Come ready to speak up, vote, laugh, and help shape the future of Phoenix in a fun and collaborative environment.
13:00 - 13:30 - Evaluating Therapeutic Potential
Getting the dose right is more than a regulatory checkbox, it’s central to unlocking a therapy’s full value. In this session, we’ll explore how biosimulation models support smarter dose selection, optimize trial design, and predict drug behavior across diverse patient populations. You’ll see how integrating these approaches early helps reduce trial failure risk, accelerate decision-making, and improve the chances of clinical and regulatory success. Real-world examples will show how model-informed drug development strategies have shortened timelines, reduced costs, and increased confidence in key program decisions.
Speakers:
Amandine Manon, PharmD, Senior Director, Clinical Pharmacology & Translational Medicine
Justin Hay, PhD, Senior Director, Regulatory Strategy and Clinical Pharmacology, Certara
13:30 - 14:15 - Preparing for Commercial Success
Success doesn’t stop at approval. This session explores the importance of planning for reimbursement and market access starting as early as Phase 2, if not before. We’ll discuss how integrating regulatory and commercial evidence requirements into your development strategy ensures you generate the right data to support pricing, access, and adoption globally. From aligning with HTA bodies to building Totality of Evidence frameworks, this session will show how smart planning and cross-functional evidence generation can significantly improve your launch trajectory, reduce late-stage surprises, and increase the likelihood of commercial success.
Speakers:
Vishwas Agashe, PhD, MSc, Associate Principal, Global Market Access, Pricing & Reimbursement, Certara
Sanja Stanisic, MSc, MIHMEP, Director, Certara Evidence & Access
15:00 – 15:15
Closing/departure
| Certara Demos - Estocolmo | 12:00- |
12:30- |
|---|---|---|
| D360™ | ||
| Drug Interaction Database (DIDB®) | ||
| SEND Explorer® | ||
| Phoenix® | ||
| Toxicology/NAMs | ||
| TFL Studio | ||
| Certara.AI | ||
| Pinnacle 21® | ||
| Drug Development Strategy | ||
| Simcyp®/QSP | ||
| Pirana® Darwin | ||
| PK Submit® |
