Certainty 2025: Model Informed Drug Development at Scale
Building on the successful Certainty events around the globe in 2024, this year’s focus is how the model informed drug development community is scaling its efforts and impacts around the globe. At Certainty 2025 we are highlighting the latest science, technologies, case studies and value that MIDD is delivering across the industry. This year we have added a development and preclinical focused track that highlights data flows and insights from lead optimization through the preclinical phase.
our schedule
Agenda coming soon.
Agenda coming soon for the following tracks: Phoenix UGM, Pinnacle21 UGM, QSP Summit, Certara Discovery
QSP Summit: Technologies and Methodologies supporting QSP at Scale
Building on the milestones of QSP Summit 2025, this dedicated Day 2 track showcases how Quantitative Systems Pharmacology (QSP) is an increasingly adopted methodology in model-informed drug development. Now in its tenth year, the summit will unite industry innovators, academics, and thought leaders to explore how computational modeling is bridging biology and pharmacology to predict clinical outcomes, inform first-in-human dose decisions, and accelerate drug development timelines. New this year, we will spotlight Certara’s emerging AI-enabled QSP platform that is enhancing predictive power, automating model refinement, and expanding the reach of mechanistic modeling. Highlights will include case studies demonstrating scalability across rare and neurodegenerative diseases, strategies for reducing reliance on animal models via non‑animal safety evaluation tools, and innovative applications like virtual patient populations and digital twins. Expect forward-looking discussions on how regulatory acceptance, AI‑integration, and rigorous mechanistic modeling are transforming QSP from a niche methodology into a foundational pillar across R&D.
Parallel learning tracks for every facet of development:
Seeing Further in Discovery and Non-Clinical Research
Drug discovery follows a Design-Make-Test-Analyze cycle, where each new set of assay results and in silico predictions inform the next generation of compound candidates. Learn how informatics and GPTs are accelerating this cycle, freeing scientists to focus on the innovative leaps required to advance new leads. Then, see how the combination of quantitative systems toxicology and on-demand visualization of SEND datasets can identify potential off-target effects and adverse events sooner. 
Ideal for: VP of R&D, Head of Chemistry, Head of Biology, Lead Toxicologist, Lead Pathologist
Latest Advances in MIDD: Insights, Examples and Perspectives
This track highlights innovative approaches in Model-Informed Drug Development (MIDD) to optimize drug development processes. Topics include the evolving regulatory landscape with the draft ICH M15 guidance, the application of Quantitative Systems Pharmacology (QSP) and Physiologically-Based Pharmacokinetic (PBPK) modeling for oncology therapies, and novel techniques for dose optimization. Experts will also discuss challenges in Phase II dosing and explore emerging technologies such as machine learning to enhance pharmacokinetic modeling accuracy.
Clinical Data Flow for Faster Analysis and Submission
Automating the flow of clinical data from source to CDISC deliverables accelerates both analysis and submission. Explore the technologies and meet the teams that will make this possible, as we examine metadata repositories, data transfer processes with automated error checking, and collaborative validation platforms. 
Ideal for: VP of Biometrics, Head of Data Standards, Head of Data Management, Heads of Biostatistics
Drug Development and Regulatory Strategy
Embracing Totality of Evidence throughout your drug development journey
Regulatory agencies are increasingly embracing the Totality of Evidence approach, reshaping drug development strategies and decision-making. Join experts from Certara’s Drug Development Solutions and Regulatory Sciences teams as they discuss this shift in regulatory philosophy, its impact on pharmaceutical development, and how companies can navigate both the challenges and opportunities it presents.
Ideal for all Executives and Leaders
