Certara’s premier client conference explores how in-silico methods and biosimulation at scale derisk every stage of development, from market to molecule
RADNOR, PA – 2025年4月22日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in model-informed drug development, today announced Certainty 2025 will be held May 7-8 in Philadelphia at the CityView Convene. The second annual U.S. conference brings together Certara customers to learn and discuss how the model-informed drug development (MIDD) community is scaling its efforts and impacts around the globe. Sessions will cover the latest science, technologies, case studies, and value that MIDD delivers across the industry.
Following his keynote address, John Crowley, President and CEO of BIO, will comment on the current state of biotech, the challenges and opportunities ahead, and how leaders across clinical development can drive innovation in today’s evolving landscape. As a father of children diagnosed with the rare and life-threatening Pompe disease, and as CEO of BIO, John champions innovation across the biotech landscape, ensuring a future where science and policy align to drive breakthrough therapies.
The two-day Certainty agenda includes more than 40 speakers from 16 different drug development organizations, along with Certara distinguished scientists and executive leaders sharing insights, trends, and case studies about the meaningful outcomes Certara clients are achieving across all phases of drug development.
“Together with our clients, Certara is working to transform the drug development process to be faster and more efficient to accelerate medicines to patients,” said William Feehery, Certara’s CEO. “While in-silico and biosimulation methods are increasingly adopted industry-wide, there remains a tremendous opportunity to further deploy these strategies at scale across every phase of development for great benefit. This is the theme of our 2nd Annual Certainty conference, with our speakers highlighting the ways this is happening throughout the industry, across novel therapies and types of organizations.”
Designed for drug developers across disciplines, including pharmacometricians, clinical pharmacologists, regulatory science professionals, biostatisticians, and data scientists, the event offers a dynamic, multi-format program with parallel learning tracks including:
Seeing Further in Discovery and Non-Clinical Research: learn how informatics, GPTs, and advanced toxicology tools are speeding up drug discovery by creating space for scientists to focus on innovation.
Latest Advances in MIDD: Insights, Examples, and Perspectives: explore the evolving regulatory landscape around MIDD and the use of emerging technologies like machine learning, quantitative systems pharmacology (QSP), and physiologically-based pharmacokinetic (PBPK) modeling to optimize drug development processes.
Clinical Data Flow for Faster Analysis and Submission: new this year, a development and preclinical-focused track that will highlight data flows and insights from lead optimization through the preclinical phase.
Drug Development and Regulatory Strategy: Hear how regulatory agencies’ adoption of the Totality of Evidence approach is reshaping the strategic drug development process.
Navigating Early Drug Development: Gain insights into the financial, timeline, and attrition challenges in early drug development—and how leveraging modeling, simulation, and regulatory expertise enables strategic decision-making to de-risk and accelerate development for long-term program sustainability.
P21 User Group Meeting: Get a strategic look at the unified product roadmap across Pinnacle 21 and learn about our upcoming innovations, including a new Rules Editor for customizable validation, enhanced Metadata Repository (MDR) capabilities, and support for mapping specifications to streamline dataset standardization.
Phoenix User Group Meeting: 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.
PBPK Real World Applications Workshop: Gain insights from industry leaders on the most recent advancements in PBPK modeling applications, including drug-drug interaction (DDI) assessment, formulation development, label claim support, and more.
Gen AI in Document Creation: Experts from Certara will cover best practices for organization change management in GenAI for regulatory writing, how to create and govern prompts for accurate content generation, and GenAI applications beyond the CSR and other late clinical documents, including chemistry, manufacturing, and controls (CMC), pharmacokinetic (PK) report analysis, labeling, and more
Furthering its commitment to showcasing the future of modeling and simulation technology to improve drug development and delivery, Certara will highlight the following new product introductions available to Certara clients in 2025:
Phoenix Cloud:Phoenix, the industry-leading platform for PK/PD analysis and modeling, has new cloud-based modules including AI-enabled report creation, helping to automate and streamline the pharmacokinetics workflow.
Pinnacle 21 Metadata Repository: Building on its validation engine, Pinnacle 21’s clinical data standardization software, will now enable metadata creation and management designed to streamline the trial data workflow process by reducing study setup time, enhancing data quality, and ensuring compliance with CDISC standards.
Certara IQ: Certara will share an early look at its next-generation modeling platform, which is built on secure Generative AI-enabled model referencing, producing high-speed simulation capabilities and will be broadly available this fall.
Certainty by Certara is a global program featuring industry thought leaders from the Certara client community around the world who are utilizing the model-informed drug development framework, including biosimulation, data science, and drug development expertise to accelerate bringing new medicines to patients.
For more information about Certara’s global Certainty program, which includes in-person events in the US (Philadelphia), China, Korea, Japan, and EMEA, visit https://certainty.certara.com/ to learn more.
