ISSX 27th North American Meeting

At the ISSX 27^th North American Meeting, themed “Back to the Future: DMPK Foundations and New Concepts,” Certara will demonstrate how its biosimulation platforms and strategic expertise help researchers understand, predict, and optimize pharmacokinetics and drug metabolism across diverse therapeutic modalities.

Leveraging platforms such as Simcyp® Simulator for physiologically based pharmacokinetic (PBPK) modeling, Certara helps teams predict human PK from preclinical and in vitro data, evaluate drug–drug interaction potential, assess variability across patient populations, and de-risk development decisions earlier in the pipeline.

Visit us to learn how our solutions support confident, model-informed strategies from discovery through clinical development.

Trusted by 200+ pharmaceutical and biotech companies, as well as regulatory agencies, Certara’s Drug Interaction Database (DIDB®) provides unparalleled access to qualitative and quantitative human in vitro and clinical data. By incorporating information on extrinsic and intrinsic factors such as co-medications, excipients, food products, natural products, organ impairment, and genetics, DIDB® enables informed decision-making and supports the development of safer, more effective therapies.

• Retrieve information using 70+ pre-formulated queries
• Optimize and validate PBPK models and static predictions
• Support drug labeling recommendations
• Calculate clinical DDI risk using static prediction models and generate submission-ready reports
• Quickly identify relevant concomitant medications
• Gain insights beyond DDIs

Our cross-funtional approach emphasizes operational efficiency with a dedicated program lead to reduce complexity for biotech and pharma copmanies while ensuring continous, scalable coverage.

• Target product profile (TPP) and development strategy – develop a product strategy by assessing competition, viability, pricing, market access and regulations.
• IND-enabling/FIH planning, design and regulatory strategy – develop functional plans, drug development strategies and study designs to ensure TPP alignment.
• IND/FIH-enabling execution and reporting – oversee drug development, non-clinical studies, vendor management, DMPK analyses and translational modeling
• IND authoring and submission – prepare and submit regulatory documents, including FIH protocol, Investigator Brochure and IND/CTA filings.
• FIH execution/reporting – guide CRO selection, manage study execution, analyze data, and prepare for the next development phase.

The Simcyp PBPK Simulator is the industry leader and most widely adopted platform for PBPK modeling in drug development. Developed through the expertise of a 25 year-long consortium involving 37 leading global pharmaceutical companies, the Simcyp PBPK Simulator is recognized and licensed by 11 regulatory agencies worldwide.

• Drug Interaction Database (DIDB)
• Fact Sheet: Strategic Early Development Solutions
• Brochure: Simcyp™ PBPK Simulator
• Center of Excellence in Drug Interaction Science
• Blog: What are the most common in vitro drug-drug interaction study gaps?
• On-demand webinar: The Future of DIDB
• On-demand webinar: Optimizing DDI Knowledge throughout Drug Development
• White paper: Assessing Transporter-Mediated DDIs
• Blog: Why cancer drug programs need human mass balance studies
• Publication: Dose Optimization Informed by PBPK Modeling: State-of-the-Art and Future