In 2022, Simcyp continued its leadership in advancing the use of physiologically based pharmacokinetics (PBPK) and quantitative systems pharmacology (QSP) for innovative drug development and regulatory science. We share some highlights here:
New Drug Approvals
The industry-leading Simcyp whole body PBPK Simulator platform is used for virtual decision-making in drug development, from early development through clinical, regulatory approval and post-marketing phases. The Simcyp Simulator predicts how the drug will move through the body and how a drug is affected by other medications, ethnicity, age, genetics and disease-state.
Simcyp is a proven approach for reducing, informing and/or eliminating clinical trials. The Simcyp Simulator has been used to predict drug performance on untested patient populations, advise on dosing decisions, and inform drug labels for >100 novel drugs. This translates into hundreds of label claims approved by global regulators using Simcyp in lieu of costly clinical studies.
Driving Advances in Technology
We are experiencing a rapid expansion in drug development, fueled by our increased understanding of systems biology and underlying pathology; the proliferation of reliable data sources, such as genomics, proteomics and high throughput screening; and an explosion in computing capabilities. Simcyp harnesses these technology advances and combines them with regulatory guidance to innovate our PBPK, QSP and QSTS software platforms and apply new learnings via tech-enabled consulting. This year, new product launches include:
Winner of 2022 Edison Award for
COVID-19 Vaccine Model
Certara’s COVID-19 Vaccine Model uses QSP to facilitate global vaccine decision-making, helping to answer questions such as what are the optimal dose and timing, are there differences in immune response with age and ethnicity, and what is the expected duration of antibody response.
Second Year in a Row for Simcyp:
R&D 100 Award
Secondary Intelligence software has won an R&D 100 Award, which recognizes the top 100 “R&D pioneers and their revolutionary ideas in science and technology” each year. Secondary Intelligence software is the first and only application that quantitatively predicts the risk of adverse effects and safety issues derived from secondary pharmacology that may impede the clinical development of a drug.
Since its inception in 2000, the Simcyp team has committed itself to teaching and education to advance our field. 2022 was another prolific year for the team, with workshops, on-line training, podium speeches, poster presentations, peer reviewed publications, and webinars.
Further, during the past 2 years, Simcyp was invited to speak by global regulators (FDA, EMA, PMDA) at more than 10 workshops/events focused on advances in PBPK and QSP.